Big Win for Pharmaceutical Victims

Clifford A. Rieders, Esq.

The Pennsylvania Supreme Court, in Lance v. Wyeth, 4 A.3d 160 (Pa. Jan. 21, 2014), denied a pharmaceutical company’s attempt to limit responsibility for a lack of due care resulting in personal injury or death to just two grounds: drug impurities or deficient warnings. It held, instead, that a pharmaceutical company also violates its duty of care if it introduces a drug into the marketplace, or continues a previous tender, with actual or constructive knowledge that the drug is too harmful to be used by anyone. This case arose from Wyeth’s manufacture and sale of Pondimin and Redux, weight reduction drugs popularly known as “Fen-Phen” and “Phen-Fen.”

While the court reiterated that it has declined to extend strict liability into the prescription drug arena, it has not immunized drug companies from other governing aspects of Pennsylvania tort law delineating product-manufacturer duties and liabilities.

The court rejected Wyeth’s argument that the Supreme Court should invoke policy justifications to scale back the existing duty of pharmaceutical companies to independently and vigilantly protect against unreasonable health risks that may be posed by products made for human consumption. The court refused to make a substantive change in the law subjecting manufacturers to liability for dangerous drugs.

The court noted that Pennsylvania courts would permit defendants to adduce evidence of compliance with government regulation in their efforts to demonstrate due care when conduct is in issue. But federal regulatory involvement does not warrant a departure from Pennsylvania’s system of civil redress, where there is a demonstrated lack of due care in the face of an existing duty.

Importantly, the court recognized the emergence of direct-to-consumer advertising and the evolution of the health-care delivery system encompassing new forms of managed care. Whether the learned intermediary doctrine provides immunity is not relevant given that the premise of the patient’s claim is that Wyeth knew or should have known of information that it did not convey to prescribing physicians, namely that Redux was so dangerous that it should not have been ingested by anyone. In such scenarios, the prescribing physician, as an intermediary, is not likely to be appropriately “learned” relative to the critical subject matter. “Accordingly, in a situation in which no warning would be sufficient, the learned intermediary doctrine should not apply to diminish the duties of pharmaceutical companies, or to insulate them from liability for a lack of due care.” Slip Opinion p. 39-40.

A company that is responsible for tendering 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. A manufacturer’s negligent conduct can occur at any stage of the marketing process: in the initial design of the drug, in the failure to investigate information about the risks the drug poses, and in its decision to continue to sell the drug in spite of those unreasonable risks. The defendant’s unreasonable behavior at any point in this process should be sufficient to give rise to negligence liability when such conduct results in injury. The court agreed that the law of negligence establishes a duty, on the part of manufacturers, which can be viewed on a continuum from the requirements of: a warning that the drug may pose risks, to a stronger warning if justified by the known risks, to non-marketing or discontinuance of marketing when it becomes or should become known that the product simply should not be used in light of its relative risks. The court notes the possibility that the law in Pennsylvania might overlap with the Restatement Third Products Liability § 6(c).

The Supreme Court expressed the fact that it was convinced that a manufacturer or supplier has the 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.

In sum, under Pennsylvania law, a pharmaceutical company violates its duty of care if it introduces a drug into the marketplace, or continues a previous tender, with actual or constructive knowledge that the drug is too harmful to be used by anyone. “There has been no supported presentation here which would persuade us to immunize companies from the responsibility to respond in damages for such a lack of due care resulting in personal injury or death.” At Slip Opinion p. 47.

Clifford A. Rieders, Esq. served as Amicus Curiae for Pennsylvania Association for Justice and the American Association for Justice. He is also the author of Pennsylvania Medical Malpractice: Law & Forms (2013). Plaintiff counsel in this matter was President's Club Member, Tobias Millrood, Esq. of Pogust Braslow & Millrood, LLC, Conshohocken.