Pfizer Fact Sheet
Pfizer to pay $2.3 billion to resolve criminal and civil health care liability relating to fraudulent marketing and the payment of kickbacks
- Largest combined federal and state health care fraud settlement in the history of the Department of Justice
- Resolution includes $1.3 billion in criminal fines and forfeiture and a combined federal and state civil False Claims Act settlement of $1 billion
Criminal Plea
- Pfizer subsidiary Pharmacia & Upjohn, Inc. (Pharmacia), which was acquired by Pfizer in 2003, has entered a plea agreement
- One count information charging felony misbranding under 21 U.S.C. §§ 331(a), 333(a)(2) and 352 of the drug Bextra
- Criminal resolution includes $1.195 billion criminal fine and a criminal forfeiture of $105 million
- This is the largest criminal fine ever imposed in a United States criminal prosecution
- Bextra was approved in 2001 by the Food and Drug Administration (FDA) for the signs and symptoms associated with osteoarthritis, rheumatoid arthritis and primary dysmenorrhea (PD) (menstrual cramps)
- Pfizer marketed Bextra off label for acute pain and surgical pain and at dosages above the maximum levels approved by FDA
- From 2002 through April 2005, Pfizer used false and misleading claims of safety and efficacy to promote Bextra for unapproved uses and for dosages above the approved level. Pfizer did this in the following ways:
- Headquarter Marketing Plans: Pfizer’s marketing team positioned Bextra for acute pain, surgical pain, and other unapproved uses, created sales materials and messages to promote Bextra for these uses, commissioned market research to test its sales materials, confirmed these unapproved messages, and allowed the promotion of Bextra for these purposes to continue. In such documents, Pfizer’s marketing
- team stated as the “intended” use and message for Bextra that Bextra was for “acute pain.”
- Field Force Implementation: Pfizer’s sales force promoted Bextra directly to physicians for these unapproved uses and dosages, including by drafting and distributing proposed physician standing orders and hospital wide protocols and pain pathways that called for unapproved uses of Bextra.
- Payments and other Remuneration to Physicians and Purported Consultants: Pfizer and Pharmacia used so-called advisory boards, consultant meetings and other forums and remuneration, including travel to lavish resorts, to promote Bextra to medical prescribers for unapproved uses and dosages and with false and misleading claims as to its safety and efficacy
- Sham Physician Requests for Off-Label Information: Pfizer’s sales force created sham physician requests from physicians for medical information in order to send unsolicited information to physicians about unapproved uses and dosages
- Distributing Samples for Unapproved Uses and Dosages: Pfizer’s sales force provided promotional samples and otherwise promoted Bextra for unapproved uses and dosages to surgeons and other medical prescribers who had no FDA-approved use for the Bextra samples, or at that dosage
- Control of Purportedly Independent Medical Education to Disseminate Off-Label Messages: Pfizer sponsored purportedly independent continuing medical education programs (“CME”) to disseminate specific messages about unapproved uses of Bextra, including promoting the use of Bextra for acute pain and surgical pain
- Use of a Publication Strategy and Outside Vendors to Foster and Draft Publications to Disseminate Off-label Messages: Pfizer also promoted Bextra for unapproved uses and dosages by initiating, funding and sometimes drafting articles about Bextra for unapproved uses without appropriate disclosures of Pfizer’s role
- Prior convictions and settlements of Pfizer entities:
- In 2007, Pfizer subsidiary Pharmacia & Upjohn, Inc. paid $34 million and pled guilty to paying kickbacks for formulary placement of its drugs and entered into a Deferred Prosecution Agreement for off-label distribution of the drug Genotropin
- In 2004, Pfizer subsidiary Warner-Lambert pled guilty and paid more than $430 million to resolve criminal charges and civil liability in connection with its fraudulent marketing practices with respect to the drug Neurontin
- In 2002, Pfizer, and its subsidiaries Warner Lambert and Parke-Davis, paid $49 million to resolve civil claims that it had failed to report best prices for its drug Lipitor as is required under the Medicaid Drug Rebate Statute
- Prior convictions and settlements of Pfizer entities:
Civil Settlement
- Combined federal and state civil settlement of $1 billion
- Federal government’s share of the settlement amount is $668,514,830
- States’ (which are entitled to a portion of the settlement attributable to the Medicaid program) share of the settlement amount is $331,485,170
- Resolves allegations that Pfizer violated the federal False Claims Act by knowingly causing false or fraudulent claims to be submitted to, or causing purchases by, Medicaid, Medicare and other federal health care programs by:
- Illegally promoting the drugs Bextra, Geodon, Zyvox, and Lyrica for uses not approved by the FDA and that were not medically-accepted indications for which the United States and state Medicaid programs provided coverage;
- Making and disseminating unsubstantiated and false representations about the safety and efficacy of Bextra, Geodon, Zyvox, and Lyrica;
- Paying kickbacks to health care providers to induce them to prescribe Bextra, Geodon, Zyvox, and Lyrica;
- Paying kickbacks to health care providers in connection with its marketing of nine other drugs: Aricept, Celebrex, Lipitor, Norvasc, Relpax, Viagra, Zithromax, Zoloft, and Zyrtec (Kickback Drugs)
- Allocation of combined civil settlement amount by drug:
- Bextra: $502,524,316
- Geodon: $301,462,065
- Zyvox: $97,945,019
- Lyrica: $48,223,886
- Kickback Drugs: $49,844,714
- Settlement proceeds will be distributed among the following programs: Medicaid (federal and state share), Medicare, Department of Defense-TRICARE, Office of Personnel Management-Federal Employee Health Benefits Plan, Department of Veterans’ Affairs, Department of Labor, Bureau of Prisons
- Medicaid (federal and state portion) is the largest part of the recovery, constituting $705,287,596 of the combined civil settlement amount
- Comparison of on-label and off-label usages for Bextra, Geodon, Zyvox and Lyrica:
Bextra
FDA Approved Indications | Off-Label Uses Promoted |
– Osteoarthritis – Adult rheumatoid arthritis – Primary dismennorhea | – Acute pain – Various types of surgical pain – Dosages above approved maximum |
Geodon
FDA Approved Indications | Off-Label Uses Promoted |
– Schizophrenia – Acute manic or mixed episodes associated with bipolar disorder – Geodon Intramuscular is indicated for treatment of acute agitation in schizophrenic patients for whom treatment with Geodon is appropriate | – Depression – Bipolar maintenance – Mood disorder – Anxiety – Aggression – Dementia – Attention Deficit Hyperactivity Disorder – Obsessive compulsive disorder – Autism – Posttraumatic stress disorder – Unapproved patient populations (including pediatric and adolescent patients) – Dosages above approved maximum |
Zyvox
FDA Approved Indications | Off-Label Uses Promoted |
– Vancomycin-Resistant Enterococcus faecium infections – Nosocomial pneumonia – Community-acquired pneumonia – Complicated skin and skin structure infections (including diabetic foot infections without concomitant osteomyelitis) | – Infections caused by methicillin-resistant Staphylococcus aureus (“MRSA”) generally, rather than only those types of MRSA infections for which Zyvox was FDA-approved |
Lyrica
FDA Approved Indications | Off-Label Uses Promoted |
– Adjunctive therapy for adults with partial onset seizures – Management of post-herpetic neuralgia – Management of neuropathic pain associated with diabetic peripheral neuropathy – Fibromyalgia | – Chronic pain – Neuropathic pain – Perioperative pain – Migraine |
Administrative Resolution
- Pfizer has entered into a comprehensive five-year Corporate Integrity Agreement with the Office of Inspector General, Department of Health and Human Services
- Requires enhanced accountability, increased transparency, and wide-ranging monitoring activities conducted by both internal and independent external reviewers
- Also requires:
- that Audit Committee of Pfizer’s Board of Directors annually review the company’s compliance program and certify as to its effectiveness;
- that senior executives annually certify about compliance:
- that Pfizer notify doctors about the global settlement and establish a mechanism doctors can use to report questionable conduct by any Pfizer representative; and
- that the company post on its Web site information about payments to doctors, such as honoraria, travel, or lodging
- First Corporate Integrity Agreement to require that a pharmaceutical manufacturer proactively identify potential risks associated with promoting individual products and that it implement a plan to mitigate the identified risks
- If Pfizer fails to comply with its obligations, it risks exclusion from Federal health care programs and monetary penalties
Qui Tam Actions- The civil settlement also implicates the following eleven different lawsuits containing overlapping allegations against Pfizer under the qui tam, or whistleblower, provisions of the federal False Claims Act, 31 U.S.C. § 3730:
- United States et al. ex rel. Blair Collins v. Pfizer, Inc.
- Civ. No. 04-11780 (D. Mass.)
- United States et al. ex rel. John Kopchinski v. Pfizer, Inc. et al.,
- Civ. No. 05-CV-12115 (D. Mass.)
- United States ex rel. Dana Spencer v. Pfizer, Inc.
- Civ. No. 05-12326 (D. Mass.)
- United States et al. ex rel. Glenn DeMott v. Pfizer
- Civ. No. 05-12040 (D. Mass.)
- U.S. ex rel. Wetherholt v. Pfizer, Inc.
- Civ. No. 06-10240 (D. Mass.)
- United States et al. ex rel. David Farber and Casey Schildhauer
- v. Pfizer, Civ. No. 07-10304 (D. Mass.)
- U.S. ex rel. Willson v. Pfizer, Inc.,
- Civ. No. 07-11115 (D. Mass.)
- United States et al. ex rel. Ronald Rainero v. Pfizer,
- Civ. No. 07-11728 (D. Mass.)
- United States et al. ex rel. Mark Westlock v. Pfizer, Inc. et al.,
- Civ. No. 08-11318 (D. Mass.)
- United States ex rel. Robert A. Liter v. Pfizer,
- Civ. No. 06-00176 (E.D. Ky.)
- United States et al. ex rel. Stefan Kruszewski v. Pfizer, Inc.,
- Civ. No. 07-4106 (E.D. Pa.)
- Pursuant to the terms of the civil settlement agreement, the United States has agreed to pay six relators, or whistleblowers, a total of approximately $102 million in satisfaction of the rights any of the relators may have to a share of the federal proceeds under the False Claims Act:
- John Kopchinski: $51,500,999
- Stefan Kruszewski: $29,013,420
- Ronald Rainero: $9,321,369
- Glenn DeMott: $7,431,505
- Dana Spencer: $2,743,637
- Blair Collins: $2,354,582
