Articles Posted in Product Liability

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According to St. Jude Medical Inc. its Riata defibrillator leads have a higher failure rate than was disclosed when it stopped selling the product.

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Riata has an insulation failure rate of 0.63 percent, more than the 0.47 percent disclosed last December, according to a recent warning letter to doctors.

Extractions of Riata leads were linked to two patient deaths and a serious injury. Devices with the flaw, caused when the insulation surrounding the wires is penetrated, may also fail to deliver electric shocks when needed, the company said.

Different Medical Study Failure Results

Other studies showed higher failure rates. An Irish medical center found 15 percent of patients had wires protruding from the insulation when they underwent fluoroscopic screening, an advanced imaging technique. A German study of 357 patients found 8 percent needed surgery after a failure with a Riata lead. Both sets of researchers recommended closer screening for patients.

What are Pacemaker Leads?

Leads are flexible wires threaded through veins to the heart muscle that help defibrillators deliver jolts of electricity to shock hearts back into rhythm.

Recommendations to handle the defective product?

According to St. Jude, the implications of the insulation failures aren’t clear, and they advise doctors to continue routine monitoring of patients with Riata leads.

The wires shouldn’t be automatically replaced, and there is no consensus on treatment even for patients with damaged leads who aren’t suffering electrical malfunctions.

Fluoroscopic screening recommended

Researchers have urged fluoroscopic screening of patients with the Riata leads, since the complications can trigger shocks when they aren’t needed and failure to administer a shock when the heart stops beating properly.

Defibrillator patients are between a shock and a hard place; they need the device to perform when needed, otherwise they die, but they do not like unnecessary shocks, which is extremely painful.

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Pfizer, the manufacturer of Zoloft, has filed a motion to consolidate all federal Zoloft birth defect lawsuits. Pfizer requested that they be centralized before one judge for pretrial litigation as part of a multidistrict litigation, or MDL.

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On January 18, Pfizer asked the U.S. Judicial Panel on Multidistrict Litigation to create a Zoloft MDL in the U.S. District Court for the Southern District of New York.

Zoloft Birth Defect Lawsuits

A growing number of plaintiffs throughout the country have filed a Zoloft lawsuit against Pfizer, raising similar allegations that use of the antidepressant during pregnancy caused children to be born with a variety of severe birth defects and serious malformations.

New York Federal MDL

According to Pfizer, there are currently at least 59 lawsuits over Zoloft, which involve common claims and questions of fact. Furthermore, according to Pfizer, the Zoloft birth defect litigation should be consolidated to prevent conflicting pretrial rulings, reduce duplicative discovery and to serve the convenience of the parties, the witnesses and the federal court system.

Pfizer has proposed that the federal Zoloft cases should be centralized in New York, near the drug maker’s headquarters, which would provide a central location and easy access to the company’s records and important witnesses.

Pfizer has also offered the Northern and Southern Districts of Mississippi and the Nothern District of Ohio as possible alternate locations.

The majority of the complaints over Zoloft are currently pending in the U.S. District Court for the Eastern District of Pennsylvania, where at least 48 of lawsuits are pending.

Zoloft Indications

Zoloft (sertraline) was released 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).

Zoloft Birth Defects

Recently, medical research and adverse event reports have suggested that use of Zoloft during pregnancy may increase the risk of serious and potentially life-threatening health problems for babies. These side effects include persistent pulmonary hypertension in newborns (PPHN), 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.

The U.S. Judicial Panel on Multidistrict Litigation is expected to hear oral arguments on the motion during a hearing scheduled to occur on May 31, at the E. Barrett Prettyman U.S. Courthouse in Washington, D.C.

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A multiple sclerosis drug made by pharmaceutical giant Novartis is under intense investigation after at least 11 patients taking the medicine died.

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The drug, Gilenya, was licensed in 2010 in the European Union and by the FDA to treat patients with a severe type of multiple sclerosis.

European Medicines Agency Investigating Gilenya

The deaths raise concerns Gilenya could trigger heart problems after patients take their first dose, according to a recent statement issued by the European Medicines Agency. The agency, which is now investigating the drug, said it isn’t clear if it caused the deaths.

One of the deaths was in the U.S., where a patient died within 24 hours of taking the first dose.

The European agency said it didn’t know where the other 10 deaths occurred, but that they were reported to its drug database, which monitors side effects from medicines in the European Union.

FDA Investigating Gilenya

The U.S. Food and Drug Administration said it also is conducting a data analysis but has not made any definitive conclusions and does not know when its review will be complete.

Scope of the problem

More than 30,000 patients have taken Gilenya worldwide. The European Medicines Agency advised doctors to increase their monitoring of patients after the first dose of the medicine. The agency said the risk of a slow heart rate after the first dose of Gilenya was known when it was approved.

Novartis AG said it was advising doctors of new recommendations on using Gilenya. They include continuous heart monitoring during the first six hours after patients take their first dose and measuring their blood pressure and heart rate every hour. This new guidance applies only to patients taking their first dose, Novartis said in a statement.

Gilenya’s Prescribing Warning

Gilenya’s prescribing information includes a warning about bradycardia (slow heart rate) and/or atrioventricular conduction block (conduction disorder of the nervous impulse in the heart) in the first hours after starting the drug.

Interacting Medications

Due to the fact that Gilenya has been linked with these problems, the FDA also advises close monitoring of patients on certain medications (class Ia or class III antiarrhythmic drugs, beta-blockers, calcium channel blockers), as well as those with a low heart rate, history of syncope (fainting), sick sinus syndrome, second degree or higher conduction block, ischemic heart disease, or heart failure when they start treatment with Gilenya.

The use of Gilenya has not been studied in these patients, who are at an increased risk of slow heart rate. The patient who died was on a beta-blocker (metoprolol) and a calcium channel blocker (amlodipine) – again, both of which are associated with bradycardia and heart blocks.

Stronger Warning Needed?

Although there are recommendations such as obtaining an electrocardiogram on patients at increased risk for cardiac side effects prior to starting the drug and advising patients about the signs and symptoms of bradycardia, there may need to be a stronger warning about patients on medications that could also cause heart rate problems.

Perhaps people on these kind of medications or with certain heart problems should NOT take Gilenya at all. According the the manufacturer, Novartis, this is the first death within 24 hours of taking the first dose of Gilenya out of the 28,000 patients who have been started on the drug.

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As the Band played on, another tale of corporate greed and misdeeds, in the Dark City.

A Stryker Corp. (SYK) unit has pled guilty and will pay a $15 million fine. The medical-device maker was on trial on charges it marketed an unapproved mixture of products for strengthening human bone growth.

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The unit, Stryker Biotech, and three Stryker sales representatives were on trial in federal court in Boston on a 13-count criminal indictment claiming conspiracy and wire fraud.

Stryker Biotech agreed to plead to one misdemeanor count of misbranding a medical device and prosecutors agreed to drop the case against the Massachusetts-based Stryker Biotech.

Dangerous Product Sold to Surgeons
The U.S. prosecutors said Stryker Biotech made $12.5 million by misbranding and selling the bone growth mixture to surgeons over a two-year period.

The U.S. had charged Stryker Biotech with misbranding and its sales force with conspiring to defraud surgeons into combining the company’s OP-1 and OP-1 Putty with the bone filler Calstrux. Some patients suffered adverse side effects and required more surgery.

“That mixture was never studied clinically,” Assistant U.S. Attorney Susan Winkler told the jury in her opening statement on Jan. 12. “They did not know if it worked. They did not know if it was safe, and they marketed it to doctors anyway.”
No FDA Exemption for the Product
The U.S. Food and Drug Administration allowed the company to supply its products under a narrow, provisional humanitarian exemption. The company had no FDA approval for mixing in Calstrux, which was later pulled from the market, the U.S. says. Stryker Biotech tracked 63 adverse events in more than 10,000 procedures involving the bone mixture.

The case is U.S. v. Stryker Biotech LLC, 09-cr-10330, U.S. District Court, District of Massachusetts (Boston).

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The FDA is blasting DePuy Orthopaedics, a subsidiary of Johnson & Johnson, over the selling of artificial knee and hip replacement implants without FDA approval.

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The FDA issued a warning letter to DePuy Orthopaedics in December about the regulatory problems, after inspectors visiting a plant in Warsaw, Indiana discovered implants being manufactured there that were never given FDA approval.

The letter, released by the FDA, has forced DePuy to remove 14 different implant components from the market until the issue can be resolved.

DePuy officials told FDA investigators that the components found at the plant were custom devices made for specific patients, and therefore did not have to get premarket approval. The FDA disagreed, saying that none of the devices qualify as custom devices.

According to the FDA, “although the devices’ size and shape may vary with each patient’s anatomy, the standardized design characteristics do not vary among the devices manufactured.” The FDA further stated that “the fact that final specifications are tailored to match a patient’s anatomy does not preclude a clinical study or submission of a marketing application for the devices.”
Not only should the devices not have been sold, but they were manufactured with poor quality control procedures, the FDA warning letter notes. The letter cites the company for using poor design validation procedures, not having a process in place for handling customer complaints and other regulatory violations.

DePuy Orthopaedics was the focus of a major artificial hip system recall in August 2010 when it pulled 93,000 ASR metal hip implants from the market. The ASR hip recall has triggered more than 3,500 lawsuits against the company.

The federal DePuy ASR litigation has been consolidated for pretrial proceedings in the U.S. District Court for the Northern District of Ohio as part of an MDL, or multidistrict litigation.

At the time of the recall, Johnson & Johnson indicated that the DePuy ASR failure rate was about 12%. Some expects have suggested that the actual percentage of people who are likely to experience problems with their implant, including loosening, metal poisoning and possible revision surgery, is going to be substantially higher.

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The judge presiding over all federal Bard Avaulta vaginal mesh lawsuits has asked the parties to develop a list of potential bellwether cases. These bellwether cases would be prepared for early trial dates in the multidistrict litigation (MDL).

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More than 250 lawsuits over C.R. Bard vaginal mesh filed in federal courts throughout the United States have been consolidated before Judge Goodwin for pretrial litigation as part of an MDL.

Plaintiff and defense lawyers are to identify eight cases each to be considered for early discovery.

Transvaginal Mesh Injuries

The Bard Avaulta vaginal mesh litigation continues to grow against devices for repair of pelvic organ prolapse (POP) and female stress urinary incontinence (SUI).

The surgical mesh products have been linked to a risk of severe complications, including erosion of the mesh into the vagina, recurrence of urinary problems, pain and disfigurement.

The litigation initially only included Bard Avaulta mesh products, and now includes at least 29 other types of vaginal mesh made by C.R. Bard or their subsidiaries, including Pelvicol, PelviLace, PelviSoft, Pelvitex, Uretex and Align mesh.

Additionally, a number of similar complaints have been filed against Boston Scientific, American Medical Systems (AMS) and a division of Johnson & Johnson, Ethicon/Gynecare.

January MDL Consolidation Hearing

On January 26, the U.S. Judicial Panel on Multidistrict Litigation (JPML) will hear arguements over whether the vaginal mesh lawsuits involving these other manufacturers should also be centralized as part of three separate MDLs before Judge Goodwin in the U.S. District Court for the Southern District of West Virginia for coordinated handling.

Growing Number of Mesh Lawsuits

Public awareness about the risk of vaginal mesh problems increased following an FDA warning issued in 2011 about an increasing number of adverse event reports associated with the products.

In July 2011, the FDA issued surgical 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.

Earlier this month, the FDA mailed a letter to several device makers calling for more post-marketing studies into the rate of complications with vaginal mesh systems, which many believe is the beginning of tighter regulations aimed at protecting women from these serious and debilitating problems.

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The FDA is under fire to hold a new hearing to evaluate the safety of Yaz and Yasmin birth control pills, after conflict of interest issues have been raised regarding some of its advisory committee members.

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Allegedly several FDA advisory committee members who voted to keep Yaz and Yasmin on the market had worked as consultants for, or received funding from, Bayer, the YAZ Yasmin manufacturer.

Project On Government Oversight Letter

The government watchdog group Project On Government Oversight (POGO) wrote a letter on January 11 to the agency’s commissioner, Margaret Hamburg, requesting that a new hearing be convened.

In December, the committee voted 15 to 11 that the benefits of Yaz, Yasmin and other drospirenone-based birth control pills outweigh the health risks, allowing Bayer to narrowly dodge a Yaz and Yasmin recall.

Subsequently, it has been discovered that at least four of the committee members had financial ties to Bayer.

The number of members who may have had conflicts of interest is the same as the winning margin of the vote to recommend that the FDA keep the drugs on the market.

According to POGO, “We are troubled by the industry ties of some of the FDA joint committee members who reviewed the safety of Yaz and Yasmin on December 8, 2011. Because of the industry ties of these members, the joint committee’s conclusion—which amounted to an endorsement of the safety of these oral contraceptives—should be disregarded.”
Financial Conflict of Interest

According to POGO, committee members Drs. Paula Hillard, Anne E. Burke, and Elizabeth G. Raymond received research funding or were paid as consultants for Bayer or one of its subsidiaries. Internal Bayer e-mails referred to Hillard as a “huge” Yasmin advocate.

These folks voted to recommend that the FDA allow the birth control pills stay on the market, despite research that suggests an increased risk of blood clots, pulmonary embolism, stroke, gallbladder disease, deep vein thrombosis, heart attack and sudden death associated with side effects of Yaz and Yasmin.

Discovery Documents made public

The documents revealing their connections to Bayer became public as a part of the discovery process in ongoing Yaz lawsuits and Yasmin lawsuits. The lawsuits are part of a federal Yaz MDL, or multidistrict litigation, which has centralized and consolidated claims by thousands of women.

Almost 11,000 women have filed a federal lawsuit against Bayer alleging that they suffered injuries as a result of the drug maker’s failure to adequately warn about the risk of health problems from Yaz, Yasmin and other drosperinone-based birth control pills.

Drospirenone the Culprit?

Drospirenone is a newer type of synethetic progestin that is used in combination oral contraceptives. It was originally introduced by Berlex Laboratories in Yasmin. Berlex was acquired by Bayer Healthcare and an updated version of Yasmin was introduced called Yaz. Recently, Bayer introduced a third version, marketed as Beyaz, which includes a folate supplement.

Generic versions of Yaz and Yasmin are also now available from other manufacturers. Generic versions of Yaz and Yasmin include Ocella, Gianvi, Loryna, Safyral, Syeda and Zarah, all of which contain drospirenone.

The FDA released a report in 2011, that suggested drospirenone-based birth control pills may increase the risk of blood clots by 75% over older birth control pills. They also doubled the risk of heart attacks and strokes in users who were new to birth control, with some health problems appearing in less than three months after women started to take the pills.

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Merck & Co. has agreed that all Propecia lawsuits filed in federal district courts throughout the United States by men who experienced sexual problems after using their hair-loss drug should be consolidated before one judge for pretrial proceedings.

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Merck Prefers New Jersey

Merck has suggested that the U.S. Judicial Panel on Multidistrict Litigation should transfer all cases to the U.S. District Court for the District of New Jersey, where 41 of the 53 lawsuits over Propecia have already been filed.

Some plaintiffs proposed that the Propecia MDL be centralized in the U.S. District Court for the Eastern District of New York, or, in the alternative, in the U.S. District Court for the Western District of Washington.

Merck’s attorneys claim that moving the cases to the Eastern District of New York, or the Western District of Washington, would be inefficient because the courts lack familiarity with issues already addressed in a number of the cases.

Judicial Panel on Multidistrict Litigation

The U.S. Judicial Panel on Multidistrict Litigation is expected to hear arguments on the consolidation of the lawsuits over Propecia at a hearing scheduled for March 29, 2012 in San Diego, California.

It appears that all parties agree that centralizing the Propecia cases as part of an MDL, or multidistrict litigation, would serve the convenience of the parties, prevent duplicative discovery and avoid conflicting pretrial rulings. However, the MDL panel will have to determine what is the most appropriate transfer jurisdiction.

What is the problem with Propecia?

Propecia (finasteride) is approved for the treatment of male pattern baldness. It is a low-dose version of Proscar, approved in 1992 for the treatment of benign prostatic hyperplasia.

Men who took the hair loss formula say that Merck failed to warn consumers of the risks of long-term erectile dysfunction from Propecia, as well as loss of libido, infertility, anxiety, depression and other problems.

In the United States, Merck has suggested warned that the sexual side effects of Propecia are temporary, indicating that cases observed during clinical trials resolved after users stopped taking the medication.

Merck has different European warning

Merck has been forced to provide additional warnings to men in certain other countries, indicating that post-marketing reports have indicated that some men experience sexual problems that persist.

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A Kansas woman is has filed a product liability lawsuit which was allegedly caused by side effects of Cymbalta. Cymbalta is manufactured by Eli Lilly and Co. She developed a dangerous skin reaction, known as Stevens-Johnson syndrome.

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Nanci Matos, filed the Cymbalta lawsuit in the U.S. District Court for the District of Kansas on January 6.

Matos alleges that she developed Stevens-Johnson syndrome from Cymbalta, a popular antidepressant and anti-anxiety medication.

Matos began taking Cymbalta in November 2009. By December, she indicates that she started to show signs of a skin reaction and was hospitalized in January 2010.

Stevens-Johnson Syndrome (SJS) is an auto immune reaction that can be caused by some medications. The medical condition is typified skin blisters, severe rash and the skin may separate from the body. When the skin lesions affect more than 30% of the body, the condition is referred to as toxic epidermal necrolysis (TEN).

Treatment for SJS or TEN typically involves inpatient care at a hospital Intensive Care Unit (ICU) or Burn Unit, and the conditions can be fatal in many cases.

Matos’ Stevens-Johnson syndrome lawsuit claims that Eli Lilly failed to adequately warn doctors and patients that Cymbalta side effects could cause dangerous skin reactions.

According to the lawsuit, the FDA asked the company as early as 2007 to investigate potential link between Cymbalta and skin reaction problems, but Eli Lilly allegedly ignored that request and a number of other warnings by experts until September 2011, when the Cymbalta label was updated to include a warning of SJS and other skin reaction side effects.

Matos accuses Eli Lilly of strict liability, negligence, breach of warranty, misrepresentation, fraud and violations of consumer protection laws. She seeks damages for disfigurement, pain, suffering, mental anguish, embarrassment, shame, loss of enjoyment of life, loss of consortium and other injuries.

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Topamax can result in serious birth defects such as cleft palate or cleft lip. These occur when parts of the soft and hard palate fail to completely fuse together. The defect can result in a notched lip, or in severe cases, an open groove that extends from the nose to the roof of the mouth. Cleft lip and cleft palate birth defects can also cause problems eating and communicating, and can increase the risk of ear infections.

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What is Topamax?

Topamax is an anti-convulsant drug used to treat epileptic seizures. In addition, Topamax is also prescribed to help prevent migraine headaches. The chemical name for Topamax is Topiramate, and its generic name is Topiragen.

Topamax Problems

In 2009, the makers of Topamax were charged by the Department of Justice of promoting the drug to physicians for unapproved purposes. Such promotions are called “off label” since they encourage use of the drug for purposes not listed on the packaging, and not approved by the FDA. The manufacturers of Topamax plead guilty and paid $75.37 million for violating the False Claims Act, as well as $6.14 million in criminal fines.

Topamax Lawsuit

A product liability or defective product claim for Topamax is a type of pharmaceutical claim in which a person is injured as the result of taking a medication. The cleft lip and palate birth defects were not originally listed as side effects of Topamax, prompting the FDA to update the pregnancy warnings.

Topamax Medical Studies

Topamax has been shown by numerous studies to cause serious birth defects, such as cleft lip or cleft palate. Serious malformations may require expensive surgery or speech therapy, which can be costly.

The UK Epilepsy and Pregnancy Register, as well as the North American ARF Pregnancy Registry, noted a higher incidence of oral clefts in children whose mothers took Topamax during pregnancy.

What was Topamax prescribed for?

Topamax is prescribed to treat epileptic seizures, as well as for the prevention of migraines. However, Topamax has been applied for many off-label uses, such as bulimia, post traumatic stress disorder, obesity, and smoking cessation.

When did the FDA issue a new warning for Topamax?
In March 2011, the FDA increased the pregnancy warning for Topamax to Category D, which means there is positive evidence of fetal risk.

The FDA required new warnings in 2011 after data from the North American Antiepileptic Drug Pregnancy Registry found that children born to mothers who took Topamax during the first trimester of pregnancy experienced an oral cleft about 1.4% of the time, compared to a prevalence rate of between 0.33% and 0.55% associated with other epilepsy drugs.

When did the FDA approve Topamax?

Topamax was approved to treat epileptic seizures in 1994. In 2004, the FDA approved is for use in the treatment of migraines.

The FDA estimates that approximately 32.3 million prescriptions for Topamax or a generic equivalent were issued from January 2007 through December 2010. In many cases the drug is prescribed for off-label uses.

Is Topamax sold under any other names?

Yes. A generic version of Topamax was approved in 2006, called Topiragen. It is distributed by Mylan Pharmaceuticals.

Who are the manufacturers of Topamax?

Ortho-McNeil Neurologics and Noramco, Inc. discovered Topamax in 1979. Both companies are divisions of Johnson & Johnson.