The Franklin v. Parke-Davis lawsuit was a significant case in the pharmaceutical industry. It was filed in 1983 by a woman named Deborah Franklin.
Deborah Franklin's son, Christopher, had been prescribed a medication called Dilantin, which is used to treat seizures. The medication was manufactured by Parke-Davis.
The lawsuit alleged that Parke-Davis had failed to warn patients and doctors about the risks of birth defects associated with taking Dilantin during pregnancy.
Case Details
In August 1996, Dr. David Franklin filed a qui tam complaint against Warner-Lambert under the False Claims Act.
The complaint proposed a novel theory that Warner-Lambert had perpetrated a fraud against the federal government by causing doctors and patients to submit claims for reimbursement to Medicaid that Medicaid should not pay for.
Franklin's suit remained sealed for three years while the Department of Justice decided if it would intervene and take over the case.
In 1999, the government declined to intervene, and the case moved forward with Franklin as the lead plaintiff.
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The defendants sought to have the complaint dismissed, arguing that the causal link between any representations made by Parke-Davis sales representatives and reimbursements for off-label Neurontin prescriptions was too remote.
Judge Patti B. Saris disagreed, finding that if it could be proven that the off-label marketing of Neurontin caused doctors to prescribe the drug and submit prescriptions to Medicaid, then the company would indeed be liable under the False Claims Act.
The case established for the first time that drug companies could be held liable under the False Claims Act for off-label promotion of pharmaceutical products.
The complaint listed several counts, including direct sales to the Veterans Administration, illegal kickbacks, and fraudulent statements to physicians.
Parke-Davis moved to dismiss the case, arguing that Franklin failed to plead fraud with particularity and failed to state a claim upon which relief could be granted.
The court partially granted and partially denied the motion to dismiss, allowing some claims to proceed while dismissing others.
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Frequently Asked Questions
Who bought Parke-Davis?
Parke-Davis was acquired by Warner-Lambert in 1970, with the merger being completed in 1974. It later became a subsidiary of Pfizer after the company acquired Warner-Lambert in 2000.
What is the history of Parke-Davis and Co?
Parke-Davis was founded in 1866 by Hervey Parke and George Davis in Detroit, Michigan, where they pioneered the standardization of medications and developed a systematic method of clinically testing new drugs. This marked the beginning of a legacy in the pharmaceutical industry that continues to shape the field today.
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