A couple from Washington D.C. has added their claim to the Pradaxa multidistrict litigation, alleging that the blood thinner caused the wife’s stroke.

Plaintiff Sarah N. says she took Pradaxa starting in January 2012 as a treatment for non-valvular atrial fibrillation. The next October she suffered a stroke and was hospitalized for about a month.

Sarah attributes the stroke to the Pradaxa she took during that period. She says that defendant Boehringer Ingelheim Pharmaceuticals, the maker of Pradaxa, failed to put an adequate warning about Pradaxa bleeding on the drug’s label.

She claims that the defendant knowingly concealed information about that risk from patients and their doctors. She says that because of the defendant’s alleged failures and misrepresentations, she was unaware of the risks associated with Pradaxa; and had she been so aware, she says, she would not have taken that drug.

Sarah’s husband Rufus is also bringing his own claim for loss of consortium as part of the same Pradaxa lawsuit. Loss of consortium is a claim that the spouse of an injured person can bring to recover compensation from the effect of the injury on the couple’s marital relationship. Rufus says because of his wife’s stroke, he now has to act as her caregiver.

Pradaxa, or dabigatran, was a new anticoagulant medication first approved by the FDA in October 2010. Before Pradaxa entered the market, warfarin (also known by the brand name Coumadin) had been the go-to medication for reducing the risk of stroke and systemic embolism in patients with atrial fibrillation.

Sarah and Rufus accuse the defendant of over-promoting Pradaxa. Boehringer Ingelheim initially promoted Pradaxa as a better alternative to warfarin, according to Sarah’s Pradaxa lawsuit. Unlike warfarin, the company said, Pradaxa did not require ongoing blood monitoring or certain dietary restrictions.

What Boehringer Ingelheim failed to make clear, according to Sarah and Rufus, is that Pradaxa has no reversal agent that can stop excessive Pradaxa bleeding once it starts. That lack of a reversal agent makes Pradaxa bleeding potentially deadly, the plaintiffs say. The plaintiffs also accuse Boehringer Ingelheim of overstating the efficacy of Pradaxa for preventing stroke and systemic embolism.

The plaintiffs cite information from the FDA showing that the agency had received over 500 reports of deaths in the U.S. linked to Pradaxa as of the end of December 2011.

The federal agency also received more than 900 reports of gastrointestinal hemorrhages, more than 300 reports of rectal hemorrhages, and more than 200 reports of cerebrovascular accidents associated with Pradaxa.

Sarah and Rufus’s Pradaxa lawsuit is part of the Pradaxa multidistrict litigation, or MDL, going on in an Illinois federal court. This MDL is a collection of over 2,600 Pradaxa lawsuits consolidated into a single court to make pre-trial proceedings more efficient and more consistent. Unlike in a class action lawsuit, each plaintiff in an MDL maintains their claim as an individual lawsuit.

The Pradaxa MDL is underway in the U.S. District Court for the Southern District of Illinois, MDL No. 2385, overseen by Judge David R. Herndon. Rufus and Sarah’s individual Pradaxa Lawsuit is Case No. 3:15-PX-1055.