On April 29, 2025, the United States Attorney for the Southern District of New York announced that the United States has settled a civil fraud lawsuit against Gilead Sciences, Inc. (“Gilead”), a large pharmaceutical manufacturer, that, among other things, develops, manufactures, and sells drugs for the treatment of infectious diseases, including HIV/AIDS. The settlement resolves claims that Gilead offered and paid kickbacks in the form of honoraria payments, meals, and travel expenses to healthcare practitioners who spoke at or attended Gilead speaker events to induce them to prescribe Stribild®, Genvoya®, Complera®, Odefsey®, Descovy®, and Biktarvy® (the “Gilead HIV Drugs”) in violation of the Anti-Kickback Statute (“AKS”) and thereby caused false claims for the Gilead HIV Drugs to be submitted to and paid by federal healthcare programs in violation of the False Claims Act.
Under the settlement, which was approved on April 29, 2025 by U.S. District Judge Paul A. Engelmayer, Gilead agreed to pay a total sum of $202 million, of which $176,927,889.28 will be paid to the U.S. and the remainder will be paid to various states. As part of the settlement, Gilead also made extensive factual admissions regarding its conduct.
As part of the settlement, Gilead admitted and accepted responsibility for certain conduct alleged by the U.S., including the following:
- Gilead paid many high-volume prescribers of HIV drugs tens or hundreds of thousands of dollars in honoraria to prepare and present as HIV Speakers. For instance, one HIV Speaker, who received over $300,000 in total honorarium payments, wrote prescriptions for Gilead HIV Drugs that resulted in over $6 million in Medicare, Medicaid, and TRICARE payments.
- On many occasions, Gilead covered the travel costs of HIV Speakers who traveled long distances to speak at HIV Speaker Programs at desirable travel destinations, such as Hawaii, Miami, and New Orleans. This was sometimes in response to an HIV Speaker’s request to be booked for an HIV Speaker Program in that city.
- Sales representatives in Gilead’s HIV therapeutic area (“Sales Representatives”) organized HIV Speaker Programs at high-end restaurants across the country. For instance, a significant percentage of the HIV Speaker Programs held in New York City were held at expensive restaurants, such as the James Beard House, Del Posto, Asiate, Palma, Vaucluse, Ilili, and Limani. In particular, Gilead held 157 HIV Speaker Programs at the James Beard House, making it one of Gilead’s most used venues for HIV Speaker Programs. A dinner at the James Beard House typically included approximately six courses with alcoholic beverage pairings.
- Sales Representatives repeatedly invited numerous doctors and other healthcare providers to attend the same HIV program over and over. Many repeatedly attended HIV Speaker Programs covering the exact same topic, often within a short period of time.
- Over 250 prescribers of the Gilead HIV Drugs attended HIV Dinner Programs on the same topic three times or more within a six-month period. And over 80 of them attended five or more HIV Dinner Programs on the same topic within a six-month period.
- Further, many healthcare providers who were paid to be HIV Speakers on a particular topic also attended HIV Dinner Programs on exactly the same topic, often within less than six months after speaking.
- In certain instances, the same group of doctors repeatedly attended the same HIV Speaker Programs together at various restaurants. In many instances, they attended a HIV Dinner Program less than two weeks after speaking on the same topic.
- During the Relevant Time Period, Gilead’s policies and procedures failed to prevent Sales Representatives and Regional Directors in its HIV therapeutic area from improperly providing honoraria payments, meals, and travel expenses to healthcare providers who spoke at or attended HIV Speaker Programs to induce them to prescribe the Gilead HIV Drugs.
In connection with the filing of the lawsuit and settlement, the Government joined a private whistleblower lawsuit that had been filed under seal pursuant to the False Claims Act.
If you have information regarding false claims having been submitted to Medicare, Medicaid, TRICARE, other federal health care programs, or to other federal agencies/programs, and the information is not publicly known and no actions have been taken by the government with regard to recovering the false claims, you should promptly consult with a False Claims Act attorney (also known as qui tam attorneys) in your U.S. state who may investigate the basis of your False Claims Act allegations and who may also assist you in bringing a qui tam lawsuit on behalf of the United States, if appropriate, for which you may be entitled to receive a portion of the recovery received by the U.S. government.
Visit our website or call us toll-free in the United States at 800-295-3959 to be connected with qui tam lawyers (False Claims Act lawyers) in your U.S. state who may assist you with a False Claims Act lawsuit.
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