93-Year-Old Sunday School Teacher Dead One Week after Using Pradaxa

On January 24, 2012, one week after being prescribed Pradaxa, the anticoagulant medication, Ms. Thelma Suber, a 93-year-old Sunday school teacher from South Carolina, died of an uncontrollable gastrointestinal (GI) bleed caused by her use of Pradaxa.

This is the allegation of the plaintiff Max Suber, her husband of sixty-five years and trustee for the heirs of Ms. Suber, in a Pradaxa GI bleed lawsuit filed in US District Court in Minnesota on April 15, 2014. The defendant in the lawsuit is the manufacturer of Pradaxa, Boehringer Ingelheim Pharmaceuticals, a German company incorporated in Delaware.

Pradaxa is a direct thrombin inhibitor that is indicated to reduce the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation. Pradaxa was approved by the Federal Drug Administration (FDA) on October 19, 2010 as an alternative to warfarin, the only oral anticoagulant available in the US for reducing stroke and systemic embolism in patients with atrial fibrillation. Unlike warfarin which requires dietary restrictions and regular blood testing to monitor blood clotting tendencies, Pradaxa was marketed as a safer and more convenient alternative to warfarin that required no blood monitoring, dosage adjustments, or dietary restrictions.

According to the suit, Boehringer Ingelheim spent $67,000,000 in 2010 alone in promoting Pradaxa. In 2011, the defendant initiated 1.5 million marketing/sales visits by its sales force to US primary care physicians, internists, group practitioners, cardiologists, and practice nurses spending another $464,000,000 in promotional efforts.

Pradaxa GI bleed lawsuit claims Pradaxa “unreasonably dangerous”

The Pradaxa lawsuit alleges that, despite the defendant’s claims regarding the safety, effectiveness, and benefits of the drug, Ms. Suber and her physicians were unaware, and could not have reasonably learned through due diligence or the original labeling of the drug, that she would be exposed to the risk of excessive and/or uncontrollable bleeding which caused her death.

The key design flaw in Pradaxa, as alleged by the lawsuit, is that, unlike warfarin, there is no known agent to reverse the anticoagulation effects of Pradaxa. Once hemorrhaging or bleeding begins, the attending physician has no means to stop the bleeding.

The lawsuit further claims that if there was sufficient warning from the defendant in either its labeling or promotional efforts for Pradaxa that there was a risk of uncontrollable bleeding, Ms. Suber would not have used the medication considering that there were safer alternatives that did not carry the same risks.

The plaintiff alleges negligence in that Boehringer Ingelheim Pharmaceuticals “owed a duty to the general public and specifically to the Decedent to exercise reasonable care in the design, study, development, manufacture, promotion, sale, labeling, marketing, and distribution of Pradaxa”.

The plaintiff is demanding compensatory damages for wrongful death, medical and hospital expenses, loss of income, loss of consortium, and other damages according to proof. Plaintiff also demands punitive damages from the defendant for deliberately and wantonly misleading the public and the Decedent so as to maximize sales and profits at their expense.

500 deaths in US in 14 months linked to Pradaxa

As of December 31, 2011, the FDA had received over 500 reports of deaths of people in the US linked to Pradaxa since its FDA approval in October, 2010. In addition, there were over 900 reports of gastrointestinal hemorrhaging, over 300 reports of rectal hemorrhaging, and over 200 reports of cerebrovascular accidents suffered in the US linked to Pradaxa.

On April 29, 2014, the Suber lawsuit was transferred to the Southern District of Illinois multidistrict legislation for coordinated or consolidated pretrial proceedings in front of Judge David R. Herndon.

$650 million Pradaxa settlement agreement announced

On May 28, 2014, Boehringer Ingelheim announced today it had reached a $650 million comprehensive settlement covering 4,000 pending Pradaxa GI bleed lawsuits.

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