Benicar Lawsuits Filed Throughout Federal Court System Top 1,000 Cases

The number of Benicar lawsuits filed against Daiichi Sankyo and Forest Laboratories continues to grow, with more than 1,000 complaints now pending in the federal court system, where lawyers are scheduled to meet this week for a status conference.

Since April, all federal product liability lawsuits filed over side effects of Benicar have been centralized as part of a multidistrict litigation (MDL) before U.S. District Judge Robert Kugler in the District of New Jersey.

The cases are consolidated for discovery and pretrial proceedings, since they all involve 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, with plaintiffs claiming that they suffered severe and debilitating diarrhea months or even years after first use of the medication.

At the time the MDL was established, there were approximately 35 Benicar diarrhea cases pending in 23 different U.S. District Courts. Now, according to a joint status report (PDF) submitted in advance of a status conference scheduled for Wednesday, there are at least 1,034 complaints.

As part of the coordinated Benicar MDL proceedings before Judge Kugler it is expected that a small group of lawsuits will be selected for a “bellwether” program, where the parties will complete case-specific discovery in preparation for a series of early trial dates, which will be used to gauge how juries are likely to respond to certain evidence and testimony that will be offered throughout the litigation.

According to the status report, plaintiffs indicate that they believe proposals should be submitted by the end of September for the section of cases that will make up a bellwether discovery pool and trial pool. However, attorneys for the drug maker suggest that it is premature to discuss a bellwether process at this time, since the parties do not yet have a good understanding of what the inventory of cases looks like.

During the status conference set for September 2, Defendants indicate that they will request that the court address a “growing backlog of unserved complaints,” stating that Daiichi Sankyo has only been served with 355 of the filed complaints to date. Therefore, the drug maker intends to ask the court to begin dismissing cases that are not properly served within 120 days. However, there are only six cases that would currently qualify.

In their response, Plaintiffs’ attorneys point out that six cases out of 1,034 not served in a timely manner does not constitute a “growing backlog.” They also indicate that the six cases of concern will be served by Wednesday, and that the defendants should go through the proper process of asking for the cases to be dismissed, which would allow them to respond.

In addition, the plaintiffs’ attorneys say it has been difficult to serve the company with complaints because Daiichi Sankyo is not accepting email or certified mail as means of serving the complaints. The attorneys say they’ve asked the company for the names and addresses of agents that could receive the complaints, but the defendants have not cooperated.

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.

Following coordinated pretrial proceedings in the MDL and any bellwether trials, if the parties fail to reach Benicar settlements or otherwise resolve the litigation, 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.