by Lanier Law Firm

BALTIMORE – Drug company Hoffmann-La Roche (OTCMKTS – RHHBY) bilked U.S. federal and state governments out of $1.5 billion by misrepresenting clinical studies and falsely claiming that its well-known influenza medicine Tamiflu was effective at containing potential pandemics, according to a recently unsealed whistleblower lawsuit.

The lawsuit claims the drugmaker’s scheme involved publishing misleading articles falsely stating that Tamiflu reduces complications, severity, hospitalizations, mortality and transmission of influenza. The company then used those articles to aggressively market the drug to the government for pandemic use. Relying on the supposed truthfulness of Roche’s claims, federal and state governments spent about $1.5 billion to stockpile Tamiflu to combat influenza pandemics, according to the complaint.

“As alleged in the complaint – Tamiflu does not do what Roche promised,” said attorney Mark Lanier of the Houston-based Lanier Law Firm. “Roche hid this fact for many years by selectively citing its studies and suppressing the data about Tamiflu. The company utilized lobbyists, key opinion leaders and ghostwriters to promote Tamiflu with a deceptive promise to governments fearful of an influenza pandemic.”

The lawsuit brings claims under the False Claims Act, which allows individuals to bring claims on behalf of the government. Unsealed on September 10, the lawsuit seeks reimbursement of taxpayer funds spent to purchase tens of millions of courses of Tamiflu for the Strategic National Stockpile. 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.

Whistleblower Dr. Thomas Jefferson, a physician and public health researcher affiliated with the respected global Cochrane Collaboration research network, has researched neuraminidase inhibitors like Tamiflu for more than two decades. He began questioning Tamiflu’s efficacy in 2009 and spearheaded efforts to have the company release the underlying clinical study data. When he finally received the data in 2013, Dr. Jefferson analyzed it and concluded that the clinical data does not support Roche’s claims about Tamiflu’s effectiveness for use in an influenza pandemic, the lawsuit states.

According to the data as analyzed by the Food and Drug Administration, Tamiflu’s effectiveness is limited to a small benefit of reducing the duration of flu symptoms and preventing onset of symptoms but not transmission or infection. In addition, as early as 2000, the FDA had warned Roche that data did not support its broader efficacy claims and that such statements were misleading.

“The lawsuit alleges that Roche was well aware that Tamiflu is an ineffective product for fighting influenza pandemics,” said attorney Clayton Halunen of Minneapolis-based whistleblower law firm Halunen Law. “Yet Roche masterfully marketed this drug to fill Roche’s coffers at taxpayer expense. This is precisely the type of corporate behavior the False Claims Act is designed to stop.”

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.

Source.

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