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 The verdict was a victory for the drugmaker in its first trial over
allegations it defectively designed Testim, a skin gel, and
negligently misrepresented its risks.
Matthew Maletta, Endo's chief legal officer, said in a statement
that Testim was safe and Endo would continue to vigorously defend
against similar claims.
Endo and its subsidiaries face some 1,290 other Testim lawsuits in
state and federal courts across the country, the company's latest
regulatory filing in November showed.
The case is part of a larger litigation at the Illinois court. Some
6,000 plaintiffs allege that a range of defendants, such as AbbVie
Inc, Pfizer, Inc, Endo Pharmaceuticals, Inc and GlaxoSmithKline, had
failed to warn of cardiovascular risks from their testosterone
drugs.
AbbVie is the only other company that has faced trials over its
testosterone replacement drug AndroGel. It lost both those trials.
Trials against the other manufacturers are due in 2018.
Thursday's verdict involved Steve Holtsclaw of Tennessee, who had
been using Testim for more than half a year to treat chronic
fatigue. He suffered a heart attack in July 2014 and was
hospitalized twice, but has since recovered.
Lawyers for Holtsclaw did not immediately respond to a request for
comment.
Holtsclaw alleged Endo misrepresented Testim's risks when marketing
it to his physician, pushing him to prescribe the gel for off-label
uses, including chronic fatigue.
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Auxilium, which Endo acquired in 2014, in court papers rejected all
allegations. It said Holtsclaw had been unable to prove that Testim
caused his heart attack, citing his "numerous medical conditions
that put him at risk for cardiovascular disease."
Auxilium also said Testim complied with U.S. Food and Drug
Administration regulations at the time and was safe and effective
when prescribed as approved in 2002.
The FDA has generally approved testosterone replacement products for
men with low or no testosterone due to medical conditions such as a
genetic failure of the testicles.
In 2014, the FDA convened an advisory committee to consider the
adverse cardiovascular outcomes associated with testosterone
replacement therapy.
On the committee's recommendation, the FDA in May 2015 required all
prescription testosterone manufacturers to warn about cardiovascular
risk on their drug labels.
(Reporting by Tina Bellon; Editing by Richard Chang)
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