Daiichi Sankyo and Forest Laboratories, makers of the enormously popular blood pressure medication Benicar, are opposed to the creation of a multidistrict litigation (MDL) for a flurry of product liability lawsuits accusing the drug makers of creating a medication that caused patients to suffer chronic diarrhea and other gastrointestinal problems, including a condition known as sprue-like enteropathy.
In December, the U.S. Judicial Panel on Multidistrict Litigation (JPML) granted Daiichi Sankyo and Forest Laboratories additional time to prepare its response to a motion to create a multidistrict litigation for Benicar lawsuits.
On Jan. 23, the extended deadline to file the motion, Daiichi Sankyo and Forest Laboratories argued in their brief that it opposed centralizing the nearly two dozen cases filed in federal courts across the country because the lawsuits are already underway and centralizing them could negatively impact the cases and prejudice the defendants.
“The olmesartan litigation involving Benicar, Benicar HCT and Azor is driven by a small number of Plaintiffs’ counsel before a few courts, and involves cases that will turn on highly individualized, case-specific legal and factual issues that are not susceptible to common proof,” they write in their motion opposing centralization.
“Defense counsel is already informally coordinating common discovery in these actions before a handful of courts to maximize efficiencies. Creating an MDL (multidistrict litigation) proceeding will only add to the burden, expense and uncertainty of this litigation, and would prejudice Defendants as these actions would have to start anew before a different court.”
Sprue-like enteropathy symptoms are similar to those of celiac disease, which is an intolerance to gluten. Common symptoms include severe and/or chronic diarrhea, substantial weight loss, nausea, vomiting, malnutrition, dehydration and an electrolyte imbalance.
Many plaintiffs in Benicar lawsuits were first diagnosed with celiac disease before figuring out Benicar was the culprit. The Benicar lawsuits accuse the manufacturers of failing to adequately warn users of the gastrointestinal risks associated with the drug.
Had they been made aware of the risks, the plaintiffs maintain that they could have opted not to take the drug, avoiding unnecessary pain and suffering, as well as permanent intestinal damage.
A study published in the October 2014 Journal of Clinical Pathology found that up to 50 percent of Benicar patients suffered sprue-like enteropathy compared with about 20 percent of patients who used other blood-pressure lowering medications.
Patients say they have had extended hospital stays for sprue-like enteropathy, for which the symptoms may not manifest for months or years after taking the medication.
Each year, doctors write more than 11 million prescriptions for the hypertension medication, making it the most widely prescribed blood pressure medication in the country. It has been approved by the U.S. Food and Drug Administration (FDA) since April 2002. In 2013, the FDA issued a decision to require that patients be warned about the risk of severe sprue-like enteropathy caused by olmesartan, an ingredient in Benicar, Benicar HCT, Azor, Tribenzor, and generic drugs.
In the Benicar lawsuits, plaintiffs are seeking compensation for medical bills, pain and suffering, and sometimes permanent injuries to their intestines.
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