Home Benicar Lawsuits

Benicar Lawsuits

People who took Benicar filed lawsuits claiming they were unaware it could cause serious gastrointestinal problems. In 2017, Benicar manufacturer Daiichi Sankyo and co-promoter Forest Laboratories agreed to a $300 million settlement to compensate nearly 2,000 patients for their injuries. Benicar has not been taken off the market.

Last Modified: March 21, 2024
Fact Checked
Fact-Checked

Editors carefully fact-check all Drugwatch.com content for accuracy and quality.

Drugwatch.com has a stringent fact-checking process. It starts with our strict sourcing guidelines.

We only gather information from credible sources. This includes peer-reviewed medical journals, reputable media outlets, government reports, court records and interviews with qualified experts.

Why Trust DrugWatch?

Drugwatch.com has been empowering patients for more than a decade

Drugwatch.com has provided reliable, trusted information about medications, medical devices and general health since 2008. We’ve also connected thousands of people injured by drugs and medical devices with top-ranked national law firms to take action against negligent corporations.

Our team includes experienced medical writers, award-winning journalists, researchers and certified medical and legal experts. Drugwatch.com is HONCode (Health On the Net Foundation) certified. This means the high-quality information we provide comes from credible sources, such as peer-reviewed medical journals and expert interviews.

The information on Drugwatch.com has been medically and legally reviewed by more than 30 expert contributors, including doctors, pharmacists, lawyers, patient advocates and other health care professionals. Our writers are members of professional associations, including American Medical Writers Association, American Bar Association, The Alliance of Professional Health Advocates and International Society for Medical Publication Professionals.

About Drugwatch.com

  • Assisting patients and their families since 2008.
  • Helped more than 12,000 people find legal help.
  • A+ rating from the Better Business Bureau.
  • 5-star reviewed medical and legal information site.
Learn More About Us

Testimonials

"Drugwatch opened my eyes to the realities of big pharmacy. Having a family member with major depression and anxiety, I was looking for information on her medications. I found information that was very helpful, that her psychiatrist never told her."
Marianne Zahren Patient’s Family Member
  • Google Business Rating
  • BBB A+ Rating Logo

People filed the first federal Benicar lawsuits in 2014 after the Food and Drug Administration warned that drugs containing olmesartan could cause sprue-like enteropathy, a disease known to cause severe diarrhea and weight loss.

On Sept. 23, 2019, Judge Robert B. Kugler entered an order to establish a qualified settlement fund. As of Oct. 15, 2019, a total of 111 Benicar lawsuits remained in a multidistrict litigation in New Jersey. None remained by November 2022.

Other drugs included in MDL No. 2606 were Benicar HCT, Azor and Tribenzor. According to the master complaint, plaintiffs alleged defendants knew or should have known that drugs containing olmesartan could cause side effects known as olmesartan associated enteropathy (“OAE”).

OAE includes conditions such as villous atrophy, inflammation, nausea, vomiting, chronic diarrhea, malnutrition, dehydration, atrophy, kidney failure, weight loss, abdominal and gastrointestinal pain, colitis and gastritis. Some plaintiffs died from their injuries.

Gastrointestinal injuries Alleged

George Williams was one of the first plaintiffs to file a suit against Daiichi Sankyo over injuries suffered from Benicar. After beginning treatment with Benicar, Williams was hospitalized for more than 100 days over a span of four years.

Not knowing that Benicar was the culprit, Williams continued to use the drug. His condition became so severe he eventually had to be fed through a tube.

In his lawsuit filed in New Jersey Superior Court, Williams claimed olmesartan, the active ingredient in Benicar, caused severe, chronic diarrhea that also contributed to a compression fracture in his back and his developing cataracts in both eyes.

Colon Inflammation

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

These injuries included sprue-like enteropathy and lymphocytic colitis, a condition characterized by chronic, watery, non-bloody diarrhea.

Others alleged the drugs caused them to develop microscopic colitis, which is inflammation of the colon or large intestine resulting in persistent watery diarrhea and cramping.

Lawsuits also mentioned collagenous colitis, which is inflammatory bowel disease affecting the colon. The condition also features chronic, watery diarrhea without bleeding.

Benicar Pill
Benicar Pill
Azor Pill
Azor Pill
Tribenzor Pill
Tribenzor Pill

Misleading Marketing Claims

In 2015, federal judges consolidated 15 Benicar lawsuits against Daiichi and Forest Labs into a single legal action called a multidistrict litigation (MDL).

New Jersey courthouse
EXPAND
As of September 2018, more than 1,900 Benicar lawsuits remained pending in the U.S. District Court for the District of New Jersey.

The MDL grew as patients filed hundreds of additional lawsuits.

As of April 2019, despite the settlement, there were 1,025 lawsuits still listed as pending in the federal MDL out of more than 2,300 that had been filed.

There were roughly 70 other cases combined in New Jersey state court.

Accusations in Benicar Lawsuits

According to a master federal 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 fact that the U.S. Food and Drug Administration warned Sankyo in 2006 that 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 cease making claims that Benicar is superior to other drugs.

Did You Know?
The lawsuits said that if the companies had not misled doctors and consumers, they would not have taken Benicar and would not have been injured.

The agency directed corrective measures, including discontinuing use of approximately 50 promotional pieces dated all the way to 2002. The companies were also told to provide corrective messages to physicians who had received the materials.



Kickback Settlement Noted

Lawsuits 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. The fees were part of Daiichi’s Physician Organization and Discussion programs.

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

Most Opted for Settlement

Under the terms of the 2017 settlement, Daiichi Sankyo could have walked away from the entire deal if at least 95 percent of the plaintiffs did not agree to participate.

All but five plaintiffs opted into the settlement as of August 2018, meaning the deal is moving forward even as other litigation continues.

A portion of the money will pay attorney fees and expenses of the plaintiffs’ legal team and for a claims administrator to oversee payments.

Daiichi Denied Wrongdoing

Despite agreeing to the multimillion-dollar payout, Daiichi Sankyo denied any liability for the injuries plaintiffs suffered and said “this litigation is 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.”



Please seek the advice of a medical professional before making health care decisions.