In re Pennsylvania Diet Drugs Litigation

41 Pa. D. & C.4th 78, 1999 Pa. Dist. & Cnty. Dec. LEXIS 171
CourtPennsylvania Court of Common Pleas, Philadelphia County
DecidedMarch 12, 1999
Docketno. 9709-3162
StatusPublished
Cited by3 cases

This text of 41 Pa. D. & C.4th 78 (In re Pennsylvania Diet Drugs Litigation) is published on Counsel Stack Legal Research, covering Pennsylvania Court of Common Pleas, Philadelphia County primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
In re Pennsylvania Diet Drugs Litigation, 41 Pa. D. & C.4th 78, 1999 Pa. Dist. & Cnty. Dec. LEXIS 171 (Pa. Super. Ct. 1999).

Opinion

LEVIN, J.,

Before this court are plaintiffs’ motion for class certification, defendants’ memorandum of law in opposition to plaintiffs’ motion for class certification and all responses thereto. Plaintiffs seek certification of a medical monitoring claim on behalf of a class of “all persons in the Commonwealth of Pennsylvania who have used fenfluramine (sometimes referred to as ‘Pondimin’) and/or dexfenfluramine (sometimes referred to as ‘Redux’).” For the reasons stated below, we grant certification of plaintiffs’ medical monitoring claim on behalf of all persons in the Commonwealth of Pennsylvania who have used fenfluramine and/or dexfenfluramine and who have not been diagnosed with primary or pulmonary hypertension or valvupathy.

INTRODUCTION

Michael Ciocco, Christine Gazillo and Dennis McBride, plaintiffs, assert claims for medical monitoring on behalf of themselves and all Pennsylvania residents who have “used dexfenfluramine and/or fen[80]*80fluramine.” Defendants, Intemeuron Pharmaceuticals1 and American Home Products Corporation,2 are pharmaceutical companies who manufactured, marketed, distributed or sold the popular diet drugs dexfenfluramine and fenfluramine.3 Plaintiffs allege that defendants failed to exercise reasonable care in designing, manufacturing, selling, testing, advertising, promoting, and distributing fenfluramine and dexfenfluramine because they knew or should have known that these drugs individually or in combination with another anorectic drug, phentermine, created a high risk of unreasonable, dangerous side effects including but not limited to valvupathy,4 pulmonary hypertension (PH) and primary pulmonary hypertension5 (PPH) but failed to notify regulatory authorities, doctors, researchers or the public.

[81]*81Plaintiffs claim that defendants knew of various studies linking dexfenfluramine and fenfluramine consumption to heart valve problems. As early as the 1970s, plaintiffs claim defendants had knowledge about European studies which showed an association between fenfluramine use and primary pulmonary hypertension but failed to notify the Food and Drug Administration. Plaintiffs additionally assert that defendants knew between 1994-1996 of 30 cases of heart-valve problems among diet pill users in Belgium. More recently, in March of 1997, plaintiffs claim that defendants met with doctors at the Mayo Clinic and learned about studies which found that 30 percent of 291 asymptomatic patients who took the diet drugs had damaged heart valves. Other studies conducted before the Food and Drug Administration’s September 15,1997 recommendation that dexfenfluramine and fenfluramine be withdrawn from the market also purportedly gave defendants knowledge about the risk of heart valve damage in persons who consumed dexfenfluramine and/or fenfluramine.6 Despite their purported knowledge, defendants, plaintiffs [82]*82claim, failed to adequately disclose the information to physicians, the public and regulatory authorities. In addition, plaintiffs maintain that defendants “knew of and encouraged (tacitly and otherwise) and profited from [the use of dexfenfluramine and fenfluramine with phentermine, despite knowing that such use] was not FDA recommended, was especially hazardous, was not recommended and had not been systematically tested by appropriate clinical trials.” Pis.’ consolidated compl. at ¶45.

As a result of defendants’ alleged negligence, plaintiffs claim that they “and members of the class have been exposed to a hazardous and dangerous substance or substances which have caused them to be at a significantly increased risk of developing serious injury or disease.” Pis.’ consolidated compl. at ¶46. Due to their purported increased risk, plaintiffs allege they require periodic medical tests and examinations to detect and to prevent the development of these diseases and others which may be associated with dexfenfluramine and fenfluramine consumption. Plaintiffs request that defendants fund and that the court supervise a medical monitoring program which would provide medical tests and examinations for users of dexfenfluramine and/or fenfluramine.7 In addition, plaintiffs’ proposed medical monitoring program would:

“(1) locate persons who use or used fenfluramine and/or dexfenfluramine and notify them of the potential harm from such use;
“(2) fund the design and implementation of further studies of the long-term effects on fenfluramine and/or [83]*83dexfenfluramine users, including population-based studies of and for the benefit of the class, including the establishment of an adverse health effects registry;
“(3) fund research into possible cures for the detrimental effects of fenfluramine and/or dexfenfluramine use;
“(4) gather and forward to treating physicians information relating to the diagnosis and treatment of injuries which may result from using fenfluramine and/or dexfenfluramine, individually or in combination with phentermine.” Pis.’ amd. consolidated compl. at ¶69.

Defendants deny all substantive allegations of plaintiffs’ complaint and argue that plaintiffs have not satisfied the requirements for class certification set forth in Pennsylvania Rules of Civil Procedure. Thus, defendants contend the litigation of these issues should have to proceed, if at all, on an individual basis.

The pleadings in this matter are closed. The court held argument on the merits of plaintiffs’ motion for class certification on October 1,1999. Accordingly, this court makes the following findings of fact.

II. FINDINGS OF FACT

(1) Michael Ciocco is a resident of the Commonwealth of Pennsylvania who, pursuant to a prescription, purchased and consumed fenfluramine and phentermine in combination and dexfenfluramine individually.

(2) Christine Gazillo is a resident of the Commonwealth of Pennsylvania who purchased and consumed fenfluramine in conjunction with phentermine, which was prescribed to her for combination use.

[84]*84(3) Dennis McBride is a citizen of the Commonwealth of Pennsylvania who purchased and consumed dexfenfluramine pursuant to a prescription.

(4) Wyeth Laboratories Inc. (WLI) is a subsidiary of American Home Products Corporation (AHP), has its principal place of business in Wayne, Pennsylvania and is incorporated in Delaware. WLI distributed dexfenfluramine in Pennsylvania.

(5) Wyeth Ayerst Laboratories Division of American Home Products Corporation (WALD) is an unincorporated division of American Home Products Corporation, has its principal place of business in Wayne, Pennsylvania and is incorporated in Delaware. WALD marketed, promoted and sold both fenfluramine and dexfenfluramine and distributed them in Pennsylvania.

(6) A.H. Robins Company is a subsidiary of American Home Products, has its principal place of business in Richmond, Virginia and is incorporated in Delaware. Robins manufactured and marketed fenfluramine, which was sold in Pennsylvania.

(7) Interneuron Pharmaceuticals Incorporated has its principal place of business in Lexington, Massachusetts and is incorporated in Delaware. Intemeuron promoted dexfenfluramine as “Redux” to health care providers located in Pennsylvania.

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Bluebook (online)
41 Pa. D. & C.4th 78, 1999 Pa. Dist. & Cnty. Dec. LEXIS 171, Counsel Stack Legal Research, https://law.counselstack.com/opinion/in-re-pennsylvania-diet-drugs-litigation-pactcomplphilad-1999.