The U.S. District Court for the District of Vermont held that federal law does not preempt state law in a drug product liability case involving generic forms of metoclopramide. Toxic tort litigator and author Margie Searcy Alford reviews and comments on the court’s decision in Kellogg v. Wyeth (612 F. Supp. 2d 421 [D. Vt. 2009])
Plaintiff Ethel Kellogg took the drug metoclopramide for four years and allegedly developed numerous medical problems as a result. Kellogg sued defendant Wyeth, the maker of the brand name drug Reglan, and several makers of generic forms of the same drug. Kellogg alleged among other things that the drug was only safe for short-term use but that the makers encouraged long-term use and knew that many doctors were prescribing the drug for long-term use.
Kellogg alleged in some of her counts that the makers of the drug failed to warn adequately of the dangers associated with long-term use. The makers of the generic drug argued that Federal Drug Administration (FDA) regulations and approval of the label preempted them from giving warnings other than those warnings approved by the FDA and given by the maker of the brand named drug. The court found that federal law did not preempt the manufacturers of the generic drug from giving warnings of the dangers of long-term use of the drug.
In this Emerging Issues Commentary, toxic tort attorney Margie Searcy Alford includes a summary of requirements to put a generic drug on the market, the presumption against preemption, and the standard for judging 12(b)(6) and 12(c)(3) motions.
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