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Warfarin, the industry standard blood thinner, has effectively prevented the formation of blood clots for 61 years. Beyond its proven efficacy, the drug’s anticoagulant effects can be reversed. In the event of internal bleeding or hemorrhage, warfarin saves lives, restoring the body’s natural ability to save itself.
But a “new generation” of anticoagulants promised patients with atrial fibrillation (Afib) new hope, as big marketing campaigns touted improved efficacy and lowered risks. Leading the charge: Pradaxa, approved in 2010 on the back of strong clinical trial results.
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Five years later, Pradaxa’s manufacturer has settled more than 4,000 lawsuits for $650 million.
Numerous damning allegations against embattled German company Boehringer Ingelheim have been substantiated in unsealed court documents. Rigorous analyses have thrown the results of those promising clinical trials into doubt.
And Pradaxa remained without an antidote until October 2015.
With no reversal agent for such a great length of time, Pradaxa put patients at risk of suffering irreversible “bleeds,” unstoppable hemorrhaging in the brain and gastrointestinal tract.
In thousands of claims, plaintiffs argued that Boehringer Ingelheim had buried its product’s lack of an antidote, minimized early risk estimates and failed to warn the public of Pradaxa’s dangers.
Now those claims have been settled. But the legal community believes Boehringer’s exposure to liability has only begun. More patients may be eligible to file Pradaxa lawsuits.
Banville Law is here to help.
Our experienced personal injury attorneys have been taking on huge drug companies for years. We’ve turned our full attention to the ongoing Pradaxa litigation, and have every intention of protecting patient rights long into the future.
If you or a loved one suffered a major bleeding event linked to Pradaxa, contact our lawyers today for a free consultation. Learning more about your own case eligibility comes at no cost and no charge.
Pradaxa was approved in October of 2010. By March of 2011, the US Food & Drug Administration (FDA) had received over 930 severe adverse event reports detailing the tragic consequences of irreversible Pradaxa bleeding, including:
According to QuarterWatch, an independent drug safety watchdog, Pradaxa’s 932 severe adverse event reports outnumbered those for any of the 800 other drugs tracked by the non-profit, including warfarin.
Red flags were raised at the FDA, which released a public safety announcement that December.
By the summer of 2012, some 21 patients had filed Pradaxa lawsuits against Boehringer Ingelheim.
Patients who had suffered internal gastrointestinal bleeding, rectal bleeding, stroke, cerebral hemorrhage and myocardial infarction (heart attack) all brought their own claims against the company, along with several survivors on behalf of their deceased loved ones.
Plaintiffs claimed Boehringer had marketed Pradaxa as significantly safer than older treatments like warfarin, but failed to adequately warn the public and health community that Pradaxa “can cause life-threatening irreversible bleeds.”
A note on Pradaxa’s lack of an antidote, plaintiffs argued, was “buried” on the 4th page of the drug’s “Prescribing Information” booklet, and placed under the heading “Overdosage,” not “Warnings & Precautions” or “Adverse Reactions.” In their eyes, this information, vital to any physician attempting to mitigate a patient’s risks, should have appeared front-and-center in Pradaxa’s warning label.
To read a characteristic complaint, filed by widow Bertha Bivens in March of 2012, click here.
Soon, these claims would be consolidated in a Multidistrict Litigation (MDL): MDL 2385 – Pradaxa (Dabigatran Etexilate) Products Liability Litigation.
While the initial lawsuits had been filed in numerous Federal District Courts across the country, they were eventually transferred to the US District Court for the Southern District of Illinois. The Honorable David R. Herndon was selected to preside over the MDL.
Since each plaintiff leveled similar allegations against Boehringer, it suited all parties involved to make the litigation as efficient as possible. Multidistrict Litigation is one legal mechanism used to “streamline” pre-trial proceedings.
The individual Pradaxa claims were “transferred,” sent to a single Federal Court and overseen by a single Federal Judge. The lawsuits remained in the Southern District of Illinois for the duration of pre-trial proceedings, including “discovery,” in which plaintiffs and Boehringer exchanged evidence with one another.
MDL is intended to eliminate redundant or conflicting rulings. Judge Herndon was allowed to make rulings on the questions of fact and law shared by all of the consolidated lawsuits, and those decisions applied equally to every claim. For their part, medical experts and witnesses were able to provide testimony once, in a single deposition, to avoid conflicting statements.
By September 2012, the number of consolidated Pradaxa lawsuits had grown to 72.
As the litigation progressed, numerous studies sought to investigate the true risks and benefits of Pradaxa, comparing the drug’s link to excessive bleeds against those associated with warfarin.
By 2014, more than 4,000 injured patients had leveled personal injury lawsuits against Boehringer Ingelheim, Pradaxa’s manufacturer. Several major developments surfaced as the MDL neared its first “bellwether” trial.
On February 26, 2014, unsealed court documents revealed that Boehringer had concealed unfavorable study results from FDA safety experts. The story was first reported by Bloomberg Business.
After Pradaxa’s approval, the FDA asked Boehringer to calculate a “death rate,” by comparing the high number of severe bleeding reports to the total number of patients taking the drug. The company quickly shot back an estimate: 6.1 out of every 10,000 Pradaxa patients experienced a fatal bleeding event.
With those numbers in hand, the FDA told Boehringer to return to an older study, one submitted during Pradaxa’s approval process, and analyze its numbers again. But the company actually performed two analyses, the unsealed documents disclosed.
Only one of these analyses would be sent to the FDA.
Boehringer chose to send favorable results. Including only patients for whom bleeding had been logged as the primary cause of death, the company submitted a risk ratio of 5.8 out of 10,000 to the FDA.
The second analyses, which looked at patients who had experienced severe bleeding and died of any cause, found an incidence of 19.5 fatal events for every 10,000 Pradaxa patients. But those results weren’t submitted to the FDA.
While Judge Herndon had placed an early emphasis on settlement negotiations, he took pro-active measures to speed the litigation up, scheduling a number of “bellwether” trials for mid-2014. These lawsuits, considered representative of the other claims, were meant to proceed to trial first.
“Bellwethers” are extremely common in Multidistrict Litigations, a way of “testing the waters.” After airing evidence and witness testimony in open court, plaintiffs and defendant gain a better understanding of how a jury may perceive additional trials.
If juries hand down verdicts in favor of plaintiffs, many large corporate defendants will decide to enter settlement negotiations immediately, rather than spending inordinate sums on individual trials.
But before any trials could commence, Herndon would fine Boehringer nearly $1 million for withholding documents illustrating Pradaxa’s development and marketing process.
Warfarin treatment entails strict diet regulation, routine blood testing, and frequent dosage changes. These exacting measures are the only way to ensure that the drug’s risk of bleeding doesn’t outweigh its clot-fighting benefits.
Pradaxa, on the other hand, has been sold as a “one size fits all” wonder drug. According to Boehringer’s marketing line, patients don’t require dosage adjustments and don’t need blood tests.
But internal corporate communications made public in early 2014 revealed that Boehringer employees fought to quash a study that may have given the lie to the company’s “one size fits all” pitch.
The problem, as unsealed court documents showed, was that patients absorb Pradaxa at different rates. The study, conducted by Boehringer researcher Paul Reilly, found that some people absorb so little of the drug that it isn’t effective, while others absorb it so quickly that it increases their risk for excessive bleeding.
Reilly’s conclusion? Monitor patients’ blood levels to keep them within an optimal range. But that would have required testing, and Boehringer had worked for decades to prove that Pradaxa didn’t require any blood tests. So company employees fought to conceal Reilly’s results.
On the eve of Herndon’s first bellwether trial, Boehringer made a stunning announcement: to avoid “the distraction and uncertainty of protracted litigation,” the company had entered a settlement agreement for $650 million.
While individual settlement offers would vary depending on the facts of each plaintiff’s case, a rough calculation suggests that each injured patient would have received as much as $162,500.
But even following its huge settlement offer, Boehringer Ingelheim has faced continued scrutiny.
In May of 2014, Bloomberg broke another major revelation: a reanalysis of the RE-LY study, upon which Pradaxa’s approval was based, had discovered at least 22 severe bleeding events that had not been included in the study’s initial results.
Eight months later, a huge review of Pradaxa’s use in real-world clinical settings found a higher risk of bleeding compared to warfarin, with an 85% uptick in the rate of gastrointestinal bleeds.
For many in the legal community, the Pradaxa litigation seems far from over. Numerous patients may still be eligible to file irreversible bleeding lawsuits.
Banville Law has joined forces with an alliance of experienced personal injury attorneys to investigate potential Pradaxa claims. Our lawyers are ready to answer your pressing legal questions, at no charge and no obligation.
If we can help, our services are offered on a contingency-fee basis. We believe that everyone deserves experienced legal counsel, with no jargon: just common-sense solutions in your fight for justice. That’s why you owe us nothing until we win a court award or settlement in your favor.
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