W&L Responds to Report of FDA Panelists’ Financial Ties to Stents

December 8, 2006, New York, NY—As the Food and Drug Administration panel converged last week in Washington to review the incidence of lethal blood clots linked to drug-eluting stents, a Bloomberg News article revealed that six physicians who have been advising U.S. regulators on the matter, have financial ties to Johnson & Johnson, maker of the Cypher (Cordis) Stent, and Boston Scientific Corp., maker of the Taxus Express2 Paclitaxel-Eluting Coronary Stent. The panel has just recommended allowing those dangerous products to remain on the market.

Of today’s FDA decision, Paul J. Pennock, director of the drug and medical device litigation unit at Weitz & Luxenberg, P.C., said, “It is unsurprising that the Panel would vote in favor of the stents despite the strong evidence that drug-eluting stents carry life-threatening risks.”

Pennock has handled many high-profile cases dedicated to the public's welfare, among them litigation related to the dangerous contact-lens solution ReNu with MoistureLoc, manufactured by Bausch & Lomb.

Weitz & Luxenberg, one of the leading plaintiffs’ personal injury litigation law firms in America, has been following the research on late in-stent thrombosis—blood clots occurring within the stent more than 30 days after implantation. Researchers have found that the clots can lead to heart attacks, a repeat revascularization procedure, open-heart surgery and even death.

Most recently, an analysis by the Cleveland Clinic Foundation, published November 29th in the American Journal of Medicine, found that blood clots are four to five times more likely to develop in patients with drug-coated stents, compared to the older, bare-metal versions. Data presented at the hearing from a comprehensive Swedish Registry, which followed outcomes for three years, showed that after six months, a significant increase in the rate of blood clots was associated with a corresponding increase in the rate of heart attack and death; a fact that both device manufacturers have long disputed. It would appear that some of the conflicted members of the panel ignored this significant evidence.

Given the seriousness of medical issue before the panel, the FDA’s decision to use physicians who have monetary stakes in the products under review, is a betrayal of the public’s trust. In 2004, a similar predicament occurred in a decision to allow Vioxx back onto the market. Nearly all of the panelists with financial ties to the drug companies who made that class of pharmaceuticals reportedly voted to allow it; however, in that case, the FDA later chose to reject the advice of compromised physicians.

People who have been harmed by drug-coated Taxus or Cypher stents can contact Weitz & Luxenberg. Interested parties should call the Client Relations department at 1 (800) 476-6070 or via e-mail by writing to clientrelations@weitzlux.com. You may also visit our website, www.weitzlux.com

About Weitz & Luxenberg, P.C.: Weitz & Luxenberg, founded in 1986, is one of the leading plaintiffs’, mass torts, product liability, and personal injury litigation law firms in America. We have tried other pharmaceutical product liability cases in the New Jersey mass tort court, including the noted $13.5 million victory in the Vioxx case McDarby v. Merck (docket no. ATLL129605), earlier this year, including what is considered to be the first punitive-damage verdict in New Jersey against a pharmaceutical company. We are involved in the other New Jersey mass torts involving dangerous drugs, including PPA, Propulsid, Accutane, Vioxx and Bextra/Celebrex and Seroquel. The firm has also played leading roles in national and local litigations involving asbestos, silicone breast implants, and the pharmaceutical products DES, Rezulin, and Baycol as well as medical malpractice, and general negligence, among others. A forerunner in the legal fight against environmental polluters, Weitz & Luxenberg has worked with clients harmed by MTBE, mercury and trichloroethylene, among others.

Weitz & Luxenberg is no longer accepting Taxus Stent cases.

see also:

Research Center FREE TAXUS Stent Lawsuit Information
For FREE TAXUS Stent lawsuit info, you need the right law firm for you

W&L Press Release 12.08.06 W&L Responds to Report of FDA Panelists’ Financial Ties to Stents
Six experts on FDA Stents Panel had financial ties to drug companies

Taxus Stent Taxus Stent Lawyer Information
Lawyer provides informational update on taxus stent health risk.