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United States ex rel. Franklin v. Parke-Davis

147 F. Supp. 2d 39 (2001)

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United States ex rel. Franklin v. Parke-Davis

United States District Court for the District of Massachusetts
147 F. Supp. 2d 39 (2001)

AR

Facts

Dr. David Franklin (plaintiff) brought a qui tam action claiming that Parke-Davis (defendant) was promoting off-label uses of its drugs and receiving payment from the federal government for those off-label uses. If a drug was used for an off-label use (a use not approved by the Food and Drug Administration), that use could not be reimbursed through Medicaid. Franklin claimed that he was hired by Parke-Davis to make exaggerated or false claims for Parke-Davis drugs and their off-label uses. These misrepresentations led Parke-Davis to violate the False Claims Act by intentionally making material, false statements that led the government to pay money to Parke-Davis. Parke-Davis argued that the False Claims Act could not be used to enforce compliance with government regulations regarding drugs.

Rule of Law

Issue

Holding and Reasoning (Saris, J.)

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Casebooks

Food and Drug Law

Key Terms