Benicar Enteropathy is Not Rare and More Lawsuits Coming: Plaintiffs

As the debate over whether to centralize all Benicar lawsuits pending in the federal court system continues, plaintiffs in support of the consolidated pretrial proceedings are disputing recent claims by the drug maker that suggested reports of enteropathy from Benicar side effects are rare, suggesting that a large number of complaints will soon be filed by individuals who have suffered chronic diarrhea and other gastrointestinal problems.

A motion is currently pending before the U.S. Judicial Panel on Multidistrict Litigation, which seeks to consolidate all Benicar enteropathy cases filed throughout the federal court system against Daiichi Sankyo and Forest Laboratories, centralizing the lawsuits before one judge for coordinated discovery and pretrial handling.

The request was originally filed in late December by Annette Johnson, who is one of several dozen individuals who have filed nearly identical complaints in courts nationwide, alleging that the drug makers failed to adequately warn about the link between Benicar and sprue-like enteropathy, which is a gastrointestinal disorder associated with chronic diarrhea, weight loss, malnutrition and other debilitating symptoms that may surface months or even years after starting to use the blood pressure drug.

Johnson and other plaintiffs argue that centralizing the claims before one judge as part of a federal multidistrict litigation (MDL) is necessary to avoid duplicative discovery into common issues in the cases, eliminate conflicting pretrial rulings and to serve the convenience of the parties, witnesses and the courts.

Daiichi Sankyo and Forest Laboratories filed a brief in opposition to the creation of a Benicar MDL last week, indicating that the centralized proceedings are not necessary since the litigation is too small, involving only a few law firms nationwide. The drug makers also indicated that reports of enteropathy are rare, suggesting that the informal consolidation was more appropriate.

In a reply brief (PDF) filed on January 30, Johnson disputes the assertions made by the drug makers, indicating that at least 24 Benicar lawsuits have been filed in the federal court system, involving 16 different plaintiffs’ law firms. Those cases are currently spread out among 13 different U.S. District Courts nationwide.

Johnson also describes the drug makers’ assertion that reports of Benicar-induced enteropathy are rare as “misguided”.

“The reason the condition has until now been reported as rare is because the association between Benicar and sprue-like enteropathy was only recently discovered,” according to the brief filed by Johnson.

The first information about the link between Benicar and enteropathy was not published until 2012, when the Mayo Clinic described cases similar to celiac disease among users of the blood pressure drug, which resolved when the medication was no longer used.

“The Mayo Clinic study reported 22 patients suffering from [Benicar]-induced gastrointestinal injuries. By late 2012, one of the study’s authors, Margo Herman, M.D., had identified a total of 60 probable cases of severe sprue-like enteropathy,” the brief notes. “Dr. Herman believes ‘it is the tip of the iceberg.’”

A number of other researchers have since identified hundreds of cases of sprue-like enteropathy linked to Benicar use, Johnson argues. This suggests that the litigation will continue to grow as more and more claims are filed by Benicar enteropathy lawyers who are continuing to review claims.

Benicar Sprue-Like Enteropathy Risks

Following the Mayo Clinic study, the FDA required Daiichi Sankyo and Forest Laboratories to update the Benicar warning label in July 2013, providing information to the medical community for the first time that users of the blood pressure drug may face an increased risk of sprue-like enteropathy.

The FDA warnings indicated that there is “clear evidence” that use of the medication may cause users to suffer chronic diarrhea, abdominal pain, weight loss and other symptoms, which may surface months or even years after the medication is started.

Benicar (olmesartan medoxomil) is part of a family of Daiichi Sankyo hypertension drugs, which also includes Benicar HCT, Azor and Tribenzor. All of the blood pressure drugs include the active ingredient olmesartan, which has been linked to the development sprue-like enteropathy.

Although the medication has been on the market for more than 10 years, information about the risk Benicar diarrhea problems were not recognized within the medical community until the FDA warnings, resulting in many former users experiencing complications from the medication for years.

In many cases, users have repeatedly been hospitalizations because doctors were unaware that the symptoms may be caused by their blood pressure medication. The Benicar problems have often been misdiagnosed as Celiac disease or unclassified sprue, resulting in continued use of the medication, which could leave users with long-term intestinal damage.

Although the diarrhea symptoms associated with sprue-like enteropathy typically resolve when the medication is no longer used, the problems can cause permanent damage to the intestines, known as villous atrophy from Benicar.