Japanese drugmaker Daiichi Sankyo and Forest Laboratories agreed to pay $300 million to settle roughly 2,300 state and federal cases involving claims that the hypertension medication Benicar caused unexpected side effects, mainly severe gastrointestinal problems. A U.S. subsidiary of Daiichi Sankyo actually manufactured Benicar while Forest Laboratories marketed it.

On August 1st, lawyers for both sides signed the agreement which settles the more than 2,000 cases now pending on the federal docket in the U.S. District Court for the District of New Jersey, an additional 100 cases pending in multicounty litigation in Atlantic County, New Jersey, and will also resolve all suits related to the high blood pressure drugs Benicar, Benicar HCT, Azor, and Tribenzor.

Symptoms and Settlement Requirements

Plaintiffs suing the companies claimed that Benicar was defectively designed and that they were not adequately warned of numerous harmful side effects, citing severe diarrhea, vomiting, abdominal pain, kidney failure, stomach issues, and excessive weight loss in the lawsuit.

The settlement requires at least 95 percent of all claimants to opt in, and they must also provide documentation to be eligible for compensation. The financial payout to each plaintiff will depend on the extent of their injury and how long they were hospitalized.

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By settling, Daiichi Sankyo did not admit liability and continued to defend its drug.

“Daiichi Sankyo is committed to the health and safety of all patients taking our medications,” said executive chairman Glenn Gormley 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.”

Daiichi Sankyo also said the $300 million settlement would not have any impact on its financial position because most of the settlement money would likely come from insurance companies.

Lawyers for plaintiffs were pleased with the outcome. Attorney Adam Slater, who helped negotiate the settlement, told Bloomberg that the accord was reached as the the judge was preparing to schedule the cases for trial.

“This is a good settlement for thousands of people who suffered serious gastrointestinal problems because of this drug,’’ Slater said.

Studies Link Benicar to Gastrointestinal Injuries

Benicar (olmesartan medoxomil) is an angiotensin II receptor antagonist used to treat high blood pressure by keeping blood vessels from constricting, and was first approved by the U.S. Food and Drug Administration for treatment of hypertension in 2002.

Over the next decade, however, physicians observed more and more cases of chronic diarrhea and sprue-like enteropathy in patients taking Benicar. In one Mayo Clinic study from 2012, 14 of 22 patients taking olmesartan required hospitalization for chronic diarrhea and severe weight loss. All of the patients recovered after they stopped taking the drug.

As other studies also began uncovering a possible link between Benicar and an increased risk of severe intestinal malabsorption resulting in severe diarrhea, the Food and Drug Administration began its own investigation.

By 2013, the FDA concluded that the drug can indeed cause intestinal issues and subsequently required label changes to alert consumers of the risks.

“The U.S. Food and Drug Administration (FDA) is warning that the blood pressure drug olmesartan medoxomil (marketed as Benicar, Benicar HCT, Azor, Tribenzor, and generics) can cause intestinal problems known as sprue-like enteropathy,” it announced in a July, 2013 statement.

Plaintiffs claimed that the companies knew about risks before the 2013 FDA warning but knowingly hid the information and misrepresented the drug’s safety to consumers.

Benicar Settlement Aided by Focus on Causation

According to the New Jersey Law Journal, the settlement came about due to the early focus on whether the drug actually caused injuries. Plaintiff attorney Slater told the news outlet that  U.S. District Judge Kugler and U.S. Magistrate Judge Joel Schneider wanted to have a hearing on causation so plaintiffs would not need to prove it in later trials.

“This settlement happened because of Judge Kugler and Judge Schneider, who really masterfully managed this massive litigation. They really kept everyone’s feet to the fire,” Slater said.