Dallas Fort Worth Injury Lawyer Blog

Analysis of data from the Women's Health Initiative, postmenopausal women who were on a statin at study entry had almost a 50% greater risk of diabetes than those who weren't on the cholesterol-lowering drugs, according to a report in the Archives of Internal Medicine.

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Potential Link Found Between Statins and Diabetes

Recent research has suggested a potential link between statins and the development of diabetes, most notably a meta-analysis that found a 9% increased risk of the disease with statin use.

Women's Health Initiative Study

Data was reviewed for 153,840 women, mean age 63, who didn't have diabetes when they were enrolled in the study in 1993. About 7% of them were on statins at that time.

Through follow-up ending in 2005, there were 10,242 cases of new-onset diabetes.

In initial analyses, researchers found that statin use at baseline was associated with an increased risk of diabetes, and that association remained significant in multivariate analyses controlling for age, race, and weight.

The researchers found that statin use was associated with a higher risk of diabetes in women with a body mass index (BMI) under 25 than in those who had a BMI of 30 or higher. They said differences in phenotype, such as weight distribution, may explain the association.

Risk of diabetes also was similarly elevated, by about 50%, for women with and without heart disease, and was similar if women used either high- or low- potency statins.

Take Home Message

This study found that older women who take statins may be at an increased risk for developing type 2 diabetes. Note that the risk was seen with all types of statins.

The researchers said the study was limited by its observational nature, and because individual statin analysis may be confounded by the fact that women may have changed statin type before developing diabetes.

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.

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

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

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.

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 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 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" »

As a Crestor Side Effect attorney and cardiologist, I am writing this blog article to highlight the side effects of cardiac for patients who are taking statins, particularly Crestor to manage their high cholesterol levels.

According to new medical studies, the use of statins, especially Crestor, can be a major cause of cardiomyopathy, a heart problem caused by heart muscle weakening. Statins are prescribed to lower cholesterol levels. The drugs do this by by inhibiting the key enzyme HMG-CoA reductase, which is involved in the cholesterol synthesis pathway. But a side effect of statins leads to reduced levels of Coenzyme Q10, an important chemical required for proper muscle functioning.

A 2009 Lancet article focused on that issue and indicated that statins, like Crestor, as one cause of heart failure. (See Florkowski, S Molyneux, P George, M Lever, N-3 polyunsaturated fatty acids and statins in heart failure, Lancet 2009.)

Cardiovascular side effects from Crestor use are serious and may be life-threatening. If you or a loved one experienced cardiovascular injury or death, congestive heart failure, or immune-mediated necrotizing myopathy while taking Crestor, you may have a claim.

Crestor (generically known as Rosuvastatin), is an oral prescription drug designed to reduce the cholesterol blood levels when used together with lifestyle changes of diet and exercise. AstraZeneca, the manufacturer, designed the drug to reduce the production of cholesterol in the liver and by increasing the liver’s ability to remove “bad” LDL cholesterol. Crestor has been marketed as a "super-statin" because it claims to lower LDL cholesterol more than other statin drugs.

There are currently five statin drugs on the market in addition to Crestor: Lescol (fluvastatin), Lipitor (atorvastatin), Mevacor (lovastatin), Pravachol (pravastatin) and Zocor (simvastatin). Baycol (cerivastatin), another statin drug, was removed from the market in 2001 because of serious side effects reported by patients.

Crestor History
The FDA withheld approval for Crestor following concerns to the recall of Baycol and the kidney and muscle side effects reported in Crestor drug trials that were similar to those associated with Baycol. The FDA approved Crestor in August 2003 for the 5, 10, 20, and 40 mg doses following a clinical trial involving approximately 12,000 patients. The 80 mg dosage was not approved.

In March 2004, the non-profit organization Public Citizen asked the FDA to remove Crestor from the market, stating that Crestor side effects were severe and that the drug should never have been placed on the market. Read the FDA response to the Public Citizen petition on Crestor. The FDA issued a Public Health Advisory for Crestor on June 9, 2004, warning of the “increased risk for serious muscle toxicity (myopathy) associated with Crestor use, especially at the highest approved dose of 40 mg.”

In March 2005, the FDA issued an alert warning that “Rhabdomyolysis (serious muscle damage) has been reported in patients taking Crestor as well as other statin drugs. The labeling for Crestor has been revised to include information on the safe use of Crestor to reduce the risk for serious muscle toxicity, especially at the highest approved dose of 40 mg.”

Zocor Side Effects and Warnings
FDA in June 2011 warned about the risk of muscle injury in patients taking the highest dose of anti-cholesterol Zocor. Now patients and plaintiffs considering a Crestor lawsuit may be considering if the FDA’s Zocor warning applies to Crestor side effects. The FDA has recommended to patients and doctors that, “Zocor, Simvastatin 80 mg should not be started in new patients, including patients already taking lower doses of the drug.”
Click here for Public Citizen opinion of Zocor.

SEARCH Study Results Leads to FDA Zocor Warning
The recent FDA study was based on data from the trial SEARCH (Study of the Effectiveness of Additional Reductions in Cholesterol and Homocysteine) which assessed the frequency of serious cardiovascular injuries, including heart attack and death, in patients who took the maximum Zocor dosage of 80 mg as compared to those who took only 20 mg of the drug.

Crestor Side Effects Similar to Zocor Warning
Zocor muscle injuries are similar to the Crestor side effects. The higher the dosage of a “super-statin,” the greater the risk a patient runs of developing Crestor side effects such as muscle pain and weakness, and the potentially fatal rhabdomyolysis, in which muscle fiber breakdown products is released into the bloodstream and causes kidney damage or failure.

Continue reading "Crestor Side Effects & Cardiomyopathy" »

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 " »

Every day, we are hearing a lot of bad news about the osteoporosis drug Fosamax. Made by Merck & Co., Fosamax has been a successful bone disease treatment on the market for over a decade. In January 2009, medical studies were released that hit the drug and its manufacturer hard. The first study links Fosamax to osteonecrosis, of the jaw, and the second, links Fosamax to esophageal cancer. Are these reports the Titantic that is about to hit the Fosamax iceberg?

Fosamax works by attacking cells in the body responsible for bone breakdown, which can help patients dealing with osteoporosis. At the same time, if the drug is too efficient, it can cause the bone to grow too dense, which takes up inner bone space where bone marrow is found. Bone marrow is responsible for bone healing and growth, so without enough marrow, the bone will die. If you do break a bone that has been subjected to Fosamax and similar drugs it won't heal.

Medical studies linking the drug to esophageal cancer report that many of those affected had used the drug for over two years. One thing is certain - we are only seeing the tip of the iceberg when it comes to Fosamax injuries. Currently there are over 1,000 Fosamax lawsuits in litigation, and as more studies are done to confirm the allegations against the drug, we may see even more patients coming forward.

Fosamax, when used over time, can cause dead jaw, and Fosamax femur fractures have been a major problem in some cases. When you have osteoporosis, your bones become extremely fragile, and fractures can happen even with just a bump or gentle fall. Most often, fractures happen in the hips, spine, and wrists. If you break your hip, you typically need major surgery to fix it, and even then, you may have problems walking for the rest of your life. With spinal fractures, the same is true, and patients generally have back pain and may have to deal with deformities.

Fosamax and the following drugs Actonel (risedronate sodium) tablets, Actonel with Calcium (risedronate sodium with calcium carbonate tablets), Atelvia (risedronate sodium) delayed-release tablets, Boniva (ibandronate sodium) tablets, Fosamax (alendronate sodium) tablets and oral solution, Fosamax Plus D (alendronate sodium/cholecalciferol) Tablets, Reclast (zoledronic acid) Injections are now required to have clear warning labels regarding low-energy, or low trauma fractures of the femoral shaft (leg bone).

As a Fosamax osteoporosis attorney, I suggest discussing this drug with any elderly female friends and relatives as they may be unaware of the current crisis and the FDA's warnings.

Continue reading "Texas Titanic About to Hit The Fosamax Iceberg?" »

A lawsuit has been filed against Merck, in the U.S. District Court for the District of New Jersey. The complaint alleges that the drug manufacturer warned European users that the drug Propecia may cause sexual problems in men, but did not provide American users the same warning.

According to the complaint, plaintiffs were prescribed Propecia to combat male pattern hair loss, and they suffered serious sexual dysfunction.

The lawsuit alleges that the warnings about the risk of sexual problems from Propecia differed significantly in Europe from the label warnings to users of Propecia in the U.S.

In Europe, Propecia labels stating that erectile dysfunction problems may persist after the patient discontinues use treatment with Propecia were added in 2008.

Propecia (finasteride) was approved in 1992 for the treatment of benign prostatic hyperplasia, and also is approved to treat male pattern baldness.

Last month researchers from the U.S. published a study in the Journal of Sexual Medicine that found side effects of Propecia were linked to sexual problems in men. Researchers indicated that the class of drugs known as 5-alpha-reductase inhibitors can cause loss of libido, depression erectile dysfunction, reduced semen production and growth of male breast tissue.

The lawsuit over Propecia charges Merck with negligence, failure to warn, strict product liability, and breach of warranty.

Continue reading "Propecia Use Can Lead to Permanent Sexual Dysfunction" »

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 Fort Worth Benzene Lawsuit Attorney, I have been writing over the past month a series of stories on the Environment and Toxicity.

According to a new study, mothers who live in Texas neighborhoods with higher levels of benzene, a pollutant from refineries and tailpipes, are more likely to have babies with a serious neurological defects.

Texas leads the nation in benzene releases, accounting for more than 34% of emissions.

This study for the first time, links benzene to a neurological birth defect and demonstrates that air pollution can harm a fetus.

Researchers from the UT School of Public Health and Texas Dept of State Health Services conducted the study, which appeared in the journal Environmental Health Perspectives.
Houston Chronicle 10/28/2010

Read Article: Houston Chronicle

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" »

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 " »

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" »

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" »

A new diabetes drug -- to be called Victoza if approved -- works better than Byetta, a head-to-head clinical trial shows.

Byetta is the first of the class of type 2 diabetes drugs called GLP-1 analogs. The drug takes advantage of the body's own signaling system to increase insulin output in response to meals.

Byetta is a popular drug, and it's helped many patients. But liraglutide -- soon to be called Victoza if approved by the FDA -- works better, says Lawrence Blonde, MD, director of the diabetes clinical research unit at Ochsner Clinic Foundation, New Orleans.

"Our direct comparison study shows patients who took liraglutide once a day had a greater reduction in [average blood sugar levels] at the end of the 26-week study than did [Byetta] twice a day," according to Blonde . "Obviously, once-a-day injections would be preferred by many patients because of the convenience -- and it is not tied to meals. Liraglutide can be taken any time as long as you take it the same time each day."

Continue reading "Victoza for Diabetes: Better Than Byetta?" »

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 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" »

Pregnant women who took a popular epilepsy drug, also widely used to treat migraines, pain and psychiatric disorders, had children whose I.Q. scores were significantly lower than those whose mothers took a different antiseizure medication, a new study has found.

The drug, valproate, sold generically and under the brand name Depakote, remains the second-most-popular antiseizure medication used for epilepsy, but earlier studies found that use during pregnancy also increased the risk of developmental delays and major malformations.

The risks that other epilepsy drugs may pose are not clear, experts say. While some are likely to be safer than others, there have not been enough studies to guide patients and their doctors. About half of the women who take valproate are not epileptics.

Continue reading "I.Q. Harmed by Epilepsy Drug in Utero" »

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" »

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 " »

A new study finds that almost a quarter of a sample of people exposed to toxic dust after the 9/11 attack in New York City still suffer from diminished lung capacity.

The rate of lung problems is about 2.5 times more than would be expected in people who smoke, according to co-author Dr. Jacqueline Moline, director of the World Trade Center Medical Monitoring and Treatment Program Clinical Center.

Continue reading "Aftermath of 9/11" »

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 " »

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 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" »

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 " »

Boston Public Health Commission is proposing some of the nation’s strictest smoking regulations; banning the sale of cigarettes at drugstores and on college campuses, and shutting down the city’s 10 cigar and hookah bars by 2013.

The commission said, the goal is to discourage young people from buying tobacco products, to keep a harmful product out of stores that promote health, and to protect employees who are exposed to secondhand smoke.

The Board of Health will vote on the regulations on Nov. 13. If approved they will take effect within 60 days.

“Should tobacco be treated as any other consumer good? No,” said Barbara Ferrer, director of the Board of Health. “We do not sell guns everywhere, we do not sell alcohol everywhere and we do not need to be selling tobacco everywhere. They are all dangerous products, and they all require regulation.”

Continue reading "Boston Plans Tougher Regulations on Tobacco " »

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.

A new medical study out recently shows that Medtronic's new drug-coated stent was associated with more heart attacks and blood clots than a rival stent made by Johnson & Johnson.

Results from the cardiology study named Sort Out III, which included more than 2,000 patients, showed that heart patients who received the Medtronic device, called Endeavor, had more heart attacks and blood clots and needed repeat procedures more often than those treated with the J&J stent, known as Cypher.

Continue reading "Study Shows Problems with Medronic's Heart Stent" »

Ovarian cancer is one of the most difficult cancers to diagnose, making it one of the most deadly. The ovaries are not accessible for examination, and the symptoms that are associated with ovarian cancer are vague and can be confused with other less life-threatening conditions.

Because of its hidden nature, ovarian cancer often is not caught in time to save the patient. According to the U.S. National Cancer Institute, three of every four ovarian cancer cases are diagnosed at an advanced stage, after the malignancy has spread beyond the ovary.

Continue reading "Ovarian Cancer Update" »

The FDA is "evaluating" new adverse-event reports for 20 drugs, the agency announced in September. A 2007 federal law requires the FDA to disclose all its investigations into reports of possibly drug-related adverse events.

The reports on the list come from the FDA's early-warning system for drugs already on the market. This Adverse Event Reporting System (AERS) collects reports from patients, hospitals, doctors, and drug companies about suspicious problems that might be related to a medication.

Continue reading "20 Drugs on FDA Watch List" »

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.

BRUSSELS - European scientists warned that many teenagers across Europe could suffer permanent hearing loss after five years if they listen to MP3 players at too high a volume for more than five hours a week.

The risk for hearing damage depends on sound level and exposure time.

Continue reading "MP3 Players Can Cause Permanent Deafness" »

Eli Lilly & Co. has agreed to pay $62 million to some states, to settle claims it improperly marketed Zyprexa, its top-selling drug, to patients who did not have schizophrenia or bipolar disorder, its only approved uses.

Attorneys general from several states had accused Lilly of marketing Zyprexa for off-label uses and inadequately disclosing the drug's side effects to health-care providers. Doctors are free to prescribe drugs for uses not approved by the FDA, but drug companies cannot market them for those situations.

But Lilly has settled more than 31,000 product liability claims against the drug since 2005, paying out more than $1.1 billion. The drugmaker still faces separate litigation with 11 other states, generally involving consumer protection issues or Medicaid reimbursement.

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.

A new study claims that the most common global strain of HIV began spreading in humans around 1900 in sub-Saharan Africa.
This study, which is published in Nature, found that HIV began spreading between 1884 and 1924, around the same time urban centers in west central Africa were established.

Previous studies have shown that HIV spread from chimpanzees to humans in southeastern Cameroon.

Nurses count sponges and surgical instruments when a procedure begins and ends, so that they are not left inside a patient. Cases of retained foreign objects are rare -- occurring once in every 5,000 surgeries -- discrepancies in counts happen in 13% of surgeries, according to a recent surgical study.

The mistake is one of the hospital-acquired conditions that the Centers for Medicare & Medicaid Services will stop paying for as a complicating condition later this year.

Continue reading "New Technologies for Counting Sponges" »

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.

A new study out this week in JAMA suggests that common drugs which are recommended as first-line therapy for chronic obstructive pulmonary disease, or COPD raises the risk of heart attacks, strokes and death.

COPD refers to two incurable lung diseases, chronic bronchitis and emphysema most commonly caused by cigarette smoking.

Continue reading "Bronchodilators May Cause Increase In Heart Problems" »

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.