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The Supreme Court appeared split this week over whether a federal law on drug labeling should pre-empt a jury's $7 million verdict against Wyeth, in the case of a Vermont woman who lost her arm to gangrene after being given a Wyeth drug for a migraine headache.

 

The case, Wyeth v. Levine, is a major milestone in the effort by the pharmaceutical and other industries to free themselves of state court tort litigation by embracing instead a single federal regulatory regime. This is known as “federal pre-emption.”

 

But the case could be decided narrowly, giving little guidance about broader pre-emption issues beyond the area of drug labeling.

 

In 2000, Vermont guitarist Diana Levine was injected with the Wyeth drug Phenergan by means of an intravenous method that was discouraged but not forbidden by the labeling, which had been approved by the Food and Drug Administration.

 

The drug went into an artery rather than a vein, resulting in gangrene and amputation of Levine's right forearm, effectively ending her musical career.

 

She settled a lawsuit with the clinic and its personnel for $700,000, but pursued separate litigation against Wyeth in state court, arguing that its failure to prohibit the "IV-push" injection method amounted to a failure to warn and a product defect. A jury agreed, and the Vermont Supreme Court upheld the verdict, rejecting Wyeth's pre-emption argument.

 

Attorney Andrew Tauber, who was at the Court for the oral argument, predicts a narrow ruling that will grant federal pre-emption in cases like Wyeth's "where there are no allegations that the company withheld information" about potential risks and where the FDA rejected a stronger warning label.

 

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