Inadequate labeling or human error?

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

Nothing contained in this blog is to be construed as necessarily reflecting the views of the Pacific Research Institute or as an attempt to thwart or aid the passage of any legislation.

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