The U.S. Food and Drug Administration (FDA) is warning the public that the blood pressure drug olmesartan medoxomil—sold under the brand names Benicar, Benicar HCT, Azor, and Tribenzor—might cause an intestinal problem called “sprue-like enteropathy.” It was originally patented by the Japanese pharmaceutical company Daiichi Sankyo.
Benicar is a popular drug. In 2010, more than six million Benicar prescriptions worth more than $550 million were filled. In 2012, 10.9 million Benicar prescriptions were dispensed to 1.9 million users.
The FDA believes that Benicar might cause an intestinal problem known as sprue-like enteropathy, a condition that is similar in character to Celiac disease. Symptoms include:
- Severe diarrhea
- Chronic diarrhea (symptoms that don’t stop over time)
- Substantial weight loss
- Villous atrophy (erosion of the villi, the hair-like lining of the small intestines that absorb food into the body)
At this time only a handful of Benicar lawsuits have been filed against Daiichi Sankyo or other manufacturers. Although, millions of people took Benicar so it’s possible that many people suffered adverse side effects and will file suits in the future.
No mass Benicar settlement has been announced at this time, likely because so few lawsuits have been filed to date. If more plaintiffs come forward, then a settlement might occur.
Benicar Class Action
There are no known Benicar class action lawsuits at this date. Even if there were, class actions often aren’t the best way forward for someone injured by drugs like Benicar. In a class action, the plaintiffs benefit from streamlined pretrial proceedings, but if they are successful, they’ll accept a cash award that’s distributed equally. In personal injury cases such as those filed by Benicar users, the damages might vary among plaintiffs, so a class award might over- or under-compensate some plaintiffs. Individual lawsuits allow plaintiffs to receive compensation commensurate with the damages they’ve suffered, and sometimes if enough plaintiffs are injured they can join a multidistrict litigation (MDL) or a state-court equivalent that takes advantage of the benefits offered by class actions but allows plaintiffs to retain their individual cases for compensation purposes.
It is difficult to predict the exact amount of compensation that someone injured by Benicar might receive in a lawsuit. The biggest factors are the extent of the plaintiff’s injuries, the amount of work the plaintiff might have missed, and whether the plaintiff was married. A lawsuit can result in two types of compensation: economic and non-economic damages. Economic damages are those that the plaintiff can easily quantify at a trial, such as medical expenses and lost earnings. Non-economic damages can’t be so easily established and can often require expert testimony. Examples include pain and suffering and loss of spousal companionship.
One FDA Study Found a Clear Association Between Benicar and Sprue-Like Enteropathy
In a July 2013 drug safety communication, the FDA based its conclusion that Benicar might cause sprue-like enteropathy after investigating 23 adverse event reports of patients who had been diagnosed with the condition after taking the drug. The agency found that symptoms of sprue-like enteropathy can develop months or years after Benicar use begins. Some of the 23 users required hospitalization, but when they discontinued using the drug all patients reported improvement. The FDA believes that delayed hypersensitivity to the drug in the intestines or a cellular immune response are the possible reasons for the long latency period between initial use of the drug and development of symptoms of sprue-like enteropathy.
A year earlier, researchers at the Mayo Clinic published a case series identifying 22 other people who took Benicar and developed sprue-like enteropathy. Of the 18 patients who had follow-up biopsies of their intestines after discontinuing Benicar treatment, all of them showed signs of improvement.
How Can a Lawsuit Help Me?
If you or a loved one took Benicar and you believe it caused sprue-like enteropathy, a lawsuit can help you hold the manufacturer accountable. The amount of compensation from a Benicar lawsuit can include damages for full medical expenses, lost earnings, pain and suffering, and other damages. The process begins by talking about what happened with a Benicar lawyer from the Rottenstein Law Group. If you have any questions about your situation, call 1 (888) 976-8529 or click on this link.