Benicar
Benicar General Information
Benicar is one of America’s most popular blood pressure and hypertension medications. Unfortunately, the drug which has been on the U.S. market since 2002 has recently been linked to very serious side effects.
Benicar is in a class of medicines called angiotensin II receptor blockers, or ARB for short. ARB’s work by preventing the blood vessels from restricting and raising a person’s blood pressure. Side effects typical of Benicar can include nausea, abdominal pain, weight loss, vomiting, and diarrhea to name a few. However, the recent side effects that Benicar has been linked to can lead to hospitalization and permanent intestinal damage.
Lawsuits filed in the U.S. against Japanese pharmaceutical giant Daiichi Sankyo are alleging that Benicar caused dangerous side effects such as sprue-like enteropathy and villous atrophy. Sprue-like enteropathy can cause chronic diarrhea, and villous atrophy damages the intestine’s ability to absorb nutrients. Both of these side effects require hospitalization and can result in permanent gastrointestinal injuries.
The possibility that Benicar might cause such dangerous side effects led the FDA to require that Daiichi update Benicar’s warning label in 2013. The FDA’s request asked Daiichi to add a warning that Benicar might cause sprue-like enteropathy months or even years after taking it. Unfortunately for Daiichi, updating a product label would be the least of their worries over the next few years.
In January of 2015, charges were brought by the U.S. Department of Justice against Daiichi, alleging that Daiichi violated the Federal Anti-Kickback Statute. The charges alleged that the company paid kickbacks to doctors in an effort to induce doctors to prescribe Daiichi’s drugs. Daiichi ultimately settled the charges against the company for $39 million, and agreed to enter into a 5 year corporate integrity agreement which allows the Department of Health and Human Services to monitor the company’s conduct.
Current State of Litigation
As a result of the dangerous side effects that consumers have reported after taking Benicar, over 1200 plaintiffs brought lawsuits against Daiichi in the United States. The lawsuits brought against the pharmaceutical company allege that Daiichi failed to warn consumers about the potential for Benicar to cause such serious side effects. Additionally, many lawsuits are alleging that Daiichi was aware of the dangerous side effects all along.
The pending lawsuits have been transferred to a multidistrict litigation (MDL) in the U.S. District Court for the District of New Jersey under Judge Robert B. Kugler. Transferring cases to an MDL allows for coordinated pretrial proceedings and avoids having to go through discovery and pretrial hearings on an individualized basis.
Currently, parties in the MDL are selecting cases to be bellwether trials. Bellwether trials allow both parties to test their arguments in an effort to resolve the entire litigation. Judge Kugler has ordered there to be 20 bellwether trials in total, but those trials will probably not be heard until late 2016 or early 2017.
