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Lance v. Wyeth

Supreme Court of Pennsylvania

September 13, 2011, Argued; January 21, 2014, Decided

No. 17 EAP 2011, No. 18 EAP 2011

Opinion

 [*235]  [**436]   MR. JUSTICE SAYLOR1

This appeal concerns whether, under Pennsylvania products-liability law, a pharmaceutical company is immune from the responsibility  [***2] 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.

 [*236]  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.  [***3] 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  [**437]  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  [***4] and serious coronary impairments,  [*237]  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.

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624 Pa. 231 *; 85 A.3d 434 **; 2014 Pa. LEXIS 205 ***; CCH Prod. Liab. Rep. P19,314; 2014 WL 260309

PATSY LANCE, ADMINISTRATRIX FOR THE ESTATE OF CATHERINE RUTH LANCE, DECEASED, Appellee v. WYETH, FORMERLY KNOWN AS AMERICAN HOME PRODUCTS CORPORATION, Appellant;PATSY LANCE, ADMINSTRATRIX FOR THE ESTATE OF CATHERINE RUTH LANCE, DECEASED, Appellant v. WYETH, FORMERLY KNOWN AS AMERICAN HOME PRODUCTS CORPORATION, Appellee

Prior History:  [***1] 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.

Lance v. Wyeth, 2010 PA Super 137, 4 A.3d 160, 2010 Pa. Super. LEXIS 1612 (Pa. Super. Ct., 2010)

CORE TERMS

manufacturers, prescription drug, negligent design, marketing, warnings, pharmaceutical company, drugs, risks, products, design-defect, design defect, withdraw, amicus, theory of liability, strict liability, benefits, patients, lack of due care, preserved, cause of action, inter alia, marketplace, prescribed, deference, labeling, terms, unreasonable danger, product liability, immunity, courts

Torts, Products Liability, Types of Defects, Marketing & Warning Defects, Theories of Liability, Negligence, Strict Liability, Civil Procedure, Pleadings, Complaints, General Overview, Summary Judgment, Evidentiary Considerations, Absence of Essential Element, Judgments, Evidentiary Considerations, Entitlement as Matter of Law, Manufacturing Defects, Governments, Courts, Judicial Precedent, Authority to Adjudicate, Common Law, Design Defects