At the end of September, United States District Judge George L. Russell III ruled that Hoffman-La Roche must answer to whistleblower charges that it falsified claims of the effectiveness of its drug, Tamiflu, in fighting influenza and fraudulently induced the United States government to stockpile millions of doses for a feared flu pandemic.
According to the qui tam lawsuit filed by Dr. Thomas Jefferson, a public health researcher affiliated with the Cochrane Collaboration research network, Roche falsified scientific conclusions and engaged in a high-powered marketing and lobbying campaign to win government contracts. Dr. Jefferson has researched neuraminidase inhibitors similar to Tamiflu for over two decades and in 2009, began to question Tamiflu’s effectiveness. At that time, he began to put pressure on Roche to release the underlying clinical study data. In 2013, he received the data and after analyzing it, concluded that it did not support Roche’s claims about the effectiveness for use in an influenza pandemic.
Additionally, as early as 2000, the United States Food and Drug Administration (FDA) even went so far as to warn Roche that the data it was putting forth did not support their claims and that their statements were misleading, based on its own data analysis. Despite that warning and the lack of support, federal and various state governments spent over $1.4 billion between 2005 and 2009, stockpiling Tamiflu in the event of a flu pandemic.
Roche had filed a motion to dismiss the lawsuit under the False Claims Act. However, Judge Russell ruled that Roche’s marketing and alleged false statements about the efficacy of Tamiflu were material and capable of influencing the government’s purchasing decisions.
With the case going forward at this juncture, Roche is potentially liable for a judgment in excess of $4 billion – triple damages under the False Claims Act and civil penalties.
“We were confident that the court would deny the motion and are excited to present these compelling facts to a jury,” said whistleblower lawyer Clayton Halunen of Minnesota-based Halunen Law. “We are particularly pleased that the court applied the proper standard for materiality—whether a defendant’s false statements are capable of influencing the government’s payment decisions.”
“The False Claims Act has important safeguards to protect taxpayers and prevent unscrupulous corporations from making false claims to win government contracts,” said trial lawyer Chris Gadoury of The Lanier Law Firm in Houston. “This case is more important than ever as our government responds to the desperate need to stockpile protective equipment and supplies for the Covid-19 pandemic.”
Interestingly, the Lanier Firm, one of the firms on the case, was the main firm at the center of the Vioxx settlements in the 2000’s.