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NEGLIGENCE-POST-SALE DUTY TO WARN

Claim was that Wyeth was negligent in placing unreasonably dangerous drug on the market which was ultimately withdrawn.  In Pennsylvania, products liability law is superseded as it applies to prescription drugs under Comment k of the Restatement 2nd of Torts 402A.  Due to the inherent risks associated with prescription drugs, the Supreme Court is limited to potential causes of action to a plaintiff who alleges a strict liability claim against a drug manufacturer.  The plaintiff may advance only two theories:  1) a manufacturing defect claim; or 2) a failure to warn claim.  A failure to warn claim must be analyzed with negligent standards under Restatement 2nd of Torts 388.  Pennsylvania is one of the few states that afford Comment k protection to all prescription drugs as a matter of law.  A design defect claim for strict liability is not permitted in Pennsylvania when it is asserted against a manufacturer of prescription drugs.  A drug cannot be deemed unreasonably dangerous even if it is defectively designed so long as the drug is manufactured properly and contains adequate warnings.  We agree however that Comment k does not apply to a negligent design claim.  The Restatement 2nd of Torts §395 addresses a manufacturer’s negligent design of products.  Comment k is confined to strict liability claims and has no application to claims sounding in negligence.  There is no duty to recall in Pennsylvania.  The FDA decides whether to recall a drug.  A drug manufacturer’s post-sales duty to warn of dangerous propensities provides consumers with a remedy and sufficient protection against risks.  Pennsylvania has not adopted independent tort for negligent failure to test.  There is no duty to test in Pennsylvania. Restatement 3rd of Torts Products Liability §6(c) has not been adopted.  Lance vs. Weyth, 4 A.3d 160 (Pa. Super. 2010).