Liability for Pharmaceutical Manufacturers Expands for the First Time to Include Design Defect Claims


Product liability law in Pennsylvania has been fundamentally altered as it relates to the manufacturing and selling of prescription drugs. Manufacturers are now subject to design defect claims following a recent state Supreme Court ruling. In Lance v. Wyeth, the Court held for the first time that a Plaintiff can bring a design defect claim against a pharmaceutical manufacturer for harm resulting from the ingestion of an FDA-approved prescription drug.

In Lance, the Plaintiff alleged causes of action for negligent marketing and negligent failure to remove Redux from the market. The trial court granted Wyeth’s motion for summary judgment on the grounds that the pharmaceutical company was immune from Lance’s negligence claims under Pennsylvania common law, which only recognized causes of action based upon a manufacturing defect or failure to warn. On appeal, the Superior Court reversed, holding that the Plaintiff should have been permitted to pursue what was essentially a claim for design defect. The court noted, however, that claims for negligent marketing, testing and failure to withdrawal were not viable.

Both parties appealed to the state Supreme Court. On appeal, Wyeth argued that pharmaceutical companies are immune to claims of design defect pursuant to Pennsylvania’s adoption of the Restatement Second of Torts, Section 402A, comment (k), which bars strict liability claims against prescription drug manufacturers. Wyeth further contended that the Court should give deference to the FDA’s approval of Redux for sale in the United States. The Supreme Court disagreed, concluding that a pharmaceutical company can be liable under a negligent design defect theory for placement into the marketplace of a drug that it knows to be too harmful for use by the public. The Court also rejected Wyeth’s argument for deference to the FDA noting that final drug approval does not absolve a pharmaceutical company of its responsibility to exercise due care.

Though the Court did not address the impact of its holding upon generic drugs manufacturers, they will still have the federal preemption defenses available to them under Mutual Pharm. Co., Inc. v. Bartlett, 133 S. Ct. 2466, 186 L. Ed. 2d 607 (2013). However, with design defect now a viable cause of action, an increase in the number of lawsuits may be expected with claimants likely asserting increasingly creative theories of liability. Regardless of possible defenses and the sufficiency of a claim, this newly recognized cause of action is likely to make litigation expenses skyrocket since the scope of relevant evidence will expand to include information relating to years of formulas, designs, testing results and other related product information. 

Topics:  Design Defects, FDA, Manufacturers, Pharmaceutical, Prescription Drugs, SCOTUS, Wyeth

Published In: Civil Procedure Updates, Personal Injury Updates, Products Liability Updates, Science, Computers & Technology Updates

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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