STORY FROM: Drugs & Medical Devices

Comment k Defeats Design Defect Claims Asserted Against Serophene Maker, Ala. Federal Judge Rules

BIRMINGHAM, Ala. — An Alabama federal judge has held that design defect claims asserted against the maker of the fertility drug Serophene are barred by comment k of the Restatement (Second) of Torts, which limits the liability of prescription drug manufacturers.

However, in the March 21 order, Judge Madeline Haikala of the U.S. District Court for the Northern District of Alabama allowed the plaintiff’s failure-to-warn claims to proceed, ruling that at this stage of the proceedings, they are adequately pled.

From August 1993 through January 1994, Ashlye Barcal’s mother took Serophene (clomiphene citrate) to help her conceive, and became pregnant ...

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