Articles Posted in Product Liability

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

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.