Articles Posted in Product Liability

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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.

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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.

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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.

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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.

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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.

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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.

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The plaintiff lost the trial of a Levaquin lawsuit. The man suffered two ruptured Achilles tendons after taking the popular antibiotic.

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The jury determined that the drug maker failed to adequately warn consumers and doctors of the risk of tendon damage from side effects of Levaquin.

A Minneapolis jury ruled that Johnson & Johnson failed to provide sufficient warnings about the risk of Levaquin tendon ruptures, but found that the company was not responsible for injuries suffered by the 78 year old plaintiff.

Clifford Straka could not prove that his injuries were caused by the antibiotic.

According to the lawsuit, Straka’s doctor had been unaware of the risk of tendon ruptures when she prescribed Levaquin because there was not adequate label warning.

Although there has been information about the potential risk of tendon damage on the drug’s label since it was first approved by the FDA in 1996, Straka alleged that those warnings were insufficient and that the drug maker actively attempted to downplay the risk for years.

FDA Black Box Warning

In July 2008, the FDA required that a “black box” warning be added about the side effects of Levaquin and other similar antibiotics, which is the strongest warning that can be placed on a prescription medication.

3,700 Lawsuits Still Pending

Straka is one of more than 3,700 people who are pursuing a lawsuit over tendon damage from Levaquin. All of the federal cases have been consolidated as part of an MDL, or multidistrict litigation, which is centralized in U.S. District Court for the District of Minnesota.

This trial was considered a “bellwether”, as the parties were using the results to gauge how juries are likely to respond to similar evidence in other cases and possibly help the parties reach a Levaquin settlement agreement.

This is the third straight trial win for Johnson & Johnson and the fourth to go to trial.

In December 2010, the first trial ended in a $1.8 million award for the plaintiff, including punitive damages to punish the drug maker for their conduct.

The drug maker successfully defended the second trial, which ended in June 2011, and the third trial, which ended in October.

The first two trials were held in federal court. The third trial was held in New Jersey state court, where about 1,900 of the cases are currently pending.

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According to a Johnson & Johnson lawyer, J&J properly warned of the risks of its antibiotic Levaquin and shouldn’t be held liable for tendon injuries sustained by a 78-year-old man.

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Clifford Straka, tore two Achilles tendons after taking the drug for pneumonia, sued J&J and its Ortho-McNeil Pharmaceutical unit in 2008. Straka said his doctor wasn’t aware when she prescribed the drug that Levaquin was linked to an increased risk of tendon damage in elderly patients.

Johnson & Johnson denies liability

Johnson & Johnson, has denied any failure to warn and contended that Straka needed Levaquin to treat the pneumonia.

According to Johnson & Johnson, “The label from day one in 1996 was adequate.” “The information was out there and available to the doctors and everyone else.”
Levaquin Lawsuits

The lawsuit is the third federal case to go to trial in Minnesota alleging J&J and its unit, now known as Janssen Pharmaceuticals, downplayed the risks of the antibiotic to boost sales.

J&J lost the first, a jury verdict for $1.8 million in 2010, and won the second last year. The company also won the first state case in October, when a New Jersey jury rejected the claims of two plaintiffs.

Levaquin Tendon Ruptures

J&J is facing more than 3,700 claims involving Levaquin in state and federal courts.

FDA Warning

In 2008, the U.S. Food and Drug Administration required all makers of antibiotics in Levaquin’s class, called fluoroquinolones, to increase warnings about tendon ruptures.

The jury of 7 women and 5 men have begun deliberating.

The case is Straka v. Johnson & Johnson (JNJ), 08-05742, combined for trial in In re Levaquin Products Liability Litigation, 08- md-01943, U.S. District Court, District of Minnesota (Minneapolis).

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Product liability lawsuits against generic drugs are facing a tough uphill battle, which usually ends in dismissal, as exemplified by the Fosamax update below.

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U.S. District Judge Joel A. Pisano, has dismissed claims against Watson Pharmaceuticals, the manufacturer of generic versions of the popular osteoporosis drug. Plaintiffs had alleged that their generic version of Fosamax caused femur fractures to develop suddenly, with little or no trauma at all.

Following a court order on January 17, Watson Pharmaceuticals has been dismissed as a defendant in several Fosamax lawsuits. These were filed by plaintiffs who suffered an atypical femur fracture after taking generic versions of the drug.

Pliva v. Mensing

The order comes as a result of a recent Supreme Court decision in Pliva v. Mensing, which allows generic drug makers to be shielded from liability for failure to warn about harmful or even deadly side effects of medications they make, since FDA regulations require that their products must carry the same warnings as the name-brand versions.

The complaints against Watson raised similar allegations to those that have also been filed against Merck, the manufacturer of the name brand version of the medication.

In these cases, plaintiffs allege that the drug makers failed to adequately research the side effects of Fosamax or provide adequate warnings to consumers of the medical community.

FDA Warnings for Fosamax

In October 2010, the FDA required new warnings about the risk of bone fractures from Fosamax and other similar bisphosphonate medications.

Merck and generic Fosamax makers now warn consumers that they should seek immediate medical attention if they experience new groin pain or thigh pain while taking the drug, which can occur weeks or months before a complete Fosamax thigh bone fracture.

All federal Fosamax lawsuits over femur fractures have been consolidated as part of an MDL, or multidistrict litigation, which is centralized before Judge Garrett E. Brown in the U.S. District Court for the District of New Jersey.

Visit my website for further Fosamax femur fracture information

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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.

Read more here and visit my website for further information.

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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.