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
This release was issued through WebWire(R). For more information visit
http://www.webwire.com.
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SOURCE Napoli Bern & Associates, LLP
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CONTACT:
Marc Jay Bern, Senior Partner of Napoli Bern
& Associates, LLP, Cell +1-516-361-4909, MJBern@napolibern.com
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