The Benicar enteropathy lawsuit settlement resulted in a **$358 million resolution** for over 2,300 plaintiffs who alleged the blood pressure medication caused severe intestinal damage known as sprue-like enteropathy. Pharmaceutical manufacturer Daiichi Sankyo initially proposed a $300 million settlement in August 2017, which increased after at least 97 percent of claimants—approximately 2,230 individuals—opted into the agreement. The settlement received court approval in September 2017, with the majority of cases resolved by June 2018 and all remaining claims concluded by 2022.
For context, a plaintiff who took Benicar for several years and developed chronic diarrhea, lost significant weight, and required hospitalization would have been eligible for compensation through this settlement. Individual payouts varied based on injury severity, duration of suffering, and documented medical costs, though specific average amounts were never publicly disclosed. A portion of the total fund also covered plaintiffs’ attorney fees, litigation expenses, and Claims Administrator costs. This article examines the medical condition at the heart of the litigation, the timeline from FDA warning to final resolution, how settlement amounts were determined, and what the closed status of this MDL means for anyone who may have experienced similar harm but missed the filing window.
Table of Contents
- What Medical Condition Triggered the Benicar Enteropathy Lawsuits?
- How the $358 Million Settlement Was Reached
- Why Individual Payouts Varied Significantly
- Timeline From FDA Warning to Case Resolution
- What Happens If You Experienced Symptoms But Never Filed
- Comparing Benicar to Other Pharmaceutical Settlements
- Current Status and Lessons From the Litigation
What Medical Condition Triggered the Benicar Enteropathy Lawsuits?
The central allegation in the Benicar litigation was that olmesartan—the drug’s active ingredient—caused a condition called **sprue-like enteropathy**, also referred to as olmesartan-associated enteropathy (OAE). This intestinal disorder mimics celiac disease but occurs in patients without gluten sensitivity. Affected individuals experienced chronic, severe diarrhea that persisted for months or years, often accompanied by dramatic weight loss and malnutrition that required hospitalization. In July 2013, the FDA issued a formal warning about this connection, noting that patients taking olmesartan-based medications like Benicar could develop these debilitating gastrointestinal symptoms.
The agency’s alert came after researchers documented cases where patients improved significantly—sometimes within days—after discontinuing the medication. Many plaintiffs later testified that their doctors initially misdiagnosed them with celiac disease or irritable bowel syndrome, subjecting them to unnecessary dietary restrictions and treatments while the actual culprit continued doing damage. The medical evidence presented during litigation showed that sprue-like enteropathy caused villous atrophy, meaning the finger-like projections in the small intestine that absorb nutrients became flattened and dysfunctional. Unlike temporary gastrointestinal side effects common with many medications, this condition caused sustained harm that, for some patients, led to long-term digestive complications even after stopping Benicar.
How the $358 Million Settlement Was Reached
Daiichi Sankyo announced the initial $300 million settlement agreement on August 1, 2017, after years of consolidated litigation in federal Multi-District Litigation proceedings. The company faced over 2,300 individual lawsuits that had been centralized for pretrial proceedings. Rather than face potentially years of additional trials and the uncertainty of jury verdicts, both sides negotiated a global resolution. The settlement figure increased to $358 million after the opt-in period closed and at least 97 percent of eligible claimants agreed to participate.
This high participation rate—2,230 claimants—strengthened the finality of the resolution for the manufacturer while ensuring widespread compensation for plaintiffs. Settlement approval came in September 2017, and most claimants received their distributions by June 2018. However, reaching a settlement did not constitute an admission of wrongdoing by Daiichi Sankyo. Like most pharmaceutical settlements of this nature, the company resolved the claims without acknowledging that Benicar caused the alleged injuries or that it failed to adequately warn patients and physicians. Plaintiffs who found this lack of accountability troubling could have opted out to pursue individual litigation, though doing so meant foregoing guaranteed compensation for the uncertainty of trial.
Why Individual Payouts Varied Significantly
The settlement established a claims process where compensation depended on several individualized factors rather than equal distribution among all plaintiffs. Claimants who suffered more severe injuries, endured longer periods of illness before diagnosis, or accumulated higher medical expenses received larger allocations from the fund. This tiered approach is standard in mass tort settlements where injury severity ranges dramatically across the plaintiff population. For example, a plaintiff who experienced chronic diarrhea for six months before their doctor identified Benicar as the cause would likely receive less than someone who suffered for three years, was hospitalized multiple times, and developed lasting malnutrition-related health problems.
Documentation mattered enormously—plaintiffs with comprehensive medical records, hospitalization evidence, and clear timelines connecting their symptoms to Benicar use were positioned for higher payouts. A significant limitation for many claimants was that attorney fees, litigation costs, and Claims Administrator expenses came out of the total settlement fund before distribution. While contingency fee arrangements mean plaintiffs pay nothing upfront, these deductions—often ranging from 25 to 40 percent depending on the firm—substantially reduced net compensation. Someone entitled to a $100,000 gross award might receive $60,000 or less after these subtractions.
Timeline From FDA Warning to Case Resolution
The path from initial FDA warning to complete litigation closure spanned nearly a decade. When the FDA issued its July 2013 safety communication about olmesartan and sprue-like enteropathy, it marked the first official government acknowledgment of the risk. Litigation began in earnest in 2014 as affected patients, now armed with regulatory confirmation of the drug-disease connection, filed lawsuits against Daiichi Sankyo. The cases consolidated into MDL proceedings allowed for coordinated discovery, expert witness development, and bellwether trials that would inform both sides about likely outcomes.
This process—though time-consuming—proved more efficient than litigating thousands of similar cases independently across different federal courts. By 2017, sufficient evidence had developed for meaningful settlement negotiations. After the September 2017 approval and June 2018 distribution to most claimants, a small number of cases remained in various procedural stages. These were resolved by 2022, at which point the MDL officially closed. As of 2025 and 2026, no active Benicar enteropathy litigation exists, and the window for new claims has effectively closed due to statutes of limitations in all relevant jurisdictions.
What Happens If You Experienced Symptoms But Never Filed
The closed status of the Benicar MDL presents a significant barrier for anyone who experienced sprue-like enteropathy but never joined the litigation. Statutes of limitations—which vary by state but typically range from two to four years from the date of injury or discovery—have now expired for virtually all potential claimants. The settlement process required opt-in by specific deadlines, and those deadlines have long passed. If you took Benicar, experienced severe gastrointestinal symptoms, and never connected your condition to the medication, your legal options are now extremely limited.
Some states have discovery rules that could theoretically extend filing deadlines if you only recently learned that Benicar caused your condition, but successfully arguing this after a decade of public litigation and FDA warnings would be challenging. An attorney consultation could clarify whether any narrow exceptions might apply to your specific circumstances. This situation illustrates a broader limitation of mass tort litigation: compensation depends not only on suffering harm but on learning about potential legal claims within applicable time windows. Patients whose doctors never mentioned the Benicar connection, or who attributed their symptoms to other causes, may have missed their opportunity for legal recourse through no fault of their own.
Comparing Benicar to Other Pharmaceutical Settlements
The $358 million Benicar settlement, while substantial, falls in the mid-range for pharmaceutical mass tort resolutions. By comparison, Vioxx settlements totaled approximately $4.85 billion, and various opioid manufacturer settlements have reached tens of billions. However, the Benicar litigation involved a smaller plaintiff population with a more specific type of injury, making direct comparisons imprecise.
What distinguished the Benicar litigation was the relatively clear medical causation. Unlike some pharmaceutical cases where the drug-injury connection remains scientifically contested, the FDA’s 2013 warning explicitly identified olmesartan as causing sprue-like enteropathy. This regulatory backing strengthened plaintiffs’ cases and likely contributed to Daiichi Sankyo’s decision to settle rather than face ongoing trial risks.
Current Status and Lessons From the Litigation
The Benicar enteropathy MDL stands as a concluded chapter in pharmaceutical litigation with no ongoing legal activity. For patients currently taking Benicar or its generic equivalents, the litigation’s legacy is an updated drug label that now includes warnings about sprue-like enteropathy—information that was allegedly inadequate or missing when plaintiffs first developed their injuries.
The case reinforced the importance of post-market surveillance and the role that patient-reported adverse events play in identifying drug risks that clinical trials may miss. Sprue-like enteropathy from olmesartan was not identified until the medication had been on the market for years and thousands of patients had already been affected. For individuals taking any long-term medication, the Benicar litigation serves as a reminder to report persistent unexplained symptoms to both their physicians and the FDA’s adverse event reporting system.
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