In the summer of 2010, the Pennsylvania Superior Court issued three opinions concerning products liability causes of action cognizable under Pennsylvania law against manufacturers of prescription drugs and the requisite proof required to sustain such claims.  As a backdrop to considering these decisions, it should be remembered that Pennsylvania does not recognize a claim for failure to withdraw or recall a drug from the market; an independent tort claim for failure to test; or a strict liability claim for design defect, but it does recognize a negligent design defect claim.

First, in a "non-precedential" decision issued on July 26, 2010 in Owens v. Wyeth, 2010 WL 2965014 (Pa. Super., July 26, 2010), the Court clarified that a failure to warn claim requires proof that a different warning would have prevented the physician from prescribing the drug.  There, the plaintiff allegedly developed primary pulmonary hypertension ("PPH") from the prescription diet drug Pondimin.  There was no "black box" warning of PPH on the label but both the package insert and the Physician's Desk Reference warned of this risk.  The prescribing physician was aware of the risk of PPH before prescribing the Pondimin and testified that the risk of PPH was outweighed by the benefits of the drug because the patient was at risk for a fatal obesity-related illness.  From that, the Court concluded that the physician still would have prescribed Pondimin to the patient even if there had been a black box warning concerning the risk of PPH.  Accordingly, summary judgment in favor of Wyeth was affirmed on the claim of failure to warn because the plaintiff was unable to establish that failure to warn proximately caused her injury.

The plaintiff in Owens also argued that the Pondimin warning was inadequate because it failed to warn of valvular heart disease ("VHD"), a condition which she did not develop.  Again, the Court found, based upon the physician's testimony, that such a warning would not have prevented him from prescribing the drug.  Although Pennsylvania has recognized a cause of action when over-promotion of a drug effectively nullifies adequate warnings, Baldino v. Castagna, 478 A.2d 807 (Pa. 1984), this plaintiff made no such allegations, so her "negligent marketing" claim also failed.  Lastly, the Court rejected her claim for failure to withdraw or recall the drug from the market and her negligent failure to test claim, both as simply not recognized in Pennsylvania.

The next day, in Cochran v. Wyeth, Inc., 2010 WL 2902717 (Pa. Super., July 27, 2010), the Superior Court affirmed summary judgment in favor of Wyeth, holding that in order to establish proximate causation, a plaintiff must prove that the warning failed to disclose the risk of his/her particular injury.  As in Owens, there was a warning regarding PPH, but not regarding VHD, and the patient developed PPH.  This time, the doctor testified that he would not have prescribed the drug, Redux, had he known of the risk of VHD.  Nevertheless, the Court held that a plaintiff cannot establish proximate causation where a non-disclosed risk never materialized into an injury.

Lastly, in Lance v. Wyeth, 2010 WL 2991597 (Pa. Super., Aug. 2, 2010), the plaintiff argued that Redux was "unreasonably dangerous" and that the drug's "risks outweighed its benefits as to all possible classes of users of that medication."  The Superior Court held that a design defect claim for strict liability is not cognizable under Pennsylvania law when asserted against a manufacturer of prescription drugs.  Where a drug is deemed unavoidably unsafe, the plaintiff has no strict liability cause of action, but can proceed under a negligence theory.  Additionally, the Lance court was "persuaded by the majority of modern jurisdictions" not to impose on a manufacturer a common law duty to recall a drug, deferring to the FDA's power to withdraw approval of a prescription drug.  Lastly, the Court held that "negligent failure to test" is not a viable cause of action, reasoning that unless the manufacturer's breach of its duty to test leads it to produce a product defective in design, manufacture or warning, no injury can result.  Breach of a duty to test, by itself, cannot cause any injury.

Based upon these three recent appellate decisions, claims for negligent failure to withdraw/recall a drug and failure to test are not viable in Pennsylvania; in failure to warn cases, a plaintiff must show that the prescribing physician would have altered his/her prescribing decision with a stronger warning; and failure to warn remains a viable cause of action, but only a failure to warn of the injury sustained, not of some other undiagnosed or unrealized injury.