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Last updated on Friday, March 6, 2009
(UNDATED) - The U.S. Supreme Court says drug warning labels don’t necessarily shield manufacturers from lawsuits.
The court upheld a Vermont woman's $7-million-dollar verdict against Wyeth, the maker of the anti-nausea drug phenergan, after she suffered gangrene from an injection of the drug and lost part of her arm.
The drug carries FDA warning against administering it by injection, but a 6-3 majority says Vermont state law opens the door to sue anyway.
Indianapolis Attorney Irwin Levin is suing Wyeth over other treatments. He says the ruling means drug companies, including Indianapolis-based Eli Lilly, have a responsibility to make meaningful disclosures about side effects.
"Marketing just has to be told, 'look, guys, we've got to tell people the downside of the drugs that we're asking them to pay a lot of money for,'" Levin says.
Dissenting Justice Samuel Alito argues the FDA warning was clear but ignored by a physician's assistant. Levin says it's a jury's job to assess who's to blame.
Lilly Spokesman Ed Sagebiel says there are no pending lawsuits against Lilly that would be affected by the ruling. He says the company is reviewing the decision to determine whether it needs to change any of its labeling practices.
Sagebiel says the FDA is in the best position to evaluate drug safety, and says the ruling "undermines" people's reliance on the agency.
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