[IMG]http://simplefeed.consumerreports.org/rsrc/i/1/_/supreme_court_rules_against_wyeth_in_drug_labeli_2 33212557/4.gif?f=3dcb3160-01dc-11dc-32a2-0019bbc55f7f&s=AewyNia7NTvDvhaDemju5DEsbnVsbCwwLDA *[/IMG] Supreme Court rules against Wyeth in drug labeling case
Pharmaceutical companies can now be held liable if a patient is harmed by one of their drugs, even if the U.S. Food and Drug Administration has approved its warning labels, says a U.S. Supreme Court ruling against the drugmaker Wyeth today. In a 6-3 decision, the high court ruled that FDA labeling approvals do not pre-empt state laws and shield companies from damages as part of liability claims. A Vermont jury awarded $7 million in legal damages to Diana Levine, once a professional guitarist. Part of her arm had to be amputated after she was improperly injected with the anti-nausea*medication Phenergan made by Wyeth as part of her treatment for migraine.
"The court's decision is a major win for consumers," said Jim Guest, President of Consumers Union. "Too many drug and medical device manufacturers are evading safety laws. The FDA is clearly outmanned, and the agency needs better tools to protect consumers. Today's decision ensures that consumers retain basic protections and remedies under state laws while we wait for long-overdue reforms at the FDA."
A recent*Consumer Reports poll*showed*that one in six Americans who has ever taken a prescription drug has experienced a side effect that was serious enough to send him or her to the doctor or hospital, was life-threatening, or caused a significant disability or incapacity, but the majority of consumers don't know they can report those side effects to the FDA. Collecting reports about serious side effects is an important function of the FDA's MedWatch program. Often a drug's full safety profile emerges only after it has been on the market awhile and taken by a large number of patients.
Read the Supreme Court's Wyeth v. Levine decision*, and for more on reporting adverse side effects*of drugs, see the FDA's MedWatch program or call 1-800-332-1088.
*links to pdf

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