Topic: Product Liability

A study recently published in the Archives of Internal Medicine reports that serious adverse drug events reported to the FDA more than doubled  between 1998 and 2005.  As defined by the FDA, serious adverse drug events involve drug reactions that “result in death, birth defect, disability, or hospitalization, or are otherwise life threatening or require intervention to prevent harm.” 

The Federal District Court for the Northern District of California recently ruled that the FDA’s premarket approval (“PMA”) process for Class III devices does not preempt state law causes of action. 

A New York state appellate court recently reversed a denial of summary judgment on a medical device failure to warn claim.  Mulhall v. Hannafin, 2007 N.Y. Slip Op. 06529 (N.Y. App. Div. Aug. 30, 2007).  In doing so, the court addressed a number of interesting issues concerning the required elements of a failure to warn claim under New York law. 

Federal courts in three separate pharmaceutical products liability actions recently excluded plaintiffs’ expert testimony concerning causation of damages.