Lance v. Wyeth, Formerly Known Home Prods. Corp.

• Decision Date: 21 January 2014
• Court: Pennsylvania Supreme Court
• Parties: Patsy LANCE, Administratrix for the Estate of Catherine Ruth Lance, Deceased, Appellee v. WYETH, Formerly Known as American Home Products Corporation, Appellant. Patsy Lance, Administratrix for the Estate of Catherine Ruth Lance, Deceased, Appellant v. Wyeth, Formerly Known as American Home Products Corporation, Appellee.

85 A.3d 434

Patsy LANCE, Administratrix for the Estate of Catherine Ruth Lance, Deceased, Appellee

v.WYETH, Formerly Known as American Home Products Corporation, Appellant.

Patsy Lance, Administratrix for the Estate of Catherine Ruth Lance, Deceased, Appellant

v.Wyeth, Formerly Known as American Home Products Corporation, Appellee.

Supreme Court of Pennsylvania.

Argued Sept. 13, 2011.

Decided Jan. 21, 2014.

Robert C. Heim, Esq., Judy L. Leone, Esq., Friedrich Wilhelm W. Sachse, Esq., Dechert LLP, Philadelphia, Raymond Michael Williams, DLA Piper US, LLP, Philadelphia, for Wyeth Appellant in Case No. 17 EAP 2011.

Stephen B. Devereaux, Esq., Geoffrey M. Drake, Esq., Chilton D. Varner, Esq., King & Spalding, LLC, for The Product Liability Advisory Council Inc. Appellant Amicus Curiae in Case No. 17 EAP 2011.

Tobias Lael Millrood, Esq., Pogust, Braslow & Millrood, L.L.C., Conshohocken, Michael L. Williams, Esq., Williams Love O'Leary & Powers, P.C., Philadelphia, Howard Jonathan Bashman, Esq., Willow Grove, for Patsy Lance Appellee in Case No. 17 EAP 2011.

Clifford Alan Rieders, Esq., Rieders, Travis, Humphrey, Harris, Waters & Waffenschmidt, Williamsport, for American

Association for Justice and Pennsylvania Association for Justice Appellee Amicus Curiae in Case No. 17 EAP 2011.

Tobias Lael Millrood, Esq., Pogust, Braslow & Millrood, L.L.C., Conshohocken, Howard Jonathan Bashman, Esq., Willow Grove, for Patsy Lance Appellant in Case No. 18 EAP 2011.

Clifford Alan Rieders, Esq., Rieders, Travis, Humphrey, Harris, Waters & Waffenschmidt, Williamsport, for American Association for Justice and Pennsylvania Association for Justice Appellant Amicus Curiae in Case No. 18 EAP 2011.

Barbara R. Binis, Esq., Ira Steven Lefton, Esq., Henry Falkner Reichner, Esq., Michael T. Scott, Esq., Reed Smith, LLP, Philadelphia, Raymond Michael Williams, Esq., DLA Piper US, LLP, Philadelphia, for Wyeth Appellee in Case No. 18 EAP 2011.

Stephen B. Devereaux, Esq., Geoffrey M. Drake, Esq., Chilton D. Varner, Esq., King & Spalding, LLC, for Product Liability Advisory Counsel Appellee Amicus Curiae in Case No. 18 EAP 2011.

BEFORE: CASTILLE, C.J., and SAYLOR, EAKIN, BAER, TODD, McCAFFERY, and ORIE MELVIN, JJ.

OPINION

Justice SAYLOR.¹

This appeal concerns whether, under Pennsylvania products-liability law, a pharmaceutical company is immune from the responsibility to respond in damages for a lack of due care resulting in personal injury or death, except per two discrete grounds, namely, on account of drug impurities or deficient warnings.

The designated appellant, Wyeth, was a Delaware corporation,² previously known as American Home Products Corporation. The company manufactured and/or supplied two related appetite suppressants which were prescribed by physicians and weight-loss clinics prolifically in the mid–1990s. The trade names of these pharmaceutical cousins were Pondimin and Redux.

Pondimin was fenfluramine, of which the active, appetite-suppressing ingredient was dexfenfluramine. Fenfluramine apparently was available since the 1970s but was not widely administered until two decades later.

In 1992, Pondimin came to be paired with phentermine, an amphetamine which was thought to offset at least some of the undesirable effects of fenfluramine. This drug regimen gave rise to the shorthand terms, “fen-phen” and “phen-fen.” See generally In re Diet Drugs, 582 F.3d 524, 529–30 (3d Cir.2009) (discussing this history); In re Diet Drugs (Phentermine, Fenfluramine, Dexfenfluramine) Prod. Liab. Litig., 553 F.Supp.2d 442, 449–50 (E.D.Pa.2008) (same).

Redux, which was purified dexfenfluramine, apparently was made to engender Pondimin's anorectic effect without the need for the drug pairing.³ Redux was approved for use as a prescription drug in the United States by the Food and Drug Administration (the “FDA”) in April 1996. Per the FDA's directive, the product packaging contained a prominent warning of an increased risk of pulmonary hypertension (“PPH”).

By mid–1997, there were also reports of an association between dexfenfluramine and serious coronary impairments, including valvular heart disease. In September 1997, Wyeth and the FDA announced that Pondimin and Redux would no longer be made available in the United States. In the aftermath, thousands of lawsuits were filed asserting that the drugs caused injuries and deaths. See generally In re Diet Drugs, 553 F.Supp.2d at 449 (characterizing the phenomenon as a “tidal wave of litigation”). The present civil action is one among these.

The case was commenced against Wyeth and affiliated entities in the fall of 2006 and was integrated into the First Judicial District Complex Litigation Center's mass tort program under an apparently loose application of the “phen-fen” denominator.⁴ Pursuant to this program, Appellee (as the decedent's administratrix) lodged a short-form complaint, incorporating by reference the averments of a general master long-form complaint advanced against Wyeth and about two dozen other defendants under the docket, In re: “Phen–Fen” Litigation in Philadelphia Court of Common Pleas, May Term 1999, No. 0001. Appellee alleged that her daughter, Catherine Lance, ingested Redux for several months in 1997 and that the drug caused PPH, from which she died within a month after her diagnosis in 2004.

Appellee couched her central claim as “Negligence—Unreasonable Marketing of a Dangerous Drug and Unreasonable Failure to Remove the Drug from the Market before January 1997.” Short–Form Complaint at ¶ 12, Lance v. Wyeth, Nov. Term 2006, No. 000926. According to the complaint, Wyeth “owed a duty to [Catherine] not to introduce onto the market a drug that was unreasonably dangerous for any person to use,” and Redux was “so unreasonably dangerous and defective in design that it should never have been on the market.” Id. ¶¶ 13–14. An incorporated count from the master long-form complaint asserted that Wyeth “failed to exercise ordinary care in the design, research, development, manufacture, sale, testing, ... and/or distribution of,” inter alia, Redux. See Gen. Master Long–Form Complaint at ¶ 65, In re Phen–Fen, May Term, 1999, No. 1. Notably, as well, Appellee explicitly stated that she was not advancing a claim based upon inadequate labeling.

Wyeth lodged a motion for summary judgment, arguing that Appellee had failed to assert a cognizable cause of action. Centrally, Wyeth contended that the only allegations which would support liability against a pharmaceutical company based upon adverse effects from the use of a prescription drug were of impurities or deficient warnings. In furtherance of its theory that drug manufacturers should be shielded from products liability under any other legal theory, Wyeth discussed: the role of federal regulation, including the FDA's decision to approve Redux as safe and effective for prescription use; ⁵ the positioning of learned intermediaries ( i.e., physicians) in a decision-making role relative to the appropriate use of the drug in individual cases; ⁶ and this Court's refusal to extend strict liability to prescription drug manufacturers, see Hahn v. Richter, 543 Pa. 558, 560, 673 A.2d 888, 889 (1996), consistent with the treatment for “unavoidably unsafe products” reflected in comment k to Section 402A of the Restatement Second of Torts. Restatement (Second) of Torts § 402A cmt. k (1965) (specifying a main avenue for pursuing strict products liability, per a widely accepted formulation of the American Law Institute).

The terms of comment k are set forth here, since these remarks are discussed prominently throughout the present litigation:

k. Unavoidably unsafe products. There are some products which, in the present state of human knowledge, are quite incapable of being made safe for their intended and ordinary use. These are especially common in the field of drugs. An outstanding example is the vaccine for the Pasteur treatment of rabies, which not uncommonly leads to very serious and damaging consequences when it is injected. Since the disease itself invariably leads to a dreadful death, both the marketing and the use of the vaccine are fully justified, notwithstanding the unavoidable high degree of risk which they involve. Such a product, properly prepared, and accompanied by proper directions and warnings, is not defective, nor is it unreasonably dangerous. The same is true of many other drugs, vaccines, and the like, many of which for this very reason cannot legally be sold except to physicians, or under the prescription of a physician. It is also true in particular of many new or experimental drugs as to which, because of lack of time and opportunity for sufficient medical experience, there can be no assurance of safety, or perhaps even of purity of ingredients, but such experience as there is justifies the marketing and use of the drug notwithstanding a medically recognizable risk. The seller of such products, again with the qualification that they are properly prepared and marketed, and proper warning is given, where the situation calls for it, is not to be held strictly liable for unfortunate consequences attending their use, merely because he has undertaken to supply the public with an apparently useful and desirable product, attended with a known but apparently reasonable risk.

Id. (emphasis modified).

In the simplest terms, Wyeth expressed its position as follows:

In essence, Plaintiff asserts that even though Wyeth adequately warned about all of the risks of Redux, and even though the FDA determined that Redux was both safe and effective and approved it for sale, the FDA was wrong and Redux should not have been on the market. Pennsylvania does not recognize such a claim for prescription drugs.

Wyeth's Motion for Summary Judgment at 2, Lance v. Wyeth, Nov. Term, No. 000926. According to Wyeth's submission, as well, “[j]uries and the judiciary do not have the requisite knowledge, resources, or societal mandate to make the decision as to...