| May. 11th, 2009 05:17 pm FDA vs. the law From: http://www.nature.com/nbt/journal/v27/n5/full/nbt0509-397.html
<snip> "Nine years ago, Diana Levine lost her arm to gangrene after a physician's assistant improperly injected Wyeth's anti-nausea drug Phenergan (promethazine hydrocholoride), causing the drug to come into contact with arterial blood. Over two times the dose recommended on the label was administered, and the medical personnel persisted with the procedure despite Levine's protestations of pain. Levine sued the physician and physician's assistant, settling the suit out of court.
She then went after Wyeth (p. 399), alleging that the company had failed to provide sufficient warnings in Phenergan's labeling to indicate that the drug was "not reasonably safe for intravenous administration." Her attorney argued Wyeth was negligent because the drug label should have warned physicians not to use the intravenous (IV)-push method at all. The jury agreed, awarding Levine $7.4 million, which was subsequently reduced to $6.7 million. Phenergan's label includes six statements (two in all capital letters and boldface type) explicitly warning that injecting the drug into arterial blood poses a high risk of tissue damage. In 1988, Wyeth had suggested to FDA a strengthening of Phenergan's label to warn about inadvertent administration into the artery via the IV-push method—exactly the issue targeted in the Levine suit. Ironically, though, FDA declined the labeling change presumably because the benefits of retaining IV-push injection as a treatment option for patients outweighed the risks. Thus, the regulator discouraged the manufacturer from making the label change that it was subsequently sued for not making. When the Wyeth v. Levine appeal reached the United States' highest court last year, the drug company argued that FDA's oversight of Phenergan's label preempted Levine's claims of negligence on the basis of Article IV of the US Constitution. But in a 6–3 split decision this March, the Supreme Court disagreed with this interpretation, ruling that there is no preemptive language in the statutes governing drug regulation. Thus, any doubt over the invalidity of FDA preemption for drugs is now at an end." <snip>
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