Takeda Agrees to Pay $13.6M to Resolve False Claims Allegations Relating to Improper Payments to Physicians

Takeda Pharmaceuticals, U.S.A. Inc. has agreed to pay $13,670,921 to resolve allegations that it knowingly caused the submission of false claims to Medicare and other federal health care programs by paying kickbacks to healthcare providers to induce prescriptions of Trintellix, an antidepressant medication that Takeda marketed and sold to treat major depressive disorder.

"The Department of Justice is committed to vigorously pursuing violations of the False Claims Act arising from illegal kickbacks," said Assistant Attorney General Brett A. Shumate of the Justice Department's Civil Division. "Such conduct can erode the trust that patients place in their healthcare providers and lead to higher drug costs for American taxpayers."

"This settlement demonstrates the continued commitment of my office to ensure that patients' best interests remain paramount," said U.S. Attorney Eric Grant for the Eastern District of California. "Prescribing decisions should not be influenced by drug companies' payments or side perks made available to physicians."

"Alleged kickback schemes such as those described in this matter undermine the trust that patients place in their providers and federal health care programs," said Acting Deputy Inspector General for Investigations Scott J. Lampert of the U.S. Department of Health and Human Services, Office of Inspector General (HHS OIG). "This settlement underscores that HHS-OIG, together with our law enforcement partners, will investigate and hold accountable entities that attempt to disguise purported honoraria or other improper payments as legitimate compensation. Decisions regarding patient care should never be influenced by extravagant meals or other inducements."

"As the investigative arm of the Department of Defense Office of Inspector General, the Defense Criminal Investigative Service is committed to protecting the integrity of programs that directly affect our service members and their families," said Special Agent in Charge John E. Helsing for the Department of Defense Office of Inspector General, Defense Criminal Investigative Service (DCIS), Western Field Office. "When companies use kickbacks to influence prescribing, they erode trust in healthcare providers, misuse federal healthcare funds, and put the health and readiness of our warfighters at risk. DCIS will continue working with our law enforcement partners and the Department of Justice to stop schemes that threaten those who faithfully serve our country."

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 the judgments of healthcare professionals are not compromised by improper financial incentives.

The civil settlement resolves allegations that, from January 2014 to October 2020, Takeda paid improper remuneration, including in the form of speaker honoraria and meals at high-end restaurants, to healthcare professionals to induce them to prescribe the antidepressant medication Trintellix in violation of the Anti-Kickback Statute. The United States contends that Takeda selected certain healthcare providers to be part of the Trintellix speaker bureau and provided them paid speaking opportunities with the intent that the speaker honoraria and meals would induce them to prescribe Trintellix. The government further contends that certain prescribers who attended multiple programs on the same topic and received meals and drinks from Takeda received no educational benefit from attending duplicate programs.

This year the Administration launched the Task Force to Eliminate Fraud and the National Fraud Enforcement Division to enhance the Administration's war on fraud, waste, and abuse in federal programs. When unscrupulous actors exploit these programs for their own financial gain, they defraud the government, harm the people these programs are designed to aid and protect, and undermine American businesses that play by the rules. The Civil Division's FCA enforcement plays a critical role in combatting such fraudulent schemes, recovering billions of dollars for the American taxpayers, and holding wrongdoers accountable. FCA matters will continue to be on the forefront of the battle against fraud, and the Civil Division's FCA work will support and advance the mission of the Task Force to Eliminate Fraud and the National Fraud Enforcement Division.

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 Eastern District of California, with assistance from the Defense Criminal Investigative Service and HHS's Office of Inspector General.

The investigation and resolution of this matter illustrate the government's emphasis on combating healthcare 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).

Trial Attorney Kimya Saied of the Justice Department's Civil Fraud Section and Assistant U.S. Attorney David Thiess for the Eastern District of California handled the matter.

The claims resolved by the settlement are allegations only and there has been no determination of liability.