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Qualified Regulatory Compliance Defense

Peter Schuck of Yale Law School has a nice Commentary in The American Lawyer (here seen via Law.com in favor of a "qualified regulatory compliance defense" to drug manufacturers' tort liability. FDA approval of a drug or device should ordinarily pre-empt "design defectd" liability, unless plaintiff can show that the manufacturer failed to fully inform the FDA of risks of which the manufacturer was or should have been aware.



Rafael Mangual
Project Manager,
Legal Policy

Katherine Lazarski
Manhattan Institute


Published by the Manhattan Institute

The Manhattan Insitute's Center for Legal Policy.