Dallas Fort Worth Injury Lawyer Blog

A Children’s Motrin product liability lawsuit has been allowed to move forward. The plaintiffs allege that Johnson & Johnson failed to warn about the risk of serious and potentially deadly skin problems from Motrin.

U.S. Magistrate Judge Maria Valdez rejected a motion to dismiss by McNeil Consumer Healthcare, a subsidiary of Johnson & Johnson.

The complaint alleges that McNeil failed to properly warn consumers that side effects Motrin may included a risk of Stevens-Johnson Syndrome (SJS) and toxic epidermal necrolysis (TEN) reactions.

The lawsuit was brought on behalf of two minor children and their parents. The children were diagnosed with SJS and TEN in 2009 after taking Children’s Motrin to treat fevers.

According to McNeil, SJS and TEN side effects were so rare that it did not need to warn consumers about them. Valdez rejected that argument, saying it was not a defense against a failure to warn.

SJS and TEN often result in the need for treatment in a hospital Intensive Care Unit (ICU) or Burn Unit, and the conditions can be fatal in many cases. The condition can cause organ damage, disfigurement through skin loss, and blindness.

The Motrin skin problems are listed as a potential side effect on prescription-strength ibuprofen, but the lower-dose over-the-counter versions marketed as Motrin and Children’s Motrin do not warn that the drug could cause Stevens-Johnson Syndrome or Toxic Epidermal Necrolysis.

In addition, over-the-counter Motrin labels in some other countries do carry such warnings.

Last year, the drug maker was crushed by a Los Angeles jury that awarded more than $48 million to a man diagnosed with SJS after taking Motrin as a teen.

In May, a Philadelphia jury awarded $10 million in a Children’s Motrin lawsuit brought by the family of Brianna Maya, a 12-year-old girl who has been left blinded in one eye and suffered burns over 84% of her body after taking the drug in 2000.

In that case, the jury also ruled that Johnson & Johnson was negligent in failing to provide proper warnings about the risk of SJS and TEN from Children’s Motrin on the medication’s label.

Read more here and visit my website for further information.

This is an interesting issue of conflict of interest, impartiality and doing the right thing, as reported by the Wall Street Journal.

Talk about the fox guarding the chicken house! In December, an advisory panel for the U.S. Food & Drug Administration (FDA) voted to recommend by 15-11 margin that the benefits of Yaz, Yasmin and similar pills made with the synthetic progestin, drospirenone, outweighed their risk of dangerous blood clots.

Now it has come to light that three of the FDA advisors who voted with the majority had ties to Bayer AG, the maker of the drugs, that were not disclosed by the agency.

According to a report from The Wall Street Journal, (WSJ) those advisors were:

• The panel's chair, obstetrics professor Julia V. Johnson of the University of Massachusetts Medical School, told the WSJ in an email that she has been an "investigator in four research studies from Bayer or Berlex [a Bayer unit]," including one that involved the use of a drospirenone product in post-menopausal women. In her email, Dr. Johnson said she has "received no funding or grants" for her work.

• Paula Hillard, an obstetrics professor at Stanford University School of Medicine, who Bayer documents said ""enables us to now have another huge ... Yasmin advocate here in Nor Cal—she will be well utilized!" Another Bayer "tactical brief" from 2010 describes a video clip the company planned at the time with Dr. Hillard to deal with the blood clots and other safety issues. She told the WSJ she received $10,000 for her work.

• Anne E. Burke, professor of gynecology and obstetrics at Johns Hopkins Bayview in Baltimore, who declared in published articles that she received research funding from Bayer.

Their ties to Bayer were not revealed by the. According to the WSJ, the panelists' Bayer ties were first disclosed in a joint article by the British medical journal BMJ and Washington Monthly. Details of their work with Bayer also were revealed in documents in the ongoing Yaz and Yasmin litigation in federal court in Illinois.

The fact that the three were allowed to vote at all, however, does raise some ethical questions. Experts acknowledge that significant ties between committee members and drug makers could result in biased recommendations

As mentioned by an expert polled for his opinions on the matter by the WSJ, "Lack of disclosure undermines the credibility of the advisory committee process and undermines public trust in the fairness of the regulatory process."

Interestingly it should be noted that one panelist, Dr. Sidney Wolfe of the consumer group Public Citizen, was stripped of his voting rights by the FDA because he had publicly criticized the drugs' safety in newsletters published by the group.

Is it any wonder that the general public has lost faith in its government, particularly when it comes to the governmental watch dog, the FDA? The FDA instead of being the wonder dog, is essentially has become a toothless canine alongside all the other toothless and powerless federal agencies.

Look at the examples of Medtronic Infuse bone graft injuries, the defective DePuy ASR and Pinnacle metal on metal hips, defective Cardiac Pacemaker leads, Transvaginal mesh, the dangerous drugs including Accutane, Fosamax, Plavix, Tylenol, Actos, Nuvaring, SSRI left on the market with inadequate warnings.

Big Pharma putting profits before people.

Read more here and visit our website for more information.

Novartis is under the gun over the deadly side effects caused by Tekturna (Aliskiren), its blood pressure pill, the so called "wonder drug."

Recently Tekturna's clinical trials were canceled by Novartis due to a high number of strokes and kidney problems among diabetic test subjects. Tekturna HCT, Valturna, TekAmlo and Amturnide are all variations of Teckturna (Aliskiren).

ALTITUDE Study

During the ALTITUDE clinical trials, Novartis was testing Tekturna and hoping that a positive result could lead to an expansion of its use in the treatment of diabetic hypertension. The results were disastrous. Novartis discovered that Tekturna may actually increase the risk of non-fatal strokes, kidney problems and other health risks.

Health Canada Investigates

As a result of the Tekturna clinical trial findings, a safety review of the potential Tekturna problems was launched in Canada, by their federal regulators, Health Canada. The Novartis anti-hypertensive drug is sold under the brand name Resilez.

What did Novartis do Wrong?

According to experts, Novartis engaged in extraordinary reckless behavior. Novartis was allegedly instructing its sales representatives to engage in "off-label marketing" of Tekturna, TekturnaHCT, Valturna, TekAmlo and Amturnide for use in the diabetic patient population while claiming it had "protective effects" on these patients.

In fact, it was not specifically indicated for use in diabetic patients and actually caused serious adverse health effects.

Novartis' Aggressive Off Label Marketing

Novartis engaged in an aggressive off-label marketing campaign to promote Tekturna, TekturnaHCT, Valturna, TekAmlo and Amturnide specifically for use in the diabetic patient population, a use for which each of the drugs is not indicated and most importantly not FDA approved.

Novartis Sales Reps Under Fire

Because Tekturna is the only drug on the market that is a Direct Renin Inhibitor, this allowed for Novartis to heavily promote the drug (or one of its combinations) for use in the diabetic patient. Sales representatives voiced concerns about selling these drugs for uses for which they were not indicated. Company managers refused to budge.

In fact, sales representatives were trained to illegally used an unbranded sales aid (approved for a disease state, not a drug) that showed the effect of Renin in a rat kidney in order to sell Tekturna and Valturna to the diabetic patient population. This sales aid was used by Novartis to convince medical prescribers that these drugs had positive health effects for the diabetic patient population.

Novartis trained its sales representatives to make claims that Tekturna, TekturnaHCT, Valturna, TekAmlo and Amturnide would significantly lower blood pressure, protect the heart, protect the kidneys and protect end organs. Flash cards anyone?

Medical Claims Not Supported

Such claims were unsupported by medical science and in fact, contrary to medical data that suggests that the drugs Tekturna, TekturnaHCT, Valturna, TekAmlo and Amturnide cause an increase in cardiovascular risk, including stroke, renal complications, hyperkalemia and hypotension, especially in the diabetic patient population.

What Novartis Knew or Should Have Known?

During the time that Novartis was actively engaging its sales representatives to use such tactics, it is believed by some that Novartis possessed and still possesses information that Tekturna, TekturnaHCT, Valturna, TekAmlo and Amturnide causes serious health risks, some of which has been released via the ALTITUDE clinical trial.

According to some experts, Tekturna, TekturnaHCT, Valturna, TekAmlo and Amturnide have minimal blood pressure lowering effects and are of little benefit to patients. To the contrary, these drugs can cause more harm than good. Moreover, Tekturna, TekturnaHCT, Valturna, TekAmlo and Amturnide carry serious cardiovascular and renal side-effects when used in combination with an ACE or ARB, a use which is most common.

Novartis Paid Kickbacks?

On December 20, 2011, Novartis temporarily suspended the promotion of Tekturna, TekturnaHCT, Valturna, TekAmlo and Amturnide for use in combination with an ACE inhibitor or ARB.

But prior to its December 20th action, Novartis paid kickbacks in the form of speaker fees and "Lunch and Learns" in order to promote Tekturna, TekturnaHCT, Valturna, TekAmlo and Amturnide to the diabetic patient population.

More Information

For another great article on the topic, look at Attorney Larry Jones, of Jones Ward's blog.

For more information about Tekturna lawsuits, feel free to contact The Dr Shezad Malik Law Firm or dangerous drug attorney Dr Shezad Malik by clicking here: DrMalik@ShezadMalik.com.

The off label use of Medtronic Infuse(R) bone graft has been associated with severe side effects including in some cases, death.

Medtronic Infuse(R) Bone Graft What is It?

Medtronic, Inc. and Medtronic Sofamor Danek USA, Inc. designed and marketed the Infuse(R) Bone Graft device (“Infuse(R)”) for lumbar spine surgery. Infuse(R) is a bio-engineered bone filling material containing a bone morphogenetic protein (“BMP”), and is used as an alternative to grafting a patient’s own bone.

Infuse(R) is a genetically engineered protein -rhBMP to help fuse vertebrae in the lower (lumbar) spine in order to treat degenerative disc disease.

Side Effects including:

Excessive swelling of the neck

Difficulty swallowing, or speaking

Compression of the airway

Medtronic Infuse(R) Off Label Use

Infuse(R) Bone Graft, is only approved for a limited surgical procedure, but Medtronic allegedly illegally promoted it for a number of off-label procedures according to a pending lawsuit filed in the Superior Court of California. Case No.: BC465313

Medtronic Infuse(R) only cleared for Anterior Lumbar Surgeries

Infuse(R) was approved by the Food and Drug Administration (“FDA”) on July 2, 2002, for use only in the lower region of the spine (at levels L4 through S1) to treat degenerative disc disease, and was approved only for anterior surgeries at L4 through S1.

That meant that it was initially approved only to be used by surgeons, when the surgeons placed the cage within the vertebrae in the lumbar region of the back, and only by entrance through the abdomen.

Infuse(R) has never been approved by the FDA for use in other parts of the body or for use in any other type of procedure, and any such uses are “off-label” uses.

The Medtronic California Infuse(R) Lawsuit

The plaintiff alleges that while physicians may use FDA-approved medical devices in any way they see fit, companies are not permitted to promote off-label uses for their medical devices or to pay doctors inducements or kickbacks to promote the off-label uses or to perform procedures using the devices off-label.

FDA Adverse Event Reports

At least 280 reports of adverse events involving Infuse(R) have been made to the FDA. Approximately 75% of those reports involve off-label use.

On July 1, 2008, the FDA issued a Public Health Notification about complications from the off-label use of Infuse(R) in the neck, or cervical, area of the spine. The FDA reported that it had received 38 reports over a four year period through July 1, 2008, of complications from cervical uses of Infuse(R); and, that some reports were of life-threatening and fatal events. Some of the complications were associated with swelling of the neck and throat tissue, which resulted in compression of the airway and/or neurological structures in the neck, and patients reported difficulty swallowing, breathing and speaking.

Several patients required emergency treatment, including tracheotomies and the insertion of feeding tubes. FDA Public Health Notification: Life-threatening Complications Associated with Recombinant Human Bone Morphogenetic Protein in Cervical Spine Fusion, issued July 1, 2008.

Dr Shezad Malik recommends that folks who have been treated with Infuse Bone Graft and experienced side effects outlined above should fill out a MedWatch Form at www.fda.gov and explore their legal rights.

Read more here, visit my website for further information and review my blog.

According to company e-mails, Bayer AG, Germany’s largest drugmaker, may have tried to market the Yasmin family of birth- control pills for unapproved uses and misled women about the health risks of the drugs.

Bayer unit officials discussed promoting the contraceptive known as Yaz, a spinoff of Yasmin, for treatment of all types of premenstrual syndrome, according to Bloomberg news. The FDA approved Yaz only for the most severe form of Pre Menstrual Syndrome (PMS), known as Premenstrual Dysphoric Disorder (PMDD).

Bayer faces more than 10,000 lawsuits over injuries allegedly caused by the contraceptives. The FDA reports of at least 50 deaths tied to the pills from 2004 to 2008. Bayer’s contraceptives, which contain the hormone drospirenone, have been the focus of regulators who question their safety.

In October, the FDA warned that women taking the pills were 74 percent more likely to suffer blood clots than women on other low-estrogen contraceptives. According to the FDA report, the FDA examined data on 835,826 women who took pills containing the hormone, including Bayer’s Yasmin line of birth-control pills. The FDA has scheduled its December 8 hearing on drospirenone- containing contraceptives, because of “the conflicting nature of the findings from six published studies evaluating this risk."

Injured women suing Bayer allege that internal company files show Berlex and Schering officials withheld some information from patients, doctors and the FDA about the drug’s risk for blood-clots. The plaintiffs also allege that company officials wrongfully claimed Yasmin and Yaz to be just as safe as rival birth-control pills.

In January, Bayer is scheduled to face the first mini trials, known as bellwether trials, of lawsuits in which Yaz and Yasmin are alleged to have caused blood clots, which can lead to pulmonary embolism, deep vein thrombosis, heart attacks and strokes. The trials are to take place in Illinois and Pennsylvania.

The FDA said Bayer made misleading claims about Yaz in television advertising, the drugmaker was forced to spend $20 million on correcting the ads. U.S. regulators said in 2008 that Bayer touted the pill’s effectiveness and downplayed “serious risks associated” with it in two 60-second television ads.

Bayer agreed to run new ads stating Yaz hadn’t been approved as a treatment for all forms of PMS or acne as part of a settlement of a claims brought by 27 U.S. state attorneys general.

Bayer bought Schering, then a rival German drugmaker, and its New Jersey-based Berlex unit for $21.8 billion to acquire the Yasmin line of contraceptives.

About 10,400 suits have been filed over injuries allegedly caused by the contraceptives, according to Bayer officials in an October filing with the U.S. Securities and Exchange Commission.

The federal cases are consolidated for pretrial purposes In Re Yasmin and Yaz (Drospirenone) Marketing, Sales Practices and Product Liability Litigation, 09-md-02100, U.S. District Court for the Southern District of Illinois (East St. Louis).

As a Yaz, Yasmin and Ocella Pulmonary Embolism attorney and Texas Medical doctor, I am providing this blood clot side effect update.

Women taking pills containing the hormone drospirenone were 74 percent more likely to experience clots than those on low- estrogen pills, according to the latest Food and Drug Administration report.

There is an FDA conference in December that is going to examine and address the health risks associated with birth control pills Yaz and Yasmin. Thousands of patients have already filed a Yaz or Yasmin lawsuits against pharmaceutical manufacturer Bayer Corporation. The injured plaintiffs claim that the drugmaker aggressively highlighted the birth control pills benefits while minimizing the serious side effects such as Yaz deep vein thrombosis, pulmonary embolism, stroke and death.

FDA Investigates Yaz, Yasmin and Ocella Increased Blood Clots Side Effects
The FDA has been investigating the health risks associated with Yaz, Yasmin and Ocella. In 2011, the FDA has issue two warnings about the birth control pills, indicating that the national health agency “remains concerned” about the increased risk of blood clots and other potentially life-threatening side effects associated with the birth control pills.

Yaz and its predecessor, Yasmin and the generic version, Ocella, all contain a synthetic female sex hormone known as drospirenone. Medical studies show that all birth control pills have an increased risk of blood clots, but the risk is even greater with drospirenone-containing pills such as Yaz, Yasmin and Ocella.

The FDA is set to hold a meeting with the Reproductive Health Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee on December 8 to comb through the mass of “conflicting” data concerning Yasmin, Yaz and Ocella blood clots.

The recommendations of that FDA meeting could have profound implications and affect the outcome of the Yaz lawsuits. The FDA may revise the drug labels again (revised in 2010 and 2011), or issue stricter warnings regarding the birth control bills or may even ban the pills from the market altogether due to the dangers of Yaz blood clots. The last scenario is highly unlikely.

As a Transvaginal Mesh recall attorney and Texas medical doctor, our law firm is fielding many calls from concerned women regarding the complications they are suffering as a result of a defective mesh medical device that has been implanted.

watch the abc news video here

One of the most frustrating things our potential clients tells us is that they do not know what type of device has been implanted. To complicate matters even more, there are about 11 manufacturers of these Vaginal Mesh devices in the United States and also each company has several models and types of vaginal mesh product.

Invariably these women have had redo surgeries with more hardware implanted but they are still symptomatic and experiencing side effects. To make things easier for these potential Trans Vaginal Mesh victims, I have listed here a list of the 5 largest manufacturers and the commonly used mesh devices and the types of product that may have been implicated as being defective or those that have been recalled.

Hopefully this blog will provide a "one stop shop" that folks can review and refer to in their search for vital information and to see if they may have a claim.

In the United States, data from mesh manufacturers reveal that in 2010 approximately 300,000 women underwent surgical procedures to repair Pelvic Organ Prolapse, POP and approximately 260,000 underwent surgical procedures to repair Stress Urinary Incontinence, SUI.

According to mesh manufacturers, approximately one out of three POP surgeries used mesh and three out of four of the mesh POP procedures were done transvaginally. Over 80 percent were done transvaginally with mesh.

Transvaginal Mesh Brands – Johnson & Johnson Ethicon Women’s Health
Several hundred lawsuits are pending in New Jersey state court against Ethicon for injuries allegedly caused by several transvaginal mesh products. Lawsuits claim that Johnson & Johnson knew that Ethicon TVT products were unreasonably dangerous but continued to manufacture and sell them regardless.

Brand names of Johnson & Johnson/Ethicon’s transvaginal mesh patches include:

Ethicon TVT
Gynecare TVT Sling
Gynecare Gynemesh
Gynecare Prolift Mesh
Gynecare Prolene Mesh
Prolene Polypropylene Mesh Patch
Secur

TVT = tension-free vaginal tape

Transvaginal Mesh Brands – C.R. Bard
These cases are consolidated as part of the federal Bard Avaulta litigation, which was centralized last year in West Virginia for coordinated pretrial proceedings.

In October 2010, the U.S. Judicial Panel on Multidistrict litigation ordered that all federal Bard Avaulta pelvic mesh lawsuits be consolidated before U.S. District Judge Joseph R. Goodwin in the Southern District of West Virginia as part of an MDL, or multidistrict litigation.

Brand names of Bard’s transvaginal mesh patches:

Avaulta Plus™
BioSynthetic Support System
Avaulta Solo™
Synthetic Support System,
Faslata® Allograft
Align
Pelvicol ® Tissue
PelviSoft® Biomesh
Pelvitex™ Polypropylene Mesh
Pelvilace
Uretex
Ugytex

Transvaginal Mesh Brands – American Medical Systems, Boston Scientific
SPARC® is a type of transvaginal mesh patch produced by American Medical Systems (AMS) designed to treat stress incontinence.

In recent months, a growing number women throughout the United States have filed a transvaginal pelvic mesh lawsuit against Boston Scientific and other manufacturers raising similar allegations. The products, which are commonly used for repair of pelvic organ prolapse (POP) and female stress urinary incontinence (SUI) have been found to erode through the vagina, shrink, cause infection, pain and other complications.

Boston Scientific transvaginal mesh patch brands include:

Advantage™ Sling System
Lynx™ Suprapubic Mid-Urethral Sling System
Obtryx® Curved Single
Obtryx® Mesh Sling
Prefyx Mid U™ Mesh Sling System
Prefyx PPS™ System

All these systems use Advantage® Mesh - The Advantage Mesh is designed to reduce the risks of mesh deformation during tensioning and irritation to the anterior vaginal wall.

American Medical Systems SPARC Transvaginal Mesh Implants
Several different companies, including Minnesota based American Medical Systems, manufacture transvaginal mesh product to treat urinary incontinence and other conditions such as pelvic organ prolapse.

The American Medical Systems SPARC Transvaginal Mesh Approach

The SPARC system is a mesh sling that is put under the urethra to support it during normal daily activities. According to American Medical Systems, most patients regain continence almost immediately after surgery. It is marketed as an outpatient, minimally invasive treatment that can have significant and long term benefits for the patient.

American Medical Systems manufactures numerous products, known as pelvic mesh, vaginal mesh, and bladder slings, designed to treat pelvic organ prolapse and/or stress urinary incontinence. These products include: Apogee, Perigee, Elevate, SPARC, MiniArc, MinArc Precise and Monarc.

Please search this blog for other Vaginal Mesh articles, frequent updates and important information.

As a Yaz, Yasmin and Ocella Deep Vein Thrombosis, Pulmonary Embolism and Stroke Attorney, we are providing this timely update. Watch the old Yasmin advertisement here.

According to a recent population-based study, newer forms of progesterone in contraceptives result in higher venous thromboembolic (VTE) risk than older drugs.

According to Ojvind Lidegaard, MD, of Rigshospitalet at the University of Copenhagen, Denmark, an international expert, women on the pill with the older, levonorgestrel version were at three times the risk of VTE as those not on any hormonal contraception.

But oral contraceptives containing desogestrel, gestodene, drospirenone, or cyproterone boosted the risk six to seven times over that of non-users, the group reported in BMJ.
The researchers explain that newer forms of progesterone in combination hormonal contraceptives carry higher venous thromboembolic (VTE) risk than older forms.

Furthermore, they point out that this study found that women on the pill with the older, levonorgestrel version were still at threefold elevated risk of VTE compared with those not on any hormonal contraception, whereas those on the newer versions were at six and sevenfold risk.

The Food and Drug Administration is already studying the possible increased risk of blood clots with pills containing the drospirenone. The F.D.A. says its preliminary results suggest a 1.5-fold increased risk compared with other hormonal contraceptives, to about 10 women in 10,000 from 6 women in 10,000.

These findings were based on the national registry data in Denmark from 2001 through 2009, after the launch of the newest synthetic progesterone, drospirenone.

Other studies over the decades also have found almost universally elevated VTE risk with hormonal contraception, with the estrogen and progestogen (synthetic progesterone) components both appearing to play a role.

The risks appear real and may lead many clinicians to prescribe a combined oral contraceptive with levonorgestrel whenever possible.

The updated analysis included more than 1.2 million non-pregnant 15- to 49-year-old women in Denmark without a history of thrombotic disease. Data came from national vital status, inpatient, cause of death, and pharmacy registries.

From 2001 to 2009, 4,307 first-ever VTEs occurred in this cohort. Most were deep vein thrombosis only (63.6%) or pulmonary embolism with or without deep vein thrombosis (26.2%).

Compared with women not taking hormonal contraception, confirmed venous thromboembolism was elevated for users of oral contraceptives containing 30 to 40 μg ethinylestradiol plus the following:

Levonorgestrel, with a relative risk of 2.9
Desogestrel, with a relative risk of 6.6
Gestodene, with a relative risk of 6.2
Drospirenone, with a relative risk of 6.4

With levonorgestrel-containing pills as the comparator, rate ratios of confirmed venous thromboembolism adjusted for length of use were:

2.2 with desogestrel
2.1 with gestodene
2.1 with drospirenone

Lower estrogen doses were associated with modestly lower VTE risk for oral contraceptives with norethisterone, levonorgestrel, desogestrel, or gestodene but not with drospirenone, the investigators reported.

More information
The American College of Obstetricians and Gynecologists has more about birth control pills.

Primary source: BMJ
Source reference:
Lidegaard Ø, et al "Risk of venous thromboembolism from use of oral contraceptives containing different progestogens and oestrogen doses: Danish cohort study, 2001-9" BMJ 2011; 343: d6423.

Additional source: BMJ
Source reference:
Hannaford PC "The progestogen content of combined oral contraceptives and venous thromboembolic risk" BMJ 2011; 343: d6423.

Jick S, Hernandez R "Risk of non-fatal venous thromboembolism in women using oral contraceptives containing drospirenone compared with women using oral contraceptives containing levonorgestrel: case-control study using United States claims data" BMJ 2011; DOI: 10.1136/bmj.d2151.
[Get full-text PDF from Pubget]

Vaginal Mesh / Bladder Sling attorneys are currently evaluating and investigating the latest medical device tragedy to be afflicting women of a certain age.

Countless women who had a vaginal mesh or bladder sling medical device implanted to treat pelvic organ prolapse have experienced life altering internal injuries, urinary problems and other significant medical complications as a result of problems with the mesh, which may actually provide no real benefit over other surgical methods of treating pelvic organ prolapse.

Vaginal Mesh Lawsuit Update
Many personal injury cases have been filed throughout the United States by women who experienced complications as a result of the defective and negligent design of a vaginal mesh pelvic support system.

Vaginal mesh, which is also referred to as a pelvic mesh, is a surgical product that is implanted into the vaginal area to prevent pelvic organ prolapse (POP), which can occur in women after childbirth or surgery. Pelvic organ prolapse causes the uterus or womb to fall into the vaginal area, which can also lead to the bladder and bowels slipping out of place and putting pressure on the vagina, causing considerable pain and discomfort, as well as urinary incontinence.

Complaints over vaginal mesh implants claim that negligent designs increase the risk that women may suffer severe complications, physical pain and suffering, deformity and the need for additional corrective surgery. Furthermore, the FDA acknowledged in July 2011 that there is no evidence that vaginal mesh bladder sling surgery provides any greater clinical benefit than non-mesh surgeries.

Vaginal Mesh Injuries
The FDA issued a statement about all vaginal mesh implants in July 2011, indicating that the agency has received thousands of reports of complications after the bladder sling mesh has been implanted, and also warn of an increased risk of organs being punctured during the surgery to implant the devices.

Complications with vaginal sling implants reported by women include:

Infection
Erosion of the mesh into the vagina
Recurrences of prolapse
Urinary problems
Bowel, bladder and blood-vessel perforations
Injury to nearby organs
Pain during sexual intercourse

In many cases, transvaginal sling problems have required multiple surgeries to remove the mesh. Even after surgery, women may be left with permanent and disfiguring injuries.

As an Actos Blader Cancer attorney and Texas medical doctor, I am providing this latest update regarding the diabetic drug, Actos.

The European Medicines Agency (EMA) issued an update on the safety concerns for Actos on October 21, indicating that the drug is still a valid diabetes treatment. But, due to the Actos bladder cancer risk, it should only be used when other treatments have failed. This update is similar to the latest one issued by United States regulators.

Watch the ABC News report here.

European drug regulators indicate that they are not recommending an Actos recall, even though the diabetes drug has been linked to an increased risk of bladder cancer. Instead, doctors have been recommended to only use Actos as a second or third line treatment options for diabetics.

The statement is meant to add information to the July opinion by the EMA’s Committee for Medicinal Products for Human Use (CHMP), which confirmed that the side effects of Actos include a risk of bladder cancer.

CHMP determined that while there was a risk of bladder cancer, there are still some diabetes patients for whom the risk was manageable because other drugs fail to bring their diabetes under control. The committee recommended careful screening of patients being prescribed the drug and close monitoring while they are on Actos to watch for signs of bladder cancer. The European Commission still has to agree to adopt the opinion as a decision.

Actos (pioglitazone) was introduced as a treatment option for type 2 diabetes in July, 1999. Until recently, it was Takeda Pharmaceuticals’ best-selling drug, with sales of $3.4 billion last year.

In June, France required a recall of Actos after a review of public insurance data identified an increased incidence of bladder cancer with Actos use.

FDA officials began reviewing the potential risk of Actos bladder cancer problems in September 2010, after interim data from an on-going 10 year study found that users may face an increased risk the longer they take the drug.

In the United States, new Actos cancer warnings were approved by the FDA in August 2011, indicating that patients who use the drug for more than a year may face an increased risk of bladder cancer.

A growing number of individuals throughout the U.S. are filing an Actos bladder cancer lawsuit against Takeda, alleging that the drug maker failed to provide adequate warnings for consumers or the medical community. Many of the complaints indicate that Takeda should have removed Actos from the market, arguing that the risk of bladder cancer outweighs the minimal benefits.

Some expert estimates suggest that more than 1,000 cases may ultimately be included as part of the Actos litigation. A panel of judges is scheduled to meet on December 1 to decide whether all federal Actos lawsuits should be consolidated as part of an MDL, or multidistrict litigation.

As a Johnson & Johnson Gynecare TVT Trans Vaginal Mesh injury attorney and Texas medical doctor, I am providing this timely update.

Johnson & Johnson (JNJ), the world’s second-biggest health-care products maker, is facing many lawsuits over its Gynecare TVT vaginal implant. The Gynecare TVT implant is based on a similar device pulled from the medical device market more than a decade ago for safety reasons.

The lawsuits are the latest to implicate the shoddy and perfunctory approval process for medical devices at the U.S. Food and Drug Administration, which has cleared faulty hip implants and malfunctioning defibrillators.

In the case of vaginal mesh implants, the FDA continued approving the mesh devices made by J&J and other companies based on their similarity to Boston Scientific Corp’s ProteGen even after it was pulled amid safety complaints. Today, the makers of the entire category of implants face more than 600 lawsuits from women who claim the devices caused serious injury.

The devices treat urinary incontinence and pelvic organ prolapse, in which internal organs slump into the vagina. They were allowed on the market as result of the agency’s approval process, known as 510(k), which relies on the premise that if one device has been cleared by the FDA then similar devices need little if any testing in patients.

In July, the FDA issued a statement saying it is unclear whether prolapse implants provide any benefit over traditional surgery. The statement came three years after the agency first acknowledged a problem in a 2008 report that said mesh complications were serious. An advisory panel of physicians said last month that the FDA should demand more clinical testing of the devices.

According to J&J, its vaginal mesh products are safe and the J&J's Gynecare TVT was based on the Boston Scientific product.

But according to 510(k) critics, the chain of approvals that began with Boston Scientific’s device highlight a major flaw in the 510(k) process. The system lets manufacturers get clearance for a product by citing its similarity to an already approved device, known as a “predicate.” That second device can be cited as the basis for a third, the third to clear a fourth and so on. And if a first device is recalled, they don’t necessarily look at the second, third or fourth device that are based on that.

The unfortunate Vaginal Mesh story began in 1996, when Boston Scientific gained clearance for ProteGen, the first vaginally implanted mesh designed specifically to treat incontinence. Two years later, J&J won approval for a similar device, called Gynecare TVT. Under the 510(k) system, J&J was not required to conduct human testing because the company claimed its device was “substantially equivalent” to the Boston Scientific device.

A year later, Boston Scientific voluntarily pulled about 20,000 ProteGen meshes, saying it had received 123 reports of problems, including discomfort, pain during sex, and erosion of vaginal tissue. But J&J and at least two other manufacturers, American Medical Systems and Covidien Plc (COV), soon came out with products that traced their design back to ProteGen.

The FDA has said it does not know the number of women who have received the implants since 1998, though it estimates almost 300,000 were used in 2010. All of the devices were approved through the 35-year-old 510(k) system, used by the FDA to review some 90 percent of device applications each year. The same process was used to clear the 93,000 artificial hips pulled by J&J last year due to high failure rates, as well as hundreds of external heart defibrillators recalled since 2005 by Minneapolis-based Medtronic Inc. (MDT)

J&J named ProteGen as a basis for the Gynecare TVT, noting in its application that “technologically, both the new device and predicate device are the same.” By that time, complaints about Boston Scientific’s device were already reaching the FDA. A year after J&J’s TVT won clearance, Boston Scientific voluntarily recalled about 20,000 of its meshes.

J&J’s Gynecare TVT later became a predicate for the IVS Tunneller I, made by Dublin-based Covidien, and the Sparc Sling, made by the American Medical Systems unit of Endo Pharmaceuticals Holdings Inc. (ENDP), based in Chadds Ford, Pennsylvania. Those, in turn, were cited to clear future versions, each said to be “substantially equivalent” to its predecessors, according to FDA records. In 2003, Boston Scientific settled 738 suits over its mesh for an undisclosed sum.

The safety debate has presented a dilemma for manufacturers, who have avoided clinical tests for the devices by calling them similar to one another and now say the products have advanced far beyond the earlier versions.

The FDA advisory panel disagreed. The 17-member group, comprised mostly of pelvic surgeons, recommended at last month’s hearing that some vaginal meshes be reclassified as high-risk devices requiring new studies to stay on the market.

The FDA appears to be inching toward a decision. At the September hearing, Colin Pollard, director of the FDA’s obstetrics and gynecology devices branch, said it may take as long as three years to issue new rules. Until then, current models can stay on the market, he said.

As a Plavix Dangerous Drug attorney and Texas medical doctor, I am providing this Plavix litigation update.

Plavix manufacturers Bristol-Myers Squibb and Sanofi-Aventis are calling for the centralization and consolidation of all Plavix lawsuits filed in federal courts throughout the United States on behalf of users of their blockbuster blood thinner who allege that side effects of Plavix resulted in serious personal injuries and even death.

The U.S. Judicial Panel on Multidistrict Litigation will hold a hearing On December 1, to determine whether at least 13 lawsuits over Plavix filed in New Jersey, New York and Arizona should be centralized before one judge for coordinated handling during pretrial proceedings.

Bristol-Myers Squibb and Sanofi-Aventis are arguing that centralizing the cases before Judge Freda Wolfson in the U.S. District Court for the District of New Jersey would serve the convenience of the parties, prevent duplicative discovery and conflicting pretrial rulings from different judges.

The Plavix suits allege that the drug makers failed to adequately research their medication or warn about the risk of Plavix side effects, which could increase the risk of serious and potentially life-threatening bleeding, as well as a rare blood disorder known as thrombotic thrombocytopenic purpura (TTP).

In filed opposition statements, plaintiffs gave a number of reasons they feel consolidation would further slow their cases. The plaintiffs argue that the New Jersey cases are advanced in their depositions, and combining them with the cases from New York and Arizona would slow things down considerably. They also claim that the non-New Jersey cases are much newer and will involve recent events, like the FDA’s 2010 black box warning that some genetic traits prevent Plavix from being effective, that are irrelevant to the New Jersey cases.

The U.S. Food and Drug Administration on March 2010, added a boxed warning to the anti-blood clotting drug Plavix (clopidogrel), alerting patients and health care professionals that the drug can be less effective in people who cannot metabolize the drug to convert it to its active form.

Plavix reduces the risk of heart attack, unstable angina, stroke, and cardiovascular death in patients with cardiovascular disease by making platelets less likely to form blood clots. Plavix does not have its anti-platelet effects until it is metabolized into its active form by the liver enzyme, CYP2C19.

People who have reduced functioning of their CYP2C19 liver enzyme cannot effectively convert Plavix to its active form. As a result, Plavix may be less effective in altering platelet activity in those people. These “poor metabolizers” may not receive the full benefit of Plavix treatment and may remain at risk for heart attack, stroke, and cardiovascular death.

Defendants argue that the cases all involve common fact issues surrounding the drug makers’ research and development of Plavix. They also argue that the timing for consolidation is appropriate, as no single case has reached the phase of depositions of “common” fact and expert witnesses who may have knowledge relevant to all Plavix suits.

Plavix (clopidogrel) is prescribed to prevent blood platelets from sticking together to form clots. It is often prescribed to reduce the risk of heart attacks, strokes and blood clotting when drug coated stents are used in patients with arteriosclerosis and in other at-risk patients.

Plaintiffs allege that they suffered injuries as a result of their unnecessary use of Plavix, such as gastrointestinal bleeding, severe ulcers and a rare blood disorder known as TTP. Some complaints also allege that Plavix did not provide the promoted benefit of reducing the risk of a heart attack or stroke, raising questions about the effectiveness of Plavix among some users.

In November 2009, the FDA issued a public health advisory warning that side effects of Prilosec may interfere with Plavix effectiveness, increasing the risk of heart attack, death or other injuries for patients.

In March 2010, a Plavix “black box” warning was added to alert patients and healthcare professionals that the anti-clotting drug may not work in some patients due to genetics. The FDA indicated that a genetic test is available to determine whether patients are able to metabolize Plavix efficiently and suggested that doctors should consider another medication for at-risk patients who are confirmed to have the gene variant.

As a Medical Device Product Liability attorney and board certified medical doctor, I am providing this important update regarding Cochlear Implants. Cochlear Ltd., the world's biggest maker of hearing implants, an Australian company, recalled its latest range of devices after a recent, unexplained increase in failures.

The voluntary recall of the Nucleus CI500 implants, which Cochlear says are the slimmest titanium hearing implants available, will affect many patients.

The company said it identified an increase in the number of Nucleus CI512 implants failing in recent weeks. Chief Executive Chris Roberts said the company has stopped manufacturing the Nucleus CI500 line, which made up 70% of the company's sales of implant units for fiscal 2011. Cochlear has about 65% of the global hearing-implant market.

People fitted with CI500 units but who have not experienced any problems are being advised to continue using the devices. The voluntary recall of the Nucleus CI500 range includes the CI512 model as well as the CI513, CI551 double array implant and ABI 541 auditory brainstem implant.

It does not affect its earlier Nucleus Freedom range or its Nucleus 5 external hearing devices. Production of the CI500 devices has stopped and patients needing bionic ear implants are being offered the Nucleus Freedom model, which has been on the market for seven years.

Roberts said Cochlear was halting manufacture until the cause of the faults was uncovered. According to Roberts, he was unable to say how long it would take before the devices were back on sale but said if any changes had to be made, the company would need to get regulatory approval from the countries where the units are sold.

Cochlear sold more than 17,000 of its Nucleus 5 range of devices in the 2010/11 financial year, representing 70 percent of its total bionic ear sales in 100 different countries. The Nucleus 5 range includes the thinnest hearing implants on the market at just 3.9 millimeters (0.15 of an inch) thick. Cochlear had promoted them as "a new design that is built to last a lifetime."

The National Institutes of Health in the U.S. puts the total cost including device, surgery and follow-up care of an implant at US$60,000. Mr. Roberts said there are about 25,000 registered users of the CI500 range and the company isn't recalling those products that have already been implanted. Cochlear said less than 1% of CI512 implants have failed since they were launched in 2009.

If failure occurs, the implant safely shuts down without injuring the recipient, the company said in a statement, adding that if the device does fail, the patient could be re-implanted with an earlier model from Cochlear's Nucleus Freedom implant range.

Cochlear's Nucleus CI500 is designed to correct hearing loss resulting from damage to the cochlea, a pea-sized structure deep within the ear with hair cells that communicate sound signals to the brain. The implanted device coverts sounds to electrical energy, which it transmits directly to hearing nerves.

Cochlear implants don't restore normal hearing but can give people who are deaf or severely hard of hearing a representation of sounds and help them understand speech, according to the National Institute on Deafness and other Communicative Disorders' website. About 219,000 children and adults world-wide had received such implants as of December, according to the institute.

Industry Problems with Cochlear Implants
Cochlear Americas, a Colorado-based cochlear implant manufacturer, agreed to pay $880,000 to resolve allegations that it paid illegal remuneration to health care providers to induce purchases of cochlear implant systems, according to the Justice Department. Cochlear Americas is a subsidiary of an Australian company, Cochlear Limited.

The settlement resolved a lawsuit brought by a whistleblower, Brenda March, in 2004. The lawsuit, filed in the District of Colorado, alleged that Cochlear Americas violated the Anti-kickback Act and the False Claims Act by paying various forms of illegal remuneration to physicians who prescribed the use of the Cochlear-manufactured devices for Medicare and Medicaid patients.

Advanced Bionics (California) has had several recalls and is awaiting approval from the Food and Drug Administration to resume sales in the U.S. after its latest recall due to a leakage that could lead to neural tissue damage. Advanced Bionics was fined the maximum fee of $1.1 million by the Food and Drug Administration for switching their supplier without notifying the FDA nor having the FDA approval. The cochlear implant was recalled “because of excessive moisture that could leak into the devices and cause device failure and possible surgery.” The CEO, Jeffery Greiner, was also fined $75,000.

Advanced Bionics also produced a cochlear implant with a positioner that had an increased number of people coming down with meningitis post surgery of which some people died from. Other Cochlear Implant manufacturers also have cases of meningitis post surgery.

According to the FDA, silicone oil is the cause of problems with Aviara contact lenses sold by CooperVision, which were removed from the market in August after a number of consumers suffered torn corneas, hazy vision and other potentially serious complications. Nearly two months after problems were first announced, contact lens giant CooperVision Inc. and federal health regulators have amped up public warnings about nearly 780,000 recalled contact lenses, urging users to return the potentially defective products and to seek medical care if they show symptoms of harm.

The FDA announced on Friday that it was classifying the CooperVision Aviara contact lens recall as a Class 1 medical device recall, which is the most serious category the agency can use to label a recall. The class 1 designation means that the FDA believes that use of a device carries a reasonable probability of serious adverse health consequences or death.

More than 778,000 CooperVision Aviara contact lenses were impacted by the recall, which was not widely publicized until the FDA criticized the company last week for failing to take sufficient steps to make sure consumers were aware of the contact lens problems.

The FDA also complained that CooperVision only reported that some users had experienced hazy vision and did not identify the cause of the problems, which involved silicone oil on the lenses. The recalled Aviara contact lenses were were manufactured between November 1, 2010 and August 3, 2011, and were sold at Costco, LensCrafters and Wal-Mart, among other retailers.

The FDA recommends that any consumers who have the lenses return them and contact their eye care specialist immediately if they experience any problems after wearing the recalled lenses.

Production of the CooperVision contact lenses has been stopped so that the company can fix the problem. The manufacturer estimates that Avaira Toric contact lenses will be shipping in normal amounts again by December.

CooperVision has not released a complete list of lot numbers affected by the recall. Consumers who suspect they have lenses affected by the recall can visit the CooperVision web page at www.coopervision.com/recall and enter the package lot number to see if their lenses are included.

As a Yaz Birth Control Coma and Blindness Injury attorney and Texas medical doctor I am providing this YAZ, Yasmin and Ocella update.

ABC’s chief law and justice correspondent, Chris Cuomo, interviews Carissa Ubersox, a former pediatric nurse who started taking Bayer’s Yaz birth control pills when she wanted to look her best for her wedding and “saw commercials suggesting help with bloating and acne.” Two months after Ubersox started to take Yaz birth control pills, she developed massive blood clots in both lungs and fell into a coma that lasted for two weeks. When she woke up, she was blind.

All birth control pills come with some risk of developing blood clots, and Bayer “cites its own studies as proof that Yaz is just as safe as other birth control pills.” However, Dr. Susan Jick of the Boston University School of Medicine has authored an independent study involving a million women that finds Yaz’s risk to be two to three times higher than other birth control pills. ABC reports that two Bayer-sponsored studies find no difference in risk, while four independent studies all find increased risk.

Ubersox believes that Yaz birth control pills, which once seemed like a “miracle drug,” are the reason that she developed blood clots in both her lungs and is now blind. She and thousands of other women are now suing Bayer for Yaz’s negative side effects. Bayer denies any wrongdoing and would not answer ABC’s questions about Yaz birth control pills.

We having been blogging and providing much needed information on the side effects of YAZ, Yasmin and Ocella for the past 2 years and have filed many lawsuits in the Southern District of Illinois federal court. This is where the Bayer oral contraceptive lawsuits have been federally consolidated. Click here to read our 113 articles on YAZ, Yasmin and Ocella.

The first case we filed in this Bayer oral contraceptive litigation had similar fact pattern as the above ABC video. In our lawsuit, our client was a woman in her mid forties who was on Yaz for a short time period. She, one night, was noted to be making gurgling sounds while she was asleep. This was noticed by her husband who immediately recognized that something was not quite right. He immediately called 911 and started CPR.

She was taken emergently to the local ER, she was shocked multiple times on route to the ER, by the paramedics and again in the ER had to be resuscitated for several hours. She practically died several times that night, but she had an immense will to live and survived the tragic ordeal. Like the victim in the video, she also suffered from a massive pulmonary embolism. She was also placed in a medically induced coma and when she recovered she noticed she had developed cortical blindness and severe neuro-muscular weakness.

Currently she is being looked after at home by her husband and family. Bayer has refused to accept any liability in these lawsuits to date.

As a Dallas Medtronic Infuse Lawsuit and side effect attorney and medical doctor I am providing this update regarding the problems associated withe Medtronic Infuse medical product.

Medtronic, a medical device company is in the news regarding reports about its synthetic bone growth product Infuse. In 2008, the U.S. Department of Justice began investigating whether Medtronic had been illegally promoting "off-label" use of Infuse.

The Spine Journal reported in its June 2011 edition concerns about Infuse and Medtronic's research. In 2004, a small group of doctors wrote some research papers stating that Infuse did not cause any harm to patients. The doctors who wrote the article would eventually receive millions of dollars from Medtronic.

According to researchers, in contrast to published reports from manufacturer-sponsored studies of the Infuse spinal fusion device that incorporates a biologic bone-building drug, a new analysis of FDA documents and other data sources suggests that up to half of patients receiving the device may experience adverse events related to the drug.

The Infuse device, which delivers recombinant human bone morphogenetic protein-2 (rhBMP-2) to speed vertebral fusion in patients with chronic back pain, has adverse event rates of 10% to 50% depending on the approach, according to Eugene Carragee, MD, of Stanford University's outpatient clinic in Redwood City, Calif., and colleagues.

"This risk of adverse events associated with rhBMP-2 is 10 to 50 times the original estimates reported in the industry-sponsored peer-reviewed publications," Carragee and colleagues wrote online in The Spine Journal, which Carragee serves as editor-in-chief.

The investigators in each of 13 reports of studies funded by product manufacturer Medtronic and published from 2000 to 2009 claimed to find no adverse events attributable to rhBMP-2.

The Spine Journal reports that those doctors did not disclose their financial ties to Medtronic and that the papers repeatedly failed to report complications with Infuse. Infuse may cause unwanted, and sometimes out-of-control, bone growth. The Spine Journal found that the complication rate for Infuse was anywhere from 10 to 50 times higher than reported in the Medtronic studies.

The United States Food & Drug Administration only approved Infuse for fusions in the lower back. But, doctors have been using it "off-label" for cervical (neck) spinal fusions, too often with poor results.

Unwanted bone growth in the neck can result in:

difficulty with breathing and swallowing
tracheotomies
emergency surgery
the placement of feeding tubes
revision surgery (additional surgery needed too fix the problem)

Other reported problems with Infuse include:

male sterility
infection
cancer
bone loss
unwanted bone growth
nerve damage
incontinence

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As a DePuy ASR and DePuy Pinnacle litigation attorney, I am providing this timely update.

More than 500 lawsuits have been filed in Northern District of Texas federal court over DePuy Pinnacle hip replacements problems. The plaintiffs have alleged that DePuy hips, caused individuals to experience severe pain and early failure of their artificial hip implant.

In May 2011, the U.S. Judicial Panel on Multidistrict Litigation, JPML, ordered that every DePuy Pinnacle hip lawsuit filed in any U.S. District Court throughout the country be transferred to the Northern District of Texas as part of a multidistrict litigation, or MDL.

According to court documents released October 6, there are now at least 538 complaints consolidated before U.S. District Judge James E. Kinkeade in the DePuy Pinnacle MDL. As DePuy Pinnacle hip replacement lawyers continue to evaluate, investigate and file new cases in federal court, the number of lawsuits is expected to continue to grow. Many medical experts anticipate that thousands of people who are impacted by the alleged defective medical product, will ultimately file a complaint.

This scenario is currently being played out in the Northern District of Ohio federal court system, where another metal on metal DePuy hip product has been consolidated for litigation purposes. In August 2010, DePuy recalled its flagship artificial metal on metal hip product, the DePuy ASR.

watch this abc news video

All of the suits involve similar allegations that the DePuy Pinnacle Acetabular Cup System was defectively designed or manufactured, and that inadequate warnings were provided about the risk of early complications or problems, which have been developing within a few years of the surgery. In many cases, the DePuy Pinnacle hip replacement complications result in the need for additional surgery to replace or revise the hip replacement.

Many of the complaints allege that DePuy, a subsidiary of Johnson & Johnson, has been aware of the problems with their metal-on-metal hip implants for some time and that a DePuy Pinnacle hip recall should have been issued several years ago.

As described above, Johnson & Johnson and DePuy also face thousands of lawsuits over the recalled DePuy ASR hip replacement. The DePuy ASR hip was approved as a substantial equivalent design to the DePuy Pinnacle metal-on-metal hip, and the allegations raised regarding design problems with the two devices are similar.

Over the past year, concerns about all metal-on-metal hip replacements have been growing. Last October, the American Academy of Orthopaedic Surgeons (AAOS) issued a warning about potential problems with metal on-metal hip replacements, indicating that patients and the medical community should be aware that pain months after hip replacement surgery may be a sign of metal-on-metal hip cobalt toxicity.

Earlier this year, the FDA launched a new website to provide information about the risks associated with metal-on-metal hip replacements.

As a DePuy ASR Hip Recall attorney I am providing this update. There is a problem with metal on metal artificial hip implant devices, as highlighted on the NBC Nightly News on October 4th 2011.

According to medical experts and bio-engineers, the DePuy ASR, and DePuy Pinnacle hip implants are failing, or have failed at an unacceptably high rate. In August of 2010, there was a recall on DePuy ASR hip implant device. The ASR DePuy hip implants were surgically implanted on tens of thousands of US citizens between 2005 and early 2010.

Symptoms of a recalled ASR DePuy hip implant failure include pain in the hip region, problems walking, swelling of the hip, or lack of flexibility in the area of the hip. NBC Nightly News with anchor Brian Williams, called attention to the DePuy hip implant recall, and the issues with metal on metal hip implants on Tuesday October 4th 2011 news segment.

Unfortunately the fact is that the DePuy ASR hip implant was sold as the right hip implant for younger, or older adults, who wanted to maintain an active, or athletic lifestyle. According to medical experts there could be thousands of DePuy hip implant replacements in the US.

The medical experts indicate symptoms of the recalled ASR DePuy hip implant failure include:

Pain in the Hip Region
Problems While Walking or The Inability to Walk
Swelling of the Hip
General Discomfort
Lack of Flexibility

To view the NBC Nightly News story about problems with metal on metal hip implants, or Depuy hip implant please go to http://NBCNightlyNews.Com & click on the Health Tab

Visit msnbc.com for breaking news, world news, and news about the economy

Visit msnbc.com for breaking news, world news, and news about the economy

According to a British orthopedists’ group a hip replacement made by Johnson & Johnson’s DePuy unit fails in the U.K. as often as 49 percent of the time, or four times what the company cited in recalling the device last year.

The British Orthopaedic Association and the British Hip Society said in a statement in March 2011 that data on the ASR XL Acetabular System from four surgeons show the rate of second operations, or revisions, ranges from 21 percent after four years to 49 percent after six years.

DePuy recalled both the ASR XL and an ASR hip resurfacing system in August 2010. At the time, the company cited unpublished data from the National Joint Registry of England and Wales saying 13 percent of ASR XL patients required second surgeries in five years, and 12 percent of patients with the resurfaced hips needed such operations within five years. Both devices use metal balls and sockets to replace ailing hips.

Only the ASR XL was approved for sale in the U.S., where 37,000 were implanted. New Brunswick, New Jersey-based J&J, the world’s largest health-care company, faces over a 1,000 lawsuits in the U.S. so far over the devices.

U.K. Implants
About 10,000 of the hips were implanted in the U.K., including 5,000 or so resurfacing devices and 5,000 of the ASR XL prostheses, also known as total-hip replacements.

Lawsuits Filed
Plaintiffs have brought product-liability, negligence and failure-to-warn claims against DePuy over the devices, and are seeking medical costs, lost wages and compensation for their pain and suffering. More than 350 lawsuits have been consolidated in federal court in Ohio, and more than 220 are pending in California state court. Another group of cases is pending in New Jersey state court.

Merck said today that a federal court jury in New York found in its favor in the Secrest v. Merck case, rejecting the claim of a Florida woman who blamed her dental and jaw-related problems on her FOSAMAX use.

Chilton Varner of King & Spalding LLP, outside counsel for Merck said, "Unfortunately, the plaintiff had medical problems that cause people to develop the jaw and dental problems that the plaintiff has, regardless of whether they were taking FOSAMAX. She has a long history of invasive dental procedures and suffers from medical conditions that inhibit the body's ability to heal."

Today's verdict marks the fourth time a jury has found in Merck's favor on a plaintiff's product liability claim in the litigation regarding FOSAMAX. The plaintiff in this case alleged she used FOSAMAX and suffered various jaw problems and complications following multiple tooth extractions and failed dental implants.

At trial, Merck presented evidence that FOSAMAX is a safe and effective medication as described in the product labeling that was properly designed and did not cause the plaintiff's dental and jaw problems.

Status of Litigation
This is the fifth case regarding FOSAMAX(R) (alendronate sodium) to go to trial. Merck won three of the first four. The first three trials were conducted as part of the federal multidistrict litigation proceedings before Judge Keenan. The first case to be tried to a verdict, Maley v. Merck, resulted in a defense verdict for Merck in May 2010. The second case to be tried to a verdict, Boles v. Merck, initially resulted in a mistrial in September 2009 after the jury was unable to reach a unanimous verdict. A retrial of that case in June 2010 resulted in a plaintiff verdict, which was later reduced by Judge Keenan. The third case to be tried to a verdict, Graves v. Merck, resulted in a defense verdict for Merck in November 2010. The fourth case to go to trial, Rosenberg v. Merck, which was tried in the Superior Court for Atlantic County, New Jersey, resulted in a defense verdict for Merck in February 2011.

As of June 30, 2011, approximately 1,650 cases, which include approximately 2,050 plaintiff groups, had been filed and were pending against Merck in either federal or state court.

As an Actos Bladder Cancer Product Liability attorney and Texas medical doctor, I am providing this update regarding the status of a MDL consolidation request.

Takeda Pharmaceuticals the manufacturer of Actos and their defense attorneys have indicated that the drug maker supports a request to have all federal Actos bladder cancer lawsuits consolidated for pretrial litigation. But Takeda disagrees about where the defective product liability claims should be centralized.

On September 29, Takeda Actos lawyers filed a response with the U.S. Judicial Panel on Multidistrict Litigation, indicating that they agree with plaintiffs that an MDL, or multidistrict litigation, should be formed, but requested that the cases be transferred to either Northern District of Illinois or Western District of Louisiana.

A motion to consolidate the Actos bladder cancer litigation was first filed on August 31, by plaintiff Glen Weant, who requested that all federal Actos lawsuits be transferred to the U.S. District Court for the Southern District of Illinois before Judge G. Patrick Murphy. Since then, additional plaintiffs have filed responses proposing other U.S. District Judges to preside over the litigation.

The first Actos lawsuit was filed on July 29, 2011. According to documents filed by Takeda last week, the drug maker is now aware of at least 54 cases that have been filed in federal district courts throughout the United States. In addition, as Actos plaintiffs attorneys continue to evaluate and file new complaints on behalf of people diagnosed with bladder cancer after taking the type 2 diabetes drug, the number of claims is expected to continue to grow.

All of the complaints involve similar allegations that side effects of Actos caused users to develop bladder cancer. Plaintiffs argue that Takeda failed to properly research the medication or warn about the risk.

Takeda’s attorneys indicated that they agreed that the cases fit the requirements for an MDL and that consolidation would help prevent contradictory rulings and duplicative discovery. It would also serve the convenience of counsel, witnesses, plaintiffs and defendants, according to the drug maker’s response.

Takeda has requested that the Actos litigation be consolidated in the Northern District of Illinois, where the drug maker is headquartered and where the company’s records are located. As an alternative, the drug maker proposed the Western District of Louisiana for the Actos MDL to be centralized, as there are at least 16 cases already pending in that district.

Actos (pioglitazone) was approved by FDA to treat Type 2 Diabetes in July, 1999. It is a once-a-day pill that increases the body’s sensitivity to insulin. The medication has grown in popularity in recent years, after studies linked its primary competitor, Avandia, to an increased risk of heart attacks and death.

FDA officials began reviewing the potential risk of Actos bladder cancer problems in September 2010, after interim data from an on-going 10 year study found that users may face an increased risk the longer they take the drug. Data from the study conducted by Takeda Pharmaceuticals, the makers of Actos, indicated that after 24 months, the rate of exposure and the increased risk of bladder cancer reached statistical significance.

In June, an Actos recall was issued in France after a review of public insurance data identified an increased incidence of bladder cancer with Actos use.

The European Union’s European Medicines Agency (EMA) also conducted a review and confirmed the bladder cancer risk, calling for new warnings and a six-month review of every patient on Actos. The EMA suggested that Actos bladder cancer risk could be reduced by appropriate patient selection and exclusion.

Since then, the number of lawsuits over Actos has been steadily increasing in federal district courts throughout the United States. The U.S. Judicial Panel on Multidistrict Litigation is expected to schedule oral arguments on the motion to consolidate the cases at the next hearing, which will be held on December 1 in Savannah, Georgia.

FDA Drug Safety Communication: Ongoing Safety Review of Actos (pioglitazone) and Potential Increased Risk of Bladder Cancer After Two Years Exposure

The U.S. Food and Drug Administration (FDA) is informing the public that use of the diabetes medication Actos (pioglitazone) for more than one year may be associated with an increased risk of bladder cancer. Information about this risk will be added to the Warnings and Precautions section of the label for pioglitazone-containing medicines. The patient Medication Guide for these medicines will also be revised to include information on the risk of bladder cancer.

As a DePuy ASR and Pinnacle Replacement and Recall attorney I am providing this blog update.

As readers to my blog will note, I am a licensed Texas medical doctor as well as a product liability attorney. We are currently fielding many phone calls from concerned hip replacement patients and the biggest concern for them is residual hip pain post procedure."Is that normal?" they ask. "How do we know if we are suffering from metallosis?" "My doctor is not concerned but I still feel that something is wrong?"

The answers to these questions remain elusive for several reasons. Firstly and foremost is the lack of research, disclosure and transparency from the hip manufacturers who knew or should have known about these problems and concerns.

Secondary, the orthopedic doctors, many of whom are implanting technicians, they do not have a firm grounding in internal medicine and because of their surgical training do not have the ability to diagnose and treat these types of conditions, short of re-do surgery. They drank the manufacturers kool-aid.

Diagnosis and treatment of metal on metal hip problem requires a multidisciplinary approach including the orthopedic, internal medicine and radiological specialties. Many orthopedic surgeons have reported that tissue surrounding a failed artificial hip looks like a biological dead zone. There are matted strands of tissue stained gray and black and large strips of muscle near the hip no longer contracted. Some patients with all-metal hips, ones in which the cup and ball of a joint are made of metal, said they had trouble finding a doctor to help them.

More than 10 years ago, some researchers had warned that the hips released metallic debris that caused potential health threats to patients. But those warnings were ignored, and now doctors and patients face a mounting public health problem as one of the biggest medical device failures surfaces.

All orthopedic implants, irrespective of their composition, shed debris as they wear, from the grinding action of joints. But researchers say they believe that the metallic particles released by some all-metal hips poses a special threat. This is because scavenger cells released by the body to neutralize the foreign debris convert it into biologically active metallic ions. In some patients, this sets off a chain reaction that can destroy tissue and muscle.

So far, only a small fraction of the estimated 500,000 people in this country who received an all-metal hip over the last decade have suffered injuries. But studies suggest that those numbers will grow and that tissue destruction is occurring silently in some patients who have no obvious symptoms like pain. And that is the crux of the problem, heavy metal blood tests can be normal and yet the hip joint is breaking down silently.

A recent study in England found that all-metal hips were failing early at three times the rate of hips made from metal-and-plastic components. This artificial hips are supposed to last 15 years or more. Most people recover well from a device replacement procedure, but specialists are also seeing growing numbers of patients with complications.

In the first six months of this year, the Food and Drug Administration received more than 5,000 reports about problems with the all-metal hips, according to a recent analysis by The New York Times.

In May, the Food and Drug Administration ordered makers of all-metal hips to develop studies to determine how frequently the devices were failing and the implications for patients. But those studies are not likely to be completed for years.

The final chapter has not yet been written on these metal on metal hips and so far DePuy has only recalled the ASR model. Johnson and Johnson, the parent of DePuy, continues to sell and market their Pinnacle metal on metal hip model.

According to the concerned women who are calling our offices; they believe that the FDA and other U.S. regulators have failed them by not requiring extensive testing before allowing Johnson & Johnson (JNJ) and other manufacturers to sell the type of surgical mesh implanted in them, to hold their pelvic organs in place. Now many these callers say that they cannot work, sleep through the night, or have sex with their partners due to endless pain.

There are about 270 lawsuits pending against J&J. In all, about 600 suits have been filed against it and other mesh makers, including C.R. Bard, Boston Scientific, and American Medical Systems, acquired in June by Endo Pharmaceuticals Holdings.

The U.S. Food and Drug Administration warned on July 13 of a fivefold increase in women suffering pain and injuries after surgeons inserted mesh through vaginal incisions. Pelvic Organ Prolapse (POP) occurs when the internal structures that support the pelvic organs such as the bladder, uterus and bowel, become so weak or stretched that the organs drop from their normal position and bulge or prolapse into the vagina. While not a life-threatening condition, women with POP often experience pelvic discomfort, disruption of their sexual, urinary, and defecatory functions, and an overall reduction in their quality of life.

Surgery to repair POP can be performed through the abdomen or transvaginally, through the vagina, using stitches, or with the addition of surgical mesh to reinforce the repair and correct the anatomy.

”There are clear risks associated with the transvaginal placement of mesh to treat POP,” said William Maisel, M.D., M.P.H., deputy director and chief scientist of the FDA’s Center for Devices and Radiological Health. “The FDA is asking surgeons to carefully consider all other treatment options and to make sure that their patients are fully informed of potential complications from surgical mesh. Mesh is a permanent implant -- complete removal may not be possible and may not result in complete resolution of complications.”

In 2010, there were at least 100,000 POP repairs that used surgical mesh. About 75,000 of these were transvaginal procedures.

The FDA issued a safety communication in 2008 due to increasing concerns about adverse events associated with the transvaginal placement of mesh. Since then, the number of adverse events has continued to climb. From 2008 to 2010, the FDA received 1503 adverse event reports associated with mesh used for POP repair, five times as many as the agency received from 2005 to 2007. The reports don’t always differentiate between transvaginal and abdominal procedures.

The most frequently reported complications from surgical mesh used to repair POP include mesh becoming exposed or protruding out of the vaginal tissue (erosion), pain, infection, bleeding, pain during sexual intercourse, organ perforation from surgical tools used in the mesh placement procedure, and urinary problems. Some reports cited the need for additional surgeries or hospitalization to treat complications or to remove the mesh.

The FDA also conducted a review of scientific literature published between 1996 and 2010 comparing mesh surgeries to non-mesh surgeries. The agency review suggests that many patients who undergo transvaginal POP repair with mesh are exposed to additional risks, compared to patients who undergo POP repair with stitches alone. While mesh often corrected anatomy, there was no evidence that mesh provided any greater clinical benefit than non-mesh surgeries.

FDA recommends that health care providers:
• Recognize that in most cases, POP can be treated successfully without mesh;
• Know that surgical mesh is a permanent implant that can make any future surgical repairs more challenging and can put the patient at risk for additional complications and surgeries;
• Consider that mesh placed abdominally for POP repair may result in lower rates of mesh complications compared to transvaginal POP surgery with mesh; and
• Be sure that patients are aware of the risks and benefits of transvaginal POP repair with mesh, and inform patients if mesh is being used.

The FDA recommends that patients:
• Ask the surgeon before surgery about all POP treatment options, including those that do not involve mesh, and understand why the surgeon may be recommending treatment of POP with mesh;
• Continue with routine check-ups and follow-up care after surgery. Notify the surgeon if complications develop (persistent vaginal bleeding or discharge, pelvic or groin pain during sex); and
• Those who have had POP surgery but don’t know if the surgeon used mesh should find out if mesh was used during their next scheduled visit with their health care provider.

Last week an advisory panel agreed with FDA staff that the agency should reclassify mesh from moderate risk to high risk of harming patients if it fails, and require more studies to determine if they are safe and effective.

Personal injury lawyers say they expect a surge in lawsuits by women because of the dangers of transvaginal mesh for pelvic organ prolapse, POP. POP refers to a condition in which the uterus or bladder bulge, or prolapse, into the vagina.

None of the cases have been tried, and women must prove their claims that mesh makers knew of safety risks and failed to disclose them and that the products were defective. JNJ, Boston Scientific, Bard, and American Medical Systems told the FDA advisory panel that using mesh in transvaginal procedures is safe and effective and serious injuries are rare.

About 300,000 women in the U.S. had pelvic organ prolapse surgeries last year, including more than 70,000 who received vaginal meshes. Between 2008 and 2010, the FDA received 1,503 reports of injuries or malfunction, a fivefold increase from 2005 to 2007.

Bard, which estimated the global prolapse mesh market at $175 million, saw its own pelvic prolapse business fall about 30 percent in 2010 due to what it called “regulatory delays” on product approvals. J&J is the global leader in prolapse mesh, followed by American Medical Systems, Boston Scientific, and Bard. According to experts, the law suits are another high-profile controversy pushing the FDA toward toughening its approval process for devices. As moderate-risk devices, vaginal meshes currently need only show that they are “substantially equivalent” to existing products. A change to a high-risk status would require tests to show efficacy and safety.

As a Texas medical doctor and Actos Bladder Cancer Attorney I am providing this information and commentary. The maker of the world's best-selling diabetes drug is facing many lawsuits as adverse medical research shows that taking the pill for more than a year raises the risk of bladder cancer.

A motion was filed asking for all federal Actos bladder cancer lawsuits to be centralized before one judge for coordinated handling during pretrial proceedings as part of an MDL, or multidistrict litigation.

There are about 12 lawsuits over Actos that have been filed in federal district courts. Experts believe that hundreds of complaints that will likely be filed on behalf of individuals who claim they developed bladder cancer from side effects of Actos.

The motion was filed on August 31 by plaintiffs Glen and Nina Weant, who have petitioned the U.S. Judicial Panel on Multidistrict Litigation (JPML) to consolidate all federal Actos lawsuits in the U.S. District Court for the Southern District of Illinois before Judge Murphy. According to the filing, there are at least 12 lawsuits pending in 8 different federal district courts throughout the United States involving individuals who developed bladder cancer after Actos use.

All of the lawsuits involve similar allegations that Takeda Pharmaceuticals, the makers of Actos, failed to adequately research their medication or warn about the increased risk of bladder cancer when Actos is used for long periods of time.

Actos (pioglitazone) was approved by FDA to treat Type 2 Diabetes in July, 1999. It is a once-a-day pill that increases the body’s sensitivity to insulin. FDA officials began reviewing the potential risk of Actos bladder cancer problems in September 2010, after interim data from an on-going 10 year study found that users may face an increased risk the longer they take the drug. Data from the study conducted by Takeda Pharmaceuticals, indicated that after 24 months, the rate of exposure and the increased risk of bladder cancer reached statistical significance.

In June, an Actos recall was issued in France after a review of public insurance data identified an increased incidence of bladder cancer with Actos use. The European Union’s European Medicines Agency (EMA) also conducted a review and confirmed the bladder cancer risk, calling for new warnings and a six-month review of every patient on Actos.

Consolidation of the Actos litigation before one judge as part of an MDL is designed to reduce duplicative discovery, avoid contradictory rulings from different judges and to serve the convenience of the court, witnesses and parties. While the pretrial management of the cases in an MDL is often managed similar to how an Actos class action lawsuit would be handled, each claim will still remain an individual lawsuit.

During pretrial proceedings the Court will coordinate discovery and help facilitate a possible Actos settlement agreement. The U.S. Judicial Panel on Multidistrict Litigation is not likely to schedule a hearing on the petition until at least December 1, when they are scheduled to hold a hearing session in Savannah, Georgia.

As a Texas medical doctor and Fosamax femur fracture injury Attorney, I am fielding many calls from concerned plaintiffs regarding their side effects from using Fosamax and similar drugs. We are providing the following update and commentary.

A FDA advisory committee wants the agency to limit the duration of bisphosphonate therapy for treatment of osteoporosis. This year, the FDA required that all bisphosphonates used to prevent or treat osteoporosis warn on their labels that optimal duration of use hasn't been determined. The issue has become concerning to the FDA as reports have emerged linking long-time bisphosphonate therapy with increased risk of atypical fractures.

The Advisory Committee for Reproductive Health Drugs and the Drug Safety and Risk Management Advisory Committee met to discuss whether emerging reports of adverse events should cause the FDA to change the label to indicate that the drug not be used long term. The medical advisers did not press the issue as strongly as the F.D.A. staff itself did in a 45-page report issued on Wednesday. The staff report said studies “suggest no significant advantage of continuing drug therapy beyond five years.”

According to the FDA panel placebo-controlled trials provide data for only five years of therapy, but there is no clinical evidence that bisphosphonates work better after they are used for a long period of time.

Bisphosphonates are prescribed to some 5 million patients annually to prevent or treat osteoporosis and are highly effective at reducing the risk of osteoporotic fractures. The drugs, which include brand-names Actonel, Atelvia, Boniva, and Reclast, have been shown to reduce the risk of breaking a hip by 40% to 50% and fracturing a vertebra by between 40% and 70% by inhibiting bone resorption to prevent loss of bone mass.

In 2010, the FDA required makers of bisphosphonate drugs to add a warning to their labels about an increased risk of atypical femur fractures after an American Society for Bone and Mineral Research task force concluded that the risk is real.

The panel heard from women who were taking bisphosphonates to prevent osteoporosis when suddenly and painfully, they broke their femurs. One woman was on a subway train that screeched to a halt, and as her weight was thrust onto one leg, her femur snapped and she collapsed. Other women had similar stories -- a teacher reaching something in front of her students, a grandmother taking a large step to walk toward her grandchild, a woman walking down a front stoop to pick up the morning newspaper -- and in each case the women collapsed to the ground as their femurs snapped.

The panel was also concerned with the drug's link to deterioration of the jawbone. In 2005, the FDA added a warning on bisphosphonates about osteonecrosis of the jaw, a rare disease in which the bone in the jaw dies. In data presented Friday, an FDA reviewer said the risk for osteonecrosis of the jaw appears more prevalent after four years or more of use.

There are also some data suggesting a link to long-term use of bisphosphonates and esophageal cancer. In 2009, a study in the New England Journal of Medicine used data from FDA's Adverse Event Reporting System to identify and describe 23 patients taking alendronate who were diagnosed with esophageal cancer.

As a Texas medical doctor and Medical Malpractice attorney, I am providing this case law update and commentary.

As part of Texas's tort reform laws, enacted by the Texas legislature in 2003, one of the requirements in order to file a medical malpractice claim, was the furnishing of a medical expert's report within 120 days of filing the lawsuit.The 5th District Court of Appeals says that the legislation serves the state's interest in preventing frivolous medical liability lawsuits and related health care system costs. This medical expert report requirement is also known as the Texas' certificate-of-merit law, and is similar to many other states' medical malpractice reform.

Recently Texas' certificate-of-merit law passed another constitutional challenge after the 5th District Court of Appeals validated the requirement for plaintiffs to file an expert report demonstrating the merits of a medical liability case.

The 5th District Court of Appeals rejected arguments that the legislation amounted to an unconstitutional special law that treated medical liability lawsuits differently from other cases. Further, the court said that the provision subjecting plaintiffs who file a deficient report to financial penalties does not violate the constitutional separation powers.

Trial court judges have discretion to determine the amount of monetary sanctions and to inquire whether plaintiffs made a good-faith effort to pursue a medical malpractice or wrongful death case.

The August 12 opinion states that the expert report requirement "rationally relates to the interest of the state to prevent medical practitioners from defending frivolous claims at a high cost to the health care system."

According to the Texas Medical Association's statistics, since the 2003 law was enacted as part of a liability reform package that included a $250,000 noneconomic damages cap, Texas has seen a 50% drop in medical negligence cases, a 30% reduction in physicians' liability insurance rates and more than 20,000 newly licensed doctors.

Critics of the law state that those changes may have happened anyway because of the increase in Texas' population, which boomed as a result of the oil and gas business and the resulting need for more physicians and that as a function of doctors per capita, Texas is actually less served by the total number of physicians. So the new law is a red herring and an excuse for the insurance companies to be treated as a special interest deemed worthy of protection. Is it any wonder that the shiniest, tallest and the most aesthetically pleasing buildings in Texas are owned by insurance companies? Follow the money trail my friends.

The Texas liability reform package is now being touted as a role model for other states to deny plaintiffs their day in court.

The added expert report requirement means an extra layer of protection for physicians and hospitals. Plaintiffs in medical malpractice claims have to show ahead of discovery that they have a meritorious claim, whereas in any other personal injury claim, for example a car wreck injury case, you can take depositions and exchange discovery to determined what happened. In 2006 the Oklahoma Supreme Court ruled that invalidated the state's certificate-of-merit statute as a special law.

The Legislature's imposition of mandatory sanctions, of the defendant's cost of defense and attorny fees, if the medical expert's report is considered defective, usurps judiciary's powers and places an unfair burden on plaintiffs who make a good-faith effort to pursue a case. The cost of defense and attorney fees can be in thousands of dollars that the plaintiffs will have to pay.

This ruling arises from a wrongful death claim Joshua Hightower's parents filed after their son died from complications of rabies contracted during a kidney transplant at Baylor University Medical Center in 2004. Other patients who received organs from the same donor also died of the disease.

The Hightowers filed two physician expert medical reports supporting their claim that the surgery was risky given the donor's history of drug use and incarceration, and that the hospital and transplant doctors misrepresented the risks involved.

A trial court found the reports deficient and dismissed the case. The appeals court agreed, saying neither report showed "a connection between the donor's alleged high-risk status and the rabies virus. ... Joshua was injured by rabies, a condition of the donor that no one was aware of at the time of the surgery."

The judges said that "expert reports need not demonstrate all of a plaintiff's proof, but they must explain the basis of the expert's statement to link the conclusions to the facts."

Having been involved in many medical malpractice cases, I know first hand of the difficulties in obtaining a medical expert's report that is not conclusory and that adequately addresses the standard of care, the conduct that involves the deviation of the standard of care, the damages that result and the causation ie how the deviations caused the damages.

In other words the doctors who write these reports have to understand complex legal theories and case law in order to write reports that pass muster with the court. Doctors are not lawyers and because of their training they do not understand the legal basis of the claim. They understand the medicine but these reports are not about the medicine but law. You therefore have no medical personnel unless they have a legal background or exposure, being able to write these legal treatises which is basically required to pass the court's muster.

Meanwhile in California...
State public health officials have fined 12 California hospitals for medical errors that hurt or killed patients, according to a report. Three of the hospitals — L.A. County/USC Medical Center, Torrance Memorial Medical Center and Brotman Medical Center — are in Los Angeles County.

The penalties were issued for errors such as leaving foreign objects in patients' bodies during surgery and administrating the wrong medication. They occurred in 2009 and 2010. The fines, which hospitals can appeal, range from $50,000 to $75,000 for each mistake.

"Most of these are preventable medical errors," said Ralph Montano, spokesman for the California Department of Public Health. "Either someone was harmed or killed or likely to be harmed."

So here you have it folks, the rich get richer and the usual poor plaintiffs get the short end of the stick.

As a Texas medical doctor and Transvaginal Mesh Attorney I am providing this information and commentary.

11.6% of women who undergo surgery with transvaginal placement of Ethicon Gynecare Prolift Mesh for repair of pelvic organ prolapse (POP) have to undergo additional operations due to post operative complications.

This complication rate was found as a result of a new study, published by the American Journal of Obstetrics and Gynecology. Most of the re-operations were due to urinary incontinence that occurred after the mesh was implanted, with other problems including transvaginal mesh complications and prolapse recurrence.

Researchers reviewed the outcomes for 524 patients who received the Ethicon Gynecare Prolift vaginal mesh over a 4 year period. At a follow up of 38 months, 11.6% had to undergo reoperation after receiving the Prolift Mesh for pelvic organ prolapse. Over 50% of those reoperations were due to urinary incontinence, More than 25% due to mesh-related complications and more than 25% due to recurring prolapse. The researchers found that the number of mesh-related complications and POP decreased when experienced medical teams implanted the mesh.

The Gyncare Prolift Total, Anterior and Posterior Pelvic Floor Repair Systems was first introduced in September 2005, and Gynecare Prolift+M variations were introduced in May 2008. The vaginal mesh or bladder sling is designed reinforce weakened or damaged tissue on the pelvic floor that hold organs in place, such as the bladder, the uterus and the rectum.

Recently, the FDA issued a warning about the risk of problems with Ethicon Gynecare vaginal mesh and other similar products used for pelvic organ prolapse. The agency declared that transvaginal surgical mesh for pelvic organ prolapse does not provide any benefit over other means of treatment, and has been associated with hundreds of reports of serious problems.

Between 2008 and 2010, the FDA received more than 1,500 reports of transvaginal mesh problems after pelvic organ prolapse repair surgery, including erosion of the mesh into the vagina, contraction or shrinkage of the mesh, infection, pelvic pain, urinary problems, vaginal scarring among other complications.

A number of Gynecare Prolift mesh lawsuits have been filed against Ethicon, Inc., which is a subsidiary of Johnson & Johnson. At least 400 complaints have been filed in New Jersey state court over the Prolift mesh and other similar vaginal bladder sling products made by Ethicon, such as Gynemesh, Prolene Mesh and TVT slings.

In addition to Ethicon vaginal mesh products, problems have also been associated with slings sold by American Medical Systems (AMS), Boston Scientific, C.R. Bard and other companies. Transvaginal mesh lawyers are also reviewing potential claims against manufacturers of these products for women who experienced problems with surgical mesh for pelvic organ prolapse repair.

Continue reading "Ethicon Gynecare Prolift Mesh Linked to 11.6% Reoperation Rate" »

As a Texas medical doctor and Dallas Hydraulic Fracking Attorney I am providing this information and commentary.

The EPA is prohibited from regulating hydraulic fracturing under the Safe Drinking Water Act. On July 28, 2011, the EPA proposed federal regulations to reduce smog-forming pollutants released by the hydraulic fracturing approach to gas drilling.

According to the EPA, If approved, the rules would amount to the first national standards for fracking of any kind. The agency sets guidelines when companies inject fluids underground, but in 2005 Congress prohibited the EPA from doing so for fracking. Regulation has been left to the states, some of which compel companies to report what chemicals they use and have imposed tougher well-design standards.

The new EPA proposal would limit emissions released during the stages of natural gas production and development, and targets the volatile organic compounds released in large quantities when wells are fracked. According to the EPA, drillers would have to use equipment that captures these gases. According to environmental experts, the proposed rules represent a step by federal regulators amid a growing controversy over fracking's safety.

The American Petroleum Institute, the country's main oil and gas lobbying group, has requested that the EPA delay finalizing the rules for at least six months beyond the current Feb. 2012 deadline.

The Marcellus Shale Coalition, a group representing gas drillers in the Northeast, issued a statement criticizing the proposed regulations, saying they would "undercut" gas production.

The EPA proposal is the result of a successful 2009 lawsuit brought against the agency by WildEarth Guardians and another advocacy group alleging that the agency had not updated air-quality rules as required. The EPA is supposed to review such rules at least every eight years, but in some cases had not done so for 10 years or more.

According to Jeremy Nichols, the climate and energy program director for WildEarth Guardians, hydraulic fracturing is a major source of emissions because when fluids used to frack a well return to the surface, they carry gases that can be vented into the air. In fracking's case the soupy return contains methane, volatile organic compounds and toxic chemicals such as benzene, which generally spray into the environment. In some gas drilling areas, where emissions from drilling are particularly high, they no longer meet federal air quality standards.

The EPA proposal also calls for reducing emissions of toxic chemicals, such as cancer-causing benzene, produced by processing, transmitting and storing natural gas. Some environmentalist experts were disappointed that the proposed rules do not target methane, a potent greenhouse gas that is also the primary ingredient of natural gas. The oil and gas sector accounts for nearly 40 percent of all methane emissions nationwide, according to the EPA.

Click here. Drilling Regulatory Staffing in Your State. Search for how many wells have been drilled and how many gas regulators are in your state.

Click here. Graphics: What is Hydraulic Fracturing? Anatomy of a Gas Well

Continue reading "EPA Hydraulic Fracturing and Water Contamination" »

As a Texas medical doctor and Yaz Side Effect Product Liability attorney, I am providing this litigation update regarding the increased discovery that has been allowed in the federal MDL.

NON-BELLWETHER CASE-SPECIFIC DISCOVERY.
The judge presiding over all federal Yaz lawsuits and Yasmin lawsuits has expanded the scope of discovery in the litigation beyond the selected bellwether cases. According to Judge Herndon's most recent order, "... This matter is before the Court for case management. The Court is in the process of compiling a list of the the "oldest 100 non-bellwether" cases. Thus, a list identifying the 100 member actions that will be subject to core, case-specific discovery pursuant to Doc. [1866] will be forthcoming..."

In essence the Court is allowing case-specific discovery to move forward in up to 100 other cases filed on behalf of women who allege that side effects of the Bayer birth control pills caused them to suffer injuries. The Court has expanded the scope of discovery beyond the 24 cases selected last year to serve as a pool of bellwether lawsuits. Case-specific discovery, including depositions of individual plaintiffs, will also now be permitted in the oldest 100 non-bellwether cases that have been filed.

About 6,350 lawsuits are now consolidated as part of the Yasmin and Yaz litigation in the U.S. District Court for the Southern District of Illinois and the number of cases is expected to only increase as Yaz, Yasmin and Ocella lawyers file additional cases.

All of the suits involve claims that Bayer failed to properly research their birth control pills or adequately warn about the increased risk of serious and potentially life-threatening injuries from the birth control pills containing drospirenone, such as a stroke, heart attack, pulmonary embolism, and deep vein thrombosis. Yaz and Yasmin were the first birth control pills to contain drospirenone, a new type of progestin.

The outcome of the bellwether trials and information obtained from the additional plaintiff depositions could help facilitate an eventual Yaz settlement agreement between the parties.

Continue reading "Case Specific Discovery in Yasmin and Yaz Litigation " »

As a Texas medical doctor and Ethicon Gynecare Transvaginal Mesh Lawsuit attorney, I am providing this important update regarding the New Jersey litigation involving these products.

Several hundred patients have filed a transvaginal mesh defective product lawsuit in New Jersey state court against Ethicon, Inc. and Johnson & Johnson over side effects from their Gynecare mesh products. Gynecare mesh products are used for treatment of pelvic organ prolapse and stress urinary incontinence.

Women filed these lawsuits, received Gynecare Prolift mesh, Gynecare Gynemesh, Gynecare Prolene mesh, Gynecare TVT sling or another pelvic mesh product manufactured by Ethicon, a subsidiary of Johnson & Johnson.

These transvaginal mesh products are used strengthen damaged tissue, to repair pelvic organ prolapse (POP) and female stress urinary incontinence (SUI). These products were marketed as a safe and effective alternative to traditional surgical procedures, and women allege that Ethicon Gyncare mesh problems caused them to experience pelvic pain, infections, urinary problems, erosion of the mesh and other complications.

All of the Ethicon Gynecare mesh lawsuits filed in New Jersey state court are centralized for pretrial proceedings before Judge Higbee in Atlantic County. According to court information, there are now about 500 cases that have been filed.

The lawsuits claim that Johnson & Johnson knew the products were unreasonably dangerous, but continued to manufacture and sell them. Other a;;egations iclude manufacturing a defective product, negligence, failure to warn, strict liability and fraud.

According to a study in the Journal of the American College of Obstetricians and Gynecologists, researchers concluded that there was a high rate of vaginal mesh failure with Gynecare Prolift mesh, while providing no difference in cure rates.

Earlier, the FDA issued a warning about the risk of problems from transvaginal mesh when used for pelvic organ prolapse, indicating that the agency was unable to find any significant benefit for the products over other available means of treatment.

In addition to Johnson & Johnson’s Ethicon mesh products, problems have also been associated with transvaginal mesh sold by American Medical Systems (AMS), Boston Scientific, C.R. Bard and other companies.

Continue reading "Ethicon Gynecare Transvaginal Mesh Lawsuits" »

As a Dallas Dangerous Drug attorney, I am writing about this interesting medical study in the recent American Journal of Medicine.

According to the findings of a new medical study, patients with hypertension and heart problems who regularly take common over-the-counter painkillers could be at a greater risk of heart attack, stroke and death.

Non-steroidal anti-inflammatory drugs (NSAIDs) have been used in pain management in patients with osteoarthritis and other painful conditions. In the United States an estimated 5% of all visits to a doctor are related to prescriptions of non-steroidal anti-inflammatory drugs and they are among the most commonly used drugs. In 2004, rofecoxib, VIOXX, marketed as a cyclo-oxygenase-2 (COX 2) selective inhibitor, was withdrawn from the market after the results of a randomized placebo controlled trial showed an increased risk of cardiovascular events associated with the drug.

In this recent study, patients with heart disease and high blood pressure were at 47% increased risk of the cardiovascular events if they were chronic users of non-steroidal anti-inflammatory drugs (NSAIDs), examples include Advil, Aleve, Celebrex, Motrin and the recalled drug Vioxx.

The findings were published in the latest issue of The American Journal of Medicine. The study looked at data on 882 long-term NSAID users and 21,694 nonchronic NSAID users. All had hypertension and heart disease and had an average age of 65. Researchers found that 4.4 out of every 100 chronic NSAID users suffered a nonfatal heart attack, nonfatal stroke, or died. The rate was only 3.7 out of 100 for nonchronic NSAID users.

After five years of chronic NSAID use, high blood pressure patients with heart disease were at 126% increased risk of death and 66% increased risk of heart attack.

In June, Danish researchers published a study that found that NSAIDs could cause abnormal heart rhythms. That study, published in the British Medical Journal, found a 40% to 70% increase in the risk of atrial fibrillation among NDAID users. Use of non-aspirin NSAIDs was associated with an increased risk of atrial fibrillation or flutter. Compared with non-users, the association was strongest for new users, with a 40-70% increase in relative risk (lowest for non-selective NSAIDs and highest for COX 2 inhibitors). Atrial fibrillation or flutter needs to be added to the cardiovascular risks to be considered when prescribing NSAIDs.

In January, researchers found that all NSAIDs appeared to increase the risk of heart problems, and all except Aleve carried an increased risk of cardiovascular death. The study was published in the British Medical Journal, focusing on nonsteroidal anti-inflammatory drugs (NSAIDs). The researchers looked at the cardiovascular risk of seven different generic NSAIDs, including generic Aleve (naproxen), Advil and Motrin (ibuprofen), Voltaren and Cataflam (diclofenac), Celebrex (celecoxib), Arcoxia (etoricoxib), Vioxx (rofecoxib) and Prexige (lumiracoxib).

In June 2010, Danish researchers published a study that found evidence of NSAID heart problems, with the recalled drug Vioxx, as well as Voltaren and Cataflam being linked to the highest risk of death due to cardiovascular problems. Voltaren and Cataflam were also associated with double the risk of heart attack, while Vioxx was linked to triple the increased risk. The study was published in Circulation: Cardiovascular Quality and Outcomes, that indicated the class of drugs, which include Motrin and Advil, increase the risk of cardiovascular problems in healthy users. The study indicates that the risk appears to vary widely from brand to brand, with Vioxx, Voltaren and Cataflam as the worst offenders, and the pain reliever Aleve actually appearing to lessen the risk of death.

Lawsuits over Vioxx were filed by thousands of people following a September 2004 recall of the drug amid reports that it increases the risk of heart attacks and strokes. The prescription medication, which was approved for treatment of chronic pain from arthritis and other conditions that cause acute pain, was used by more than 80 million people worldwide.

Keywords: Coronary artery disease, Hypertension, Myocardial infarction, Nonsteroidal anti-inflammatory drugs, NSAIDs, Advil, Aleve, Cataflam, Celevrex, Heart Attack, Heart Disease, Motrin, Stroke, Vioxx

Continue reading "Chronic NSAID Usage Linked to Heart Attack, Stroke and Death" »

As a Dallas Denture Cream Side Effect Attorney, I am providing this Poligrip Zinc side effect litigation update.

GlaxoSmithKline may have paid out more than $120 million in Poligrip denture cream settlements to resolve claims brought by consumers who suffered permanent nerve damage due to zinc in the adhesive products. According to sources, the manufacturer has settled more than 100 denture cream lawsuits at an average cost of just over $1 million per case.

Glaxo agreed to remove zinc from its line of denture-cream products after researchers linked some neurological problems, including nerve damage, to use of zinc-laden denture adhesives. The company’s Super Poligrip Original, Ultra Fresh and Extra Care products all contained zinc, which improves adhesive power. Glaxo and Procter & Gamble Co. (PG), the Cincinnati-based maker of the competing Fixodent denture cream, had lawsuits filed against them consolidated before a federal judge in Florida in 2005.

Product liability lawyers allege that the drugmakers knew for years that their products contained harmful levels of zinc and failed to warn customers. Zinc poisoning can deplete the body of copper, which can lead to nerve damage, resulting in weakness in the arms and legs, balance problems and memory loss.

A flood of law suits followed a 2008 University of Texas Southwestern Medical Center in Dallas medical study of patients suffering from neurological problems. The study linked the cause to denture-cream use. According to the complaints, high amounts of zinc in the denture adhesive can enter the body through use of Super Poligrip, leading to permanent neurological problems like neuropathy, numbness, tingling, pain, weakness, loss of sensation, loss of balance, paralysis and difficulty breathing.

The first Fixodent nerve damage trial is scheduled to begin on June 20. In that case, lawyers for Florida resident Marianne Chapman allege Procter & Gamble defectively designed Fixodent by including zinc in its formulation. The consolidated case is In Re Denture Cream Products Liability Litigation, 09-02051, U.S. District Court, Southern District of Florida (Miami.)

There have been no reports of Fixodent denture cream settlements. Proctor and Gamble argues that its products contained less zinc than those of Glaxo and that it does not believe Fixodent can cause neurological damage.

All federal lawsuits over zinc poisoning from denture cream have been centralized in the U.S. District Court for the Southern District of Florida for pretrial litigation. Individual complaints filed by dozens of people throughout the United States have been consolidated to avoid duplicative discovery, inconsistent pretrial rulings from different judges and to serve the convenience of the court, the parties and the witnesses.

Continue reading "Denture Cream Zinc Poisoning Lawsuit Update" »

As a Yaz, Yasmin and Ocella side effect and blood clot attorney, and Texas Medical doctor I am providing this update regarding the bellwether trial status for the New Jersey State MDL litigation trial schedule.

The first trial dates for any Yaz, Yasmin or Ocella lawsuits pending in New Jersey state court will begin in the fall of 2012, with at least two cases to be selected as test cases out of hundreds of claims pending in the state.

There are about 1,000 Yaz, Yasmin and Ocella product liability lawsuits pending in New Jersey state courts involving claims that women suffered serious or deadly injuries as a result of side effects of Yaz, Yasmin or Ocella birth control, containing the fourth-generation progestin drospirenone which are all manufactured by Bayer.

All of the suits involves claims that Bayer failed to properly research their birth control pills or adequately warn about the increased risk of serious and life-threatening injuries from the birth control pills containing drospirenone, causing stroke, heart attack, pulmonary embolism, and deep vein thrombosis.

According to a case management order issued July 8 by New Jersey Superior Court Judge Martinotti, the first Yaz trial in New Jersey state court should be ready to go before a jury on September 10, 2012. A second trial date has been set for November 27, 2012.

The parties have been directed to identify a pool of 18 cases that may be selected for an early trial date, known as bellwether cases. Judge Martinotti has asked each side to select three cases involving allegations of pulmonary embolism, three involving claims of gall bladder injury and three involving allegations of venous thromboembolism, such as a deep vein thrombosis (DVT).

In addition to the cases pending in New Jersey state court, more than 6,000 other cases are pending in federal court and other state court systems. The federal Yaz litigation has been centralized as part of a multidistrict litigation (MDL) before Judge Herndon in the U.S. District Court for the Southern District of Illinois.

At least three trial trial dates are anticipated in the federal MDL, one involving a pulmonary embolism, one involving a gallbladder injury and one involving a venous thromboembolism, with the first Yaz trial in federal court expected to begin early next year.

QUICK FACTS: YAZ LAWSUITS ALLEGATIONS
Throughout the United States, a number of Yaz birth control lawsuits have been filed against Bayer Healthcare Pharmaceuticals, Inc., which was formerly known as Berlex, Inc. and Berlex Laboratories, Inc., claiming that the drug makers:

Failed to adequately warn consumers and the doctors about the potential risk of Yaz side effects.
Failed to adequately test and research Yaz birth control before placing it on the market, which could have shown that patients would face an increased risk of heart attacks, strokes, pulmonary embolism, deep vein thrombosis and other life-threatening health problems.
Failed to issue a Yaz recall or remove the birth control pill from the market after it became apparent that it is an unreasonably dangerous drug, for which the harmful side effects outweigh any potential benefits provided over other available birth control pills.
Aggressively marketed Yaz and encouraged misuse and overuse despite the known Yaz dangers to maximize profits at the expense of patients’ health.

The drug makers had access to all the facts concerning the potential Yaz problems, and ignored the connection between their drug and deadly side effects. Yaz safety concerns were hidden and misrepresentations were made to to convince consumers and doctors to use the birth control pill instead of other available products. This increased the drug makers’ profits at the expense of women throughout the United States. Another example of corporations putting profits before people.

In complex litigation involving a large number of claims with similar underlying facts, early trials are useful in helping the parties gauge the strengths and weaknesses of their cases, and may help facilitate a possible Yaz settlement agreement that includes other lawsuits in the litigation.

Continue reading "Yaz Injury Update: New Jersey BellWether Trials To Start" »

As a Vaginal Mesh Defective Product Lawsuits attorney, and Texas Medical doctor I am providing this important update.

According to a safety communication issued by the Food and Drug Administration, Women who have vaginal surgery to fix a gynecologic condition called pelvic organ prolapse may wind up with more problems than benefits if a plastic mesh is used.

The FDA said it plans to convene an advisory committee to determine whether to ban the mesh - manufactured by Mass-based Boston Scientific Corp., Covidien PLC of Mansfield, and several other companies - for this procedure.

About 100,000 women with pelvic organ prolapse are treated with plastic mesh each year, but in most cases, according to the FDA, the condition can be treated successfully without mesh.

Mesh-related problems reported to the FDA include painful sexual intercourse, infections, urinary problems, and bleeding, usually from the mesh eroding through the stitched tissue or from skin contracting tightly around it.

Boston Scientific, is one of several companies that already face lawsuits over the mesh. Dozens of women who said they endured painful complications after the company’s mesh was implanted filed complaints last year in a California court, and many of the cases are now being transferred to jurisdictions across the country where the plaintiffs live.

Covidien, a company incorporated in Ireland with its corporate headquarters in Mansfield, supplies mesh to Bard, which markets it to health care providers to treat pelvic organ prolapse.
According to attorneys who represent more than 100 women in a complaint against Bard lodged in federal court in West Virginia, said the manufacturers initially designed the mesh for hernia repair. While regulators gave companies clearance to market it for pelvic organ prolapse repair, they did not look to see if, mechanically or otherwise, these products worked in the pelvis. “They should have known that they needed to check and test.’’

In 2008, the FDA announced that problems could be associated with transvaginal placement of the mesh, which is used along with surgical stitches to support sagging pelvic organs such as the bladder, uterus, and bowel after they have been lifted back out of the vagina, where they descended. From 2008 to 2010, the FDA received 1,503 adverse event reports associated with mesh used for pelvic organ prolapse repair, five times as many as the agency received from 2005 to 2007. It also received three reports of deaths that were related to the mesh placement procedure.

Recent studies indicate that about 10 percent of women who have the mesh placed transvaginally experience mesh erosion within 12 months of surgery and that more than half require additional surgeries to remove the mesh. Sometimes, the mesh becomes so intertwined with scar tissue that it cannot be removed. Furthermore, the FDA found that the mesh does not make the surgery any more effective.

According to Dr. William Maisel, the FDA’s deputy director of the Center for Devices and Radiological Health, “The evidence we reviewed calls into question the clinical benefit of mesh, and it certainly shouldn’t be used routinely for all transvaginal prolapsed repairs.''

In 2010, 75,000 women had vaginal surgery with mesh to repair pelvic organ prolapse. That surgery was performed three times as often as abdominal surgical mesh repair, according to the FDA, since it does not require a painful incision through the skin and offers a less painful recuperation for women.

The FDA cited studies showing abdominal mesh repair for pelvic organ prolapse led to vaginal erosion in 4 percent of women within 23 months of surgery. The FDA urged patients with the condition to ask their surgeon about all treatment options, including those without mesh, before having the operation.

The reassessment of surgical mesh comes as FDA reviews its fast-track system for clearing medical devices, which has been largely unchanged since the 1970s. Like 90 percent of medical devices sold in the U.S., pelvic mesh was cleared under the FDA's fast-track system, which grants market approval in 90 days to devices that are considered low-risk.

Medical device manufacturers have spent the last year lobbying the FDA and Congress to speed up device approvals as the government reviews the process. Safety advocates say the agency has been overusing the system and clearing high-risk devices that should be subject to more testing.

According to Dr. Diana Zuckerman, the agency should have required the studies it is now contemplating before mesh products were approved. "If they had been required to go through the more rigorous approval process, similar to that for prescription drugs, it would have been obvious years ago that surgical mesh has more risks than benefits in many types of surgery," said Zuckerman, who directs the National Research Center for Women & Families.

The FDA will hold a meeting in September to discuss studies that would identify which patients benefit most from mesh implants. The FDA will ask panelists at the meeting whether pelvic surgical mesh should be reclassified as a high-risk device.

Surgeons began using mesh to repair hernias in the 1950s, and over the next 40 years they adapted the technique for women's health conditions. FDA cleared the first mesh for prolapse in 2002, but since it was similar to devices that had been used for decades it did not have to undergo human testing.

The mesh was approved through the FDA's 510(k) process, which calls for companies to prove that a product is "substantially equivalent" to one already on the market -- usually without clinical studies on patients. The approval process is currently being scrutinized by the Institute of Medicine on behalf of the FDA.

Among the manufacturers are Boston Scientific Corp., American Medical Systems Inc. (now part of Pennsylvania-based Endo Pharmaceuticals) and Coloplast. Other companies making the mesh include Cook Medical, Covidien PLC, C.R. Bard Inc., and Ethicon, a division of Johnson & Johnson.

Continue reading "Vaginal Mesh Injury Lawsuits" »

Is an Actos recall in the works? As an Actos Bladder Cancer attorney, and Texas medical doctor I am providing this Actos update.

Actos (pioglitazone) is one of the world's widely prescribed diabetes medications. Also marketed in combination with glimepiride (Duetact) and metformin (Actoplus Met, Actoplus Met XR), Actos is used by millions of patients with Type-2 diabetes. The drug works by controlling blood glucose levels through its action with insulin.

Now, Actos has also been linked to life-threatening side effects. In June 2011, the Food and Drug Administration (FDA) issued a warning to alert patients and healthcare professionals of an increased risk of bladder cancer associated with Actos. This followed another FDA warning, issued in June 2007, with reports of liver damage and cardiovascular problems among patients taking Actos.

If you have been diagnosed with bladder cancer or another condition you feel may be linked to taking Actos, the FDA recommends that you schedule an appointment with your doctor immediately.

Bladder Cancer Risk and Actos Usage
The FDA issued its Actos bladder cancer warning after an interim analysis of a 10-year epidemiological study conducted by the drug's manufacturer, Takeda Pharmaceuticals. The analysis showed no increased risk of bladder cancer among users as a whole. The longest-term users of Actos and those with the highest cumulative dose of the drug showed increased levels of bladder cancer.

A separate study of Actos, conducted in France, has also linked the drug to bladder cancer. The FDA is aware of these findings and has stated that it intends to conduct a thorough review of the study and its findings. The agency has also stated that it will continue monitoring data from Takeda's ongoing study.

In the meantime, the FDA has advised patients that taking Actos for longer than a year puts them at risk. The FDA recommends that patients with active bladder cancer avoid taking Actos. Physicians should use caution when prescribing Actos to patients with a history of bladder cancer, weighing the benefits of the drug to the risk of recurrence.

The FDA has also provided the following tips for patients:

Taking Actos may increase your odds of developing bladder cancer
Go to a doctor if you notice that your urine is red in color or if you see blood; if you are experiencing an extreme urge to urinate or pain while doing so; or if you are experiencing pain in your lower abdomen or back
Do not take Actos if you are receiving bladder cancer treatment
Report any side effects you notice to the FDA MedWatch program
Read the medication guide you get with your Actos prescription, which contains detailed information on risks associated with the drug

These warnings and recommendations will appear on the Warnings and Precautions section of the drug's label, and in the accompanying medication guide.

Actos Side Effects and Potential Injuries
The FDA's latest Actos warning follows another warning issued in June of 2007. At that time, the agency issued a "black box warning" requiring the manufacturers of Actos and Avandia (known as thiazolidinediones) to include warnings alerting patients and their doctors of cardiovascular and liver problems linked to the drug. Black box warnings appear on the packaging of drugs and are the strongest action taken by the FDA short of a recall.

These warnings were issued after the findings of a Cleveland Clinic study showed that thiazolidinedione use increased the risk of heart attack by as much as 42 percent. The findings also showed an increased risk of hepatitis, liver inflammation, elevated liver enzymes (an indication of liver damage) and liver failure.

Continue reading "Actos Bladder Cancer Injuries" »

As a Dallas Medical Malpractice attorney, and Texas medical doctor, I am providing this update regarding the medical malpractice cases in Miami VA hospital with improperly cleaned equipment.

A Miami U.S. Air Force vet who says he contracted hepatitis C from a colonoscopy done at the Miami VA hospital with improperly cleaned equipment will go to trial in Miami federal court. A Coral Gables veteran who filed the medical malpractice lawsuit, claims that an improper colonoscopy at the Miami Veterans’ Administration hospital gave him hepatitis C.

11,000 U.S. veterans received colonoscopies with improperly cleaned equipment at VA hospitals in Miami, Murfreesboro, Tenn., and Augusta, Ga., between 2004 and 2009. Of the veterans who had the procedure at the three facilities, five have tested positive for HIV, 25 for hepatitis C and eight for hepatitis B.

Robert Metzler, now 69, a U.S. Air Force veteran, says he got a colonoscopy at the Miami VA hospital in 2007 and two years later was told he has hepatitis C.

The lawsuits were filed after a 2009 investigation by the VA’s own Administrative Investigation Board revealed more than 11,000 colonoscopies were done at three VA hospitals using equipment that had been rinsed after each patient rather than being sterilized by steam and chemicals as called for by the manufacturer. Investigators who took apart water tubes on some of the equipment that was supposed to be clean and ready for use instead found “discolored liquid and debris.”

The AIB report said the colonoscopies in Miami were done in an environment of inadequate training, lack of supervision and inadequate communication.

U.S. Army veteran Juan Rivera of Miami sued for medical malpractice when he became HIV positive after a colonoscopy at the Miami VA hospital, that case settled out of court in March 2011.

In the Metzler case, court papers filed by the USA in April 2011 argue that the chances that the veteran contracted hepatitis C from the VA equipment are no more than “two in one trillion.” Hepatitis C can’t survive outside a human host for more than four days, the documents say, and “substantially more than four days had passed” between any previous patient with Hepatitis C who had a colonoscopy and the one performed on Metzler.

Metzler’s case is based on the claim that he had a blood test in August 2006 at the VA, with no sign of hepatitis C. His colonoscopy was in June 2007 and he was notified in March 2009 that he needed to come in to the VA for testing because the endoscope used in the procedure may have been contaminated, accodring to his lawyer. A month later, he was told he was positive for hepatitis C.

Continue reading "Miami VA Colonoscopy Hepatitis C Case Goes to Trial " »

As a Multaq Dangerous Drug attorney and Texas medical doctor, I am providing this information on a drug company sponsored trial of its drug Multaq, which was halted because of increased cardiovascular side effects and injuries.

Sanofi, maker of dronedarone (Multaq), has stopped its phase 3b trial of its antiarrhythmic drug due to an increase in cardiovascular events seen in patients with permanent atrial fibrillation - an unapproved indication for the antiarrhythmic drug. The PALLAS trial was testing the drug in patients with permanent atrial fibrillation (AF) and at least one other cardiovascular disease risk factor; at present, dronedarone is approved in patients with nonpermanent AF.

According to the primary medical investigator, ". . . there was a significant increase in major cardiovascular events, and in our study that was defined as a composite of stroke, MI, systemic embolism, or cardiovascular death. . . . These were pretty important events."

Multaq, is approved for patients with the non-permanent kind of atrial fibrillation. The trial, known as the PALLAS study, was testing Multaq’s usefulness in patients with permanent atrial fibrillation (more than 6 months of the abnormal rhythms).

Dronedarone has faced a range of criticisms since its approval in the US in July 2009, including questions about its safety/efficacy tradeoff and the design and execution of the ATHENA study. Just last week, newspapers in France reported that French health authorities had concluded that the efficacy of dronedarone was "insufficient"—an opinion that could lead to the drug being dropped from the country's drug reimbursement formulary.

Dronedarone, sold by sanofi-aventis, is currently approved to treat atrial flutter and paroxysmal or persistent - but not permanent atrial fibrillation.

The phase 3b trial, called PALLAS, had enrolled 3,148 patients with permanent atrial fibrillation, with 70% showing symptoms for more than two years, according to a company statement. Sanofi did not specify the cardiovascular events seen in the dronedarone-treated patients, or the magnitude of the increase.

In January, sanofi-aventis and the FDA warned that reports of acute liver injury associated with the drug had been received. The statement noted that patients with permanent atrial fibrillation and "vascular risk factors" are at high risk for cardiovascular events.

An earlier trial of dronedarone in patients with relatively severe heart failure, called ANDROMEDA, was halted early when mortality in patients receiving the drug was found to be twice that seen in the control group.

Sanofi-aventis has alerted healthcare professionals to several reports of liver function test abnormalities and hepatocellular injury in patients treated with its atrial fibrillation drug dronedarone (Multaq). The Dear Healthcare Provider letter included two post-marketing case reports of acute liver failure that required transplantation, occurring at four-and-a-half and six months after the start of dronedarone therapy. The patients - both female and about 70 years old - had had normal hepatic serum enzymes before starting the drug.

In the letter, sanofi-aventis instructed healthcare professionals to tell patients to immediately report any symptoms suggestive of hepatic injury. According to the FDA, these include anorexia, nausea, vomiting, fever, malaise, fatigue, right upper quadrant pain, jaundice, dark urine, or itching.

Periodic liver enzyme tests, especially in the first six months of treatment, should also be considered, according to the FDA, although it is unknown whether such a strategy will prevent the development of liver injury.

Dronedarone's prescribing information will be updated to include the guidance from the Dear Physician letter, and will be distributed after the FDA approves it. The agency confirmed that a warning about potential liver injury will be added to the drug's label.

According to the FDA, from the drug's approval in July 2009 through October 2010, about 492,000 prescriptions for dronedarone were dispensed and about 117,000 patients filled prescriptions at U.S. pharmacies.

The drug was approved with a Risk Evaluation and Mitigation Strategy to prevent use in patients with severe heart failure or in those with less severe heart failure who were recently hospitalized for the condition. Such patients had a doubling in the risk of death in a placebo-controlled study.

Continue reading "Multaq Study Stopped: Linked to Other Heart Problems" »

According to a large European study published this week, Bisphosphonates, a class of drugs used to prevent and treat osteoporosis is associated with an unusual type of thigh fracture.

According to orthopedic surgeons, they were seeing an increase in cases where are severe fractures in which the thighbone snaps in two. Last October, the federal Food and Drug Administration announced a change in labeling on the drugs to reflect the risk of atypical fractures in patients taking bisphosphonates.

In the current study, published in the New England Journal of Medicine, researchers analyzed data from all 1.5 million women in Sweden who were age 55 or older in 2008. They obtained X-rays of 1,234 of the 1,271 women with fractures and found 59 who suffered the more unusual kind of fracture.

The women with atypical fractures were also compared with 263 controls with fractures in a similar location. The researchers found that 78% of the women with atypical fractures took bisphosphonates, compared with 10% of controls.

Bisphosphonates, which include brands such as Actonel, Zometa and Boniva, are used mainly by post-menopausal women as a way to prevent fractures that are associated with osteoporosis. Some 36.5 million prescriptions were dispensed for the drugs in 2010, and total U.S. sales were more than $4.2 billion.

Bisphosphonates examples include: Alendronate (Fosamax), Etidronate (Didronel), Ibandronate (Boniva), Risedronate (Actonel), Zoledronic acid (Reclast).

Per Aspenberg, a professor of orthopedic surgery at Linköping University in Sweden and a co-author of the study, said the findings indicated a patient's risk of fracture diminished by 70% after stopping the drugs for a year. Aspenberg noted that if a person has taken bisphosphonates for five years, they could stop taking the drug and its protective effect will last for at least another five years as the risk for atypical fractures decreases. Given this finding, Aspenberg thinks patients should take a drug holiday after five years.

Continue reading "Bisphosphonate Use and Atypical Femoral Fractures " »

As a Dallas Medical License Defense Attorney, I am providing this article regarding a Houston Pain Pill Mill Doctor being busted again. It looks like this guy and his cronies did not learn their lesson. This is a quick fire way to lose your medical and pharmacy licenses.

A physician and two pharmacists arrested in a Houston high-volume pill mill operation, had previously faced disciplinary probes for distributing controlled drugs, and all three had been allowed to continue to work despite those allegations, according to professional disciplinary records.

For two years Dr. Gerald Ratinov, the state's top prescriber of the pain killer drug hydrocodone, has been under investigation by the Texas Medical Board (TMB) for operating another Harris County pill mill. At that site, an unlicensed foreign medical graduate dispensed drugs and patients received pain pills without proper examinations in 2008.

During the TMB disciplinary action, Ratinov, a 76-year-old neurologist, opened the Astrodome Health Clinic in September 2010 — another site described as a pill mill, according to the Drug Enforcement Administration. And at that clinic and two other sites, he supervised unlicensed foreign medical school graduates and others who illegally supplied pills.

Ratinov now faces felony charges for illegally operating three pill mills: the Astrodome Health Clinic, The Abundant Life and Weight Loss Center and the Hobby Medical Center.

20 people face charges resulting from this week's pill mill sting, which involved three clinics and four pharmacies. The DEA, the Department of Public Safety, the medical and pharmacy boards and other agencies participated.

Two pharmacists arrested this week already had been on probation with the state Board of Pharmacy for previous prescription problems, according to Pharmacy Board records.

Continue reading "Houston Texas Pain Pill Mill Doctor Busted Again" »

As a Fort Worth Medical Practice Attorney, I want to share this Texas Medical Board bulletin, regarding a Denton, Texas doctor's fitness to practice medicine. A Denton County doctor who is quoted saying he does "what is best for the patient" is now considered "a continuing threat to the public welfare."

Medical Board Suspends License of Denton Physician
On March 14, 2011, a disciplinary panel of the Texas Medical Board temporarily suspended, with notice, the medical license of Ramon A. Cruz, M.D., of Denton, after determining that Dr. Cruz's continuation in the practice of medicine constitutes a continuing threat to the public welfare.

The panel found that Dr. Cruz, Lic. No. K3703, engaged in sexually inappropriate behavior with several patients. Four incidents, including an alleged sexual assault, were reported by patients to Denton Police. Patients reported four incidents to Denton police, including one alleged sexual assault.

His accusers say he used "aggressive behavior" toward them dating back to 2008, but no action was taken until this week. Documents reveal one patient accused Cruz of putting "his hand down the front of her pajama pants." Another patient alleges the doctor was "grabbing her from behind and putting his hand under her shirt."

Since the suspension, four additional women contacted police saying they also were victims of Dr Cruz, who touched them sexually and made inappropriate remarks, according to police reports.

One woman described three occasions when she either was in his office or in a hospital room. She said on one occasion she was hospitalized and drowsy on pain medication when he came into the room, lifted the sheet to look at her body and then leaned over and kissed her, according to the police report.

Another woman reported to police that he kissed her and made sexual comments to her during two visits to his office in September 2009.

A third woman said that during 2003 and 2004, when she was his patient, he tried to kiss her and touch her, a police report states.

The fourth woman reported to police she was hospitalized when he touched her and kissed her against her wishes.

Most of the women who have reported the doctor’s behavior so far have said they did not report it because they thought no one would believe them.

The panel found that Dr. Cruz's actions demonstrate a pattern of inappropriate behavior, which is a continuing threat to public health and safety. The suspension remains in effect until the Board takes further action.

Continue reading "Denton Texas Medical Doctor License Suspended Over Sex Assault Allegations" »

A Fort Worth Nurse license attorney, I am providing the latest update to a story I had commented on involving 2 nurses in West Texas.

A state grand jury in Winkler County, Tex., has indicted the sheriff, the county attorney and a hospital administrator for their roles in orchestrating the prosecution of two whistle-blowing nurses after they had reported allegations of malpractice.

The sheriff, Robert L. Roberts Jr., and county attorney, Scott M. Tidwell, each face six counts, including misuse of official information and retaliation, which are third-degree felonies. Stan Wiley, the administrator of Winkler County Memorial Hospital, in the West Texas town of Kermit, was indicted on two counts of retaliation.

Read full story here at the New York Times.

Continue reading "Sheriff Charged in Texas Nurse Whistle-Blowing Case" »

As a Fort Worth Texas Medical License Defense Attorney I am writing to update the following actions by the Texas Medical Board.

The Texas Medical Board met October 28-29, 2010. Since its August 26-27 board meeting, the Texas Medical Board has taken disciplinary action against 77 licensed physicians. The actions included 11 violations based on quality of care; 9 violations based on unprofessional conduct; 4 based on other states’ action; 1 based on peer review actions; 1 based on criminal convictions; 8 voluntary surrenders; 1 suspension; 3 revocations; 10 based on inadequate medical records; 1 based on inadequate supervision; 18 corrective orders; 1 cease and desist order; and 10 orders for minor statutory violations.

If you have been subjected to a TMB Inquiry Letter or TMB Disciplinary Process, then please contact the Fort Worth Texas Medical License Defense Attorney Dr. Shezad Malik. For a no obligation, free case analysis, please call 817-900-8439, 888-210-9693 or Contact Me Online.

Houston Physician Services & Professional License Defense

Having worked in both academic teaching hospitals and private hospitals through out the United States, Dr. Malik understands, perhaps better than most, the hard work and effort it takes to achieve the medical license and then to maintain it. Dr. Shezad Malik Law Firm concentrates in the representation of physicians and medical professionals in all matters relating to their professional license defense.

We focus on:

•Medical Board disciplinary actions
•Medical staff hearings
•Medi-Care audits and fraud defense
•Dental Board disciplinary actions
•Chiropractic Board disciplinary actions
•Pharmacy Board disciplinary actions
•Health Law Consulting
•Physician Practice Analysis
•Physician Advice and Counselling
•Physician Medical Licensing disputes
•Physician Peer review and disciplinary actions
•Third party Insurance and Medicare/Medicaid Audits
•Impaired Physician: Drug, Alcohol and Substance abuse

If you are a doctor and in danger of losing your medical license or being disciplined in some other manner due to a complaint brought before the Texas Medical Board or other professional boards, you should not face this situation on your own.

Accusations brought by one’s professional disciplinary system are extremely serious with the very real possibility of a permanent loss of the privilege to practice. Seek help immediately. Contact the Dr Shezad Malik Law Firm today and speak with our Texas Medical Board complaint defense attorney, Dr Shezad Malik.

Call 888-210-9693 now for further information and a confidential consultation.

Texas License and Medical Staff Privileges

We provide Medical License Defense for all types of medical practitioners. We represent and counsel health care provider clients in licensure and medical staff privilege matters. We handle matters on behalf of physicians, dentists, pharmacists, podiatrists, chiropractors, nurses and other licensed health care providers in Texas and other states.

For a health care provider there can be serious consequences of State licensing actions or hospital adverse actions including criminal actions, actions by other states or hospitals, negative reports to state and national data banks and to third party payors.

Somebody who is facing a State health care investigation or a potential adverse action by a hospital against his staff privileges, cannot take a casual approach to his predicament. Due to the serious impact of sanctions or disciplinary actions, medical providers are recommended to obtain experienced health care attorney advice and representation.

The Dr. Shezad Malik Law Firm understands this and has the experience necessary to resolve these matters. If you have received a letter of Inquiry from the Texas Medical Board (TMB) or are facing a TMB Disciplinary Process, please call us now at 888-210-9693 for a confidential consultation.

As a Dallas Medical License and Doctor Defense attorney, I am providing an update to the story I blogged about yesterday.

In an interview with News 8, Dr. Angela Cope, the clinic stated that they stand by their decision to insert a product they still believe is safe — despite warnings of counterfeits by the FDA and the manufacturer, Bayer Pharmaceuticals.

"There is not any medical difference in a Mirena imported from Canada versus a Mirena that's imported from America," Dr. Cope said.

But now, many women want to know how they can be sure their Mirena IUD is the FDA-approved version.

Read the full story here.

Continue reading "Grapevine Gynecology Doctor Speaks Out And Defends Foreign Mirena IUDs " »

As a Fort Worth Medical Licensing and Doctor license defense attorney, I read this story with alarm. The Texas Attorney General (OAG) filed lawsuit against a Grapevine Texas women’s health clinic for selling Mirena intrauterine devices (IUDs) that were not approved for sale in the United States.

The lawsuit names Women’s Integrated Healthcare, P.A. and six of its physicians as defendants: Angela L. Cope, M.D.; Barbara Coulter-Smith, D.O.; Katrina E. Allen, M.D.; Courtney Walters, M.D.; Monica E. Lopez, M.D.; and Wendy A. Kendrick, D.O.

Read the lawsuit here.

Read the Office of Attorney General full story here.

In December 2009, the defendants voluntarily stopped selling and administering the unapproved IUDs. The Office of the Attorney General is seeking a court order requiring that the defendants only purchase and sell FDA-approved IUDs, and will impose hefty civil penalties for violations of the Texas Deceptive Trade Practices Act (TDTPA) and the Texas Health and Safety Code.

You can also bet that the Texas Medical Board will weigh in with penalties, license complaints and sanctions.

Continue reading "Grapevine Texas Gynecology Clinic Charged With Offering Unauthorized Mirena IUD" »

For almost 20 years, federal law has required hospitals and medical boards to report doctors they discipline -- for medical incompetence, unprofessional conduct, and substandard care to the National Practitioner Data Bank.

It was designed to protect the public from bad doctors, particularly those who move to another hospital or another state to try to hide their mistakes.

The Data Bank allows hospitals and other medical organizations to see a doctor's disciplinary record before hiring him or her -- with a single, simple check instead of having to contact medical boards in every state.

Read the full story here.

Continue reading "U.S. hospitals Are Not Reporting Disciplinary Action to National Databank" »

Michael Jackson's doctor is "hanging on by a thread" and must be allowed to continue practicing medicine in order to pay for his defense on a manslaughter charge in the pop star's death, the physician's lawyers said in court papers.

Responding to a bid by the California attorney general to suspend Dr. Conrad Murray's medical license pending trial, attorneys Ed Chernoff and Joseph Low said that the effect would be devastating to the doctor who already faces a slew of financial problems.

Read full story here.

Continue reading "Michael Jackson Doctor Fights to Keep Medical License" »

Tobacco smoke contamination lingering on furniture, clothes and other surfaces, dubbed thirdhand smoke, may react with indoor air chemicals to form potential cancer-causing substances, a study found.

After exposing a piece of paper to smoke, researchers found the sheet had levels of newly formed carcinogens that were 10 times higher after three hours in the presence of an indoor air chemical called nitrous acid commonly emitted by household appliances or cigarette smoke. That means people may face a risk from indoor tobacco smoke in a way that’s never been recognized before, said one of the study’s authors, Lara Gundel.

Read the full Bloomberg article here.

Continue reading "Third hand Smoke Forms Cancer-Causing Residue Indoors" »

Los Angeles is awash in billboards and other outdoor signs advertising the weight loss treatment.

One feature of life in Southern California that's become hard to avoid is the relentless advertising for a weight-loss procedure known as lap-band surgery.

The billboards feature a willowy blond in a red tank top and the phone number 1-800-GET-THIN in huge red letters. "LOSE WEIGHT WITH THE LAP-BAND!" they say.

Read the full story here in the Los Angeles Times

Continue reading "Los Angeles Lap-Band Ads" »

It occurred to Anne Mitchell as she was writing the letter that she might lose her job, which is why she chose not to sign it. But it was beyond her conception that she would be indicted and threatened with 10 years in prison for doing what she knew a nurse must: inform state regulators that a doctor at her rural hospital was practicing bad medicine.

Read the full story at the New York Times

Continue reading "Texas Nurse to Stand Trial for Reporting Doctor Malpractice" »

In the world of fashion magazines, beauty editors have often relied on prominent dermatologists and plastic surgeons to keep them current on advances in cosmetic medicine. This relationship has benefited magazines eager for beauty scoops and doctors seeking visibility — and patients.

But now the Food and Drug Administration has cracked down on one of the most widely quoted cosmetic doctors, sending shudders through the ranks of opinion leaders in fashion publishing and vanity medicine. Read the FDA Warning Letter here. Download file

Read the full story here.

Three federal agencies -- the Food and Drug Administration, the Defense Department and the National Eye Institute -- announced last week that they are launching a three-year effort to gauge how many, and which, patients suffer troubling symptoms after undergoing the vision correction procedure called Lasik.

At the same time, the FDA issued letters reminding 17 walk-in surgical centers performing Lasik surgery of their obligation to report poor outcomes and patients' surgery-related medical complaints. The letters were issued after the FDA conducted a spate of inspections of Lasik facilities and found many had no system for collecting and transmitting to the FDA data on patients' reports of post-surgical "adverse events." More inspections are to come, the FDA said.

Continue reading "Federal Agencies to Assess Potential Lasik Problems" »

An expert panel reported that two more diseases may be linked to exposure to Agent Orange, a defoliant used by the American military during the Vietnam War.

People exposed to the chemical appear, at least tentatively, to be more likely to develop Parkinson’s disease and ischemic heart disease, according to the report. The report was written by a 14-member committee charged by the Institute of Medicine with determining whether certain medical conditions were caused by exposure to herbicides used to clear stretches of jungle.

The results, though not conclusive, are an important first step for veterans groups working to get the government to help pay for treatment of illnesses they believe have roots on the battlefield. Some other conditions linked to Agent Orange already qualify.

Continue reading "Parkinson Disease and Heart Disease linked to Agent Orange" »

Two West Texas nurses have been fired from their jobs and indicted with a third-degree felony carrying potential penalties of two-to-ten years' imprisonment and a maximum fine of $10,000.

The nurses, in their 50s and both members of the American Nurses Association/Texas Nurses Association, reported concerns about a doctor practicing at Winkler County Memorial Hospital in Kermit.

They alleged that the doctor improperly encouraging patients in the hospital emergency department and in the rural health clinic to buy his own herbal "medicines," and they thought it improper for him to take hospital supplies to perform a procedure at a patient's home rather than in the hospital.

Read an earlier post.http://www.bne.state.tx.us/

Continue reading "Update: Retaliation Against West Texas Nurses for Whistle Blower Complaint" »

During the early hours of a steamy July 2003 morning, Martin Memorial Medical Center chartered a private plane and sent 37-year-old Luis Jimenez back to Guatemala without telling his relatives in the U.S. or Guatemala — even as his legal guardian frantically sought to stop the move.

The man's guardian, also his cousin, is suing the hospital for essentially deporting Jimenez, who was an illegal immigrant. The hospital, which spent more than $1.5 million on his care over three years, says Jimenez wanted to go home.

Continue reading "Jury to Decide Negligent Deportation of Illegal Immigrant" »

The last time the government embarked on a major vaccine campaign against a new swine flu, thousands filed claims contending they suffered side effects from the shots. This time, the government has already taken steps to head that off.

Vaccine makers and federal officials will be immune from lawsuits that result from any new swine flu vaccine, under a document signed by Secretary of Health and Human Services Kathleen Sebelius.

Since the 1980s, the government has protected vaccine makers against lawsuits over the use of childhood vaccines. Instead, a federal court handles claims and decides who will be paid from a special fund.

The document signed by Sebelius last month grants immunity to those making a swine flu vaccine, under the provisions of a 2006 law for public health emergencies. It allows for a compensation fund, if needed.

Continue reading "Legal Immunity set for Swine Flu Vaccine Makers" »

Two West Texas nurses have been indicted after filing an anonymous complaint about a doctor's practices with the Texas Medical Board, but the state agency says the women did nothing wrong.

The nurses are charged with misuse of official information. Each one-page indictment filed against them alleges they improperly accessed information that was not public "with intent to harm" the doctor for "a nongovernmental purpose."

Among the nurses' complaints were that the doctor improperly encouraged patients to buy herbal medicines from him and had wanted to use hospital supplies to perform a procedure at a patient's home.

The Texas Medical Board defended the nurses' actions and said it's the board's state-mandated duty to look into such complaints.

Continue reading "Texas Nurses Face Charges After Filing TMB Complaint " »

An investor with Matrixx Initiatives, Inc. the maker of Zicam, has filed a proposed securities class action lawsuit in the United States District Court for the District of Arizona on behalf of shareholders of Matrixx Initiatives, Inc., who purchased Matrixx stock between December 22, 2007 and June 15, 2009, in relation to Matrixx Initiatives alleged violations of FDA regulations involving the Zicam Cold Remedy products.

Continue reading "Zicam Matrixx Initiatives, Inc. Investor Class Action Lawsuit" »

The American Nurses Association (ANA), which represents the interests of the nation’s 2.9 million registered nurses, is joining forces with the Texas Nurses Association (TNA) to strongly criticize the recent indictment and prosecution of two registered nurses in Winkler County, Texas, for reporting to the Texas Medical Board their concerns about a physician’s standard of practice at the Winkler County Memorial Hospital in Kermit, Texas.

ANA and TNA are gravely concerned about the chilling effect the county’s actions could have on future nurse "whistle blowers" who advocate for their patients in the nation’s hospitals. An initial hearing on the nurses’ motions to dismiss the case was held July 15 in the Winkler County Courthouse but no rulings were made on any of the motions.

Continue reading "Nurse Association Targets Winkler County Hospital Texas" »

U.S. District Judge Cecilia M. Altonaga, who is handling the consolidated Fixodent and Super PoliGrip lawsuits filed over zinc poisoning from denture creams, issued an order designating lawyers to serve in leadership positions in the MDL, or Multidistrict litigation. These denture cream lawyers will perform services that benefit all of the plaintiffs involved in the litigation during the pretrial proceedings.

On June 9, 2009, the Judicial Panel on Multidistrict Litigation centralized all federal denture cream lawsuits before Judge Altonaga in the U.S. District Court for the Southern District of Florida, for coordinated discovery and pretrial litigation.

Continue reading "Denture Cream Lawsuits" »

Has a Zicam nasal cold remedy robbed you of your sense of smell, and possibly the ability to taste? If so you have probably been stricken with a condition called anosmia – loss of sense of smell, sometimes accompanied by loss of sense of taste - related to the presence of zinc gluconate in Zicam intranasal cold remedies. Like thousands of other people who have used Zicam nasal gel or swabs, you probably had no idea that these products could be so dangerous.

Matrixx Initiatives, Inc. has had to remove several varieties of Zicam nasal cold remedies from the market because of their association with anosmia. The lawyers at our firm are currently representing scores of people in personal injury lawsuits who lost their ability to smell, and in some cases taste, after using a Zicam nasal gel or swab to treat or prevent a cold.

Continue reading "Zicam Lawsuit and the FDA" »

A $31 million verdict against Miami Valley Hospital in Dayton, Ohio, could be the largest jury award for a medical malpractice case in Ohio history, though a settlement agreement makes it unlikely the hospital will have to pay that much.

As the jury was deliberating, after a four-week trial before Montgomery County Common Pleas Judge Timothy O’Connell, attorneys for the hospital and the family of Leondo Stanziano worked out a settlement agreement.

Continue reading "$31 M Verdict Against Ohio Hospital Negated by Settlement Agreement" »

Is Gary Kao a renegade physician, or maybe just a doctor who was allowed to get in over his head?

Kao is the only person whom officials have identified in the unfolding scandal over substandard radioactive seed implants at the Philadelphia VA Medical Center.

As the radiation oncologist who did most of the implants, Kao played a central role. But a cast of actors supported and directed him - week after week, for six years - until the VA suspended the program a year ago.

Those actors included a medical physicist with little experience in developing implant treatment plans, a radiation-safety committee that allowed crucial radiation-dosage calculations to go undone, and Nuclear Regulatory Commission inspectors who let Kao revise two patients' treatment plans to avoid reporting medical errors, according to the Veterans Affairs investigation report.

Continue reading "Troubles at Philadelphia VA Continue" »

A Harris County Texas jury has ruled in favor of a Houston man in a medical malpractice case, awarding him $10 million in damages stemming from a lawsuit against Methodist Hospital and the doctors who treated him there.

John German developed gangrene that required the amputation of his left leg above the knee, all the toes on his right foot and all of his fingers in the aftermath of heart surgery in 2002 .

“It’s been a long time coming, but I feel vindicated,” said German, who was a 32-year-old mechanic at the time of the care.

Continue reading "Texas Patient Awarded $10 M in Medical Malpractice Claim" »

FDA has required the manufacturers of the smoking cessation aids varenicline (Chantix) and bupropion (Zyban and generics) to add new Boxed Warnings and develop patient Medication Guides highlighting the risk of serious neuropsychiatric symptoms in patients using these products. These symptoms include changes in behavior, hostility, agitation, depressed mood, suicidal thoughts and behavior, and attempted suicide. The same changes to the prescribing information and Medication Guide for patients will also be required for bupropion products (Wellbutrin and generics)that are indicated for the treatment of depression and seasonal affective disorder.

Continue reading "FDA: Varenicline (marketed as Chantix) and Bupropion (marketed as Zyban, Wellbutrin, and generics)" »

At the request of the FDA, U.S. Marshals raided generic drug manufacturer Caraco Pharmaceutical Laboratories, Ltd., shutting down manufacturing and seizing inventory. The action came after FDA inspections found that the drug maker was continuing to fail to meet federal safety and health requirements.

In March 2009, Caraco recalled digoxin, a heart medication, after it was discovered that some tablets distributed were thicker or thinner than they were supposed to be. This created a serious risk for consumers, as receiving too much of the drug could cause a potentially life-threatening condition known as digoxin toxicity, and receiving too little of the medication could result in injury from the underlying heart condition.

Continue reading "Caraco Digoxin Manufacturer Raided by Federal Agents" »

The following is a summary of the changes effective on June 24, 2009. Click here for the complete board rules.

Chapter 162, Supervision of Medical School Students, with amendments to §162.1 Supervision of Medical Students, which clarifies the intent of the amendment previously adopted, which became effective on March 9, 2009. The Board determined that the revised language was necessary based on questions received regarding interpretation.

Chapter 165, Medical Records, with amendments to §165.3, Patient Access to Diagnostic Imaging Studies in Physician’s Office, which expands the rule to include non-static diagnostic imaging studies and imaging studies that are maintained in electronic format. The Board determined that the rule change was necessary to clarify the definition of diagnostic imaging studies for the purpose of releasing such records to requestors for medical records.

Chapter 173, Physician Profiles, with amendments to §173.1, Profile Contents, which requires that the profile of each licensed physician shall contain the physician's full name as the physician is licensed. The Board determined that the change was necessary to allow the Board to appropriately track all physicians licensed by the Board rather than allowing physicians to identify themselves under multiple names when submitting documents to the Board.

Continue reading "Texas Medical Board New Rules June 2009" »

Since its April board meeting, the Texas Medical Board has taken disciplinary action against 71 licensed physicians.
The actions included 15 violations based on quality of care; 11 actions based on unprofessional conduct; two nontherapeutic prescribing violations; six agreed orders based on inadequate medical records violations; one action based on impairment due to alcohol or drugs or mental/physical condition; four actions based on other states’ or entity’s actions; one action based on failure to properly supervise or delegate; two actions based on peer review actions; two actions based on violation of probation or prior order; one agreed order modifying a prior order; and five voluntary surrenders. Twenty-one physicians entered into administrative orders for minor statutory violations.

At its May 28-29 meeting, the board issued 526 physician licenses.

Continue reading "Texas Medical Board Disciplines 71 Doctors" »

When Debbie Daniels was scheduled to undergo a hysterectomy in 2003, her doctor suggested he do a "tummy tuck" as well.

But the obstetrician/gynecologist did not tell her that he had never been trained to perform the procedure that gets rid of excess skin and fat.

She also did not know he had been kicked off the staff of another hospital for doing tummy tucks without proper credentials -- or that he did the procedure unlike any other doctor, according to court records.

Two days after Dr. David Lee Grimes cut Daniels open and stitched her back up, her wound burst, leaving a basketball-sized hole in her belly 7 to 8 inches deep, one of her lawyers said. She had to undergo emergency surgery -- the first of many -- and be placed in a medically induced coma for a month.

Continue reading "Woman Who Sued Doctor's Insurer Awarded $3.8 M" »

The Texas Medical Board entered an Automatic Suspension Order against Rodney Norman Dotson, M.D., license number D9988, on Monday, May 4, after determining that Dr. Dotson had violated a previous disciplinary order.

The February 8, 2008, Mediated Agreed Order required, among other provisions, that Dr. Dotson take and pass the Special Purpose Examination. The 2008 order also contained a provision that, after a proper hearing, if a Board panel found that Dr. Dotson had violated this term of the 2008 order, his license could be automatically suspended.

Continue reading "Texas Medical Board Suspends License of Rodney Dotson, M.D. " »

The following is a summary of the changes effective on May 6, 2009. Click here for the complete board rules.

Chapter 166, Physician Registration, with amendments to §162.2 Continuing Medical Education, would allow members of the Board’s Expert Physician Panel up to 12 hours of formal continuing Medical Education for time actually spent in reviewing standard of care cases and providing a report to the board.

Continue reading "TMB May 2009 Board Rules Changes " »

A woman who said she developed ulcerative colitis from taking Accutane was awarded $10.5 million by a New Jersey jury. It was the third of 425 lawsuits alleging that Accutane caused inflammatory bowel disease in some users to go to trial. All three cases have resulted in multi-million dollar judgments against Hoffman-LaRoche, Inc., the maker of Accutane.

Approved by the Food & Drug Administration (FDA) in 1982, Accutane has been the subject of controversy for years. In addition to inflammatory bowel disease, the drug has been associated with myriad other serious side effects.

It was known in the late eighties for causing severe birth defects. It has also been known to cause psychiatric problems, and has been linked to 266 cases of suicide in the United States.

In addition to inflammatory bowel disease, Accutane has also been associated with problems of the liver, kidneys, central nervous system, and pancreas, as well as the cardiovascular, musculoskeletal and auto-immune systems.

Continue reading "Accutane Injury Results in $10.5 Million Judgment" »

Women who have their healthy ovaries removed when they have a hysterectomy face a higher risk of death -- including death from coronary heart disease and lung cancer -- than women who keep their ovaries, according to new research.

The finding from a study published in the May issue of the journal Obstetrics & Gynecology challenges conventional wisdom that removing ovaries along with the uterus offers the best chance for long-time survival.

Continue reading "Routine Removal of Ovaries is Questioned by New Research" »

Kaiser Permanente has agreed to pay $1 million to settle claims on behalf of five patients alleging that the HMO mishandled its kidney transplant program, endangering lives and causing deaths.

The arbitration claims were filed in 2006, found that Kaiser's Northern California kidney transplant program jeopardized hundreds of patients by forcing them into a new program unprepared to handle an enormous caseload.

Continue reading "Kaiser Permanente to Settle Kidney Transplant Claims For $1 M" »

A bill that was the subject of a 5½-hour hearing would sharply curtail the powers of the Texas Medical Board if it becomes law.

Backers argued that it would bring much-needed transparency and provide greater fairness to doctors whom, some say, the board is persecuting. They especially raised concerns about practitioners of alternative medicine and those who treat conditions such as autism.

Continue reading "Texas Medical Board Subjected to Hearing" »

Reglan side effects have been associated with the development of tardive dyskinesia, a syndrome that causes involuntary movements in the body extremities, particularly the lower face. In February 2009, the FDA required that a “black box” warning about the tardive dyskinesia problems be added to Reglan and other gastrointestinal drugs containing metoclopramide.

REGLAN LAWSUIT STATUS: Lawyers are reviewing potential claims for individuals who may be entitled to compensation through a Reglan lawsuit as a result of developing tardive dyskinesia.

Continue reading "Reglan Lawsuits" »

After a 19-year-old Orange County, Calif., man killed two neighbors in 2005, the victim's survivors sued the murderer's psychiatrist, accusing him of causing the rampage by giving his client an unstable mix of antidepressants.

But California's 4th District Court of Appeal ordered summary judgment for the doctor, saying that the patient had a pre-existing mental disorder that "necessitated" treatment.

"As early as 2001, [William] Freund had exhibited violent tendencies toward his parents," Justice Raymond Ikola wrote. "And when he later became [the doctor's] patient, he already suffered from Asperger's syndrome and the consequent frustration about his extreme social problems.

Continue reading "Calif. Appeals Court: Psychiatrist Not Liable to Patient's Victims, " »

A Michigan hospital can be sued for releasing a man who killed his estranged wife with an ax 10 days later, a federal appeals court ruled.

The decision by a three-judge panel of the 6th U.S. Circuit Court of Appeals reinstates a lawsuit filed by the estate of Marie Moses Irons against Providence Hospital.

The panel cited a federal law that requires hospitals to stabilize patients if an emergency condition exists, though it couldn't find any precedent for allowing a non-patient who alleges harm to sue.

Continue reading "Mich. Hospital That Released Man Who Killed His Wife Can be Sued" »

The 3rd Circuit has ruled that children allegedly injured by vaccines are barred from pursuing any design defect claims because Congress expressly prohibited such suits in an effort to guarantee immunity to manufacturers.

By rejecting the analysis of a recent ruling from the Georgia Supreme Court, the 3rd Circuit's ruling in Bruesewitz v. Wyeth Inc. creates a direct split between the federal courts and a state's highest court on the question of how broadly courts should read the pre-emption clause in the National Childhood Vaccine Injury Act.

Continue reading "3rd Circuit: Kids Hurt by Vaccines Cannot Pursue Design Defect Claims" »

A congressional study and a national consumer advocacy group found that the health care industry in 2004 had spent millions of dollars exaggerating the malpractice crisis in Nevada and elsewhere in the country.

But the hard-hitting television campaign of five years ago, helped persuade voters to overwhelmingly approve an industry-backed ballot initiative imposing a $350,000 cap on malpractice damages for pain and suffering. Advocates said the intent of the measure, patterned after 1975 tort law changes enacted in California that imposed a $250,000 cap, was to reduce multimillion-dollar verdicts against doctors, which would lower their insurance premiums and reduce health care costs for the public.

Continue reading "Nevada Attorneys Hope to Lift Malpractice Damages Cap " »

A Staten Island man stricken with polio has won a multimillion dollar lawsuit against a drug maker, claiming he contracted polio 30 years ago while changing his daughter's diaper.

Dominick Tenuto was awarded $22.5 million, believed to be one of the highest awards ever on Staten Island.

The lawsuit claims that the oral vaccine Tenuto's daughter received, which contained a live virus, passed through her body and infected Tenuto while he was changing her diaper.

The 61-year-old Tenuto, a former Wall Street executive, sued two years after contracting polio and losing his job.

The drug maker, Lederle Laboratories, plans to appeal.

The following is a summary of the changes effective on March 9, 2009.
Click here for the complete board rules.

Chapter 162, Supervision of Medical School and Physician Assistant Student, with amendments to §162.1, Supervision of Medical Students, provides for the supervision of a medical student who is not enrolled at a Texas medical school as a full-time student or visiting student.

Chapter 171, Postgraduate Training Permits, repeals §171.7, Inactive Status, repeals a provision that recognizes an inactive status of a physician in training permit.

Continue reading "Texas Medical Board March 2009 Board Rules Changes" »

A Houston judge is sentencing a Beaumont cardiologist on charges he molested two girls, and although Dr. Jeffrey Klem will not receive jail time, the doctor will be placed on probation and must write a letter of apology to the girls.

Dr. Klem is receiving five years deferred adjudication on each charge of Injury to a Child. Under the terms of a plea agreement, he will not have to register as a sex offender.

Continue reading "Beaumont Doctor Sentenced For Improperly Touching Two Girls" »

Chelsie Barker, now a 10-year-old girl, needs round-the-clock attention as a result of a lack of oxygen during birth in a Michigan jail.

Jail officers are being sued in federal court, for violating the girl’s constitutional rights by not getting her mother, an inmate, to a hospital for the delivery.

Their defense is Roe v. Wade, the landmark abortion decision. Attorneys for the officers say they are not liable because the child had no 14th Amendment right before she was born.

The jail officers “had sufficient warning that the child was on the way and did not get her the medical care she needed immediately prior to, during, and after the birth,” according to the U.S. District Judge.

Continue reading "Birth Injury in Jail Leads to Lawsuit " »

According to plaintiffs' attorneys AstraZeneca PLC failed to warn physicians and patients about risks associated with its widely used schizophrenia drug Seroquel.

According to documents that were just unsealed in a U.S. federal court case showed AstraZeneca knew about the risk of weight gain and diabetes in 2000.

The company "not only failed to warn physicians and patients about the risk of diabetes but they also marketed them in a way that represented that there was no risk."

Continue reading "Seroquel Increased Risks of Diabetes" »

A class of drugs to treat stomach disorders needs a strong warning about the risk of involuntary, repetitive movement on several parts of the body seen with long-term use or high doses, according to U.S. regulators.

The drugs contain the ingredient metoclopramide and are available in various forms including tablets, syrups and injections, the Food and Drug Administration said.

According to the FDA more than 2 million Americans use the medicines to treat gastroesophageal reflux disease and other stomach ailments.

Continue reading "FDA Requires Boxed Warning and Risk Mitigation Strategy for Metoclopramide-Containing Drugs" »

Dallas based dietary supplements seller Mannatech Inc. will return $4 million to customers and its founder will pay a $1 million fine for lying about the health benefits of its products, according to the Texas attorney general’s office.

Attorney General Greg Abbott said the Coppell-based company tricked people into thinking its products would prevent, treat or even cure diseases.

Continue reading "Coppell Texas Mannatech to Pay Millions to Settle Diet-Supplement Lawsuit" »

A California jury has awarded nearly $7 million to a 56-year-old woman who was unknowingly infected with herpes by a 77-year-old man.

The lawsuit alleged that Thomas Redmond knew he had genital herpes for more than 25 years but did not disclose it before his sexual relationship began with Patricia Behr and did not use a condom.

The lawsuit claimed that Behr suffered unnecessary stress and humiliation as a result of the defendant's conduct, which it called "outrageous and beyond the bounds of decency."

Continue reading "California Woman Infected With Herpes Wins Lawsuit" »

A California doctor accused of molesting female patients during medical procedures has been ordered to stop practicing medicine until further notice.

Dr. Peter Chi, has turned in his license, according to the Medical Board of California. He previously had been ordered by a San Joaquin County judge to stay away from the Beauty Renewed Laser Skin Center, where he served as the medical director.

Chi, a cosmetic surgeon, made his first court appearance and is out on $100,000 bail. He has been charged with seven counts of sexual battery by fraud, one count of sexual battery and three counts of rape by a foreign object.

A total of eight women, said that they were violated during cosmetic surgery procedures or postoperative exams at his clinic between September 2007 and December 2008. Most of the women, who were 25 to 39 years old at the time, were unconscious while the molestation occurred.

Continue reading "California Surgeon Charged With Molesting Patients " »

DALLAS — A Bedford infectious-disease specialist has been ordered to pay $7.5 million to a former maintenance man who lost his arms and legs to an MRSA infection.

Judge Jim Jordan ordered Dr. Meenakshi Prabhakar to pay David Fitzgerald after a Dallas County jury found in Fitzgerald's favor in his medical malpractice lawsuit. Prabhakar treated Fitzgerald in 2003 when he developed an infection following surgery at RHD Medical Center in Farmers Branch. Photo courtesy of Dallas Morning News

Continue reading "Dallas Doctor Ordered to Pay Man Who Lost Limbs $7.5M " »

The Florida doctor's license was revoked in the case of a teenager who planned to have an abortion but instead gave birth to a baby she says was killed when clinic staffers put it into a plastic bag and threw it in the trash.

The doctor, Pierre Jean-Jacques Renelique, was not present when the baby was born, but the Florida Medical Board upheld Department of Health allegations that he falsified medical records, inappropriately delegated tasks to unlicensed personnel and committed malpractice.

Continue reading "Florida Doctor Loses License in Live Birth Abortion Case" »

According to federal drug officials, many doctors may lose their ability to prescribe 24 popular narcotics as part of a new effort to reduce the deaths and injuries that result from these medications inappropriate use.

A new control program will result in restrictions on the prescribing, dispensing and distribution of extended-release opioids like OxyContin, fentanyl patches, methadone tablets and some morphine tablets.

Continue reading "F.D.A. to Restrict Prescriptions of Narcotics " »

At its February 5-6 meeting, the Texas Medical Board took disciplinary action against 32 licensed physicians; in addition, the board has issued one temporary suspension since its last meeting.

The actions included 11 violations based on quality of care; seven actions based on unprofessional conduct; one mediated agreed order modifying a prior order; three actions based on other states’ actions; four actions based on inadequate medical records violations; two actions based on impairment due to alcohol or drugs or mental/physical condition; one advertising violation; and four voluntary surrenders. The board also accepted the voluntary surrender of one surgical assistant’s license.

At its February 5-6 meeting, the Texas Medical Board issued 399 physician licenses.

For further information click here.

Hospital companies in Texas, many of which collect millions in state and federal funds, operate with minimal public disclosure of deficiencies. The state keeps information on complaints and inspections largely private because influential health care corporations want it that way, and Texas legislators have obliged.

As a result, it is next to impossible for the public to determine whether state enforcement works properly. Hospital lobbyists designed much of this system.

The Texas Department of State Health Services provides, on its Web site, a small amount of data on hospital fines. The department also furnishes limited and heavily redacted violation records to anyone who makes a formal open-records request, pays in advance and sometimes waits months for delivery.

Continue reading "State of Neglect: Texas Law Lets Hospitals Hide Problems" »

The Texas Medical Board (TMB) is charged with licensing physicians and enforcing the Texas Medical Practices Act. During the 2007 session and interim, TMB has been under intense legislative scrutiny for administrative, enforcement, and licensure issues. Last session, lawmakers increased the agency’s appropriation by $3.4 million — to $18.4 million for the biennium — so it can better manage the backlog of license applications. In exchange, the board was directed to cut the average processing time for a new license to 51 days. TMB reports it has met this goal and initiated an online application process to further speed up licensure.

Continue reading "Texas Medical Board Update" »

Medical malpractice reform enacted five years ago succeeded in cutting the number of lawsuits against doctors and increasing the number of physicians working in Texas.

But state medical board investigators say it also left them with an unbearable workload.

While the Texas Medical Board's staffing increased 28 percent from 112 employees in fiscal 2002 to 143 in fiscal 2008, physician and patient settlements through the board have increased 202 percent, according to the board's statistics.

In next year's legislative session, the TMB will be asking for 11 additional full-time workers to help with investigating and resolving complaints against doctors.

Continue reading "Texas Medical Board Falling Behind On Complaints " »

There are 50 items on the nursing jurisprudence examination (NJE). You must correctly answer 75% of the questions to pass the NJE. You will have two (2) hours to complete the NJE. Displayed in the upper right hand corner of the computer screen will be a digital clock and the question number so you can monitor your progress throughout the NJE.

You are permitted to access the Board of Nursing (BON) website and other resource material throughout the exam to locate the answers to questions. The NJE will run in another window, thereby leaving this window open to access reference materials on the BON website.

A Passing Result will be posted and recorded to the BON system when all 50 questions are answered and a minimum of 38 questions are answered correctly. A certificate will be available for printing at the end of the examination process. Once a passing result is recorded, Board Staff will be notified and the jurisprudence exam requirement will be updated as completed in your BON file. Keep the certificate for your records. Do not mail the certificate to the BON.

Continue reading "Texas Nursing Jurisprudence Exam" »

Rule Changes Adopted
The board adopted the following rule changes that were published in the Texas Register:

Chapter 163, Licensure, amendments to §163.5, Licensure Documentation.

Chapter 165, Medical Records, amendments to §165.1, Medical Records; §165.5, Transfer and Disposal of Medical Records.

Chapter 166, Physician Registration, amendments to§166.2, Continuing Medical Education; and §166.6, Exemption from Registration Fee for Retired Physician Providing Voluntary Charity Care.

Continue reading "Texas Medical Board Implements New Rules" »

Since its last board meeting, the Texas Medical Board took disciplinary action against 59 licensed physicians. The actions included 13 violations based on quality of care; two actions based on unprofessional conduct; three actions based on violations of probation or prior orders; three actions based on other states’ actions; six actions based on inadequate medical records; four actions based on impairment due to alcohol or drugs or mental/physical condition; two actions based on nontherapeutic prescribing; two actions based on failure to properly supervise or delegate; one action based on a criminal conviction; three voluntary surrenders; two violations of failure to obtain required continuing medical education; two administrative agreed orders; and 12 licensees agreed to enter into administrative orders with the board for minimal statutory violations.

Continue reading "Texas Medical Board Disciplines 59 Doctors and Issues 479 Physician Licenses" »

A Florida man, who is suing two Broward County doctors for malpractice in a rare case allowing a punitive damages claim.

The man claims his plastic surgeon later lied about his detached role in the botched surgery, created two sets of medical records to hide the truth and still billed his insurance company for performing surgery.

The Broward Circuit Judge issued an order in July putting punitive damages in play, and Florida's 4th District Court of Appeal on Sept. 29 denied a petition for a writ of certiorari on the issue. The trial is set for March 2.

Continue reading "Florida Med-Mal Case With Punitive Damages Claim" »

A panel of the Texas Medical Board temporarily restricted the license of a doctor based in Conroe, after determining that the doctor’s unrestricted practice of medicine presents a continuing threat to the public welfare.

The action was based on the panel’s findings that the doctor was responsible for violations in the standard of care, nontherapeutic prescribing, prescribing to persons who were known or should have been known to be engaged in substance abuse or diversion, and his failing to adequately supervise the activities of persons operating under his supervision. These findings were made as the result of a criminal investigation involving patients who had obtained narcotics prescriptions from clinics under the doctor's medical direction.

Continue reading "Texas Medical Board Temporarily Restricts Doctor's License" »

The U.S. government must pay $8.6 million in damages because a military doctor at Scott Air Force Base failed to diagnose a case of flesh-eating bacteria according to a federal magistrate judge's ruling.

The former wife of an Air Force captain, testified that she sought treatment at the base hospital emergency room for pain and swelling in her right arm in 2002.

According to court documents, the doctor was concerned the woman was a drug addict wanting a prescription, advised her to go home and take Motrin.

A month later, the situation got progressively worse and the woman was taken to the emergency room. The woman was then diagnosed with necrotizing fasciitis, a strep infection that decays soft tissue.

Continue reading "Scott AFB Doctor Liable in $8.6 M Judgment" »

More than a decade ago, Massachusetts became the first state to mandate its medical board to post physician profiles online. Patients could find a physician's hospital affiliations, hospital and medical board disciplinary actions, medical malpractice payments and other data.

The Massachusetts board's idea to display physician data on an easily accessible Web site was novel in 1996. Many physicians were skeptical in the beginning, resulting in a heated debate of how to post information that was useful to the public and fair to doctors.

"It has worked out reasonably well," said Massachusetts Medical Society President. "It is an opportunity for patients to step up and see information such as where a physician has received training, whether they are board certified, whether they have malpractice suits against them and whether or not the suit falls in what one might expect in that specialty."

Continue reading "State Medical Boards Want Transparency" »

Medicare paid a Pennsylanvia hospital $6.15 million in the 2003 to treat some of the Erie hospital's oldest, sickest patients. Now the hospital will pay $1.9M to settle a whistle-blower lawsuit that claimed the hospital submitted Medicare claims that exceeded its actual costs.

Seven hospitals have reached settlements in connection with the lawsuit, filed in 2005 by an independent hospital consultant from New Jersey. Saint Vincent is the only hospital in this region named in the suit.

Continue reading "Hospital to pay $1.9M in Whistleblower Suit" »

Diabetic supply maker Bayer Healthcare, a unit of Bayer AG, has agreed to pay $97.5 M to settle claims that it paid kickbacks to several diabetic suppliers and caused them to submit false Medicare claims, according to the U.S. Justice Department.

Bayer agreed to enter into a corporate integrity agreement -- which allows companies to continue in the federal Medicare program while requiring steps to safeguard against fraudulent behavior -- as part of the settlement, the department said.

Continue reading "Bayer Healthcare Dinged For $97.5M in Kickback Settlement" »

A panel of the Texas Medical Board has temporarily suspended the license of Eli T. Anderson, M.D., license #E6214, of Houston , after determining that Dr. Anderson's continuation in the practice of medicine presents a continuing threat to the public welfare.

The action was based on evidence the board received that Dr. Anderson tested positive for a cocaine metabolite in June, 2008, while undergoing drug testing required as a condition of his placement on five years deferred adjudication probation for possession of cocaine, a third degree felony, in Clay County, Texas, in June, 2005. In 2007, Dr. Anderson was again arrested in Lubbock for possession of drug paraphernalia. In addition, at the Board's temporary suspension hearing, Dr. Anderson admitted on the judicial record that he had used cocaine since 2002, and that he had used cocaine as recently as November, 2008.

Continue reading "Texas Medical Board Suspends License of a Houston Doctor " »

A panel of the Texas Medical Board suspended the license of Harold Clay Henderson, M.D., of Dallas, license number G3937, after determining that Dr. Henderson’s continuation in the practice of medicine presents a continuing threat to the public welfare.

The temporary suspension hearing took place Monday, October 27, under the Board’s authority, granted by S.B. 104 of the 78th Legislature, to suspend or restrict a physician’s license without notice when it determines the physician’s continuation in practice would constitute a continuing threat to the public welfare. The suspension is effective immediately.

The action was based on the panel’s finding of Dr. Henderson’s inability to safely practice medicine due to intemperate use of drugs or alcohol, or mental or physical disability. The panel also found that Dr. Henderson had aided and abetted the unlicensed practice of medicine by employing a physician in his office whose licensed was suspended.

The length of a temporary suspension is indefinite and it remains in effect until the board takes further action.

Also on Monday, a panel of the board temporarily restricted the license of Donald Delmer Pope, M.D., license #F4386, of Brownwood.

The action was based Dr. Pope’s guilty plea to a felony charge of aggravated sexual assault of a female under 14, and his receiving eight years of deferred adjudication as a sex offender. The restriction requires that Dr. Pope have no contact with any female patient under 17 and that he have an independent medical evaluation, follow the evaluating psychiatrist’s recommendations and submit the treating psychiatrist’s reports to the board.

The temporary restriction is effective immediately and remains in effect until the board takes further action.

If you have been subjected to a TMB Inquiry Letter or TMB Disciplinary Process, then please contact the Doctor Attorney Dr. Shezad Malik of Southlake, Texas. For a no obligation, free case analysis, please call 817-255-4001 or Contact Me Online.

The Texas Medical Board has named Alan T. Moore, M.D., as interim medical director of the agency.

Dr. Moore graduated with honors from the University of Texas at Austin and received his medical degree from the U.T. Southwestern Medical School, where he was a member of Alpha Omega Alpha Honor Society. He completed his anatomic and clinical pathology residency at Parkland Memorial Hospital in Dallas, where he served as chief resident during his fourth year. He also completed a hematopathology fellowship at Parkland.

Dr. Moore is board certified in anatomic pathology, clinical pathology and hematopathology. He has practiced in Austin for more than 20 years and has served as president of Clinical Pathology Associates as well as on the board of Clinical Pathology Laboratories; medical director of Seton Medical Center Laboratory; chief of Staff at Seton Medical Center; and president of the Texas Society of Pathologists. He has also served as the transplant pathologist for the Seton Medical Center Cardiac Transplant Program.

The board also named Mari Robinson, J.D., interim Executive Director of the agency following the retirement of former executive director Donald W. Patrick, M.D., J.D. Robinson began her career at TMB as a litigation attorney in 2001 and has served as Director of Enforcement since 2006.

State law requires that, if the agency executive is a non-physician, a medical director be hired.

If you have been subjected to a TMB Inquiry Letter or TMB Disciplinary Process, then please contact the Doctor Attorney Dr. Shezad Malik of Southlake, Texas. For a no obligation, free case analysis, please call 817-255-4001 or Contact Me Online.

GlaxoSmithKline PLC agreed to pay $40 million to settle claims in a class-action lawsuit that it improperly marketed the antidepressant Paxil for use in children. The suit claimed Glaxo had withheld information that the drug was neither safe nor effective in this age group.

The money will be used to reimburse health plans that paid for Paxil use by children younger than 18. During litigation, Glaxo claimed that Paxil was safe and effective, and denied promoting it for children and concealing information. Glaxo denies any wrongdoing or liability.

Other health plans are suing drug makers on similar grounds, alleging they withheld information that led the health plans to unnecessarily pay for drugs. The Paxil case is the first time a drug company has agreed to pay a settlement in such a case.

At its October 9-10 meeting, the Texas Medical Board took disciplinary action against 34 licensed physicians.
The actions included three violations based on quality of care; two actions based on unprofessional conduct; one action based on violation of probation or prior order; one action that terminated a prior suspension; two actions based on other states’ actions; one action based on inadequate medical records violations; two actions based on impairment due to alcohol or drugs or mental/physical condition; five actions based on non-therapeutic prescribing; two actions based on failure to properly supervise or delegate; two actions based on criminal convictions; three voluntary surrenders; and 10 licensees agreed to enter into administrative orders with the Board for minimal statutory violations. In addition, the board issued two cease and desist orders against unlicensed individuals.
At its October 9-10 meeting, the Texas Medical Board issued 276 physician licenses.

If you have been subjected to a TMB Inquiry Letter or TMB Disciplinary Process, then please contact the Doctor Attorney Dr. Shezad Malik of Southlake, Texas. For a no obligation, free case analysis, please call 817-255-4001 or Contact Me Online.

Texas Supreme Court earlier in September, declined to hear a case on whether or not medical malpractice damage caps violate state constitutional rights.

Attorneys for the hospital industry and the Texas Medical Association (TMA) had appealed the issue directly to the Supreme Court, bypassing the court of appeals. The attorneys claim when the Legislature in 2003 approved caps on non-economic damages, it allowed such direct appeals on constitutional questions.

The patient in the district court case had contended that the $250,000 cap violated constitutional provisions such as the right to due process, equal protection and jury trials.

Continue reading "Texas Medical Malpractice Fight" »

Medical peer review is an essential component of quality patient care. The Federal Health Care Quality Improvement Act (HCQIA) of 1986 was promulgated by Congress to grant confidentiality and immunity from liability to those who conduct reviews in good faith.

All States, recognize a privilege that generally protects information generated during the review process from discovery during unrelated litigation, such as medical liability cases.

Continue reading "Medical Peer Review" »

A panel of the Texas Medical Board suspended the license of Nancy Louise Anderson, M.D., license number F7350, after determining that Dr. Anderson’s continuation in the practice of medicine presents a continuing threat to the public welfare.

The action was based on the panel’s findings of violations of a 2008 Mediated Agreed Order, which required, among other provisions, that Dr. Anderson submit to random alcohol and drug screenings to ensure abstinence; participate in Alcoholics Anonymous programs and activities; obtain an independent medical evaluation within a prescribed time period; and cooperate with Board staff. The immediate suspension of Dr. Anderson’s license was based on her violations of the 2008 order by failing to submit to alcohol and drug screenings, failing to attend AA meetings, failing to obtain the medical examination, and failing to cooperate with the Board.

The action took place on Friday, September 26. The length of an automatic suspension is indefinite and it remains in effect until the board takes further action.

If you have been subjected to a TMB Inquiry Letter or TMB Disciplinary Process, then please contact the Doctor Attorney Dr. Shezad Malik of Southlake, Texas. For a no obligation, free case analysis, please call 817-255-4001 or Contact Me Online.

At its August 27-29 meeting, the Texas Medical Board took disciplinary action against 48 licensed physicians.

The actions included 12 violations based on quality of care; six actions based on unprofessional conduct; three actions based on violation of probation or prior board order; nine actions based on inadequate medical records violations; five actions based on impairment due to alcohol or drugs or mental/physical condition; one action based on non-therapeutic prescribing; one action based on failure to properly supervise or delegate; five voluntary surrenders; one order modification; two temporary suspensions and three administrative orders based on minimal statutory violations. In addition, the board issued two cease and desist orders against unlicensed physicians. At its meeting July 25, the Texas Physician Assistant Board took action against two physician assistants.

At its August 27-29 meeting, the Texas Medical Board issued 700 physician licenses, for a total of 3,621 physician licenses issued in Fiscal Year 2008. (See previous release at http://www.tmb.state.tx.us/news/press/2008/090808a.php )

If you have been subjected to a TMB Inquiry Letter or TMB Disciplinary Process, then please contact the Doctor Attorney Dr. Shezad Malik of Southlake, Texas. For a no obligation, free case analysis, please call 817-255-4001 or Contact Me Online.