Pennsylvania Recognizes Negligent Design Defect Claims in Pharma Cases

Earlier this week, a panel of the Pennsylvania Superior Court issued an opinion for publication in Lance v. Wyeth, a pharmaceutical case in which the plaintiff alleged that her use of Wyeth’s obesity drug, Redux, caused the development of Primary Pulmonary Hypertension (PPH) and ultimately death. The Superior Court’s opinion is significant for consumers and plaintiffs lawyers because the opinion affirmatively recognizes for the first time the viability of a claim in Pennsylvania for negligent design defect.

At the trial court level, Wyeth moved for summary judgment on a variety of grounds, including a challenge to the plaintiff’s claim that Wyeth was “negligent in placing an unreasonably dangerous product into the market.” Slip op. at 6. The trial court granted summary judgment, finding that the claim was not cognizable under Pennsylvania law. The Superior Court disagreed and reversed, holding that the claim can proceed. Although the Superior Court took issue with the plaintiff’s characterization of the claim as “Unreasonabl[e] Marketing of a Dangerous Drug” – a claim that is not available in Pennsylvania – the court ultimately concluded that the plaintiff was merely claiming “negligent design defect,” which is permitted.

The Lance court recognized Pennsylvania’s long settled adherence to the Restatement (Second) of Torts, § 402A, Comment k, which has been interpreted to disallow any strict liability claims against pharmaceutical manufacturers, whether under a manufacturing defect, design defect, or failure to warn theory. But the court correspondingly observed that Comment k is no impediment to a negligent design defect claim. Quoting in part from the Pennsylvania Supreme Court’s plurality opinion in Phillips v. Cricket Lighters, 841 A.2d 1000, 1008 (Pa. 2003), the Lance court explained:

Appellant … argues that she asserted a cognizable negligent design defect claim. … Appellant included an allegation that Wyeth breached the standard of care in designing Redux. We agree with Appellant that notwithstanding comment k in § 402A, this claim is actionable under Pennsylvania law.

It is important to note that a negligent design defect claim is not foreclosed merely because summary judgment is granted in favor of a defendant on a plaintiff’s strict liability claim. This is because a strict liability design defect claim is distinct from a negligence design defect claim. “Strict liability examines the product itself, and sternly eschews considerations of the reasonableness of the conduct of the manufacturer. []In contrast, a negligence cause of action revolves around an examination fo the conduct of the defendant.”

The Restatement (Second) of Torts, § 395 addresses a manufacturer’s negligent design of products. Unlike comment k in § 402A, this provision contains no exemption or special protection for prescription drugs.

Lance, Slip op. at 9-10 (internal citations omitted).

Plaintiffs lawyers are hailing the opinion as an important victory that will expand consumers’ ability to hold prescription drug manufacturers responsible in court.