Takeda Pharmaceuticals U.S.A., Inc. is the U.S. subsidiary of Takeda Pharmaceutical Company Limited, a major global biopharmaceutical company headquartered in Osaka, Japan It is one of the world’s leading R&D-driven pharmaceutical companies, with a strong emphasis on oncology, rare diseases, neuroscience, gastroenterology (and inflammation), plasma-derived therapies, immunology, and vaccines.
The company has a major presence, including its global hub and research center in Cambridge, Massachusetts (making Takeda the largest life sciences employer in the state). It has sites in 39 states and employs more than 20,000 people in the U.S. (part of ~50,000 worldwide).
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.
Trintellix (vortioxetine) is a prescription antidepressant medication used to treat Major Depressive Disorder (MDD) in adults. It is marketed in the U.S. by Takeda Pharmaceuticals (in collaboration with H. Lundbeck A/S, which originally developed it).
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.
Takeda (including its subsidiaries and predecessors like TAP) has faced other False Claims Act (FCA) allegations, Medicaid fraud claims, kickback-related matters, and similar government program issues in the U.S.
– – 2001 TAP Pharmaceuticals Settlement (Lupron): Takeda’s former joint venture with Abbott (TAP) paid $875 million to resolve criminal and civil charges. Allegations included providing free drug samples to doctors who then billed Medicare/Medicaid, kickbacks, and improper pricing. This was one of the largest pharma fraud settlements at the time.
– – In 2023 Takeda subsidiaries (along with others from the Shire acquisition) agreed to pay a combined ~$42.7 million to resolve Texas Medicaid Fraud Prevention Act claims. Allegations involved providing improper nursing/reimbursement support and paying nurse educators to recommend Vyvanse to Medicaid providers (~2014–2015). This was a whistleblower-initiated case.
Takeda paid ~$2.4 billion in 2015 to settle thousands of U.S. lawsuits alleging the diabetes drug caused bladder cancer and that risks were inadequately disclosed. Some claims involved marketing practices, but these were primarily personal injury/product liability.