Benicar Lawsuits

Lawsuits regarding the blood pressure medication Benicar claimed that the manufacturer, Daiichi Sankyo, failed to warn of the risks of sprue-like enteropathy. This is a disease known to cause severe diarrhea and weight loss.

People filed the first federal Benicar lawsuits in 2014 after the Food and Drug Administration warned that drugs containing olmesartan, the active ingredient in Benicar, could cause sprue-like enteropathy. These lawsuits were consolidated into multidistrict litigation (MDL), a method of expediting trials by handling several similar cases under one court.

Other drugs included in this MDL, No. 2606, were Benicar HCT, Azor and Tribenzor. Drugwatch’s partners are not currently taking these cases.

The Benicar lawsuits were handled in New Jersey through an MDL, but as of December 2024, there is no activity in this litigation. Most cases have been resolved by settlements or dismissal.

On Sept. 23, 2019, Judge Robert B. Kugler entered an order to establish a qualified settlement fund. This is a court-ordered holding account for the defendant’s settlement funds. Once the litigation is resolved, a third party will distribute this money to the plaintiffs.

This gives both parties more time to settle the details and submit all paperwork. It also allows the plaintiffs to claim a tax deduction on the settlement amount before they’ve been paid.

When a judge orders an established qualified settlement, they dismiss the defendant with prejudice. This means the case cannot be reopened unless the defendant appeals to a higher court.

The MDL is now closed.

People filed Benicar lawsuits because they claimed the drug caused serious gastrointestinal problems, and Daiichi Sankyo never warned about the risk. Lawsuits also alleged defective design, negligence and fraud.

According to this MDL’s federal master complaint, which is a document that consolidates common allegations, plaintiffs alleged defendants knew or should have known that drugs containing olmesartan could cause a side effect known as olmesartan-associated enteropathy (“OAE”). OAE is the name for sprue-like enteropathy that was caused by olmesartan use.

Accusations in Benicar Lawsuits

According to the master complaint, Daiichi spent $1 billion to promote Benicar and Benicar HCT between 2002 and 2008. The marketing materials omitted serious risks, and the drugs became top sellers.

Lawsuits cited the U.S. Food and Drug Administration’s 2006 warning to Sankyo, which stated its promotional materials violated federal regulations. At the time, Sankyo had not yet merged with Daiichi.

According to the lawsuits, the FDA ordered Daiichi Sankyo and Forest to stop making claims that Benicar is superior to other drugs.

Among the Agency’s corrective measures was discontinuing the use of approximately 50 promotional pieces dating back to 2002. The FDA also told the companies to provide corrective messages to physicians who had received the materials.

Thousands of patients who filed lawsuits over Benicar, Benicar HCT, Tribenzor or Azor claimed the drugs caused gastrointestinal injuries.

These injuries included intestinal diseases such as sprue-like enteropathy and microscopic colitis. Colitis is characterized by cramping and chronic, watery, non-bloody diarrhea due to colon or large intestine inflammation.

Microscopic colitis and sprue-like enteropathy have many overlapping symptoms, and both conditions can occur simultaneously.

Villous atrophy, another alleged injury, is when the walls of the small intestines erode, making it difficult to absorb nutrients from food.

Other plaintiffs alleged the drugs caused them to develop collagenous colitis and lymphocytic colitis, which are subcategories of microscopic colitis.

In the 2017 Benicar settlement, Daiichi Sankyo required at least 95 percent of the plaintiffs to participate. Initially, all but five plaintiffs opted into the settlement, and the funding threshold was met.

Despite agreeing to the multimillion-dollar payout, Daiichi Sankyo denied liability for the plaintiffs’ injuries, saying, “The claims made in this litigation are without merit.”

“Daiichi Sankyo is committed to the health and safety of all patients taking our medications,” Executive Chairman and President Glenn Gormley said in a statement.

“We believe a settlement is in the best interest of all and will allow us to continue our focus on bringing to market innovative medicines that help people live healthy and meaningful lives.”

Kickback Settlement

Older lawsuits from 2014 described a federal whistleblower case that resulted in a $39 million payment by Daiichi Sankyo to Medicaid programs. The U.S. Department of Justice accused Daiichi of paying physicians’ speaker fees at speaker programs such as Daiichi’s Physician Organization and Discussion programs.

Speaker programs are company-sponsored events in which health care providers speak to other providers about topics such as drugs, medical devices or diseases.

Though intended to be educational, these programs can be grounds for bribery. Here, the company allegedly offered lucrative speaker fees to physicians who met its sales target by prescribing a sufficient number of Daiichi Sankyo products, including Benicar.

As part of the settlement, Daiichi signed a corporate integrity agreement. The agreement required the company to implement reforms for five years.

Editor Lindsay Donaldson contributed to this article.