On January 21, 2014, the Pennsylvania Supreme Court held in a 4–2 vote in Lance v. Wyeth, 2014 PA. 17 EAP 2011 (PA Supreme Court 2014), that a pharmaceutical company for the first time under Pennsylvania law may face negligence claims where the drug manufacturer introduced a drug into the marketplace with actual or constructive knowledge that the drug is too harmful to be used.
This case stems from the deceased’s use of two diet drugs manufactured by a Pfizer subsidiary, Wyeth LLC, which were taken off the market after reports linked the drugs to heart disease. Wyeth was dismissed by the trial court in Philadelphia after filing a motion for summary judgment. Plaintiff appealed to the Superior Court of Pennsylvania, followed by an appeal to the Pennsylvania Supreme Court. The Pennsylvania Supreme Court ruled in favor of plaintiff and overturned the dismissal of Wyeth. The Pennsylvania Supreme Court affirmed in part and reversed in part the order of the Superior Court and remanded the case to the trial court. Wyeth can continue with discovery and may seek later rulings or a trial on the merits.
Pennsylvania currently follows the Restatement Second of Torts Section 402A with regard to product liability of manufacturers, and has not adopted the Restatement Third. Wyeth argued in its summary judgment motion and on appeal that under current Pennsylvania law it was immune from all negligence-based claims, with the exception of manufacturing defects and inadequate warnings (both of which were not plead against Wyeth by the plaintiff) consistent with the Restatement Second of Torts, Section 402A, Comment k. Wyeth argued that Pennsylvania case law and Comment k precluded negligent design claims against drug manufacturers and that no plaintiff could prove a reasonable alternative design. Citing the Pennsylvania Supreme Court’s decisions in Incollingo v. Ewing, 282 A.2d 206 (1971); Baldino v. Castagna, 478 A.2d 807 (Pa. 1984); and Hahn v. Richter, 673 A.2d 888 (Pa. 1996), Wyeth argued for the continued need to allow reasonable limitations on liability against pharmaceutical companies so that the continued availability and development of beneficial yet risky medication is not deterred.
The Pennsylvania Supreme Court, however, found that Wyeth’s argument was in tension with Pennsylvania common law, and that in none of the above-referenced cases had the Supreme Court considered allegations of a lack of due care resulting in an “untenably dangerous product being put into the marketplace.” The Supreme Court also noted that Comment k to the Restatement Second of Torts is not a “model of clarity,” and that the comment “is premised on the assumption that all products within its scope carry some net benefit (relative to risks) for some class of consumers.”
The Supreme Court also rejected Wyeth’s argument that Comment k “readily translates into the negligence arena” because there is “very distinct treatment of strict-liability versus negligence theory required under the foundational Pennsylvania decision in Azzarello” (referring to Azzarello v. Black Bros., 391 A.2d 1020 (1978)).
However, the Pennsylvania Supreme Court did recognize in this case the unique treatment afforded drug companies by stating: “While for policy reasons this Court has declined to extend strict liability into the prescription drug arena, it simply has not immunized drug companies from other governing aspects of Pennsylvania tort law delineating product-manufacturer duties and liabilities.”
Noting the advantages that the Federal Drug Administration (FDA) process affords drug manufacturers, the Pennsylvania Supreme Court stated that the creation of a design-defect immunity for drug makers is an issue that should be brought before the Pennsylvania General Assembly. “Although the company does not articulate its position in such terms, Wyeth is asking, for policy reasons, that we should insulate pharmaceutical companies from liability, even for a patent lack of due care so deleterious as to create an untenable threat to human health.” The Pennsylvania Supreme Court, therefore, rejected the argument that manufacturing defects and inadequate warnings are the only viable products liability claims against pharmaceutical companies under Pennsylvania law and allowed plaintiff’s claim – i.e., that the drug company was negligent in testing, marketing and designing its prescription drug products – to go forward in the trial court. In doing so, the Pennsylvania Supreme Court reaffirmed the application of Comment k to the Restatement Second of Torts in strict products liability matters, but found Comment k inapplicable to a negligence cause of action concerning design of prescription drugs.
In conclusion, the Pennsylvania Supreme Court held that “primary responsibility for drug safety rests with the manufacturer, which has ‘superior access to information about [its] drugs, especially in the postmarketing phase as new risks emerge,'” citing the U.S. Supreme Court decision in Wyeth v. Levine. 555 U.S. 555 (2009). The Pennsylvania Supreme Court further held that “pharmaceutical companies violate their duty of care if they introduce a drug into the marketplace, or continue a previous tender, with actual or constructive knowledge that a drug is too harmful to be used by anyone.”
Issues Remaining After Lance
In view of this decision, many issues remain, including:
- Since Pennsylvania has not adopted the Restatement Third of Torts, to what extent will this case create new arguments for plaintiffs’ counsel in other drug company litigation?
- Since the drugs allegedly used in this case had not been approved by the FDA, to what extent is this case unique to the facts involved in the current case?
- Does this decision substantially expand the liability exposure of drug manufacturers or is the holding limited to the unique facts of this case?
The majority opinion recognized that the application of appellee’s theory of liability would present more difficult questions in a circumstance in which a prescription drug “maintained its FDA approval, it remained on the market, and U.S. doctors continued to prescribe it.”