Levine suffered a terrible injury, resulting in amputation of her arm, after administration of a drug by an approved-on-the-label but risky manner that went wrong. She sued Wyeth, the drug maker, for the label wording that approved the riskier manner of application. The label language was approved by the FDA, and in reality, nobody EVER changes FDA approved label language for fear of never ending million dollar lawsuits. Levine won in state court, Wyeth appealed to the Supreme Court, and lost. They are liable, for millions in damages.
The Wyeth lawyers argued the case on "preemption", the doctrine that federal (in this case FDA) law and regulations override state law, and thus Wyeth cannot be sued in state court.
In actual fact, Wyeth manufactured the drug in accordance with all FDA regulations. Any ordinary person knows the ultra cautious FDA won't approve anything with any real risk attached. By complying with the onerous FDA approval, inspection, and labeling requirements, Wyeth did everything an ordinary person would expect a company to do. Didn't do them any good, they have to pay off, big time.
This case will encourage more suits by tort lawyers against doctors, hospitals and drug companies. This kind of jackpot justice is one reason why US health care costs twice as much as health care in every other first world country.
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