Franklin v. Parke-Davis
Franklin v. Parke-Davis | |
---|---|
False Claims Act. | |
Court membership | |
Judge(s) sitting | Patti B. Saris |
Keywords | |
False Claims Act |
Franklin v. Parke-Davis is a lawsuit filed in 1996 against
Factual background
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
According to Franklin, a
Lawsuit
In August 1996, Franklin and attorney Thomas Greene filed a qui tam complaint in the
Franklin's suit 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, since by law, Medicaid only pays for treatments that are either approved by the FDA, or are otherwise "medically accepted" (as evidenced, for instance, by being included in an approved list of drugs and their uses).[11][12][13] The suit also alleged that Warner-Lambert had broken federal kickback laws.
The suit remained sealed for three years while the Department of Justice decided if it would intervene and take over the case, which it had the right to do under the
In an opinion handed down on August 22, 2003, District Judge Patti B. Saris agreed with David Franklin, denying Warner Lambert's summary judgment motion to dismiss the lawsuit. Judge Saris found 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. In addition, Judge Saris found that the submission of false Medicaid claims was a foreseeable result of Warner-Lambert's marketing scheme.[16] 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.
Settlement
On May 13, 2004, the Department of Justice announced that it had reached an agreement with Warner-Lambert and Pfizer. Warner-Lambert agreed to pay $430 million to resolve criminal and civil liability related to the off-label promotion of Neurontin, and also agreed to plead guilty to two felony counts of misbranding drugs under the Federal Food, Drug, and Cosmetic Act, resulting in a $240 million criminal fine.[3] Civil damages under the False Claims Act were paid out to the federal government in the amount of $83.6 million, and damages paid out to the states totaled $106.4 million. Relator David Franklin was awarded one of the highest shares ever under the False Claims Act, 29.5% of the settlement, in recognition of his important role in exposing the illicit marketing scheme.[3] Pfizer agreed to institute a corporate compliance program as part of the settlement.[3] Also as part of the settlement the Consumer & Prescriber Grant Program was established to fund public programs to raise awareness of problems with pharmaceutical advertising.[17]
Impact
Since the settlement in 2004, whistleblowers and the federal government have prosecuted numerous off-label promotion cases under the False Claims Act using this case as a precedent.[18]
Subsequent research reported that the wrongful promotion of the drug was planned by integrating it into
Litigation around the marketing of
References
- ^ U.S. ex rel. Franklin v. Parke-Davis, Div. of Warner-Lambert Co., No. CIV.A.96–11651PBS, 2003 WL 22048255, at *1 (D. Mass. Aug. 22, 2003) 2003 Decision
- ^ a b Melody Petersen, Our Daily Meds: How the Pharmaceutical Companies Transformed Themselves into Slick Marketing Machines and Hooked the Nation on Prescription Drugs, New York: Sarah Crichton Books (2008).
- ^ a b c d "Press Release: Warner-Lambert to Pay $430 Million to Resolve Criminal & Civil Health Care Liability Relating to Off-Label Promotion". US Department of Justice. May 13, 2004.
- PMID 23234671.
- ^ Joseph JN, et al. Enforcement Related to Off-Label Marketing and Use of Drugs and Devices: Where Have We Been and Where Are We Going? Archived 2016-03-04 at the Wayback Machine Journal of Health & Life Sciences Law 2(2):73-108. January 2009
- ^ David S. Torborg The Dark Side of the Boom: The Peculiar Dilemma of Modern False Claims Act Litigation 26 J.L. & Health 181 (2013)
- PMID 14664664. Archived from the original(PDF) on September 17, 2010. Retrieved August 10, 2014.
- ^ a b c Melody Petersen for the New York Times. March 12, 2003 Doctor Explains Why He Blew the Whistle at Pfizer
- ^ PMID 12649230.
- ^ Franklin v. Parke-Davis, 147 F. Supp. 2d 39 (D. Mass. 2001).
- ^ a b Hogan & Hartson LLP. June 2003. FDA Update: Government Files "Statement Of Interest" in Neurontin Off-Label Promotion Case
- ^ Greene LLP Franklin v. Parke-Davis: First Off-Label Case Under False Claims Act Page accessed August 8, 2014
- ^ Stephanie M. Greene False Claims Act Liability for Off-Label Promotion of Pharmaceutical Products. Penn State Law Review, Vol. 110, pp. 41-68, 2005
- ^ Franklin at *4
- ^ Franklin at *1
- ^ Franklin at *4-*5
- ^ Rutkow, Lainie; Teret, Stephen (October 2010). "The Potential for State Attorneys General to Promote the Public's Health: Theory, Evidence, and Practice". Robert Wood Johnson Foundation Public Health Law Research Program, via FOLIO.
- PMID 22147859.
- PMID 16908919.
- ^ Andrew Pollack for the New York Times. 7 August 2015 Court Forbids F.D.A. From Blocking Truthful Promotion of Drug
- ^ Katie Thomas for the New York Times. 8 March 2016 F.D.A. Deal Allows Amarin to Promote Drug for Off-Label Use