Dallas Fort Worth Injury Lawyer Blog

A panel of federal judges will hear arguments in March on the centralization all Zoloft lawsuits filed in U.S. District Courts.

The U.S. Judicial Panel on Multidistrict Litigation (JPML) has set a hearing for March 29. The lawyers will argument whether federal complaints filed against Pfizer by parents of children born with birth defects should be centralized for pretrial proceedings as part of an MDL, or multidistrict litigation.

Pfizer filed a motion seeking that the lawsuits should be consolidated in the U.S. District Court for the Southern District of New York. MDL is designed to avoid potentially conflicting pretrial rulings from different judges, reduce duplicative discovery and to serve the convenience of the witnesses, the parties and the courts.

What is Zoloft?

Zoloft (sertraline) was introduced by Pfizer in 1991 for the treatment of depression, obsessive-compulsive disorder and anxiety. By 2007 there were nearly 30 million prescriptions, making it the most prescribed antidepressant in the United States. Zoloft belongs to a class of drugs known as selective serotonin reuptake inhibitors (SSRIs).

A growing amount of research and adverse event reports have suggested that side effects of Zoloft use during pregnancy may increase the risk of serious and potentially life-threatening health problems for babies, including persistent pulmonary hypertension in newborns (PPHN), spina bifida, heart defects, lung defects, abdominal defects, cranial defects and other malformations.

Studies have suggested that Zoloft may increase the risk of birth defects when used as early as the first trimester of pregnancy, a time when many women do not even know they are pregnant.

Dr Shezad Malik Law Firm examines the evidence of risk from metal-on-metal hips, the manufacturers’ inadequate response, and how the regulatory bodies failed.

Thousands of patients around the world may have been exposed to toxic metal substances after being implanted with poorly regulated and potentially dangerous hip devices, according to a BMJ/BBC Newsnight investigation.

The implants are the so called “metal on metal”—the head at the top and the lining of the cup it fits into are made of cobalt-chromium alloy rather than ceramic or polyethylene—and there are both total hip replacement and hip resurfacing designs.

Average failure rates at seven years are 11.8% for resurfacing and 13.6% for metal-on-metal total hip replacement, although failure rates vary with the brand used. This compares with rates of 3.3%-4.9% for hip implants made of other materials. Metal-on-metal devices have been implanted into over a million patients in the US.

Metallosis

Cobalt-chromium implants are known to release metal ions, and these ions can seep into local tissue causing reactions that destroy muscle and bone and leaving some patients with long term disability. A condition known as metallosis. The ions can also leach into the bloodstream spreading to the lymph nodes, spleen, liver, and kidneys before being excreted in urine.

Metallosis and Cancer Risk

Multiple studies and research organizations have warned about the carcinogenic potential of metal-on-metal hips. In 1990, the World Health Organization International Agency for the Research on Cancer released a monograph listing hexavalent chromium as a proved carcinogen; trivalent chromium a potential carcinogen; and cobalt ions a probable carcinogen.

Despite this risk, DePuy’s marketing of metal-on-metal hips continued unabated, with promotional material failing to reflect internal company concerns.

Uncertain Risks from Metallosis

There are no guidelines on what constitutes an unacceptably high level of cobalt ions in blood for patients receiving orthopaedic implants. DePuy’s designer and consultant, Dr Schmalzried, has said that, in patients with a well functioning device, levels should be no higher than 2 μg/L.

In fact, studies show that blood cobalt concentrations generated through the wear of some of the newer metal-on-metal total hip prostheses can reach over 300 μg/L. This is 600 times higher than physiological levels of cobalt—most healthy people have about 0.5 μg/L of cobalt in their blood.

Metal ion levels above this level have been recorded in around 20% of patients (range 5-22%) with some metal-on-metal prostheses—such as DePuy’s flagship Pinnacle hip system.
Over 300 000 Pinnacle prostheses have been put in worldwide.

Data showing raised metal ions in people with the Pinnacle have been available in the medical literature since 2008, yet the device formed a key part of DePuy’s main hip strategy in 2009,
as internal emails show.

Studies have shown raised ions with Smith and Nephew’s Birmingham total hip replacement (range 1.2-14.2 μg/L, 20%>7 μg/L),27 Zimmer’s Durom total hip replacement (range 1-12 μg/L),28 and ASR-XL total hip replacement (0.7-217 μg/L).

Also problematic are the smaller hip resurfacing implants, which are used in women and smaller men. Because these implants lubricate less well, they produce metal debris and high metal
concentrations in the blood.

Tweaking the design

Instead of alerting regulators and patients to their concerns, companies tweaked the design of their total hip implants. In 2004, in an effort to rationalize their product range and increase
usage of their implants, they shortened the trunnion (or taper)—the part of the stem that inserts into the head—to allow a few degrees greater motion and added grooves so surgeons
could use them with both ceramic and metal heads.

But these changes, coupled with bigger and bigger heads, had consequences: increased wear, high levels of metal ions in the tissues and blood, and higher rates of joint failure.

DePuy had been contacted in 2009 by Japanese surgeons with concerns about the Pinnacle metal hip system, as an internal DePuy email shows. The surgeons reported seeing “generated
metal debris between stem taper and head, and final necrosed tissue” and blamed it on the poor connection between the two.

Regulatory failure

But the regulators in Europe and the US failed to identify the design changes and their consequences for patient safety. The shortening of one of DePuy’s trunnions was cleared by the FDA in December 2004 with the comment: “The design, while not identical to the predicates, does not raise any new issues of safety or effectiveness.”

In the US, the FDA considered that the parts of metal-on-metal total hip replacements to be like other heads, cups, and stems already in use. This meant that the devices could be cleared
through a less rigorous process, called 510(k), which requires no clinical studies to show how well these large heads worked when coupled with a modified stem.

Profits over People

Why are patients still exposed to the harms of metal implant failures identified in 1975?
The answer seems to be innovation coupled with a drive for commercial success unconcerned with patient safety. The conventional total hip replacement consists of a metal head with a polyethylene cup. But these joints don’t last forever. Over time the plastic cup wears away against the hard metal head. Younger, more active people are especially likely to require early revision surgery to replace the worn out joint.

The FDA started to clear larger heads for market use in 1998 and by the end of 2010 had approved 175 implants through the 510(k) route.

And so a whole new class of implant—with the potential to release high concentrations of toxic ions—was launched onto the US and European markets without the need to conduct
clinical trials and without any long term post-marketing studies.

But resurfacing was a new technique and so, in the US, the implants had to go through the FDA’s more rigorous premarket approval process. This requires manufacturers to submit their product to clinical testing to prove it is both safe and—unlike the European process—effective for its intended use. It was this premarketing approval process that stopped DePuy’s failing ASR resurfacing prosthesis coming to market, although the ASR XL total hip replacement was passed through the 510(k) route.

Post-marketing surveillance

The FDA has now decided to gather and review all available information about currently marketed metal-on-metal hip systems, including information related to adverse events that
may be associated with increased levels of cobalt and chromium in the bloodstream.

In May 2011 the FDA wrote to about 20 manufacturers to say that it was invoking a rule requiring post-marketing studies in cases where an implant’s failure could have serious consequences.

Companies would be expected to take blood samples from patients to measure metal ions. They are also taking a decision on the classification of hip prostheses and how they should be regulated in future.

The FDA has decided to place all hip implants into a high risk category—fast track entry will be stopped.

Three women have filed a product liability lawsuit against Forest Laboratories alleging birth defects from the use of Lexapro. Lexapro is an antidepressant that each of the plaintiffs claimed to have used while pregnant.

The Lexapro lawsuits were filed on February 16 in St. Louis Circuit Court, in Missouri.

All three plaintiffs, Kimberlee Fisher, Kristy Hernandez and Leah Scott, allege that they gave birth to children who suffer from congenital defects.

Fisher’s daughter, was diagnosed with spina bifida. Hernandez's daughter was born with a club foot. Scott’s son, was diagnosed with bilateral cleft lip and cleft palate.

The complaints allege that Forest knew that side effects of Lexapro may increase the risk of birth defects but failed to provide adequate warning to consumers or healthcare providers.

All three women claim that had they known about the risk to their unborn children they would not have taken the drug.

Lexapro belongs to a family antidepressants known as selective serotonin reuptake inhibitors (SSRIs). SSRI antidepressants include Paxil, Prozac, Celexa and Zoloft. Several studies have linked the use of SSRI antidepressants during pregnancy to a risk of birth defects and malformations.

An estimated 800 Paxil birth defect lawsuits have been filed against GlaxoSmithKline over their failure to warn consumers and doctors that use of the antidepressant during pregnancy could lead to Persistent pulmonary hypertension in newborns (PPHN) and congenital heart defects in newborns.

The lawsuits also claim that the company hid test results and purposefully misled doctors about the risks associated with Paxil.

A growing number of women have filed a Zoloft lawsuit over Pfizer’s failure to warn about the risk of birth defects when that SSRI antidepressant is used during pregnancy.

At its February 9-10, 2012 meeting, the Texas Medical Board disciplined 58 physicians and issued two cease and desist orders.

Read full report here.

DISCIPLINARY ACTIONS

REVOCATION

Stogre, Rosemary Ann, M.D., Lic. No. F0771, Houston
On February 10, 2012, the Board entered a Default Order regarding Rosemary Ann Stogre, M.D., revoking her Texas physician license and resolving Formal Complaint No. 503-12-1512 filed against her by the Board at the State Office of Administrative Hearings. The complaint stated that Dr. Stogre continued to prescribe controlled substances after surrendering her DEA and DPS controlled substance prescribing privileges, and that she prescribed controlled substances to a patient without medical need and that patient died as a result of misuse of controlled substances, some of them prescribed by Dr. Stogre. Because Dr. Stogre did not respond in any form to the Formal Complaint, the allegations are deemed true.

VOLUNTARY SURRENDER

Connolly, Jule Tom, M.D., Lic. No. C6899, Austin
On February 10, 2012, the Board and Jule Tom Connolly, M.D., entered into an Agreed Order of Voluntary Surrender in which Dr. Connolly agreed to immediately cease practice in Texas and voluntarily surrender his license in lieu of further disciplinary proceedings. The Board found Dr. Connolly non-therapeutically prescribed drugs and engaged in unprofessional conduct likely to injure the public.

Genovese, Robert J., M.D., Lic. No. E5522, Edinburg
On February 10, 2012, the Board and Robert J. Genovese, M.D., entered into an Agreed Order of Voluntary Surrender in which Dr. Genovese agreed to immediately cease practice in Texas and voluntarily surrender his license in lieu of further disciplinary proceedings. The Board found Dr. Genovese failed to treat a patient according to the generally accepted standard of care.

Heistand, Michael, M.D., Lic. No. D8263, San Antonio
On February 10, 2012, the Board and Michael Heistand, M.D., entered into an Agreed Order of Voluntary Surrender in which Dr. Heistand agreed to immediately cease practice in Texas and voluntarily surrender his license in lieu of further disciplinary proceedings. The Board found Dr. Heistand failed to use proper diligence in his professional practice.

Reddick, Sybil Rochelle, M.D., Lic. No. J9294, Dallas
On February 10, 2012, the Board and Sybil Rochelle Reddick, M.D., entered into an Agreed Order of Voluntary Surrender requiring Dr. Reddick to immediately cease practice in Texas and permanently surrender her license. The basis for action was the Board’s investigation into Dr. Reddick’s nontherapeutic prescribing for one patient and Dr. Reddick’s desire to surrender her license in lieu of further disciplinary proceedings.

Taliaferro, Sharon Melissa, M.D., Lic. No. G0185,
On February 10, 2012, the Board and Sharon Melissa Taliaferro, M.D., entered into an Agreed Voluntary Surrender Order in which Dr. Taliaferro surrendered her Texas medical license in lieu of further disciplinary proceedings. Dr. Taliaferro, who is also licensed in Arkansas, entered into an order with the Arkansas State Medical Board agreeing to cease and desist from administering dimethyl sulfoxide intravenously to patients and refrain from doing so until such treatment is approved by the Food and Drug Administration.

Tang, Annie Jia, M.D., Permit No. BP20038123, Houston
On February 10, 2012, the Board and Annie Jia Tang, M.D., entered into an Agreed Voluntary Surrender Order in which Dr. Tang voluntarily surrendered her physician-in-training permit due to her desire to leave Texas. The Board found that Dr. Tang’s residency program chose not to renew her residency contract due to Dr. Tang’s medical condition. Dr. Tang’s physician found her competent to practice medicine, but Dr. Tang chose not to appeal the residency program’s decision. There were no allegations of malpractice or misconduct by Dr. Tang.

Read more here and visit our website for further information.

Continue reading " Texas Medical Board Disciplines 58 Physicians in February " »

Dr Shezad Malik Law Firm is expanding their initiatives focused on identifying recipients of metal-on-metal hip implants, that has failed, or are in the process of failing.

While one specific type of metal-on-metal hip implant called the DePuy ASR has been recalled, the group expects there to be many more recalls of metal-on-metal hip implants, because of the high probability of failure.

The 2010 DePuy Hip Replacement Recall was instituted when DePuy Orthopaedics, Inc., a division of Johnson and Johnson. Johnson & Johnson recalled its ASR XL Acetabular metal-on-metal hip replacement system, on August 24, 2010.

According to the New York Times, "The so-called metal-on-metal hips, in which a device's ball and joint are made of metal, are failing at high rates within a few years instead of lasting 15 years or more, as artificial joints normally do. The wear of metal parts against each other is generating debris that is damaging tissue and, in some cases, crippling patients."

In order to make certain all metal-on-metal hip implant recipients, with a failed hip implant, get evaluated, the Dr Shezad Malik Law Firm wants to hear from any metal-on metal hip implant recipient, if their hip implant has already failed, or if the hip implant recipient is suffering the symptoms of a metal-on metal hip implant failure.

There are many symptoms, including pain, loss of flexibility, swelling, or loss of mobility.

One of the biggest problems we have with respect to our failed medical device, or recalled drug work, is the average US consumer never hears about a drug recall, or failures involving medical devices like metal-on-metal hip implants.

If you have a friend, or loved one, who is a recipient of a metal-on metal hip implant that has already failed, or is showing symptoms of a failure, such as swelling, pain in the region of the hip, loss of flexibility, or loss of mobility, please have them call us at 888-210-9693.

European drug regulators are demanding new kidney damage warnings for Tekturna and other drugs containing the active ingredient aliskiren.

The new warnings and contraindications were announced by the European Medicines Agency (EMA) last week.

Tekturna (aliskiren) is manufactured by Novartis and was first approved in the United States in 2007 for the treatment of hypertension.

The EMA recommended that combinations of Tekturna with angiotensin converting enzyme (ACE) inhibitors or angiotensin receptor blockers (ARBs) be contraindicated in patients with diabetes or moderate to severe renal (kidney) impairment.

European officials say that the drug can be more risky to diabetic patients and those with kidney problems being given ACE inhibitors or ARBs. Furthermore the EMA is recommending that doctors with diabetic or kidney patients use another drug for high blood pressure.

The push comes after Novartis cancelled a Tekturna clinical trial known as ALTITUDE due to a shocking number of strokes and kidney problems among test subjects. The study was to justify whether Tekturna could help diabetes patients with kidney problems.

The research indicated that Tekturna side effects may increase the risk of not only strokes and kidney damage, but also may cause hypotension (low blood pressure) and hyperkalemia (high potassium).

The ALTITUDE trial involved the use of Tekturna along with ACE inhibitors or ARBs. Novartis says it will cease promoting the use of Tekturna in combination with those drugs in any patients.

Read more here and visit my website for further information.

Aimee L. Flynn, from Pennsylvania, has filed a lawsuit over NuvaRing. Flynn suffered a stroke that was allegedly caused by the popular birth control ring.

The complaint was filed in the U.S. District Court for the District of New Jersey on February 3. Flynn used the Nuva Ring contraceptive from October 2008 through February 2010.

The lawsuit names Merck & Co., Organon Pharmaceuticals, Akzo Nobel NV and Schering-Plough Corporation as defendants. Organon is a subsidiary of Shering-Plough, which was purchased by Merck.

Flynn’s lawsuit accuses the defendants of strict liability, breach of warranty, negligence and fraud. She is seeking both compensatory damages for her injuries and punitive damages.

NuvaRing releases a combination of etonogestrel and ethinyl estradiol through a small ring that is inserted into the vagina once a month.

In 2011, the FDA published a birth control study that found that the NuvaRing raised the risk of blood clots by 56% when compared to older birth control pills.

Women who used the NuvaRing were at increased risk of deep vein thrombosis (DVT), pulmonary embolism and arterial thrombotic events such as heart attacks and strokes.

A growing number of women have filed a NuvaRing lawsuit in courts throughout the United States. All of the complaints involves similar allegations that the manufacturer failed to adequately warn about the risk of blood clots from NuvaRing side effects.

In the U.S. federal court system, all NuvaRing injury cases has been consolidated for pretrial proceedings as part of an MDL, or multidistrict litigation, which is centralized in the U.S. District Court for the Eastern District of Missouri.

Flynn’s claim is likely to be transferred to that court to be included in the MDL.

Parties are scheduled to review a plan for starting potential NuvaRing settlement discussions at a hearing on February 28.

Dr Shezad Malik Law Firm is investigating NuvaRing Lawsuit Claims due to side effects that may include blood clots, Deep Vein Thrombosis, Pulmonary Embolism, Heart Attacks, Strokes, and Wrongful Death.

Read our latest filed NuvaRing lawsuit here. We have many more NuvaRing lawsuits in the preparation phase for filing.

Dr Shezad Malik law firm is a national law firm focused on fighting for the rights of serious personal injury victims. We are announcing the launch of an investigation into alleged NuvaRing side effects.

We are evaluating the following alleged NuvaRing Injuries:

Blood Clots,
Deep Vein Thrombosis (DVT),
Pulmonary Embolism,
Heart Attack or Myocardial Infarction,
Strokes,
Cerebral Thrombosis,
Retinal Thrombosis,
Cerebral Hemorrhage,
Wrongful Death

There is still time for young women who may have been injured by NuvaRing side effects, or their families, to file their own lawsuits against Merck and Organon.

To discuss a potential lawsuit claim, please contact us at 1-888-210-9693 or visit our website.

What is NuvaRing?

NuvaRing is a hormonal contraceptive device that releases a combination of etonogestrel, a synthetic generation progestin, and the estrogen, ethinyl estradiol.

NuvaRing is a small flexible ring that is designed to be inserted into the vagina once a month. It is kept in place for three weeks, and prevents pregnancy by releasing controlled amounts of those hormones into the bloodstream.

NuvaRing is marketed by Merck & Co.’s Organon subsidiary, NuvaRing was introduced to the U.S. marketplace in 2001.

Etonogestrel is a form of desogestrel, a third-generation progestin. In February 2007, the consumer advocacy group Public Citizen petitioned the U.S. Food & Drug Administration (FDA) to ban oral birth control pills that contain desogestrel, citing studies which indicated they could double the risk of blood clots compared to second generation oral contraceptives.

In 2007, the consumer advocacy group Public Citizen asked the FDA to ban oral contraceptives that contained forms of desogestral because this dangerous progestin has been implicated in a higher risk of strokes, blood clots and other cardiovascular problems.

NuvaRing releases approximately 120 micrograms of etonogestral - an active desogestral metabolite - per day, a relatively high dose of this dangerous hormone. The NuvaRing injury lawyers at our firm believe this high dose of etonogestral is responsible for the high number of cardiac side effects reports associated with NuvaRing.

NuvaRing Lawsuits.

In August 2008, the Judicial Panel on Multidistrict Litigation (JPML) ordered all federally filed NuvaRing lawsuits to be consolidated in a multidistrict litigation and transferred to Judge Rodney W. Sippel of the U.S. District Court, Eastern District of Missouri.

The lawsuits allege that Merck & Co. and Organon failed to adequately warn patients and their doctors about the potential for NuvaRing blood clots, deep vein thrombosis, pulmonary embolism, heart attacks, strokes and sudden death because of the device.

File Your Lawsuit Now

There is still time for young women who may have been injured by NuvaRing, or their families, to file their own lawsuits against Merck and Organon. To discuss a potential claim, please contact us at 1-888-210-9693 or visit our website.

Federal regulators in the United States had serious safety concerns about one variation of a recalled DePuy hip implant. Johnson & Johnson nevertheless went ahead and sold thousands of the devices in Europe, before later acknowledging that all versions of the ASR hip implant may be prone to early failure.

According to a recent New York Times investigation, the FDA rejected the DePuy ASR Hip Resurfacing System after a detailed review of its safety profile raised concerns.

DePuy Orthopaedics, a division of Johnson & Johnson, was able to market the device in Europe without the concerns of U.S. regulators being relayed to their European counterparts.

Although the ASR Hip Resurfacing System was rejected by the FDA, DePuy was able to gain permission to market a variation of the device in the United States, known as the DePuy ASR XL Acetabular Hip System.

That variation of the implant was approved under the FDA’s controversial 510(k) fast-track approval process, which only requires that a device be substantially equivalent to one that has already been approved.

DePuy argued that the ASR implant was similar to their previously approved DePuy Pinnacle metal-on-metal hip replacement.

FDA officials say that the ASR Hip Resurfacing System had more rigorous requirements because resurfacing was a fairly new technique at the time.

Both devices were metal-on-metal hip implant systems, which have since been linked to a number of safety concerns.

In August 2010, Johnson & Johnson recalled all variations of the DePuy ASR hip implant after acknowledging that the devices may be prone to fail within a few years of surgery. By the time of the recall, more than 93,000 of the two hip systems were implanted in people worldwide.

As it turns out, the resurfacing variation that the FDA rejected may have been the safer of the two systems.

Since the recall, a growing tsunami of lawsuits over the DePuy ASR hip have been filed against Johnson & Johnson in state and federal courts throughout the United States.

So far, about 3,500 DePuy ASR metal hip recipients have filed a lawsuit against the company.

Johnson & Johnson also faces over 900 DePuy Pinnacle hip lawsuits filed by individuals who have experienced problems with the older metal-on-metal hip replacement, which was used to gain approval for the ASR hip implant under the FDA’s 510(k) process.

A new medical study suggests that side effects of Pradaxa, a new blood thinner, may increase the risk of bleeding events even more than warfarin, the drug it was designed to replace.

Kansas researchers tested the use of Pradaxa during radiofrequency ablation of atrial fibrillation and discovered more than double the number of bleeding problems with Pradaxa, when compared to those seen when warfarin was used.

In a study was published in the Journal of the American College of Cardiology.

Pradaxa (dabigatran) is under increased scrutiny from federal health regulators. A large number of post-marketing reports involving severe bleeding events and deaths are reported with Pradaxa.

Pradaxa was introduced by Boehringer Ingelheim in October 2010, as an alternative to Coumadin (warfarin) for prevention of strokes among patients with atrial fibrillation.

The drug was heavily marketed as superior to warfarin, because it is easier to use and requires less monitoring. When serious bleeding events do occur, warfarin can be quickly counteracted by doses of Vitamin K or fresh frozen plasma infusions. There is no such quick fix for bleeding with Pradaxa.

According to a report by the Institute for Safe Medication Practices in January 2012, more episodes of hemorrhages with Pradaxa were reported to the FDA’s Adverse Event Reporting System during the first quarter of 2011 than were reported in association with any other drug monitored by the group.

At least 505 episodes involving Pradaxa bleeding were reported, compared to 176 cases reported with warfarin, which was second on the list.

A number of patients throughout the United States who have experienced severe bleeding problems are considering a potential Pradaxa lawsuit against Boehringer Ingelheim for failing to adequately research their medication or warn about the risk of internal bleeding.

New Jersey state court lawsuits over Accutane and generic versions have been consolidated as a mass tort in Atlantic County before Judge Carol Higbee, and the number of complaints filed in the state has more than doubled over the last year.

There are now more than 7,000 Accutane lawsuits pending in New Jersey state court. These complaints allege that the makers of the acne medication failed to adequately warn about the risk of serious and debilitating bowel problems.

All of the complaints involve similar allegations that the acne drug had inadequate warnings and that side effects of Accutane may increase risk of severe inflammatory bowel disease (IBD), including Crohn’s disease and ulcerative colitis.

The drug maker Roche, discontinued Accutane in June 2009, due to the increasing costs associated with the litigation over Accutane, but a number of generic versions remain available under names such as Claravis, Sotret, Amnesteem and generic isotretinoin.

Several Accutane trials have already occurred in New Jersey state court, with a number of multi-million dollar verdicts being returned for damages caused by Accutane.

The U.S. Judicial Panel on Multidistrict Litigation (JPML) has ordered that all federal Wright Conserve hip replacement lawsuits be transferred to one judge for coordinated pre-trial proceedings as part of an MDL, or multidistrict litigation.

The U.S. JPML centralized the Wright Conserve hip litigation before U.S. District Judge William S. Duffey, Jr. in the U.S. District Court for the Northern District of Georgia.

The complaints allege that Wright Medical Technology manufactured a defective metal-on-metal hip implant, known as the Conserve Plus, and failed to warn patients about the potential risk that the device may fail within a few years of surgery.

According to plaintiffs, the Conserve acetabular cup has a tendency to loosen and fail as metal particles are shed into the body from the metal parts rubbing against each other.

The FDA approved the Wright metal-on-metal hip replacement system under their controversial 510(k) approval system. More than 200 adverse event reports have been submitted by patients or physicians, which likely only represents a fraction of the total number of problems with Wright hip replacements.

The Wright Conserve hip system is a metal-on-metal design. And consists of cast cobalt chromium molybdenum cup that provides the connection for the cobalt chromium molybdenum femoral head.

The metal femoral head rotates within the metal monoblock Conserve Cup, which does not have a liner, resulting in the release of metal particles that can cause metal toxicity in the blood, soft tissue and bone.

According to the complaints, this can result in metallosis, tissue necrosis, pseudotumors and other problems.

Furthermore, a number of patients have filed complaints over problems with the Wright Profemur hip replacement. These involves a femoral stem that may be prone to fracture, break, degrade and ultimately fail, according to allegations raised in a number of other lawsuits.

According to new medical research, patients who have suffered a femur fracture while using Fosamax, Actonel or another bisphophonate medication can decrease their chances of having a second break if they stop taking the drug.

Findings presented at a meeting of the American Academy of Orthopaedic Surgeons indicate that the risk of suffering a second femur fracture drop significantly when people stop taking the osteoporosis drugs, which include Fosamax, Actonel, Boniva, Reclast and Zometa.

Such femur fractures involve sudden breaks that typically occur with little or no trauma at all, such as while taking a step or falling from standing height.

The researchers concluded that, “We recommend discontinuing bisphosphonate use as soon as possible after the index atypical femur fracture has occurred.” They also recommended that patients with atypical femur fractures who are also at high risk of more typical hip or femur fractures be switched to an anabolic anti-osteoporosis medication in order to minimize the chance of suppression of bone turnover, which some believe is what causes Fosamax bone fractures.

Fosamax (alendronate sodium) is the most commonly used bisphosphonate medication in the United States. Fosamax was introduced by Merck in 1995. The medication generated over $3 billion in annual sales before it became available as a generic in 2008.

In October 2010, the FDA required warnings about the risk of thigh fractures from Fosamax and other bisphosphonate medications be placed on U.S. labels.

Merck & Co. currently faces hundreds of Fosamax fracture lawsuits that have been filed by individuals who claim the drug maker failed to adequately warn about the potential risk of problems. Complaints allege that side effects of Fosamax may weaken the ability of the femur bone to repair itself from microdamage, increasing the risk of a sudden femur fracture.

A new medical study has found that the anti-clotting drug Xarelto could have less of a risk of causing a stroke than older blood thinners, but the drug appears to share of the same risks as Pradaxa.

The study, which was funded by Johnson & Johnson, the manufacturers of the new medication Xarelto. According to researchers, users of Xarelto were one-third less likely to experience brain bleeding than patients given warfarin, (Coumadin), when the drug was prescribed for the treatment of atrial fibrillation.

But, Xarelto, like Pradaxa, belongs to a new class of blood thinners that require less monitoring, but may cause severe bleeding problems that are more difficult to treat.

Pradaxa (dabigatran) is a blood thinner that was introduced in October 2010, as an alternative to warfarin for prevention of strokes among patients with atrial fibrillation. The medication has been heavily promoted by the manufacturer, Boehringer Ingelheim.

If severe bleeding problems do occur with warfarin, they can be treated by an injection of Vitamin K, fresh frozen plasma, and blood transfusions. There is no easy fix for bleeding problems with Pradaxa, and similar medications like Xarelto.

In December, the FDA announced that it was launching a safety investigation into reports of severe bleeding events with Pradaxa, after a shocking number of deaths and severe injuries were submitted to the agency’s adverse event reporting system during the first year Pradaxa was on the market.

Experts are alarmed about the safety of the drug, and some researchers have recently questioned the validity of the drug’s pre-approval clinical trials, saying that they were so flawed that the FDA should have never approved Pradaxa for the market.

The Institute of Safe Medication Practices (ISMP) reported that the FDA received hundreds of complaints about Pradaxa problems just weeks after it was released, related to bleeding events in elderly patients.

A number of individuals throughout the United States are now considering a potential Pradaxa lawsuit against Boehringer Ingelheim after suffering problems like internal bleeding, hemorrhages, heart attacks, strokes and sudden death.

The U.S. Judicial Panel on Multidistrict Litigation has decided to create three new multidistrict litigations (MDLs) for all vaginal mesh lawsuits.

These lawsuits involve products manufactured by American Medical Systems, Inc. (AMS), Boston Scientific Corp. and Ethicon, Inc. The new MDLs will be centralized in the Southern District of West Virginia, where litigation over Bard Avaulta mesh systems is already consolidated.

According to an order issued this week, all four vaginal mesh MDLs will be assigned to Chief Judge Joseph R. Goodwin.

Recently, a growing number of lawsuits over problems with vaginal mesh and bladder sling products have been filed against manufacturers of the medical devices, which are used transvaginally to treat pelvic organ prolapse (POP) and female stress urinary incontinence (SUI).

The complaints allege that design defects with the mesh products can cause women to experience painful and debilitating complications, such as infection and erosion of the mesh through the vagina.

The FDA has issued warnings about an increasing number of adverse event reports associated with the products. In July 2011, the FDA issued transvaginal mesh warning, indicating that they have been unable to find any evidence that transvaginal mesh kits used for repair of pelvic organ prolapse provide any benefit over other available means of treatment.

There are currently about 84 AMS vaginal mesh lawsuits pending in 19 federal district courts throughout the United States; 23 Boston Scientific pelvic mesh lawsuits pending in 14 different district courts; and 37 Ethicon or Gynecare mesh lawsuits pending in 22 different district courts.

All of these cases will be transferred to the Southern District of West Virginia, where Judge Goodwin will preside over pretrial proceedings. Judge Goodwin was assigned to the three new MDLs, as he already presides over more than 330 Bard Avaulta mesh lawsuits that have been transferred to his court since that MDL was formed in October 2010.

Each of the vaginal mesh MDLs will be kept separate, because they involve different manufacturers. Putting all of the litigation before one judge will help reduce scheduling conflicts, eliminate conflicting pre-trial rulings and serve the convenience of the witnesses, the parties and the courts.

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According to medical experts, a medical study underway is expected to reveal that side effects of metal-on-metal hip replacements can cause genetic damage, which could lead to an increased risk of cancer.

According to the U.K.’s Telegraph newspaper, a study to be presented next month at the British Hip Society conference will include findings that suggest the metal particles released by the grinding of metal-on-metal hip replacements could cause chromosomal changes, which may lead to kidney cancer and bladder cancer.

The findings are the latest nails in the coffin over the safety of the once-popular hip implant designs. These hips have been the subject of massive recalls and product liability lawsuits filed by individuals who allege that they are subject to failure within a few years after surgery.

The most likely cause of the genetic damage is metal debris made up of cobalt and chromium, which is released into the body when metal hip implant parts grind against each other. The particles have been linked to tissue damage, tumors, high metal ion blood counts and metal blood poisoning, known as metallosis.

DePuy Orthopaedics, a division of Johnson & Johnson, already faces a massive number of metal hip implant lawsuits. In August 2010, a DePuy ASR metal hip implant recall affected 93,000 implants worldwide and about 40,000 sold in the United States.

Approximately 3,500, of those victims who received the implant in the U.S. have already filed a DePuy ASR hip lawsuit. As more hip implants fail over time, the number of people filing product liability claims against manufacturers is bound to increase.

Recent data from the National Joint Registry for England and Wales indicates that nearly a third of patients will experience problems within six years and other estimates suggest that as many as half of all individuals who received the recalled hip system may eventually experience loosening or failure of their implant.

In May 2011, the FDA asked device manufacturers to obtain more information about the level at which the metal particles released by hip replacements becomes dangerous, how much metal they actually release and what the potential side effects of metallosis are.

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Betty Ruth Rhodes, from Illinois, has filed a lawsuit against 65 different companies, alleging that she contracted lung cancer from asbestos exposure.

The asbestos lawsuit was filed in January, in St. Clair County Circuit Court in Illinois. Rhodes, worked as a laborer for several companies from 1958 until 1990, including Borg Warner, Speedway Manufacturing and Rhodes Camper Sale.

Direct and Indirect Asbestos Exposure

Rhodes claims that direct exposure to asbestos at the job site contributed to her developing lung cancer. She also alleges that she suffered second-hand asbestos exposure from her father and husband, who carried fibers home on their clothes or in their hair.

According to the complaint, Rhodes has suffered permanent disability and disfigurement, physical pain, mental anguish, loss of potential earnings and medical costs from asbestos lung cancer. She is seeking compensatory, economic and punitive damages of more than $450,000.

Asbestos Widely Used

Asbestos was widely used in a variety of manufacturing and construction applications, with use peaking in 1973. Most uses of asbestos were banned in the mid-1980s.

Asbestos causes Lung Cancer and Mesothelioma

When inhaled, asbestos fibers can cause asbestosis, lung cancer and mesothelioma. Although the problems have most commonly been seen among individuals who worked in direct exposure, a growing number of lawsuits over second-hand asbestos exposure have been filed in recent years by family members or loved ones who worked around the toxic substance.

Asbestos litigation is the longest running mass tort in U.S. history, with the first case filed in 1929. Over 600,000 people have filed lawsuits against 6,000 defendants after being diagnosed with mesothelioma, asbestosis or other asbestos-related diseases.

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The litigants in the federal NuvaRing litigation are scheduled to meet with the Court to discuss a plan to settle the lawsuits filed by women who allege that they suffered serious blood clot injuries from side effects of NuvaRing birth control.

All NuvaRing lawsuits filed in federal district courts are consolidated for pretrial proceedings as part of an MDL, or multidistrict litigation, which is centralized before U.S. District Judge Rodney W. Sippel in the U.S. District Court for the Eastern District of Missouri.

NuvaRing is a ring birth control device that releases a combination of etonogestrel and ethinyl estradiol and is inserted into the vagina once a month.

The complaints all involve similar allegations that Merck and their Organon Pharmaceuticals subsidiary failed to properly research the birth control ring or adequately warn about the risk of blood clots from NuvaRing.

Plaintiffs claim that they have suffered injuries after taking NuvaRing birth control, including deep vein thrombosis (DVT), pulmonary embolism, heart attacks and strokes.

Following a status conference last week, the Court issued an Order that directed the parties to be prepared to discuss a preliminary plan for alternative dispute resolution at hearing set for February 28.

In January the Court ordered the attorneys to submit proposed plans for alternative dispute resolution, which would be designed to assist the parties in negotiating a potential NuvaRing settlement agreement.

While attorneys for the plaintiffs submitted a plan that calls for the appointment of a special master to oversee the negotiations, attorneys for Merck and Organon have suggested that it is premature to consider such efforts.

The parties are currently preparing a handful of lawsuits, known as “bellwether” cases, for early trial dates. The cases are designed to help the parties gauge how juries are likely to respond to certain evidence that will be introduced throughout other cases in the litigation. In complex pharmaceutical litigation, the results of such trials often factor heavily into settlement negotiations.

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Plaintiffs from Louisiana have filed a lawsuit against Pfizer that alleges the drug maker intentionally hid the link between their popular antidepressant Zoloft and congenital birth defects when the drug is taken by pregnant women.

The two Zoloft birth defect lawsuits were filed in January in the U.S. District Court for the Eastern District of Louisiana by Terry and Nelda Rolling and Joseph and Meg Mitchell.

The complaints involve children born with congenital birth defects after the mother’s use of Zoloft during pregnancy.

Many families have filed a similar Zoloft lawsuit against the drug maker, with allegations that use of the antidepressant during pregnancy caused children to be born with a variety of birth defects and malformations.

Zoloft (sertraline) was introduced by Pfizer in 1991 for the treatment of depression, obsessive-compulsive disorder and anxiety. By 2007 there were nearly 30 million prescriptions, making it the most prescribed antidepressant in the United States. Zoloft belongs to a class of drugs known as selective serotonin reuptake inhibitors (SSRIs).

In recent years, medical research and adverse event reports have indicated that side effects of Zoloft use during pregnancy may increase the risk of serious and potentially life-threatening health problems, including persistent pulmonary hypertension in newborns (PPHN), spina bifida, heart defects, lung defects, abdominal defects and cranial defects.

Studies have suggested that Zoloft may increase the risk of birth defects when used as early as the first trimester of pregnancy, a time when many women do not even know they are pregnant.

Recently, Swedish researchers published a study suggesting a link between PPHN and all SSRI antidepressants.

The lawsuits allege that data was available to Pfizer as early as 1996 that suggested their SSRI antidepressant may increase the risk of problems for children when taken during pregnancy, yet the drug maker failed to provide adequate warnings to consumers or the medical community.

By 2007, the lawsuits claim, Pfizer knew or should have known that Zoloft and other SSRIs doubled the risk of septal heart defects when taken by pregnant women due to another New England Journal of Medicine study that year. Those results were confirmed in a 2009 study.

The lawsuits allege that Pfizer willfully failed to warn consumers of the risks in order to maximize profits, resulting in a negligent breach in its duties to the medical community, users of their medication and their unborn children.

A wrongful death lawsuit has been filed against ALZA Corporation by the family of a Utah woman who died in 2010, after using one of the company’s fentanyl pain patches.

The fentanyl patch lawsuit was filed by the family of Janine Ward last month in Salt Lake City’s 3rd District Court. The complaint names ALZA Corporation, a subsidiary of Johnson & Johnson, as a defendant.

According to the claim, the fentanyl patch, also known as a transdermal patch, was defectively designed and leaked fentanyl gel when applied to Janine Ward’s skin.

Johnson & Johnson, ALZA’s parent company, first developed the first pain patch as the Duragesic patch in 1994. Since it was introduced, the fentanyl patch has been associated with manufactured problems and many wrongful death lawsuits filed by families of individuals who overdosed on fentanyl.

Fentanyl is a painkiller about 100 times more powerful than morphine, and poses a severe risk of overdose and death if the gel contained within the patch leaks out and comes into direct contact with the skin of patient or caregiver.

The gel in the patch is supposed to be contained and delivered in a regulated fashion through a membrane placed on the skin. Over the last several years the FDA has received hundreds of reports of fentanyl overdoses and deaths associated with the use of fentanyl pain patches.

In many of the cases, too much of the fentanyl was delivered through the skin due to manufacturing defects. There have been a number of fentanyl patch recalls due to defective manufacturing.

According to Ward’s family, that is what s killed her in May 2010 after using one of the patches. A toxicology report found she had lethal levels of fentanyl in her blood at the time of death.

The lawsuit claims that ALZA used a reservoir design that failed to protect Ward from a potential overdose. According to the complaint, the death may have been avoided if ALZA had used a much safer matrix design; technology the plaintiffs say was known to the company.

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A Texas plaintiff has filed a federal complaint against Biomet Orthopedics over problems with their M2A Magnum metal-on-metal hip replacement system, which she says failed shortly after being implanted.

The complaint was filed by Carol St. Cyr in January, alleging that the Biomet M2A Magnum hip replacement she received was defectively designed and manufactured.

According to allegations raised in the product liability lawsuit, the metal head and acetabular cup of the Biomet hip replacement grindr against each other, causing premature failure and leading to metal blood poisoning from cobalt and chromium fragments; a condition known as metallosis.

St. Cyr, 69, received the Biomet M2A Magnum hip replacement in May 2009. Shortly afterwards, she began to suffer groin and hip pain, problems walking, sitting and standing, inflammation and other complications.

According to experts, as the metal hip replacement parts rub against each other, microscopic particles of cobalt and chromium may be shed into the body, which can result in metal poisoning. This may result in soft tissue damage, inflammatory reactions, bone loss, asceptic fibrosis, local necrosis and other problems that may lead to the need for a risky hip revision surgery.

Concerns about the safety of all-metal implants increased in 2010, after a DePuy ASR metal hip recall was issued due to higher-than-expected failure rates. More than 90,000 of the recalled implants were sold worldwide before the problems were acknowledged by the manufacturer, and hundreds of individuals in the United States have filed a DePuy ASR hip lawsuitafter experiencing complications with the implant.

In addition to DePuy and Biomet, a number of other artificial hip manufacturers also make all-metal implants, which have also been the subject of similar product liability lawsuits.

In May 2011, the FDA asked device manufacturers to obtain more information about the level at which the metal particles shed by hip replacements becomes dangerous, how much metal they actually shed and what the potential side effects of metallosis are.

A Texas plaintiff has filed a toxic tort lawsuit against Chevron, DuPont, Exxon and other chemical companies, alleging that he developed leukemia from benzene exposure.

The benzene lawsuit was filed by Norvel Dorsey in January, in Jefferson County District Court in Texas. Dorsey named DuPont De Nemours, Chevron U.S.A., Exxon Mobil Corp. and some of its subsidiaries, Foster Wheeler Energy Corp., Gulf Oil Corp., Texaco, U.S. Steel and 4520 Corp. as defendants.

According to Dorsey, who worked as a pipefitter for various companies from 1960 until 1986, he was exposed to benzene in the workplace and through products made by the defendants. The lawsuit claims that benzene exposure led to the development of chronic lymphocytic leukemia.

The lawsuit accuses the companies of negligence, and claims that they knew their products and workplaces were hazardous to workers’ health. Dorsey claims that he suffered physical impairment, disability, and will require medical monitoring for the rest of his life.

Benzene is an industrial chemical that is used as a solvent in the production of drugs, synthetics and dyes. It has also been used as a gasoline additive, although limits have been placed on its use in fuel due to benzene’s dangerous health effects.

Exposure to benzene has been associated with the development of several fatal forms of cancer, leukemia and other conditions, such as Acute Myelogenous Leukemia (AML), Chronic Myelogenous Leukemia (CML), Acute Lymphocytic Leukemia (ALL), Chronic Lymphocytic Leukemia (CLL), Hairy Cell Leukemia (HCL), Non-Hodgkin’s Lymphoma, Multiple Myeloma, Myelodysplastic Syndrome (MDL), Myelofibrosis and Myeloid Metaplasia, Aplastic Anemia and Thrombocytopenic Purpura.

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