A product liability case against Bayer Pharmaceuticals filed by Marc Bern of Napoli Bern & Associates, LLP will be profiled on 60 Minutes Sunday night, February 17 along with his client, Josephine Randone speaking on behalf of her late husband, Joseph Randone.
In the 60 Minutes segment, a renowned researcher calculates that 22,000 patients could have been saved if the Food and Drug Administration removed the heart surgery drug, Trasylol two years ago, when his study revealed patients on the drug double their risk of kidney failure, heart failure and had a 181 percent increase in the risk of stroke.
Dr. Dennis Mangano, tells 60 Minutes correspondent Scott Pelley that Bayer, the drug’s maker, failed to tell the FDA about negative results of its own Trasylol study and that the company’s failure placed the drug’s success before patient well-being.
Mangano tells Pelley, "Good medicine demands that you protect the patient. That’s the issue here and not the drug and not the profit margin," he says.
Joseph Randone’s case is one of at least 20 filed against Bayer accused of selling a defective product, fraud and failure to warn.
The 52-year old father of two was given Trasylol during valve replacement surgery in January 2006.
His recovery was expected to take less than one week but instead he experienced kidney failure and a chain reaction of debilitating conditions including amputation of his legs and left hand, low blood pressure, feeding and breathing tubes, a pace maker, dialysis and infection during his eight month hospitalization.
Toward the end of his life he told his wife Josephine, “I can’t take it anymore.”
Attorney Marc Jay Bern says “the importance of the Trasylol litigations is to highlight the fact that often, older tried and tested medications are ignored in the face of new and untested medications that have been heavily promoted by the drug manufacturers to the detriment of the unknowing public.”
Finially, the scientist working for Bayer blew the whistle on the company's internal findings. Lawsuits began to be filed. Germany banned the drug as did Health Canada.
On November 5, 2007, drug maker Bayer Pharmaceuticals Corporation pulled Trasylol from the international market. But it took FDA two years after Dr. Mangano's initial warnings to pull it off the market during which time Dr Mangano says 1,000 lives a month could have been saved.
Bern points out that Bayer has a history of putting out defective products.
Bayer introduced Baycol, a statin drug used to lower cholesterol, which was tied to more than thirty deaths before it was withdrawn from the market, and Bayer is responsible for Factor 9, a blood clotting medication used by millions of hemophiliacs who developed HIV and AIDS from contaminated and untested Factor 9.
Napoli Bern & Associates, LLP, a nationally-known law firm advocating on behalf of injured plaintiffs in pharmaceutical and environmental tort matters, including injuries from diet drugs Fenfluramine and dexfenfluramine (ReduxTM), Rezulin, Propulsid. The firm represents clients in environmental claims arising from petroleum spills and MTBE contamination throughout the eastern United States, as well as over ten thousand plaintiffs suffering toxic exposure injuries at the site of the World Trade Center following the September 11, 2001 attacks. #