Federal Judge Dismisses Pradaxa Class Action Lawsuit

A federal judge recently ruled in favor of manufacturer Boehringer Ingelheim Pharmaceuticals, Inc. (BIPI) in a Pradaxa class action lawsuit. After reviewing the pleadings, Judge David Herndon determined that there was insufficient evidence to support many of the plaintiff’s claims, as well as the lawsuit’s attempt to certify the case as a class action lawsuit; however, Judge Herndon allowed other portions of the plaintiff’s complaint to move forward.

In many ways, Jackson v. BIPI is similar to the hundreds of other Pradaxa bleeding injury lawsuits throughout the country. Although doctors have written 700,000 Pradaxa prescriptions in the short time the drug has been on the market, serious safety concerns linger. This plaintiff had suffered serious side effects after being prescribed and ingesting Pradaxa, and he then sued BIPI alleging products liability, fraud, negligence, breach of warranty and deceptive trade practices.

What does Pradaxa do?

Pradaxa is an anticoagulant that may be too effective. The drug thins the blood to help lower the risk of stroke in patients with atrial fibrillation. Ever since the 1950s, warfarin had been the drug of choice for patients who needed a blood thinner. While warfarin requires careful and ongoing monitoring, Vitamin K is a very effective antidote in cases involving severe bleeding. Pradaxa requires no monitoring, which is the main reason doctors like the new drug. Unfortunately, there is no antidote for Pradaxa should the patient develop a serious bleeding event.

Side effects of Pradaxa can range from annoying to lethal. Some patients develop a skin rash, an upset stomach, or mild indigestion. In more dire cases reported Pradaxa side effects  include renal failure, stroke, heart attack and even death.

What are the legal implications?

Pradaxa bleeding events and other serious side effects prompted the Food and Drug Administration (FDA) to issue a warning about the drug in 2011.

To date, hundreds of patients and families have filed lawsuits against BIPI. While every case is unique, many Pradaxa bleeding injury lawsuits contain common causes of action:

• Products Liability: A typical Pradaxa lawsuit includes allegations that BIPI knew Pradaxa was a dangerous drug while it was in development, and failed to adequately warn about the risks.
• Negligence: A drug manufacturer has a duty of reasonable care to warn patients and doctors about the risks that the manufacturer knows or should know exist. By failing to warn, these Pradaxa bleeding injury lawsuits allege that BIPI breached its duty to both doctors and patients.
• Breach of Warranty: Whenever a drug manufacturer produces a new medication, there is an implied warranty that the drug is safe. Pradaxa bleeding injury lawsuits claim that Pradaxa was an unfit product, and so BIPI breached its warranty.

While this Pradaxa class action lawsuit was dismissed, Judge Herndon has said the complaint can proceed on claims of failure to warn as well as design and marketing defects.