Last week, the Hon. Judge Robert Kugler denied a motion by Benicar plaintiffs for partial summary judgment against drugmaker Daiichi-Sankyo on the matter of causation. Lawyers for the plaintiffs argued that testimony from Daiichi, in addition from information gleaned from company emails during the discovery process, constituted an admission of liability. It doesn’t mean that Daiichi is off the hook – but it does mean that the trial will take much longer.
To date, approximately 1,900 lawsuits against the Japanese pharmaceutical company have been consolidated into multidistrict litigation before a U.S. District Court in Camden, New Jersey. The cause of action involves side effects caused by Benicar, a blood pressure medication.
According to the complaints, the medication caused a condition known as sprue-like enteropathy, a disorder that mimics symptoms of celiac disease. Those symptoms include bloating vomiting, diarrhea, intestinal pain and sudden, unexplained weight loss.
In fact, until a physician at the Mayo Clinic made the connection in 2012, Benicar side effects were misdiagnosed as celiac disease. That disease is actually an auto-immune reaction to gluten, the protein found in wheat products as well as rye and barley. This happens when small, finger-like protrusions of the intestinal wall become atrophied and flattened. As a result, patients are unable to absorb nutrients from their food; in short, they literally starve to death.
The normal treatment for celiac disease is to remove gluten from the patient’s diet. However, patients at the Mayo Clinic failed to respond to dietary changes, and tests for similar conditions, including colitis, Crohn’s Disease, gastro-intestinal infections and intestinal cancer showed nothing. The Mayo Clinic then began receiving reports of drug-induced enteropathy caused by immunosuppressant medications such as Imrunan and Cellcept as well as Colcrys, a treatment for Behçet’s Disease (ulceration of the mucous membrane) and gout. Physicians found that patients who suffered from the symptoms were all being treated for high blood pressure with Benicar. Their symptoms gradually improved once they were taken off the medication.
Counsel for the plaintiffs in the current multidistrict litigation point to 38 depositions taken from present and past Daiichi employees in the U.S. and Japan, asking to submit these to the court as an admission that the company was aware of the harmful side effects of its product. According to Judge Kugler, however, the plaintiffs have failed to explain just how the documents in question prove how Benicar was actually responsible for their condition. In his rejection of plaintiffs’ request for summary judgment, Judge Kugler wrote:
Plaintiffs’ request lacks not only an explanation as to how these summaries and excerpts constitute incontestable facts upon which to base a summary judgment motion but also any jurisprudential support that defendant alleged admissions during discovery in and of themselves properly substitute for expert testimony to demonstrate general causation.
A partial summary judgment in this case would have shortened the trial considerably. Now, discovery on whether the Japanese drugmaker knew about Benicar side effects and failed to warn patients will have to wait until discovery on actual causation has been completed. According to plaintiff’s counsel, however, the evidence that will be coming out of the discovery process will be powerful. Those reports will be introduced at the end of November.