Pfizer Settles Biohaven Nurtec ODT Drug Kickback Lawsuit For $ 60 Million

Pfizer bought Biohaven Pharmaceutical in 2022 with COVID vaccine profits, largely for their rimegepant (Nurtec ODT/Vydura) anti-migrane medication.  Rimegepant has become a billion dollar drug in four years, but much of its success was due a prescriber kickback scheme.  Pfizer just settled a False Claims Act lawsuit with the U.S. Department of Justice, without admitting any liability:

https://www.justice.gov/opa/pr/pfizer-agrees-pay-nearly-60m-resolve-false-claims-allegations-relating-improper-physician

https://www.justice.gov/opa/media/1386456/dl

Pfizer Agrees to Pay Nearly 60M to Resolve False Claims Allegations Relating to Improper Physician Payments by Subsidiary
DoJ Office of Public Affairs, January 24, 2025

Pharmaceutical company Pfizer Inc. (Pfizer), on behalf of its wholly-owned subsidiary Biohaven Pharmaceutical Holding Company Ltd. (Biohaven), has agreed to pay $59,746,277 to resolve allegations that, prior to Pfizer’s acquisition of the company, Biohaven knowingly caused the submission of false claims to Medicare and other federal health care programs by paying kickbacks to health care providers to induce prescriptions of Biohaven’s drug Nurtec ODT.

“Through this settlement and others, the government has demonstrated its commitment to ensuring that drug companies do not use kickbacks to influence physician prescribing,” said Acting Assistant Attorney General Brett A. Shumate of the Justice Department’s Civil Division. “The department will use every tool at its disposal to prevent pharmaceutical manufacturers from undermining the objectivity of treatment decisions by health care providers.”

The anti‑kickback statute prohibits offering or paying anything of value to induce the referral of items or services covered by Medicare, Medicaid, TRICARE, and other federal health care programs. The statute is intended to ensure that medical providers’ judgments are not compromised by improper financial incentives.

The settlement announced today resolves allegations that from March 1, 2020, through Sept. 30, 2022, Biohaven paid improper remuneration, including in the form of speaker honoraria and meals at high end restaurants, to health care professionals to induce them to prescribe the migraine medication Nurtec ODT in violation of the anti-kickback statute. The United States alleged that Biohaven selected certain health care providers to be part of the Nurtec speaker bureau and provided them paid speaking opportunities with the intent that the speaker honoraria and meals would induce them to prescribe Nurtec ODT. The government further alleged that certain prescribers who attended multiple programs on the same topic received no educational benefit from attending repeat programs and that certain Biohaven speaker programs were attended by individuals with no educational need to attend, such as the speakers’ spouses, family members, or friends, or colleagues from the speakers’ own medical practice. The United States contends that this conduct persisted until October 2022, when Pfizer acquired Biohaven and terminated the Nurtec speaker programs.

“Patients deserve to know that their doctor is prescribing medications based on their doctor’s medical judgment, and not as a result of financial incentives from pharmaceutical companies,” said U.S. Attorney Trini E. Ross for the Western District of New York. “This settlement reflects our commitment to hold those who violate the laws accountable, regardless of their status or prestige.”

“Violations of the anti-kickback statute, such as those alleged in this settlement, can unduly influence prescribers and negatively impact taxpayer-funded health care,” said Deputy Inspector General Christian J. Schrank of the Department of Health and Human Services Office of Inspector General (HHS-OIG). “HHS-OIG will continue to collaborate with law enforcement partners to ensure that providers and corporations are held accountable if they attempt to bypass laws meant to protect the integrity of federal health care programs.”

“Investigating schemes that undermine the integrity of TRICARE, the health care system for military members and their families, is a top priority for the Department of Defense Office of Inspector General’s Defense Criminal Investigative Service (DCIS),” said Special Agent in Charge Patrick J. Hegarty of the DCIS Northeast Field Office. “Today’s announcement demonstrates our commitment to work with our partner agencies and the Department of Justice to pursue corporations that attempt to corrupt the TRICARE system.”

The civil settlement includes the resolution of claims brought under the qui tam or whistleblower provisions of the False Claims Act by Patrica Frattasio, a former sales representative at Biohaven. Under those provisions, a private party can file an action on behalf of the United States and receive a portion of any recovery. The qui tam case is captioned U.S. ex rel. Patricia Frattasio v. Biohaven Pharmaceutical Holding Company Ltd., No. 6:21-CV-06539 (W.D.N.Y.). Approximately $50.2 million of the settlement constitutes the federal portion of the recovery and approximately $9.5 million constitutes a recovery for State Medicaid programs. Ms. Frattasio will receive approximately $8.4 million as her share of the federal recovery in this case.

The resolution obtained in this matter was the result of a coordinated effort between the Justice Department’s Civil Division, Commercial Litigation Branch Fraud Section, and the U.S. Attorney’s Office for the Western District of New York.

Trial Attorney Jessica Sarkis of the Justice Department’s Civil Division and Assistant U.S. Attorney David M. Coriell for the Western District of New York handled the matter.

The investigation and resolution of this matter illustrates the government’s emphasis on combating health care fraud. One of the most powerful tools in this effort is the False Claims Act. Tips and complaints from all sources about potential fraud, waste, abuse, and mismanagement, can be reported to the Department of Health and Human Services at 800-HHS-TIPS (800-447-8477).

Like most of these settlements, the DoJ doesn't pursue the crooked physicians, so these corrupt kickback schemes continue to proliferate in pharmaceutical marketing.  $ 60 million is just a minor marketing expense for a billion dollar drug.  Pfizer/Biohaven probably pay Lady Gaga more for endorsing Nurtec ODT/Vydura.