Product Liability

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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.” 

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Read More Consumer Drug Related Injuries and Deaths More Than Doubled Between 1998 and 2005

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. 

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Read More California Federal Court: FDA Premarket Approval Process Does Not Preempt State 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. 

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Read More New York Appellate Court Addresses Duty To Warn In Medical Device Context

The Federal District Court for the Eastern District of Louisiana recently held that state failure-to-warn claims are not preempted by the labeling requirements of the Food and Drug Administration. 

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Read More Federal District Court Rules That FDA Regulations Do Not Preempt State Law Claims, Allows State Failure To Warn Claims Against Pharmaceutical Company To Proceed