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Daiichi Sankyo and Forrest Laboratories face a new product liability lawsuit that alleges a Texas woman suffered diverticulitis from Benicar side effects, as well as chronic diarrhea and symptoms of sprue-like enteropathy, which been linked to the hypertension drug in hundreds of other lawsuits.
The complaint (PDF) was filed by Linda Weatherford in the U.S. District Court for the District of New Jersey on November 11, alleging that the drug makers failed to provide adequate warnings about the risk that Benicar may cause diverticulitis and other gastrointestinal problems.
Weatherford indicates that she was prescribed Benicar in August 2005, and began to suffer chronic and severe diarrhea, which was not identified on the warning label as a potential side effect of the drug until recently. The complaint also indicates that she suffered diverticulitis from Benicar, which is a condition that occurs when pouches develop in the lining of the digestive tract and then become infected.
Diverticulitis can cause severe abdominal pain, fever, and nausea. In mild cases, it can be treated with antibiotics and changes in diet. Although diarrhea problems associated with Benicar use have mostly been alleviated when the person stops taking the drug, according to health researchers, in severe cases the repeated strain on the digestive tract may leave individuals with long-term problems.
Benicar Litigation Status
Weatherford’s complaint will be consolidated with over 1,000 similar Benicar lawsuits filed throughout the federal court system, which are centralized before U.S. District Judge Robert Kugler in the District of New Jersey, as part of a federal MDL or multidistrict litigation.
All of the complaints raise similar allegations that Daiichi Sankyo and Forest Laboratories failed to adequately warn consumers and the medical community about the potential risks associated with Benicar, which have often gone undiagnosed or misdiagnosed due to the drug makers’ failure to warn that symptoms of sprue-like enteropathy may surface months or even years after first use of the medication.
As a result of chronic diarrhea that has resulted in repeated hospitalizations over periods of several years, many of the plaintiffs also indicate that they have been left with long-term gastrointestinal damage known as villious atrophy from Benicar, which can leave them suffering from chronic malnutrition and dehydration.
The Benicar litigation has emerged since the FDA required Daiichi Sankyo and Forest to update the warning labels for the popular family of blood pressure drugs in July 2013. At that time, Daiichi Sankyo and Forest Laboratories were required to update the Benicar warning label to alert users about the risk of chronic diarrhea and sprue-like enteropathy.
Based on adverse event data that has been available to the drug makers for years, FDA officials indicated at that time that they believe there is “clear evidence” that Benicar causes some users to suffer chronic diarrhea, abdominal pain, weight loss and other gastrointestinal symptoms, which typically resolve when the medication is no longer used.
In addition to cases pending in the federal Benicar MDL, there are also a growing number of complaints filed at the state level in New Jersey, where the drug maker is based. According to a request filed on May 26, which seeks to establish similar centralized management for Benicar cases in New Jersey, there were at least 59 cases pending in the state court system.
As part of the coordinated pretrial proceedings, the parties will complete discovery into issues that apply to all claims. It is then expected that a small group of “bellwether” cases will be selected to go through case-specific discovery in preparation for a series of early trial dates, which will be designed to help the parties gauge how juries may respond to certain evidence and testimony that is likely to be repeated throughout the litigation.
If the drug makers fail to reach Benicar settlements or otherwise resolve the litigation after the bellwether trials, hundreds of individual cases may be remanded back to U.S. District Courts nationwide for separate trial dates to determine whether a failure to warn about the Benicar risks caused the plaintiff’s injury.