Benicar Side Effects Caused Kidney Failure and Other Gastrointestinal Injury, Lawsuit Alleges

According to allegations raised in a product liability lawsuits filed this week against Daiichi Sankyo and Forest Laboratories, side effects of Benicar caused a Mississippi woman to suffer severe gastrointestinal injuries, including chronic diarrhea, sprue-like enteropathy and kidney failure.

The complaint (PDF) was filed by Loisteen Williams on December 7, in the federal multidistrict litigation (MDL) established for all Benicar lawsuits pending throughout the federal court system, which allege that the makers of the popular hypertension drug failed to adequately warn about the risk of gastrointestinal problems.

Williams is a 53 year old resident of Brooksville, Mississippi, and indicates that she began taking Benicar for treatment of high blood pressure in 2007. As a result of the use of Benicar, Williams states that one of the serious gastrointestinal injuries she developed was kidney failure, which can develop from long-term diarrhea, malnutrition, dehydration and other symptoms of sprue-like enteropthy linked to Benicar side effects.

When the kidneys fail, they are unable to take the waste products out of your blood. This can cause dangerous levels of waste to build up in the blood and can be fatal. It can be reversible, but can also result in the need for regular dialysis treatments.

William’s complaint will be consolidated with more than 1,000 similar lawsuits over Benicar side effects pending before U.S. District Judge Robert Kugler in the District of New Jersey, as part of a federal MDL.

Each of the lawsuits raise similar claims, indicating that Daiichi Sankyo and Forest Laboratories knew or should have known about the risks associated with Benicar, yet withheld information from consumers and the medical community. As a result, symptoms of gastrointestinal injury on Benicar often went undiagnosed or misdiagnosed, since the problems may surface months or years after first use of the medication.

As a result of chronic diarrhea and other problems, which typically result in repeated hospitalizations over periods of several years, Williams and many other plaintiffs involved in the litigation 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.

Benicar Sprue-Like Enteropathy

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.

As part of the coordinated pretrial proceedings in the Benicar MDL before Judge Kugler, 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 injury 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.