Gilead Settles Letairis with DOJ, Faces Truvada Class Action in California

Truvada Class Action Filed in California

On September 17, 2020, the Jacksonville Police Officers and Fire Fighters Health Insurance Trust filed a class action complaint in the United States District Court for the Northern District of California against Gilead and Cipla. The complaint alleges that Gilead and Cipla entered into a pay-for-delay patent settlement agreement in 2014 that delayed entry of a generic version of the AIDS drug Truvada. Truvada had global sales of $2.6 billion in 2019.

The plaintiffs allege that, Gilead made a substantial payment to Cipla to delay entry of a generic version of Truvada. This payment was in the form of a license to produce another drug, Atripla, and a license to produce drugs for Hepatitis C in India. The exact terms of the settlement agreement are not yet known. The class period is January 25, 2018 through the present.

This case overlaps to some extent with Staley v. Gilead Sciences, Inc., No. 19-cv-2573 in the same court. Staley alleges a far broader anticompetitive scheme.

Jacksonville Police Officers & Firefighters Health Ins. Trust v. Gilead Sciences, Inc., No. 3:20-cv-06522 (N.D. Cal.)    

Gilead Letairis Department of Justice Settlement

On September 23, 2020, the U.S. Department of Justice announced a $97 million settlement with Gilead based on allegations that Gilead violated the False Claims Act by using a charitable foundation to pay Medicare co-pays for Gilead’s pulmonary hypertension drug Letairis. Letairis had over $943 million in US sales in 2018, prior to losing its patent exclusivity.

In the case, the DOJ alleged that from 2007 through 2010 Gilead essentially set up a proprietary fund within the Caring Voice Foundation (“CVF”) to provide co-pay assistance to Medicare patients for Letairis. The key fact relied upon by the DOJ was that Gilead received data from the CVF detailing how many Letairis patients the CVF had assisted, how much CVF had spent on those patients, and how much the CVF expected to spend on those patients in the future. The DOJ also alleged that Gilead referred Letairis patients to the CVF.

This case is one of a number of actions and investigations by the U.S. Attorney’s Office for the District of Massachusetts relating to abuse of patient assistance charities by pharmaceutical manufacturers.

False Claim Act Lawyers

Schneider Wallace represents whistleblowers against companies for allegations of false claims, price fixing, and other illegal acts. Schedule an appointment with our legal team to learn more about reporting illegal behavior. Schneider Wallace has offices in California, Texas, North Carolina and Puerto Rico and litigates in jurisdictions throughout the country in state and federal administrative agencies and courts.