Pradaxa Settlement

On May 28, 2014, German drug maker Boehringer Ingelheim announced its agreement to pay $650 million in order to achieve a comprehensive settlement of litigation surrounding Pradaxa (dabigatran), an anticoagulant drug plagued by controversy.

It is anticipated that this Pradaxa settlement will resolve approximately 4,000 pending cases, including over 2,350 federal lawsuits previously consolidated into a Multidistrict Litigation (MDL) in the Southern District of Illinois. The settlement news comes months before the first Pradaxa trial was slated to begin, and it is intended to bring the ongoing court battles over the drug’s safety to a conclusion.

History of Pradaxa controversy and litigation

First gaining FDA approval in 2012, Pradaxa was introduced as an alternative to warfarin, a commonly-used blood thinning drug. The makers of Pradaxa touted the fact that patients using the drug would no longer need to have routine blood testing, which was necessary while taking warfarin. In addition, Pradaxa did not require patients to follow a stringent dietary regimen, unlike warfarin.

However, after its introduction, Pradaxa became the subject of numerous reports of dangerous, uncontrollable internal bleeding connected to its use. These gastrointestinal bleeding events were often life-threatening in nature because no antidote existed to counteract the effect. Though the U.S. Food and Drug Administration (FDA) has conducted investigations of the drug and its side effects, it has made no definitive statement about Pradaxa, other than say that it continues to have a “favorable benefit to risk profile.” Having been prescribed to over 850,000 individuals in the United States, Pradaxa is alleged to have played a significant role in at least 1,000 deaths.

Allegations in Pradaxa lawsuits and Boehringer’s response

Many of the Pradaxa lawsuits eligible for settlement under Boehringer’s plan include those in which plaintiffs alleged that the drug maker negligently failed to warn consumers of known risks of the medication, marketed a defectively designed and manufactured product and engaged in misleading and insufficient labeling of the product. Common allegations also included the assertion that Boehringer did not engage in appropriate and thorough follow-up investigations when numerous adverse event reports emerged. Allegations of fraud, negligent misrepresentation and breach of warranty were also made in many, if not all Pradaxa lawsuits, because the drug produced dangerous outcomes when used in the manner foreseen by the manufacturer.

Throughout the course of Pradaxa litigation, Boehringer vehemently denied the allegations, standing squarely behind its product. The company asserted that the plaintiffs’ claims lacked merit and that the drugs’ benefits were significant. In announcing the $650 Pradaxa settlement, Boehringer attorneys stated that despite their confidence in the drug’s safety, settling the cases at this stage would prevent the company from having to face the distraction and the uncertainty of ongoing litigation. Furthermore, according to Boehringer lawyers, a global settlement of this type would guard against inconsistent trial results reached by juries of laypeople who may be unable to accurately assess scientific evidence.

How the Pradaxa settlement took shape

The settlement announcement came on the heels of a series of actions undertaken by Judge David Herndon, responsible for overseeing the federal Pradaxa MDL. The judge had issued a stay of all activities in the Pradaxa litigation, including a deposition of the drug maker’s CEO. Herndon also demanded that the MDL mediator and several plaintiffs’ lawyers meet in chambers to discuss the current state of settlement talks and explain why an agreement had not yet been reached. Subsequently, Judge Herndon appointed eight lawyers to a Claimants’ Negotiating Committee, which would be charged with negotiating with Boehringer to reach a final settlement. The next day, Boehringer announced the $650 agreement, stating that it was expected that most plaintiffs would accept the offer.

Factors influencing settlement amount

The $650 million settlement of roughly 4,000 individual lawsuits provides upwards of $165,000 per plaintiff, on average. Negotiations for settling Pradaxa cases were premised on estimates of what juries were likely to award plaintiffs, given the strengths and weaknesses of the suits. Cases that eventually went to trial would have involved jury considerations of the nature of the injuries sustained, the seriousness of the harm done and the economic effects the injuries had on the specific plaintiffs.

Common considerations that impact settlement offers in Pradaxa lawsuits include:

• The duration and seriousness of the Pradaxa-related injuries
• The overall impact of Pradaxa on the physical, emotional and mental health of the complainant
• The emotional distress and physical pain experienced now and in the future
• The total medical expenses stemming from Pradaxa use, including past, present and future costs
• Lost wages and/or diminished earning capacity
• Wrongful death losses sustained, including funeral expenses, loss of companionship, loss of financial support

Pradaxa lawsuit settlement impacts future litigation

Boehringher Ingelheim has stated that the $650 million settlement is likely to be accepted by most, perhaps all plaintiffs in pending Pradaxa litigation. Meanwhile, Pradaxa attorneys continue to assist current clients as the settlement process progresses. Though the drug maker has repeatedly denied any wrongdoing or liability relating to the manufacture or marketing of Pradaxa, the company’s willingness to enter into this comprehensive settlement agreement should go a long way toward helping plaintiffs feel vindicated in their claims and will provide the compensation to which so many victims are entitled.

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