Plaintiffs in the Benicar litigation were dealt a blow earlier this week when the first bellwether trial dates were pushed back to 2017. The trials were originally scheduled to begin in late 2016, but the latest case management order has depositions and pretrial motions running until the end of March 2017. Lawyers from both sides have managed to select 10 cases for the bellwether trials, and are in the process of preparing for the 2017 trials.
Fact discovery in the selected bellwether cases is currently due at the end of September, with plaintiffs’ expert reports due at the end of November. Expert depositions for both sides must be completed by the end of February 2017. Exact trial dates have yet to be scheduled, but it is likely they will begin mid-2017.
What Is Benicar?
Benicar is a prescription medication used for the treatment of high blood pressure and heart failure. Daiichi Sankyo developed the drug in 1995. Benicar works by relaxing blood vessels so the vessels can move blood with less effort.
Benicar has been shown to cause a condition called sprue-like enteropathy in some patients. Sprue-like enteropathy is marked by intestinal problems including severe diarrhea, which can cause severe weight loss, malnutrition, and infections. Plaintiffs in the Benicar litigation also report that several people have died of complications resulting from Benicar’s side effects.
The Trouble With Benicar
Despite the fact that high blood pressure is a lifelong affliction, the clinical trial that led to Benicar’s approval was conducted over only a three-month period. Some patients and doctors believe the incredibly short clinical trial was not long enough to detect the risk of sprue-like enteropathy.
But the short clinical trial didn’t stop Daiichi Sankyo from heavily marketing the drug. The company reportedly spent $1 billion on advertising between 2002 and 2008 alone. Just like the clinical trial, the advertising Daiichi Sankyo used also came up short. In 2013, the FDA sent the company a warning letter, stating its advertisement contained statistics from an “open-label, uncontrolled trial, which due to lack of placebo control or blinding, does not provide substantial evidence or substantial clinical experience to support the efficacy claims and presentations above.”
Plaintiffs in the Benicar litigation allege the company failed to warn of the serious side effects associated with the drug. Daiichi Sankyo is currently facing more than 1,300 lawsuits over Benicar side effects.