Benicar Maker Settles False Claims Act Violations

Newark, NJThe company that makes Benicar has agreed to pay $39 million to settle claims the company paid illegal kickbacks to doctors for prescribing its drugs. Among the drugs involved in the alleged kickback scheme are medications that contain olmesartan, including Benicar, Azor and Tribenzor. Meanwhile, lawsuits have been filed against the company by plaintiffs alleging they suffered serious Benicar side effects, including sprue-like enteropathy.

On January 9, 2015, the US Department of Justice announced that Daiichi Sankyo Inc., agreed to pay $39 million to resolve allegations the company violated the False Claims Act. The Department of Justice had alleged Daiichi Sankyo illegally paid kickbacks as a way of enticing doctors to prescribe Benicar, Azor, Tribenzor and Welchol.

“In this case, the government alleged that Daiichi paid physicians improper kickbacks in the form of speaker fees as part of Daiichi’s Physician Organization and Discussion program, known as ‘PODs,’ which were run from Jan. 1, 2005, through March 31, 2011, as well as other speaker programs that were run from Jan. 1, 2004, through Feb. 4, 2011,” the Department of Justice noted.

Various states will share in the $39 million settlement, while the whistleblower who first alerted the Department of Justice to Daiichi Sankyo’s activities will receive $6.1 million.

Meanwhile, patients have filed lawsuits against Daiichi Sankyo alleging they were harmed by the use of Benicar, with one lawsuit claiming a patient died due to side effects related to the drug. A motion to consolidate the lawsuits has been filed with the US Judicial Panel on Multidistrict Litigation, but no decision has been made. That motion requested that 15 federal lawsuits and 30 state lawsuits be consolidated for pretrial proceedings.

The lawsuits claim Benicar was unreasonably dangerous, resulting in the development of sprue-like enteropathy, a condition marked by severe diarrhea and weight loss. According to one lawsuit (Dirksen v. Daiichi Sankyo), Benicar was only tested for a three-month period, even though it is frequently prescribed for at least double that time.

Benicar, known generically as olmesartan, is prescribed to treat high blood pressure. Some plaintiffs allege the side effects they suffered were serious enough to require hospitalization and, in some cases, treatment for renal failure.

The government’s lawsuit was U.S. ex rel. Fragoules v. Daiichi Sankyo, Inc., Civil Action NO. 10-10420 (D. Mass.).