BALTIMORE – Drug company Hoffmann-La Roche falsified scientific conclusions and mounted a high-powered marketing and lobbying campaign to deceive the government about the effectiveness of Tamiflu for fighting a flu pandemic, according to new filings in a federal False Claims Act lawsuit.
The case seeks to recover more than $1.4 billion of taxpayer dollars that the federal government wrongly spent to add Tamiflu to the Strategic National Stockpile.
In a highly anticipated response to Roche’s motion to dismiss the lawsuit, whistleblower Dr. Thomas Jefferson alleges that Roche was aware that studies didn’t show that Tamiflu could protect individuals from acquiring influenza, reduce contagiousness of those infected or treat secondary symptoms. At best, studies have found that Tamiflu might slightly shorten the duration of flu symptoms.
“The government bargained for an antiviral drug to reduce influenza spread, severity, complications, hospitalization, and mortality,” said Clayton Halunen, founder of Minneapolis-based law firm Halunen Law. “But our filing alleges Roche knew that Tamiflu did none of that. And worse, because Tamiflu doesn’t prevent infections, Roche sold a drug that creates asymptomatic carriers that could worsen a pandemic – much like those feared today in the Covid-19 pandemic.”
The federal Food and Drug Administration repeatedly denied Roche’s efforts in the early 2000s to approve Tamiflu for pandemic use.
According to the latest filings by whistleblower lawyers at The Lanier Law Firm and Halunen Law, once thwarted by the FDA, Roche began a campaign to fund, produce and publish misleading medical journal articles to create the appearance that Tamiflu would be effective at responding to a flu pandemic. The global conglomerate then used those studies and articles to create a false narrative for marketing and to lobby the CDC and Congress. As alleged, federal and state governments purchased tens of millions of doses of Tamiflu for the Strategic National Stockpile based on Roche’s misrepresentations.
“Whistleblower laws serve a critically important purpose – to make sure businesses don’t overcharge the government and waste taxpayer funds,” said trial lawyer Mark Lanier, founder of The Lanier Law Firm. “The facts are clear about what Roche knew about Tamiflu’s known limitations compared to what it boasted to the government about Tamiflu’s efficacy. These are details that a jury needs to hear.”
Unsealed Sept. 10, 2019, the lawsuit seeks reimbursement of taxpayer funds. Roche is vulnerable to a judgment in excess of $4.5 billion because the False Claims Act mandates payment of triple damages, plus civil penalties.
“[Hoffmann-La Roche] concocted and executed an elaborate fraudulent scheme to sell the Government nothing more than the medical equivalent of bullets filled with sawdust. Remedying that deceit is just what the False Claims Act is intended to do,” the whistleblower’s latest response states.
The case is United States of America, ex rel. Thomas Jefferson, et al. v Roche Holding AG, Hoffman-La Roche Inc., and Genentech Inc. in the U.S. District Court for the District of Maryland. Case No. 14-CV-03665