Franklin V. Parke-Davis Case
Franklin's suit, filed under the False Claims Act, claimed that Parke-Davis (since acquired by Pfizer) had used fraudulent scientific evidence supported by "tens of thousands of payments" to doctors for "consultations" and "studies" to encourage them to prescribe the drug for conditions including migraine, bipolar disorder and attention deficit disorder, even though it was approved for use only as adjunctive treatment in patients with partial seizures and postherpetic neuralgia. Prescribing a drug for such off-label use was not itself illegal, but promoting such use was prohibited by the U.S. Food and Drug Administration and federal law.
The case revealed that the company marketed the drug for these illnesses while withholding evidence that the drug was not effective for these illnesses. After initially denying wrongdoing, Pfizer pleaded guilty on 13 May 2004 to criminal violation of the Federal Food, Drug, and Cosmetic Act and paid a criminal fine of $240 million and $152m to state and federal healthcare programmes. Under the False Claims Act, Dr Franklin received $24.6m as part of the settlement agreement.
Franklin v. Parke-Davis opened a unique window into pharmaceutical industry practices through UCSF's archiving and study of documents obtained by Franklin’s attorney Thomas Greene. The case was unique in a number of ways: it was the largest settlement obtained for U.S. taxpayers in a case not joined by the Department of Justice, it established a new standard of accountability for pharmaceutical industry marketing practices, it broadened the use of the False Claims Act to include fraudulent marketing claims (not just financial fraud) as criminal violations of federal and state law, it revealed the involvement, complicity and active participation in fraud by many renowned physicians, and it demonstrated that the medical literature which is the foundation for medical practice (particularly off-label prescribing by physicians) has been deeply adulterated by the pharmaceutical industry and its paid clinical consultants.
Read more about this topic: David Franklin (scientist)
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