Pharma Fraud

September 23, 2020

Gilead Sciences, Inc. has agreed to pay $97 million to resolve claims of paying kickbacks to Medicare beneficiaries in connection with its pulmonary arterial hypertension drug, Letairis.  From 2007 to 2010, Gilead enticed beneficiaries to purchase Letairis by allegedly referring the beneficiaries to a foundation, Caring Voice Coalition (CVC), and then making payments to CVC to cover patient copays of Letairis specifically, in violation of the Anti-Kickback Statute and Medicare rules.  Additionally, Gilead routinely obtained data from CVC that it used to inform future payments, including how many CVC clients were on Letairis, how much CVC spent on those clients, and how much CVC expected to spend on them in the future.  DOJ; USAO MA

August 24, 2020

Following a whistleblower suit by a former sales representative, DUSA Pharmaceuticals (DUSA), a Massachusetts-based subsidiary of Sun Pharmaceuticals Industries Inc. (Sun Pharma), has agreed to pay $20.75 million to resolve allegations of defrauding Medicare and the Federal Employee Health Benefit Pr­­­ogram.  According to relator Aaron Chung, senior management at DUSA and Sun Pharma allegedly encouraged doctors, via paid speaker programs and discussions, to use shorter incubation periods of 1-3 hours for Levulan Kerastick, a topical prescription medication for treating actinic keratosis (AK) of the face and scalp that had FDA-approved instructions for 14-18 hour incubation periods.  As expected, the significantly reduced incubation periods resulted in significantly reduced AK clearance rates, yet DUSA failed to inform doctors of the lower rates and even actively misinformed them that AK clearance rates were the same regardless of incubation period.  For exposing the fraudulent conduct, Chung will receive approximately $3.5 million of the settlement proceeds.  DOJ; USAO WDWA

August 13, 2020

Advanced Care Scripts, Inc. (ACS) has agreed to pay $3.5 million to resolve allegations of conspiring with Teva Neuroscience, Inc. (Teva) to pay kickbacks to Medicare beneficiaries in order to induce purchases of Teva’s multiple sclerosis drug, Copaxone.  The kickbacks came in the form of effectively covering beneficiaries’ co-pays through correlated payments to the Chronic Disease Foundation (CDF) and The Assistance Fund (TAF).  USAO MA

July 31, 2020

Canadian company Bausch Health, formerly known as Valeant Pharmaceuticals, will pay a $45 million penalty to resolve charges that its executives engaged in improper revenue recognition and misleading disclosures in SEC filings and earnings presentations between 2014 and 2015.  The company was alleged to have recorded false sales of products to specialty pharmacy Philidor Rx Services and its affiliates, which were controlled by Valeant.  In addition, Valeant allegedly misrepresented the source and materiality of revenue it received following a 500% increase in the price of its diabetes drug Glumetza.  Former CEO J. Michael Pearson will pay a civil penalty of $250,000; former CFO Howard B. Schiller will pay a civil penalty of $100,000; former controller Tanya Carro will pay a civil penalty of $75,000.  The individuals also agreed to return specified portions of their incentive compensation to the company.  SEC

July 28, 2020

A pharmaceutical company accused of paying illegal inducements to physicians has agreed to pay $3.5 million to resolve allegations of violating the False Claims Act.  In order to induce physicians to prescribe its newly-launched local analgesic, EXPAREL, Pacira Pharmaceuticals Inc. allegedly paid doctors kickbacks that were half-heartedly disguised as grant money for research.  In order to receive the so-called research grant, Pacira required EXPAREL to be placed on formulary at the physician’s institution, but did not document why such research was needed or follow up on research results.  The fraud was eventually exposed by a pharmacist in a qui tam suit; the pharmacist will receive $638,000 as part of the settlement.  USAO NJ; AG FL

July 24, 2020

Several divisions of pharmaceutical company Indivior, which marketed of the opioid-addiction drug Suboxone, pleaded guilty to felony healthcare fraud, entered into a five-year Corporate Integrity Agreement, and will pay a total of $600 million in criminal fines, restitution, civil damages, and penalties.  In six separate cases brought by whistleblowers, Indivior was also alleged to have caused false claims to be submitted to government healthcare programs including by promoting the sale of Suboxone to physicians who were prescribing it outside of medically accepted indication, misrepresenting the likelihood of Suboxone being diverted, and taking steps to delay generic competition for Suboxone. Indivior admitted making false statements about the safety of the film version of Suboxone in order to promote its sale.  In addition, the FTC claimed that violated antitrust laws through a deceptive scheme to thwart lower priced generic competition with Suboxone.  The total settlement consists of criminal restitution of $289 million; a civil settlement of $300 million, with $209.3 million paid to resolve claims by the federal government and $90.7 million to participating states; and, $10 million in penalties to the Federal Trade Commission.  The settlement also requires Indivior to take steps including the dissolution of its Suboxone sales force. Indivior was until 2014 a subsidiary of Reckitt Benckiser Group PLC, which previously paid $1.4 billion to resolve claims related to Suboxone marketing.  DOJ; USAO NJ; FTC