The straightforward question in this case is whether a pharmaceutical company is immune from responsibility to respond in damages for lack of due care resulting in personal injury or death, except for two discreet grounds, namely, on account of drug impurities or deficient warnings. The drug regimen which gave rise to the shorthand terms, “Fen-Phen” and “Phen-Fen” is at the center of this case.
Justice Saylor’s writing for the majority argued that there is greater flexibility with regard to traditional fault-based liability, i.e., negligence, where the conduct of manufacturers and/or suppliers are squarely in issue. For policy reasons the court has declined to extend strict liability into prescription drug arena. However, it has not immunized other drug companies from other governing aspects of Pennsylvania tort law delineating product manufacturer duties and liabilities.
The court wisely noted the importance of direct-to-consumer advertising and the evolution of the health-care delivery system encompassing new forms of managed care. In the situation where no warning would be sufficient, the learned intermediary doctrine should not apply to diminished duties of pharmaceutical companies, or to insulate them from liability for lack of due care.
A company which is responsible for tending into the market a drug which it knows or should know is so dangerous that it should not be taken by anyone can be said to have violated its duty of care either in design or marketing. How the claim is presented is up to the plaintiff. The court also noted that the American Law Institute has chosen to categorize the type of claim advanced under the rubric of design defect and the general requirement otherwise pertaining under the Restatement of a reasonable alternative design to establish a design defect has not been extended to the prescription-drugs context. See Restatement (Third) of Torts: Products Liability § 6(c) and § 2(b).
Footnote 37 notes that the court adopts appellee’s position that Pennsylvania law at the very least overlaps or intersects with the Restatement Third principle that a manufacturer marketing a prescription drug which it knows or should know is too dangerous for anyone to use violates the standard of due care and may be held liable under fault-based tort law.
Finally, appellee may couch the lack of due care manifested as negligent marketing. This is consistent with her prerogative as master of her own claim. Whatever the policy considerations may be in the recall-retrofit arena, the court was convinced that a manufacturer or supplier has a duty to cease further distribution of a product at such point as it may know, or may reasonably be charged with knowledge that the commodity is too dangerous to be used by anyone.
Under Pennsylvania law, 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 the drug is too harmful to be used by anyone.