Articles Posted in Product Liability

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

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.

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.

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

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

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.

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.

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

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.

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).

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.

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.

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

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.

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.

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.

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.

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.

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.