Franklin v. Parke-Davis
| U.S. ex rel. Franklin v. Parke-Davis | |||
|---|---|---|---|
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United States District Court for the District of Massachusetts |
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| Filed | August 1996 | ||
| Decided | August 22, 2003 | ||
| Case name | Franklin v. Parke-Davis | ||
| Civil Action No. | 96–11651PBS | ||
| Holding | Off-label promotion of pharmaceutical products which causes false claims for payment under the federal Medicaid program is a valid theory of recovery under the False Claims Act. | ||
| Judge | Patti B. Saris | ||
| False Claims Act | |||
United States District Court for the District of Massachusetts
Franklin v. Parke-Davis is a lawsuit filed in 1996 against Parke-Davis, a division of Warner-Lambert Company, and eventually against Pfizer (which bought Warner-Lambert in 2000) under the qui tam provisions of the False Claims Act. The suit was commenced by Dr. David Franklin, a microbiologist hired in the spring of 1996 in a sales capacity at Parke-Davis, a pharmaceutical subsidiary of Warner-Lambert (Warner-Lambert was subsequently acquired by Pfizer in 2000). In denying the defendants' motion for summary judgment, the court for the first time recognized off-label promotion of drugs could cause Medicaid to pay for prescriptions that were not reimbursable, triggering False Claims Act liability. The case was also significant in exposing the degree to which publication bias impacts the randomized controlled studies conducted by pharmaceutical companies to test the efficacy of their products. Ultimately, the parties reached a settlement agreement of $430 million to resolve all civil claims and criminal charges stemming from the qui tam complaint. At the time of the settlement in May 2004, it represented one of the largest False Claims Act recoveries against a pharmaceutical company in U.S. history, and was the first off-label promotion settlement under the False Claims Act.
After four months of employment at Parke-Davis, Franklin became disillusioned by what he believed to be the company's illegal marketing practices in connection with sales of the drug Neurontin.
In December 1993, the Food and Drug Administration (FDA) had approved Neurontin as a secondary course of treatment for epilepsy, to be used only when the first medication had not brought the epileptic seizures entirely under control. Warner-Lambert executives found the potential revenue in that indication to be too low, and decided to promote Neurontin for additional indications, for which the drug was not approved by the FDA and for which there was little to no evidence, including migraines, bipolar disorder and attention-deficit disorder. Members of the Parke-Davis sales team, including medical liaisons like Franklin, were hired to conduct this marketing. Franklin also alleged that physicians and other health care providers were paid illegal kickbacks as a quid pro quo for prescribing Neurontin, including expensive meals, stays at luxury resorts, and cash payments and that Parke-Davis hired ad agencies and marketing firms to produce articles about gabapentin describing the drug's emerging uses and recruited physicians and paid them to sign their names to the ghost written articles as authors.
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