Legal observers expect a frenzy of action in pending and new litigation against pharmaceutical companiesand perhaps sweeping up providerstriggered by a U.S. Supreme Court ruling last week that federal regulation of the industry doesnt pre-empt state liability claims.
Pharma industrys bitter pill ...
... could be impetus for devicemaker legislation, too
The case, in which the court upheld a $6.8 million verdict awarded to Vermont musician Diana Levine to compensate for the loss of her forearm caused by an injection of Wyeths nausea drug Phenergan, was a widely anticipated battle line in a war over the notion of federal pre-emption.
The court reached the opposite conclusion last year in a case involving Medtronic, finding that 1976 legislation rendered medical devicemakers immune from such lawsuits if theyve complied with Food and Drug Administration requirements. Some lawmakers are pushing legislation to change that.
The Vermont courts concluded Wyeths labeling failed to sufficiently warn clinicians of the risk of administering the drug with an intravenous push rather than a drip. Wyeth appealed, arguing that such claims obstruct the FDAs authority and that federal law precluded stricter warnings without prior FDA approval. Justice John Paul Stevens, writing for the 6-3 majority, called the first argument an untenable interpretation of congressional intent and the other premised on a misunderstanding that the FDA, rather than the manufacturer, bears primary responsibility for drug labeling.
This case illustrates that tragic facts make bad law, Bert Rein a partner in Wiley Rein, Washington, and Wyeths lawyer in the case, said in a written statement.
As their manufacturers seek to insulate themselves from those juries, providers might see more frequent changes in drug labels, said Richard Morgan, managing partner in the law firm Bowman and Brooke, Minneapolis. Morgan predicted the coming spike in drug litigation is likely to reach providers. Everyone in that chain of distribution, right up the line, will get looked at.
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