BP response

That was Wyeth v. Levine, in which the Court decided that a state tort lawsuit by a woman who had lost an arm because of an intravenous use of Phenergan (an antinausia drug) was not preempted by the fact that Phenergan had been approved by FDA.  But I think that decision probably turns on some FDA-specific issues and may not have much precedential value in other industries. 

 

The Court drew on American Honda v. Geier's discussion which distinguished "minimal" schemes of federal regulation (which merely set a floor on safety standards but allow states to set higher standards through state legislation or state tort lawsuits), vs. "optimal" schemes of federal regulation (in which the fed carefully balances costs and benefits of regulating an industry and seeks to set both a ceiling and a floor for safety standards that can be imposed on the industry).  FDA regulation had for over sixty years been considered to be a scheme of minimal regulation that only sets a floor on drug safety--a minimal safety standard to be supplemented through state tort law and regulation of medical practice, etc.  In 2006, the politicized FDA of that time had made some utterances in the preamble to a guidance document to the effect that FDA regulation now should be considered an optimal scheme of regulation which preempts state tort lawsuits against pharmaceutical companies.  Wyeth tried to latch onto those statements by FDA and get the court to give deference to them and make a ruling that FDA regulation now was an optimal scheme of regulation that should preempt state tort lawsuits against drug manufacturers.  The Court didn't buy it.  Wyeth v. Levine served to put to bed an attempt earlier this decade by a politicized FDA to aid attempts to eliminate lawsuits against pharmaceutical manufacturers.  So it was dealing with an odd set of circumstances particular to the drug industry.

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