Randone Trasylol Lawsuit Profiled on CBS' '60 Minutes'

Randone Trasylol Lawsuit Profiled on CBS' '60 Minutes'

NEW YORK, Feb. 19 /PRNewswire/ -- On November 5, 2007, under increasing government pressure, Bayer Pharmaceuticals Corporation said that it had halted worldwide sales of its drug Trasylol after a Canadian clinical study found the drug could be linked to a higher risk of death than other drugs. The Food and Drug Administration asked the company to stop selling the drug, used to prevent excessive bleeding during heart bypass surgery, pending detailed review of preliminary results from the Canadian study.

In the wake of Bayer's announcement that it was pulling its controversial heart surgery drug Trasylol from the market, nationally known plaintiff's advocates Napoli Bern & Associates, LLP commenced several litigations seeking damages for a heart patient's death. One of those litigations, arising from the death of Joseph Randone, was profiled by CBS's "60 Minutes" on Sunday, February 17, 2008. In that story, renowned medical researcher Dr. Dennis Mangano calculated 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 widespread death associated with it. Dr. Mangano also told 60 Minutes correspondent Scott Pelley that Bayer, the drug's maker, failed to tell the FDA about negative results of their own Trasylol study and that the company's failure to fully apprise the FDA of their own study's findings placed the drug's success before patient well-being.

The Randone case (Josephine Randone, Executrix Of The Estate Of Joseph Randone, And Josephine Randone, Individually, v. Bayer Corporation, et al.) was filed by Napoli Bern & Associates, LLP, and arises from horrific post- surgical complications suffered by Joseph Randone, a 52-year-old man who suffered kidney failure leading to a chain reaction resulting in his death following routine valve replacement surgery where Trasylol was utilized. 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." Bern continued, "We are suing for tens of millions of dollars on the Randone family's behalf because of Bayer's reckless conduct -- not only with regard to its marketing of Trasylol but also but for the public health debacles arising from its products Baycol and Factor 9. Baycol is known to have caused more than 30 deaths, and thousands of hemophiliacs using blood clotting medication Factor 9 developed HIV and AIDs from tainted and untested Factor 9."

Joseph Randone was administered Bayer's drug Trasylol on January 16, 2006, during the course of what should have been a Coronary Artery Bypass Graft surgery performed at Stony University Hospital, Stony Brook, New York. As a result of the use of the drug, Mr. Randone began experiencing renal insufficiency soon after heart surgery, and subsequently went into renal failure, which led to Mr. Randone suffering from hypotension (low blood pressure), wound breakdown and infection, including wounds of the abdomen and chest; he needed artificial feeding through indwelling tubes in the stomach, required further surgeries including revisions of pacemaker placement, cholecystectomy, and revision of gastrostomy tubes. As his rocky post-surgery period continued, Mr. Randone suffered gastrocutaneous fistula, a breakdown of the skin and tissue surrounding the stomach and needed a feeding tube surgically implanted. Ultimately, Mr. Randone underwent amputation of both legs and amputation of his left hand due to gangrene. The combination of all of these procedures, wounds and infections and renal failure ultimately led to his untimely death on August 8, 2006. Prior to his initial bypass surgery, Mr. Randone had no knowledge that the Trasylol that would be administered during surgery might cause such devastating injuries, and he was never told that other, safer alternative medications existed and could have been used instead of Trasylol.

Trasylol was approved by the FDA in 1993 and prior to its withdrawal from the market, was used to control bleeding in open-heart surgeries. Trasylol was indicated for prophylactic use to reduce peri-operative blood loss and the need for blood transfusion in patients undergoing cardiopulmonary bypass in the course of open-heart surgical procedures. Trasylol is a broad-spectrum protease inhibitor, which modulates the systemic inflammatory response associated with cardiopulmonary bypass surgery. The effects of Trasylol use in cardiopulmonary bypass surgery involve a reduction in inflammatory response, which translates into a decreased need for blood transfusions.

Trasylol is not the first dangerous and defective medication manufactured and marketed by Bayer Pharmaceuticals Corporation. Bayer also marketed the drug Baycol, a statin drug used to lower cholesterol, which was tied to more than thirty deaths before it was withdrawn from the market, and Factor 9, a blood clotting medication used by millions of hemophiliacs who developed HIV and AIDS from untested Factor 9.

About the Firm:

Napoli Bern & Associates, LLP, a nationally-known law firm advocating on behalf of injured plaintiffs in pharmaceutical and environmental tort matters, is based in Manhattan and Great River, New York, and has offices in Philadelphia, New Jersey, and Oklahoma. The firm has successfully litigated claims of thousands of persons injured by the diet drugs Fenfluramine and dexfenfluramine (Reduxtm), Rezulin, Propulsid and 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 after working on the debris pile at the site of the World Trade Center following the September 11, 2001 attacks.

For more information contact:
Marc Jay Bern, Senior Partner
Napoli Bern & Associates, LLP
3500 Sunrise Hwy., Suite T-207
Great River, New York 11739
Cell: (516) 361-4909
E-mail: MJBern@napolibern.com

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Source: Napoli Bern & Associates, LLP

CONTACT: Marc Jay Bern, Senior Partner of Napoli Bern & Associates, LLP,
Cell +1-516-361-4909, MJBern@napolibern.com

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