The FDA-approved label contained prominent warnings: “Extreme care should be exercised to avoid … inadvertent intra-arterial injection. Reports compatible with inadvertent intra-arterial injection … suggest that pain, severe chemical irritation … and resultant gangrene requiring amputation are likely under such circumstances.” It couldn’t be clearer.
Further, if the U.S. Supreme Court overturns preemption in Wyeth v. Levine, local judges, juries and personal-injury lawyers would replace expert FDA scientists as the de facto drug regulators. It would become nearly impossible for companies to comply with different standards in each state.
As a consequence, drug developers would curb research into new, lifesaving medicines because navigating 50 separate, jury-created approval processes would be too expensive and risky. That is bad news for patients waiting for the next generation of cures.
Lawrence McQuillan, Ph.D.
Director, Business and Economic Studies
Pacific Research Institute