Experts Say that FDA Cannot Ensure Drug Safety

By Alice Turner
17:49, August 17th 2008
53 votes
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Experts Say that FDA Cannot Ensure Drug Safety

Several top doctors have filed a friend-of-the-court brief with the Supreme Court, which highlights that the U.S. Food and Drug Administration is incapable of ensuring on its own drug safety, and that lawsuits can serve as "a vital deterrent" and protect consumers in cases in which drug companies don't disclose risks, such as the case at issue, that of Diana Levine, a Vermont guitarist, who lost her right arm below the elbow after she was injected with Phenergan, a nausea drug.

The people and organizations who are behind the amicus curiae filing include experts Anju Budhwani, M.D., Arthur Levin, MPH, Curt D. Furberg, M.D., Ph.D., Rahul Sharma, MD, MBA, and third party payor amici, including the Health and Welfare Fund and Retiree Health and Welfare Fund of the Detectives Endowment Association, Police Department, City of New York, Canton Electrical Welfare Fund of the International Brotherhood of Electrical Workers Local 540, and the Ohio Carpenters Health Fund.

Musician Diana Levine was given the Phenergan shot in the emergency room in April 2000, through an IV push that injects the drug through an existing peripheral IV line. However, it appears that the drug was delivered outside her vein, which led her to develop gangrene and lose her arm below the elbow. She won a jury award of more than $6 million from Phenergan maker Wyeth, after the State court found that the drug maker failed to explain to doctors the severity of the risks Phenergan posed to patients.

However, Wyeth did not pay a dime so far and took the case to the Supreme Court, where it will be heard on November 3. The company says that it cannot be held responsible for the accident, and it is shielded from lawsuits when their product is approved by the government.



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