Re: Nov. 28 commentary
“Court takes up pre-emption doctrine.”
It’s hard to see how “inadequate labeling,” not human error, resulted in the amputation of Diana Levine’s arm, as Thomas O. McGarity claims.
The FDA-approved label on the anti-nausea drug Phenergan 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 stated any clearer.
If the U.S. Supreme Court overturns the principle of pre-emption in Wyeth v. Levine, local juries and personal-injury lawyers would de facto replace expert FDA scientists as America’s drug regulators. Consequently, drug developers would curb research into new, life-saving medicines because navigating 50 separate, jury-created approval processes would be too costly and risky.
For patients waiting for the next round of cures, this is terrifying news.
Lawrence J. McQuillan
Pacific Research Institute
[email protected]San Francisco