The Pennsylvania Supreme Court issued a ruling on January 21, 2014 in the case of Lance v. Wyeth, 2014 Pa. LEXIS 205 (Pa. 2014), where a split Court found that drug companies are not immune to product liability claims in Pennsylvania for defective drugs. In a 56 page opinion that was upheld in a 4-2 ruling, the Court decided Lance some three years after oral argument and added to the uncertain future landscape of products liability law in Pennsylvania.
The procedural aspects of this suit stem from a grant of summary judgment on behalf of Defendant in the Court of Common Pleas of Philadelphia County. The Plaintiff brought suit alleging that defendant negligently placed a diet drug on the market, failed to withdraw it, and breached the standard of care in designing, developing, inspecting, testing and preparing the drug. On appeal, the Superior Court found that the trial court properly granted the defendant’s summary judgment on plaintiff’s strict liability claim but that it erred by applying the strict liability rule to her claims in negligence. The Pennsylvania Superior Court held that under Pennsylvania law, a negligent design defect claim was considered to be distinct from a strict liability design defect claim. Accordingly, the trial court’s decision was reversed in part and remanded back to the trial court to hear the plaintiff’s negligence design claim. Defendant appealed the decision to the Pennsylvania Supreme Court.
Lance comes from two weight-loss drugs that were widely prescribed and used in the 1990’s, which Wyeth stopped selling following reports that they were linked to heart disease. Plaintiff’s daughter died from pulmonary hypertension roughly 7 years after taking the drug. Plaintiff claimed that the drug was “unreasonably dangerous” and that Wyeth acted negligently in marketing the drug or failing to remove it from the market sooner.
Wyeth defended the claim on the basis that Pennsylvania had refused to extend strict liability to prescription drug manufacturers under Restatement 2nd 402A comment k, which describes unavoidably safe products. Wyeth’s argument was that while prescription drugs are in fact unavoidably safe, they are not unreasonably dangerous or defective when accompanied by proper warnings and directions. Wyeth’s defense was based on the long-standing notion that under Pennsylvania law, a negligent design claim against drug manufacturers was precluded because a Plaintiff could never prove a reasonable alternative design. Additionally, Wyeth argued that allowing the Plaintiffs to only bring failure-to-warn and manufacturing defect claims met a public policy need of compensating injured consumers but at the same time not discouraging the continued development of beneficial drugs. Wyeth also argued that the FDA had approved its product as evidence of the product not being unreasonably dangerous.
In a decision that is sure to have a significant impact on pharmaceutical drug litigation in the state, the Court held that Plaintiffs may assert negligence claims against pharmaceutical companies relating to the design, testing, marketing and distribution of drugs regulated by the FDA. The Pennsylvania Supreme Court rejected Wyeth’s attempts to “protect” pharmaceutical companies from negligence claims. The Court specifically addressed comment k as well, holding it inapplicable because it presumed that a medicine has some net benefit and therefore does not apply to a claim that a drug is too dangerous to be used by anyone. Essentially, the Court held that comment k was rooted in a strict liability analysis and did not readily translate into a negligence action. In justifying its decision, the Court partook in a discussion detailing the conceptual differences between strict liability claims, which focus on the product itself, and negligence-based product claims, which focus on the conduct of the manufacturer.
In addressing Wyeth’s FDA argument, the Court stated that the FDA was a government agency of limited resources. Accordingly, Pennsylvania would not give absolute discretion to a drug company based upon FDA approval, stating that while it is admissible evidence, it is not dispositive of a negligence claim. The Pennsylvania Supreme Court remanded the case back to the trial court for a determination of whether Wyeth acted negligently under the facts and circumstances presented.
The fall-out and subsequent decisions that will follow the Pennsylvania Supreme Court’s reasoning in Wyeth will certainly have an impact on pharmaceutical litigation in the state. The failure of the Court to develop a bright-line rule will leave much room for interpretation for future decisions.