 |
|
|
Musician Diana Levine, who lost her arm eight
years ago after she received treatment with one of drugmaker Wyeth’s drugs,
Phenergan, argues today before the U.S. Supreme Court that a state ruling
should be overturned. At issue is whether the federal government can limit
lawsuits by consumers who have been harmed by prescription medications. After hearing
arguments, the Supreme Court will have to decide on Monday if patients who
suffered serious drug adverse events could file a lawsuit if they consider
manufacturers of the medicines hadn’t cautioned them adequately about the risks
associated with the drugs.
Levine’s case, that could limit liability
claims against drugmakers if one of their medicines causes harm, is one of the
most watched business cases of the Supreme Court’s team.
The Vermont
musician sued the drug company after she received treatment with one of their
drugs, Phenergan, in 2000. The drug, which was administered through IV-push,
was supposed to relief her nausea, but instead, due to being improperly
injected, it forced doctors to amputate her arm.
“I never expected to sue anyone in my life,”
Levine said at the beginning of the trial. It’s just “sometimes it takes
something like this to make it known when a drug is not being used right,” she
added.
Wyeth, formerly known as American Home
Products, was found guilty of not warning doctors about the risk of Phenergan intravenous
injections. But the drugmaker argued that the label had FDA’s approval.
The jury awarded Levine $6.7 million,
agreeing that Wyeth should have been clearer in its warning label about the
risks of improperly administering the drug. Wyeth says it acted properly by
including the U.S. Food and Drug Administration’s approved warnings on the label
for its drug. The FDA-approved label allows it to be administrated via “IV-push”
(the drug is injected into a vein), intramuscular injection or a slow
intravenous drip into a vein.
Levine says Wyeth should have changed the
drug’s label to bar IV-push administration. She said she was never told the
risks of this method – that includes possible irreversible cangrene if done incorrectly,
as it was mentioned on the label – and she would have chosen another method
rather than loosing her arm.
Wyeth and the administration are asking the
high court to rule that the drugmakers may not make changes to labels without
the approval of the Food and Drug Administration and that people cannot sue
under state law for harm caused by an FDA-approved drug. The drugmaker argues
in its appeal that the federal Food and Drug Administration should be the only
one to decide whether drug labels have been properly written, instead of a jury
that can only take into consideration individual arguments of the drugs in
question.
According to the U.S. Chamber of Commerce,
the Vermont
musician case could affect millions of other business outside the
pharmaceutical industry that face liability claims.
© 2007 - 2009 - eFluxMedia