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Law.com
December
22, 2006
by Charles
Toutant
Plavix,
a popular blood-thinning drug, is the target of multiple lawsuits
by users and third-party payers, who charge that manufacturers
Bristol-Myers Squibb and Sanofi-Aventis US marketed the drug
in disregard of its potential health risks.
In
five suits filed Monday in federal court in Trenton, N.J.,
and two filed in October, the plaintiffs claim that the manufacturers
promoted Plavix and aspirin together as a regimen for the
prevention of blood clots, when safety of that therapy was
unknown.
The
plaintiffs say the manufacturers "over-promoted" the drug
and were twice ordered by the Food and Drug Administration
to withdraw ads that made overly broad claims.
Plavix
was the second most widely prescribed drug in the world in
2005, with U.S. sales of $5.9 billion, according to the pharmaceutical
market research firm IMS of Fairfield, Conn.
A
study published on April 20 in the New England Journal of
Medicine said Plavix with aspirin was no more effective than
aspirin alone, and was harmful in patients with multiple risk
factors, such as high blood pressure or high cholesterol.
"Despite
the growing body of scientific knowledge that the four-dollar
Plavix pill was not much better than a four-cent-a-day aspirin,
defendants kept promoting it to the public and physicians,
using hyperbole and outright falsification in the process,"
the plaintiffs claim.
The
suits also charge that Plavix caused serious and sometimes
fatal injuries. Among the plaintiffs is Eloise LaBarr of Bonifay,
Fla., whose husband Edward began taking Plavix with aspirin
after bypass surgery with a stent placement to repair a blocked
artery in November 2002. In December 2004, he collapsed after
suffering a serious intracranial bleeding injury and remained
on life support for two days before being pronounced dead,
with a subdural hematoma and "Plavix therapy" listed as the
causes on his death certificate, according to the suit.
Another
plaintiff, Patricia Begley of Crystal Lake, Ill., claims she
took Plavix and aspirin from December 2003 until January 2006
after a stent implantation. She stopped after being rushed
to the hospital for internal bleeding, necessitating a blood
transfusion, a week's stay in the hospital and another week
in a nursing home, according to her suit.
The
suits include counts of negligent misrepresentation, defective
design and manufacturing, breach of implied warranty, failure
to warn and violations of the New Jersey Product Liability
Act, N.J.S.A. 2A:58C-1 et seq., and the New Jersey Consumer
Fraud Act, N.J.S.A. 56.8-1 et seq. The plaintiffs seek compensatory
and punitive damages.
One
of the suits filed in October is a putative class action on
behalf of third-party payers, such as HMOs.
The
cases are assigned to U.S. District Judge Freda Wolfson. On
Dec. 12, U.S. Magistrate Judge Tonianne Bongiovanni granted
the defendants an extension until Jan. 9 to file answers to
the October suits.
The
suits are in New Jersey based on diversity jurisdiction. Bristol-Myers
Squibb is headquartered in New York with back-office operations
in Princeton. Sanofi-Aventis US is a Bridgewater, N.J.,-based
subsidiary of a French drug maker. The two companies produce
Plavix as a joint venture.
The
suits are filed by the same law firms, Miller & Associates
in Alexandria, Va., and Hersh & Hersh in San Francisco.
Mark
Burton Jr., of Hersh & Hersh, says he knows of only one other
Plavix suit to date but believes many more will be filed soon
by his firm and others.
He
notes that many of the plaintiffs are relatively young. "We
actually have quite a few clients in their 40s and 50s. These
aren't 70- and 80-year-olds that are being targeted," he says,
adding that this will make causation of injuries easier to
prove.
Michele
DiMartino of Miller & Associates' Bala Cynwyd, Pa., office
is local counsel.
Bristol-Myers
Squibb's attorney of record, Michael Tanenbaum, of Sedgwick,
Detert, Moran & Arnold in Newark, referred questions about
the case to Bristol-Myers. Company spokesman Jeff Macdonald
said there would be no comment, as did Marc Greene, spokesman
for Sanofi-Aventis, also represented by Sedgwick Detert.
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