Big Pharma Edgy After Revival of Gilead's Whistleblower Lawsuit
September 27, 2017
By Alex Keown, BioSpace.com Breaking News Staff
NEW YORK – Two years after Gilead Sciences thought a whistleblower lawsuit had been dismissed, the case is back in court. And attorney Erika Kelton said that should indicate that the courts take whistleblower allegations very seriously – and so too should big pharma.
Writing in Forbes, Kelton, an attorney specializing in whistleblower protection, pointed to the July decision of the Ninth Circuit Court of Appeals to revive a lawsuit against the California-based drug giant as a warning against fraud. The case had originally been dismissed in 2015, but earlier this year it was reopened by the appellate judges after the dismissal was appealed.
The case revolves around sources for the active ingredient emtricitabine Gilead Sciences used in the manufacture of Gilead’s HIV drugs Emtriva, Truvada and Atripla, some of the most prescribed treatments for the disease. The initial lawsuit, brought by two former employees, alleges that Gilead “violated the False Claims Act by misleading the Food and Drug Administration as to the source and quality of active ingredients used in Gilead’s HIV drugs,” Kelton said. The lawsuit alleged that Gilead sourced the drug ingredients from an unapproved Chinese source, all while telling the FDA that they came from manufacturing facilities in the U.S., Canada, Germany and South Korea. Additionally, the lawsuit said Gilead sourced the ingredients from the Chinese plant Synthetics China for three years before finally securing approval in 2010.
“To get that approval, Gilead allegedly falsified or concealed data, such as information about batches it received from the Chinese plant that had failed testing because of contamination,” Kelton said in her column.
According to the Ninth Circuit, the U.S. government has been one of the biggest acquirers of the drug for HIV patients. Over the two-year period of 2008 and 2009, the government spent more than $5 billion on the Gilead anti-retroviral drugs. The company is alleged to have hidden FDA violations from the government during that period of time.
Even after the drugs were approved, there were two recalls of contaminated products for the HIV drugs in 2014, according to the court’s opinion.
“Gilead never acknowledged or notified the FDA about the bad test results or the contamination and adulteration problems. Despite being aware of manufacturing problems with Synthetics China, Gilead allegedly released 77 lots of FTC produced by Synthetics China to its contract manufacturers before the FDA approval of the Synthetics China facility,” the Ninth Circuit said.
When arguing the case, Kelton said Gilead “attempted to minimize” the Ninth Circuits reversal by saying that the courts will become flooded with trivial lawsuits by those “seeking jackpots.” Kelton, who is an attorney specializing in representing whistleblowers, said that Gilead “must know that there is much more at stake than can be brushed off by stale criticisms of plaintiffs’ lawyers.” She argued in her column that whistleblowers have brought greater transparency to the pharmaceutical industry because they have pointed to companies that have overstepped “regulatory limits meant to protect patients and taxpayers.”