Pharmaceutical Marketing Practices: Pharmaceutical Companies Facing Competition from Generic Drug Manufacturers May Face Increased Scrutiny for Anticompetitive Marketing Practices-In Re Warfarin Sodium Antitrust Litig.1

By Brooks, Karen | American Journal of Law & Medicine, January 1, 2005 | Go to article overview

Pharmaceutical Marketing Practices: Pharmaceutical Companies Facing Competition from Generic Drug Manufacturers May Face Increased Scrutiny for Anticompetitive Marketing Practices-In Re Warfarin Sodium Antitrust Litig.1


Brooks, Karen, American Journal of Law & Medicine


Pharmaceutical Marketing Practices: Pharmaceutical Companies Facing Competition from Generic Drug Manufacturers May Face Increased Scrutiny for Anticompetitive Marketing Practices-In re Warfarin Sodium Antitrust Litig.1-The United States Court of Appeals for the Third Circuit rejected challenges to a $44.5 million settlement against DuPont Pharmaceuticals Co. ("DuPont"). The settlement ended a class-action consumer antitrust suit over the marketing of DuPont's widely used blood thinner, Coumadin.3 Specifically, the plaintiffs alleged that "DuPont's anticompetitive behavior and dissemination of false and misleading information about a lower-priced, readily available generic competitor caused them to purchase the higher priced Coumadin instead of the generic product."4 The appeal challenged the appropriateness of class certification, which included fixed co-pay consumers, out-of-pocket consumers, and third party payors ("TPPs").5

In 1997, Barr Laboratories, Inc. ("Barr") began manufacturing and marketing an PDA-approved generic form of warfarin sodium.6 Plaintiffs alleged that before and after Barr introduced its generic warfarin sodium, DuPont "published false and misleading statements concerning the bioequivalence, therapeutic safety, and efficacy of generic warfarin sodium." According to the allegations, DuPont added warnings about generic substitutes to its promotional computer program used by physicians monitoring patients on Coumadin.8 Other DuPont anticompetitive conduct allegedly included a slide presentation for health care professionals warning against the use of generic warfarin sodium and a publicity campaign claiming that Coumadin superceded the generic drug in meeting uniformity standards.9

Plaintiffs claimed that DuPont's misrepresentation campaign led them to believe that Coumadin was superior to Barr's generic equivalent. Instead of saving money by filling prescriptions with the less expensive generic drugs, consumers and TPPs continued to use Coumadin, thus allowing DuPont to maintain supracompetitive prices. To prove the anticompetitive effect of DuPont's misrepresentations, plaintiffs cited "evidence of the weak market penetration of generic warfarin sodium as compared to Coumadin." While 40-70% of prescriptions available from different manufacturers are filled with cheaper generics within one year of generic availability, one year after Barr introduced its generic version of sodium warfarin DuPont still retained 75% of the market,13 and 67% of the market at the time of suit.14

Consumers and TPPs filed a consolidated class action complaint in the District Court for the District of Delaware on behalf of all similarly situated consumers who paid for Coumadin at the supracompetitive prices. Settlement negotiations began in March 2000.16 After more than a year of negotiations, DuPont agreed to settle the claims of all primary consumers and TPPs for $44.5 million.17 The settlement was approved in August 2002.18

Nine consumers, however, challenged the settlement approval.19 In particular, they argued that the class wrongly included consumers whose co-pay was the same regardless of whether they used Coumadin or a generic product. …

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