Every San Antonian and every Texan should be concerned about a case of huge importance currently being argued at the U.S. Supreme Court. Wyeth v. Levine (“Wyeth”), is a preemption case with major implications – not just for drug company’s – but for every manufacturer of products that can seriously injure or kill our citizens.
In the Wyeth case a musician was given a shot of a Wyeth drug in her arm to treat symptoms associated with her migraine headaches. The shot caused her arm to turn gangrene and ultimately the arm was amputated. The musician alleged, among other things, that if Wyeth’s label had warned of the risk of contracting gangrene she would not have taken the shot. Wyeth is arguing at the Supreme Court that the US Food and Drug Administration (FDA) had approved the label therefore they cannot be sued even if the label was deficient and did not contain the information.
In a startling revelation, documents recently released in a congressional investigation show that career officials at the FDA have argued against the issue of the FDA blocking consumer lawsuits against drug makers. These internal memos contradict the FDA’s position in the Wyeth case. In the Wyeth case the FDA has taken the position promoted by the Bush administration that the FDA label standards should trump state laws and prevent injury lawsuits. However some FDA officials have said that it’s wrong to assume that FDA-approved drug labels are completely reliable, or that they are based on full disclosure of safety risks by drug makers.
This case is vitally important – if Wyeth wins this decision will be used by drug and medical device manufacturers to attempt to prevent Texas citizens from seeking compensation for losses and injuries when they are harmed by defective drugs or products that are regulated by the federal government. Hopefully, the revelation of the internal memos at the FDA will cause many people to question whether it is a sound policy to have federal government agencies giving immunity to drug and product manufacturers that cause grave injury just because they have been given a stamp of approval by an overworked and understaffed federal bureaucracy.
If the decision favors Wyeth, perhaps the US Congress will consider reversing the preemption doctrine pursued by the Bush Administration.
The Wall Street Journal reported these developments and much of this content was obtained from their article.