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Lance v. Wyeth

Supreme Court of Pennsylvania

January 21, 2014

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.

Argued Sept. 13, 2011.

17 EAP 2011

Appeal from the Judgment of Superior Court entered on August 2, 2010 at No. 2905 EDA 2008, (reargument denied on October 1, 2010) affirming in part, reversing in part, and remanding in part the judgment entered on September 19, 2008 in the Court of Common Pleas, Philadelphia County, Civil Division at No. 0926 November Term 2006. Appeal allowed March 15, 2011 at 600 EAL 2010. Trial Court Judge: Allan L. Tereshko, Judge. Intermediate Court Judges: Correale F. Stevens, Susan Peikes Gantman, Cheryl Lynn Allen, JJ.

18 EAP 2011

Appeal from the Judgment of Superior Court entered on August 2, 2010 at No. 2905 EDA 2008, (reargument denied on October 1, 2010) affirming in part, reversing in part, and remanding in part the judgment entered on September 19, 2008 in the Court of Common Pleas, Philadelphia County, Civil Division at No. 0926 November Term 2006. Appeal allowed March 15, 2011 at 610 EAL 2010. Trial Court Judge: Allan L. Tereshko, Judge. Intermediate Court Judges: Correale F. Stevens, Susan Peikes Gantman, Cheryl Lynn Allen, JJ.

Page 435

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

Page 436

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

SAYLOR, Justice.[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

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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

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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:

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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 a prescription drug's relative worth." Id. at 7 (quoting Hahn v. Richter, 427 Pa.Super. 130, 151-52, 628 A.2d 860, 871 (1993) (Cavanaugh, J., concurring), aff'd, 543 Pa. 558, 673 A.2d 888 (1996)).

In its summary judgment motion, Wyeth did acknowledge that Redux ultimately was removed from the U.S. marketplace, but the company posited that this did not occur on account of the relationship between the drug and PPH, but, rather, because of " new, preliminary information" related to the risk of valvular heart disease. Id. at 4-5 (quoting Wyeth Notice of Withdrawal, dated Sep. 15, 1997).[7] In terms of what was conveyed to physicians about Redux, Wyeth stressed that the approved label featured a bold-faced warning of the risk of PPH.

The common pleas court granted summary judgment in favor of Wyeth. In doing so, that court initially (and mistakenly) attributed to this Court the following explanation from a decision of the Superior Court:

Because of the desirability of permitting drugs of proven value to be marketed despite known or suspected risks in said drugs, courts have uniformly held that " a drug, properly tested, labeled with appropriate warnings, approved by the [FDA], and marketed properly under federal regulation, is, as a matter of law, a reasonably safe product. Accordingly, a person claiming to have suffered adverse effects from using such a drug, unless he can prove an impurity or an inadequacy in labeling, may not recover against the seller[." ]

Lance v. Wyeth, Inc., Nov. Term 2006, No. 0926, slip op. at 5 (C.P. Phila. Jan. 7, 2010) (quoting Leibowitz v. Ortho Pharmaceutical Corp., 224 Pa.Super. 418, 433-34, 307 A.2d 449, 458 (1973) ( en banc affirmance by an equally divided court) (quoting, in turn, Lewis v. Baker, 243 Or. 317, 413 P.2d 400, 404 (1966))). Consistent with this reasoning (albeit, that of a lead opinion from a divided intermediate appellate court), the common pleas court credited Wyeth's theory of limited liability. Furthermore, the court indicated that the learned-intermediary doctrine " nullifies [the] novel claim by Plaintiff that [Redux] was unreasonably dangerous and unfit to be prescribed to anyone." Id. at 8.

On Appellee's appeal, a three judge panel of the Superior Court (with one judge concurring in the result) found that Appellee should have been permitted to proceed with a claim of negligent design defect only. See

Page 440

Lance v. Wyeth, 4 A.3d 160 (Pa.Super.2010). With regard to Appellee's assertion of negligence, on Wyeth's part, in the company's marketing of Redux, the panel reconceptualized this claim as one asserting strict liability.[8] Having done so, the panel then credited Wyeth's position, at least in part, by reaffirming that the only two bases supporting strict products liability relative to a pharmaceutical company are manufacturing defect (or impurity) and failure to warn appropriately. See id. at 164-65 (citing, inter alia, Hahn, 543 Pa. at 560-61, 673 A.2d at 889-90, and RESTATEMENT (SECOND) OF TORTS § 402A cmt. k).

The panel next rejected Appellee's allegation that Wyeth negligently failed to withdraw Redux from the market, based on its reading of prior decisions refusing to impose a duty on manufacturers to recall or retrofit products. See Id. at 167 (citing, inter alia, Lynch v. McStome & Lincoln Plaza Assoc., 378 Pa.Super. 430, 440, 548 A.2d 1276, 1281 (1988)). As to this claim, the panel recognized a post-sale duty to warn but " defer[red] to the federal regulatory scheme and the FDA's decision as to whether a drug should lawfully remain on the market." Id. at 167. In terms of a duty to test, the panel reasoned that such allegation does not support a freestanding claim, but, rather, is merely subsumed within the principal liability theories. See id. at 169 (citing, inter alia, Kociemba v. G.D. Searle & Co., 707 F.Supp. 1517, 1527 (D.Minn.1989)).

As previously noted, however, the panel credited Appellee's position that it had asserted a cognizable claim of negligent design defect against Wyeth. Initially, the panel discussed the distinction between strict-liability and negligence as follows:

" Strict liability examines the product itself, and sternly eschews considerations of the reasonableness of the conduct of the manufacturer. In contrast, a negligence cause of action revolves around an examination of the conduct of the defendant."

Lance, 4 A.3d at 166 (quoting Phillips v. Cricket Lighters, 576 Pa. 644, 658, 841 A.2d 1000, 1008 (2003) (plurality)).

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The panel's treatment then segued into a discussion of Section 395 of the Restatement Second, which provides:

A manufacturer who fails to exercise reasonable care in the manufacture of a chattel which, unless carefully made, he should recognize as involving an unreasonable risk of causing physical harm to those who use it for a purpose for which the manufacturer should expect it to be used and to those whom he should expect to be endangered by its probable use, is subject to liability for physical harm caused to them by its lawful use in a manner and for a purpose for which it is supplied.

RESTATEMENT (SECOND) OF TORTS § 395. The panel pronounced that Section 395 " addresses a manufacturer's negligent design of products." Lance, 4 A.3d at 166. Additionally, it emphasized that the provision is independent of Section 402A, to which comment k is appended, and reasoned that there was " no exemption or special protection for prescription drugs," relative to claims under Section 395. Id.

Finally, the panel alluded to Section 6(c) of the Restatement Third of Torts: Products Liability, which provides:

A prescription drug or medical device is not reasonably safe due to defective design if the foreseeable risks of harm posed by the drug or medical device are sufficiently great in relation to its foreseeable therapeutic benefits that reasonable health-care providers, knowing of such foreseeable risks and therapeutic benefits, would not prescribe the drug or medical device for any class of patients.

RESTATEMENT (THIRD): PRODS. LIAB.. § 6(c) (1998). The panel did not evaluate the merits of such liability theory, but rather, simply stated, " [o]ur Supreme Court has never adopted this provision, and it runs contrary to law as stated in Hahn and the Restatement (Second) of Torts, § 402(a)." Lance, 4 A.3d at 169.[9]

Wyeth and Appellee lodged the present cross-appeals challenging, respectively, the Superior Court's holdings that pharmaceutical companies are not immune (under Pennsylvania law) from claims of negligent drug design, and that claims of negligent marketing, testing, and failure to withdraw are unviable. Our review of these legal issues is plenary.

In its brief, Wyeth leads with the argument that Appellee has forfeited any design-defect claim, in light of her alleged failure to adequately preserve and present such a claim. See Pa.R.A.P. 302(a). In this regard, the pharmaceutical company highlights that Appellee has consistently styled her central claim as one centered upon " negligent marketing and negligent failure to withdraw" — not " negligent design defect." Brief for Wyeth at 12. Wyeth further contends that Appellee failed to advance a defective-design theory in her opposition to the company's summary judgment motion, in her statement of matters presented on appeal, see Pa.R.A.P. 1925(b), and in the statement of questions involved included in her appellate brief filed in the Superior Court, see Pa.R.A.P. 2116. Under the circumstances as ...


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