Benicar Improper Labeling Lawsuit Settlement and “Failure to Warn”
In late July 2017, Daiichi Sankyo agreed to pay up to $300 million in more than 2,000 U.S. cases surrounding the Japanese drugmaker’s failure to warn that its blood pressure medication, Benicar, can cause gastrointestinal (GI) illness.
The first of these lawsuits was filed in early 2014, shortly after the U.S. Food and Drug Administration (FDA) ordered the manufacturer to make changes to its improperly labeled products that should have warned of the drug’s risks of severe GI side-effects. The cases filed separately in many U.S. states were eventually consolidated in a multidistrict litigation (MDL) in a New Jersey federal court.
Fifteen test cases in the MDL called “bellwethers” – cases which attorneys on both sides use to weigh the effectiveness of their respective arguments – were entered into the court’s docket for the fall of 2017. But before any of them went to trial, Benicar’s manufacturer, Daiichi Sankyo, began settling with the plaintiffs from which the 15 bellwethers were selected.
Injured victims alleged that until a decade after the drugs hit the market, Benicar, along with its affiliate drugs Benicar HCT, Azor, and Tribenzor, carried no labels or literature that warned of the GI side-effects, which included:
- Sprue-like enteropathy (symptoms of which include severe, chronic diarrhea with substantial weight loss, as well as abdominal pain, fatigue, bloating, nausea, vomiting, and anemia)
- Lymphocytic colitis (a condition characterized by chronic, watery, non-bloody diarrhea)
- Microscopic colitis (inflammation of colon/large intestine resulting in persistent watery diarrhea and cramping)
- Collagenous colitis (inflammatory bowel disease affecting the colon, also presenting as chronic, watery diarrhea with the absence of bleeding).
Failure to Warn Explained
A failure-to-warn lawsuit centers on an injured plaintiff’s allegation that the company – in this case, drugmaker Daiichi Sankyo – knew a prescription medication displayed a number of specific health risks but failed to disclose them to consumers. And even though it can be “assumed” that many useful drugs do come with “inherent yet non-specific risks” that cannot be completely removed but still allow the drug to function as intended, all of these risks must be disclosed in writing somewhere in the product literature that accompanies the drug. Without this warning, the dangers that doctors and patients are not aware of can cause great harm to those who take the medicine.
From a procedural perspective, failure-to-warn claims are much like other personal injury civil cases. The injured plaintiff’s attorney must show that the manufacturer knew of the dangers associated with their products, did not disclose them, and because of this, the plaintiff was hurt by that product.
In order to win a failure-to-warn claim or lawsuit, the plaintiff’s drug injury lawyer must prove the following chain of events:
- The defendant drug manufacturer knew the product was dangerous.
- The defendant had a legal duty to warn consumers of the danger.
- By failing to warn, the defendant neglected its legal duty.
- And because of that negligence, the plaintiff was injured by the product.