Pennsylvania Appellate Court Adopts Negligent Design and Post Sale Duty to Warn in Pharmaceutical Cases, but Rejects Other Theories

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In two recent decisions in pharmaceutical products liability cases, the Pennsylvania Superior Court (Pennsylvania’s intermediate appellate court) addressed several issues of first impression in Pennsylvania’s appellate courts.

In this diet drugs case, the plaintiff alleged that the defendant breached the standard of care in the design, development, inspection, testing and preparation of its drug, that it negligently placed an unreasonably dangerous drug on the market, and that it negligently failed to withdraw the drug from the market upon discovering that it was unsuitable for public consumption.  On the other hand, the plaintiff did not assert claims for manufacturing defect or failure to warn – claims that Pennsylvania’s appellate courts have traditionally recognized in pharmaceutical products liability actions.

The Superior Court likened plaintiff’s unreasonable marketing claim to a design defect claim sounding in strict liability.  Because the Pennsylvania Supreme Court has adopted comment k to section 402A of the Restatement (Second) of Torts in prescription drug cases and rejected strict liability theories where drugs are manufactured properly and are accompanied by adequate warnings, the Superior Court affirmed the lower court’s dismissal of plaintiff’s unreasonable marketing claim to the extent that it averred a strict liability design defect claim.  However, confining comment k to strict liability claims, the Superior Court recognized a prescription drug design defect claim sounding in negligence as actionable under Pennsylvania law and reversed the lower court’s dismissal to that extent.

In addressing plaintiff’s claim for negligent failure to withdraw and recall the drug at issue from the market, the Superior Court declined to impose a duty to recall upon a drug manufacturer and affirmed the decision of the lower court.  In so holding, the Superior Court followed its earlier decision in a non-pharmaceutical case that there is no common law duty to retrofit and joined the majority of jurisdictions that have decided not to impose a duty to recall on a manufacturer.  The Superior Court deferred to the federal regulatory scheme and the FDA’s decision as to whether a drug should lawfully remain on the market.  However, distinguishing earlier Pennsylvania decisions rejecting post-sale duty to warn claims and holding, without citation to any Pennsylvania authority, that such decisions are not applicable to pharmaceutical cases, the Superior Court imposed a post-sale duty on drug manufacturers that as long as the manufacturer’s drug remains on the market, the manufacturer has a post-sale duty to warn of the drug’s dangerous side effects of which it knows or has reason to know.

The plaintiff also maintained that her claims alleging unreasonable marketing and negligent failure to withdraw were sustainable because they were akin to a claim of negligent failure to inspect and/or test.  But, the Superior Court concluded that a claim for negligent failure to test is not a viable claim under Pennsylvania law, and that if there is a duty to inspect or test under Pennsylvania law, the failure to inspect or test does not give rise to an independent cause of action, but is subsumed by other types of recognized claims – such as claims for manufacturing and design defects and for failure to warn.  As to plaintiff’s claim that she averred a viable claim under section 6(c) of the Restatement (Third) of Torts, the Superior Court explained that the Supreme Court has never adopted that provision as the law of Pennsylvania and that it was obligated to follow Supreme Court precedent.

The defendant has requested reconsideration or rehearing before the Superior Court en banc.  It argues that the issue of negligent design defect was not properly before the Superior Court and that a negligent design defect claim would encourage second-guessing of the federal regulatory scheme applicable to prescription drugs and improper avoidance of the Supreme Court’s rule that an FDA-approved prescription drug with an adequate warning is not defective or unreasonably dangerous.  As the defendant stated in its Petition for Rehearing, “Allowing jurors or judges to second-guess the ‘reasonableness’ of a drug company’s conduct in designing an FDA-approved drug is just as contrary to the notion of FDA-deference as would be allowing a jury or judge to second-guess the design itself, something which the Pennsylvania courts have clearly precluded.”

In this other diet drugs case, which was based upon an alleged failure to warn, the plaintiff allegedly sustained primary pulmonary hypertension (“PPH”) as a result of her ingestion of the drug at issue.  The drug’s manufacturer had warned of the risk of PPH, but at deposition, the physician who prescribed the drug for the plaintiff testified that he would not have prescribed it if he had known that the drug also carried the risk of valvular heart disease (“VHD”), a risk of which the manufacturer had not warned.  Thus, the argument went, plaintiff would not have been prescribed and taken the drug and would not have developed PPH if the prescribing physician had been warned that the drug also carried the risk of VHD.

The Pennsylvania Superior Court held that because the plaintiff sustained PPH, a risk of which the manufacturer warned, and did not sustain VHD, as a matter of law, she could not establish that the manufacturer’s failure to warn of the risk of VHD proximately caused her injury.  In order to prove proximate causation, a plaintiff must establish that he or she suffered the precise injury that the manufacturer allegedly failed to disclose.