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The U.S. Supreme Court ruled that the 3rd Circuit U.S. Court of Appeals has to reconsider its rejection of a false advertising suit over AstraZeneca Plc's Nexium anti-ulcer treatment.
The Supreme Court ruled in Wyeth v. Levine that Congress, in setting up the federal drug-approval system through the Federal Drug Administration (FDA), intended to allow traditional product liability suits, based on state laws, to be an additional layer of protection for pharmaceutical consumers.
The court stated, "Congress did not intend FDA oversight to be the exclusive means of ensuring drug safety and effectiveness,"
The lands highest court did not address the issue of whether doctors should be warned not to use a disputed injection method. The court also did not rule on the issue of whether a traditional products liability lawsuit based on state law would be allowed when it is centered on a proposed warning that the FDA considered and rejected.
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