Benicar Diarrhea Cases in MDL Continue to Mount as Discovery Gets Underway

As a growing number of Benicar lawsuits continue to be filed throughout the federal court system by individuals who have suffered chronic diarrhea and other gastrointestinal problems following use of the popular blood pressure drug, the U.S. District Judge presiding over the cases has approved a plaintiffs fact sheet (PFS) that will require certain information to be provided about each claim.

Since April, all federal product liability lawsuits filed over side effects of Benicar have been centralized before U.S. District Judge Robert Kugler in the District of New Jersey for coordinated discovery and pretrial proceedings as part of an MDL, or multidistrict litigation.

Each of the complaints raise similar allegations that Daiichi Sankyo and Forest Laboratories failed to adequately warn consumers and the medical community about the risk that users may develop sprue-like enteropathy following use of Benicar, causing severe diarrhea and sudden weight loss that may surface months or even years after first use of the medication.

At the time the MDL was established, there approximately 35 Benicar diarrhea cases pending in 23 different U.S. District Courts. However, according to recent case records, the number has skyrocketed over the past 90 days.

In a joint report (PDF) filed by the parties before a status conference on Tuesday, the defendants indicated that they have been served with 205 complaints. However, the drug makers indicate that the court clerk said late last month that 500 cases have already been filed.

Following the status conference, Judge Kugler entered an order (PDF) approving a Plaintiff Fact Sheet (PFS) that requires each individual who has filed a lawsuit to answer certain questions under oath as the first step in the discovery process.

In the 38 page questionnaire, plaintiffs must provide information regarding the specific Benicar drug they used, dates of prescriptions, when they were diagnosed with sprue-like enteropathy or a related condition and the names of treating physicians. Plaintiffs are also required to provide certain personal information, family history and other details relevant to their claim.

Benicar Litigation Status

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. Although the medication had been on the market for more than ten years, this was the first notice provided to consumers about the potenital link between Benicar and diarrhea symptoms.

Based on adverse event data that has been available to the drug makers for years, FDA officials concluded that there is “clear evidence” that Benicar may cause users to suffer chronic diarrhea, abdominal pain, weight loss and other gastrointestinal symptoms, which typically resolve when the medication is no longer used. However, after experiencing these problems over long-periods of time, users may face a risk of suffering villous atrophy from Benicar, which results in permanent gastrointestinal problems and reduced digestive capability, leading to chronic malnourishment and dehydration.

Plaintiffs in the lawsuits allege that Daiichi Sankyo and Forest Laboratories knew or should have known about the link between Benicar and diarrhea problems for years, yet placed their desire for profits before consumers safety by withholding the information.

In addition to cases pending in the federal 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.