Pradaxa Stroke Lawsuit Alleges Failure to Warn

Many lawsuits filed against Boehringer Ingelheim with regard to its medication Pradaxa (dabigatran) allege that the drug results in irreversible bleeding events, which have reportedly caused the deaths of hundreds of patients. However, as one patient discovered, the drug has another potentially deadly consequence: stroke upon abrupt discontinuation.

John P. Horgan III and Dorothy L. Horgan of California filed a Pradaxa stroke lawsuit against the pharmaceutical giant, alleging that Mr. Horgan was not advised of this risk when he began using Pradaxa. They filed their lawsuit on May 29, 2014 in the Superior Court for San Francisco County. The plaintiffs have requested a jury trial and they demand compensation for physical injuries, pain and suffering, medical expenses, and other economic damages. Mrs. Horgan demands compensation for loss of consortium.

Plaintiff alleges failure to warn

The problems for the Horgan family began in May of 2012 when Mr. Horgan was prescribed Pradaxa. Later in 2012, the plaintiff anticipated undergoing an ablation procedure. It is common for surgeons to request that patients discontinue certain drugs prior to surgeries because of the risk of excessive bleeding. To reduce risks from the surgery, the plaintiff was asked to discontinue using Pradaxa on September 23, 2012. He complied with the request.

According to the Pradaxa lawsuit, Mr. Horgan arrived at the hospital three days later for the ablation procedure when he was suddenly diagnosed with a stroke. Like many other medications, it is considered unsafe to abruptly discontinue Pradaxa. Abrupt discontinuation can significantly increase the risk of adverse events; in particular, the discontinuation of Pradaxa has been linked to a rise in the development of stroke.

Mr. Horgan was allegedly never warned of this risk, according to his lawsuit. His product liability complaint alleges that the defendants “…through their affirmative misrepresentations and omissions, concealed from plaintiff and plaintiff’s physicians the true and significant risks associated with Pradaxa use” and its abrupt discontinuation.

According to the lawsuit, the plaintiff never would have consented to the use of Pradaxa had he or his healthcare provider been properly informed of the risk of stroke.

Plaintiff expects to require lifelong medical care

As an alleged result of the defendants’ failure to warn of the risks, the plaintiff expects to require lifelong medical care, including monitoring and medications. He alleges diminished enjoyment of life, physical pain, mental anguish, and fear of additional health consequences.

Although the plaintiff’s Pradaxa stroke lawsuit does not discuss specifics, many stroke survivors do indeed suffer from permanent complications. Depending on the exact nature of the damage to the brain, stroke survivors may suffer from paralysis, memory loss, cognitive trouble, and problems with speech and swallowing.

Stroke survivors often lose their independence and their ability to care for themselves, and they frequently suffer from emotional challenges.

FDA warnings and adverse event reports

Since Pradaxa was approved in October of 2010, a flood of adverse event reports have come to light. Patients who used Pradaxa allege serious side effects, including uncontrollable bleeding that lacks an antidote, heart attack, and liver failure.

Late in 2011, the FDA issued a Drug Safety Communication to announce a safety review it was conducting. It is thought that the FDA was prompted to do so by the more than 500 reports of deaths connected to the drug, along with hundreds of other serious side effects.

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