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Patients and drug companies are still waiting
for a decision of the U.S. Supreme Court in Levine’s case. The case Wyeth &
Levine could affect millions of other business outside the pharmaceutical
industry that face liability claims.
Levine’s case, one of the most watched
business cases of the Supreme Court’s team, seeks answers to questions like: Can
the federal government limit lawsuits by consumers who have been harmed by a
prescription medication?, Can the drug makers make changes to the labels
without the approval of the Food and Drug Administration?
According to recent reports about the case,
attorney Seth Waxman, arguing for Wyeth, told the court that the prescribing
instructions for the drug, Phenergan, “plainly comprehended and warned about
the specific risks” of giving the drug in the way Levine received it.
The Vermont
musician, Diana Levine, received treatment with Phenergan in 2000. The drug was
supposed to relief her nausea but it was improperly injected and the woman lost
her arm. Wyeth, formerly known as American Home Products, was found guilty of
not warning doctors about the risk of Phenergan intravenous injections. 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.
The drug’s labels mentioned possible irreversible
cangrene if the procedure called “IV-push” was done incorrectly.
On the other hand, Levine's lawyer said
Wyeth knew the injection method used for Levine was dangerous and the company
should have put a stronger warning on the drug. Levine said she was never told
the risks of this method and she would have chosen another method rather if she
knew she would loose her arm. Wyeth’s attorney said the label had FDA’s
approval. As it was mentioned on the label, the drug could be administrated via
“IV-push” (the drug is injected into a vein), intramuscular injection or a slow
intravenous drip into a vein. The company insisted they were not allowed to
change the warnings due to FDA rulings.
An answer is still awaited in this case and
drug makers want to know if they can be held responsible for harm caused by the
drugs after they have been approved by the FDA.
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