On May 28, 2014, German drug company Boehringer Ingelheim announced that it would be settling over 4,000 lawsuits filed for injuries allegedly caused by its “new generation” anticoagulant Pradaxa. In federal and state courts across the country, thousands of patients said the drug, designed to prevent the formation of blood clots, had led to indescribable suffering. Among the plaintiffs stood numerous widows and widowers, who had lost their loved ones to Pradaxa’s devastating side effect: irreversible bleeding.
In its settlement, valued at $650 million, Boeringher Ingelheim settled those claims, but wasn’t required to accept any wrongdoing. Despite damning allegations of fraud and deception, the company “continue[s] to stand resolutely behind Pradaxa,” according to corporate counsel chief Andreas Neumann.
Can Patients & Survivors Still File Pradaxa Lawsuits?
Attorneys are still pursuing Pradaxa lawsuits, on behalf of patients closed out of the 2014 settlement agreement and those who suffered excessive bleeding since that time. In fact, some legal experts believe a second round of Pradaxa litigation will be even better for patients who were harmed.
Boeringher’s settlement came on the eve of the first Pradaxa trial, and the allegations leveled at the company have still never been scrutinized inside a courtroom. If new Pradaxa lawsuits are set before juries, it’s quite likely that plaintiffs will be awarded far more than the $162,000 offered to the average patient in the initial Pradaxa settlement.
That means it may be the best time to begin considering filing a bleeding lawsuit of your own.
No Antidote: Can Patients Ever Be Considered Safe From Bleeding?
Like all blood thinners, Pradaxa carries a risk of excessive bleeding. On one level, that’s what blood thinners do; they make it more difficult for blood to clot. Thus it’s no surprise that some patients on Pradaxa, in emergency situations or after surgical procedures, would bleed more than the average patient.
But unlike more traditional anticoagulants, including warfarin, Pradaxa wasn’t released with an antidote. In other words, there was no way to stop the bleeding once it started. With warfarin, on the other hand, a shot of Vitamin K functions as an adequate reversal agent.
An antidote to Pradaxa now exists. It’s called Praxbind and was granted “accelerated approval” by the FDA on October 16, 2015. But critics say that any reversal agent, no matter how effective, has come 5 years too late. Pradaxa was approved on October 19, 2010. By 2013, it was raking in $21 million per year for Boeringher, all without an antidote to offer patients.
Wave Of Bleeding Reports Mars Approval
The problem with this scheme, however, was immediately clear. In 2011, the year after Pradaxa’s approval, the FDA received more adverse event reports involving Pradaxa than any other approved drug. The Institute for Safe Medication Practices, a non-profit that combs through FDA databases for warning signs, found 3,781 adverse event reports naming Pradaxa as the likely cause of patient harm in 2011. Number 2 on the list was warfarin itself, but with only 1,106 reports, the traditional blood thinner lagged far behind its revolutionary competitor in adverse event reports filed.
Of those severe adverse events, nearly 63% involved hemorrhage, or bleeding. Gastrointestinal and intracranial bleeds appeared most prevalent. 14% of the bleeds were said to be lethal, twice as many fatal bleeding events were reported in regard to warfarin patients. To date, more than 1,000 patient deaths have been ascribed to the anticoagulant effects of Pradaxa.
If those statistics are any guide, it would seem clear that Pradaxa causes far more bleeds, of a more serious nature, than warfarin. That was troubling news, especially since Boerhinger Ingelheim had been marketing the drug as safer than its traditional competitors, off the back of a sweeping clinical trial called RE-LY.
RE-LY: Did Clinical Trial Stack The Deck In Pradaxa’s Favor?
RE-LY, ultimately published in the New England Journal of Medicine, found that for patients with atrial fibrillation, Pradaxa lowered the risk of stroke and blood clots compared to warfarin, while maintaining the same risk of major hemorrhage. Add in the idea that, unlike warfarin, Pradaxa doesn’t require regular blood monitoring and Boerhinger Ingelheim’s new anticoagulant looked ready to sweep the market.
But no sooner had the paper been published then independent medical researchers were questioning its results.
The Therapeutics Initiative, a Canadian drug safety group funded by the government of British Columbia, noted that RE-LY wasn’t conducted as a double-blind study. In other words, test administrators knew which patients were receiving Pradaxa and which patients were being given warfarin. That’s a major problem in any area of scientific research, since the treatment patients receive from study administrators can have a major impact on how well they do with medications.
In fact, one of the FDA’s own clinical reviewers had already pointed out this deficiency, criticizing RE-LY for the possibility of “ascertainment bias” during pre-approval advisory meetings. This would become a persistent criticism of RE-LY: instead of creating data that could be generalized over a broad patient population, the study was conducted inside a “fishbowl,” with study administrators (either consciously or unconsciously) selecting which patients to include in the final results.
For one, RE-LY’s patients tended to be younger than most of the patients who would actually receive Pradaxa in the real world. Those study subjects also had fewer additional medical conditions than people likely to be prescribed the drug. These inaccuracies, according to the Therapeutics Initiative, meant that Pradaxa’s approval was “premature, pharmacologically irrational and unsafe for many patients.”
Leveling The Playing Field
In 2015, a group of public health researchers at the University of Pittsburgh set out to investigate Pradaxa’s true risks and benefits, using patient records from “real-world clinical practice” rather than a carefully-selected group of clinical trial participants.
Using records from Medicare, the researchers compared outcomes between patients who had been diagnosed with atrial fibrillation and then prescribed either Pradaxa or warfarin. Here are their results:
- Pradaxa patients suffered 30% more bleeding events
- Pradaxa patients suffered 58% more major bleeding events
- Pradaxa patients suffered 85% more gastrointestinal bleeding events
- Warfarin patients suffered 78% more intracranial hemorrhaging events
Despite Pradaxa’s relative safety where cranial bleeds are concerned, the researchers ended their study by saying that Pradaxa “should be prescribed with caution, especially among high-risk patients.”
Will New Plaintiffs’ Have To Start Over?
As soon as Pradaxa’s potential risks became apparent, patients began to file lawsuits, claiming the drug’s manufacturer had failed to warn them of the dangers. By May of 2014, more than 4,000 patients and survivors had taken legal action against Boeringher Ingelheim. The response was so overwhelming that a Multidistrict Litigation (MDL) was established, sending each individual claim to a federal court in Illinois.
In Illinois, the cases began pre-trial proceedings together. A roster of plaintiffs’ attorneys was appointed to lead the litigation, developing legal strategies and identifying crucial evidence to gather. Those strategies were developed, and the evidence was gathered, in preparation for trial. As we’ve seen, Boehringer decided to settle the cases before any trials could take place.
As a result, those plaintiffs’ attorneys we mentioned asked the Honorable David R. Herndon, the judge presiding over the litigation, to discharge them of their duties. Herndon complied, in Case Management Order 95, disbanding the MDL’s Plaintiffs’ Steering Committee. He also granted a request to “destroy or return all confidential and highly confidential documents and derivative materials” to Boehringer Ingelheim.
Herndon noted a “small number of lawyers claiming to represent Post Master Settlement Agreement Claimants […] who have not yet filed lawsuits.” The judge made it clear that those attorneys who file lawsuits on behalf of new patients won’t be entitled to the documents gathered by past lawyers.
Despite that setback, many attorneys are still committed to pursuing justice for patients who missed out on the initial Pradaxa settlement.
Latest Pradaxa Updates
By Laurence P. Banville
May 31, 2018 – Second Bellwether Trial For Pradaxa Results In Jury Verdict To The Defense
On May 7, a Connecticut state jury returned a verdict in the second bellwether trial for Pradaxa in favor of the defense, the drugmakers Boehringer Ingelheim Pharmaceuticals. The plaintiff, in this case, claimed that Pradaxa was the cause of her gastrointestinal bleed which required 2 days of hospitalization. The jury found that the plaintiff had not proven her claim of negligence and therefore, returned the verdict in favor of the defense.
April 25, 2018 – Pradaxa Reversal Agent Approved By FDA
Boehringer Ingelheim announced on April 17, that the reversal agent for their anticoagulant, Pradaxa had received full approval from the FDA. In October 2015, the FDA granted accelerated approval for Praxbind which would be able to keep its approval if the results of the phase III RE-VERSE AD trial were acceptable. The results showed that Praxbind did reverse the effects of the effects of the blood thinner and no adverse safety signals were observed during the trial.
March 9, 2018 – Makers Of Pradaxa Announce New Research Analyses Will Be Released
The American College of Cardiology 67th Annual Scientific Session will be held in Orlando, Florida on March 10 – 12. Boehringer Ingelheim announced this month that analyses of 3 major trials which examine their anticoagulant Pradaxa and its reversal agent Praxbind will be presented at this event. There will be six abstracts discussed.
February 28, 2018 – Study Shows Pradaxa And Similar Drugs May Increase Stroke Risk For A-Fib Patients
In a new study conducted and published in The BMJ medical journal, researchers in the UK followed patients with atrial fibrillation. The data of 6,977 patients was studied and of those patients, 2,434 of them were given a blood thinner within 60 days of their diagnosis. Researchers discovered that patients who had a chronic kidney disease and used an anticoagulant, either a vitamin K agonist or direct oral anticoagulant, increased their risk for a stroke rather than prevented it as the medication is intended.
January 26, 2018 – New Blood Thinner Outperforms Pradaxa In Korean Market
Of the new generation blood thinners that have replaced Warfarin, Lixiana by Daiichi Sankyo is the newest to come onto the market in Korea. This non-vitamin K antagonist anticoagulant has outperformed Boehringer Ingelheim’s Pradaxa despite being a latecomer to the NOAC (non-vitamin K antagonist oral anticoagulant) market. Lixiana’s monthly prescriptions began to exceed those of Pradaxa in July of 2017. By November Lixiana’s prescription soared up 19.8 % to 1.95 billion beating Pradaxa again which had 1.63 billion prescriptions. The current market leader, however, is Xarelto which had 3.55 billion prescriptions in November 2017.
December 28, 2017 – Labor Union In Korea Upset Over Pradaxa Maker’s Early Retirement Program
On December 12, Boehringer Ingelheim announced their plan for an early retirement program in the company’s Korean unit for the cardiovascular disease department’s 49 employees. The labor union states that the company violated bargaining rules because they only notified them 2 days prior to this announcement rather than the agreed upon 50 days. Boehringer Ingelheim decided to disintegrate the unit after 2 of their drugs, Pradaxa and Twynsta, underperformed.
November 30, 2017 – Results Of Study On Pradaxa Reversal Agent Released
The phase III RE-VERSE AD study evaluated the safety and effectiveness of idarucizumab, or Praxbind, as it is sold in the United States. Praxbind is the reversal agent for the anticoagulant Pradaxa. Results of two of the analyses were announced on November 13, 2017, at the American Heart Association Scientific Sessions 2017 in Anaheim, California. The results found Praxbind to be effective within minutes at reversing the effects of the anticoagulant so that emergency measures such as surgery can take place if needed.
October 19, 2017 – Study Finds Pradaxa Bleeding Risks Increase When Taken With Some Drugs
A study that was published on October 3 in the Journal of the American Medical Association in which researchers looked at the new generation anticoagulants and the potential for bleeding when they are taken with other drugs. Safety concerns surrounding drugs such as Pradaxa and Xarelto have been present despite the heavy marketing that the drugs do not require as much monitoring as alternative blood thinners such as warfarin. The study completed in Taiwan found that the risks of major bleeding increased when patients took one of the new generation blood thinners at the same time as amiodarone, Rifadin (rifampin), Diflucan (fluconazole), or Dilantin (phenytoin).
September 22, 2017 – New Report Links Anticoagulants To Highest Number Of Reported Prescription Medication Injuries
The Institute for Safe Medication Practices (ISMP) analyzed data from the CDC and recently published a report which concluded that the prescription medication which is most likely to result in patients visiting the emergency room is blood thinners, such as Pradaxa. The data that was analyzed shows almost 22,000 injuries related to anticoagulants last year, including over 3,000 fatalities. Almost half of these reported injuries required a hospital stay. Due to the fact that the FDA only tracks voluntary reports, the CDC states that the real number of injuries caused by blood thinners could be as much as ten times greater than the numbers recorded.
August 31, 2017 – Mississippi Woman Files Pradaxa Lawsuit
Boehringer Ingelheim Pharmaceuticals settled a multidistrict litigation in 2014 for $650 million over their blood thinner, Pradaxa after plaintiffs alleged that the company failed in its duty of reasonable care with labeling and/or marketing, testing, design, and manufacturing. Now, after the settlement, a new lawsuit has been filed by a Mississippi woman who claims in her suit that the anticoagulant caused her to suffer a severe gastrointestinal bleed which required hospitalization. In her suit, she claims that the drug maker failed to provide adequate warnings of the risks present when taking the drug.
July 17, 2017 – Final Results Of Study On Pradaxa Reversal Agent Complete
The final results of the RE-VERSE AD study were released by Boehringer Ingelheim on July 11. The findings were presented at the International Society on Thrombosis and Haemostasis 26th Biennial Congress in Berlin, Germany and simultaneously published in the New England Journal of Medicine. The study results showed that Praxbind was able to completely and successfully reverse the effects of the anticoagulant Pradaxa. The authors reported that there were no serious adverse safety signals related to the reversal agent observed in the study.
June 27, 2017 – Pradaxa Lawsuit Filed By Family Of Deceased Man
A family is suing Boehringer Ingelheim Pharmaceuticals Inc. after the death of their family member, in November 2012, who was using the anticoagulant, Pradaxa, which is manufactured by the company. The family did not partake in the previous $650 million Pradaxa settlement over fatal bleeding risks when taking the blood thinner. The plaintiffs in the wrongful death suit claim that the pharmaceutical company’s widespread discovery misconduct should carry over to this case. The case is scheduled to go to trial this month.
May 26, 2017 – Several Plaintiffs File Pradaxa Lawsuit Alleging Injuries From Side Effects
On April 3, three plaintiffs filed a lawsuit against Boehringer Ingelheim Pharmaceuticals Inc. and several others in the San Francisco County Superior Court. The complaint alleges negligence for failing to warn consumers of the dangerous side effects of uncontrollable and/or excessive bleeding that occur when taking the anticoagulant, Pradaxa. The plaintiffs all claim to have suffered injuries they attribute to their use of the drug.
April 28, 2017 – FDA Grants Tentative Approval Generic Form Of Pradaxa
On Wednesday, April 19, the U.S. Food and Drug Administration granted tentative approval to the drugmaker Glenmark to sell the generic form of the drug Pradaxa. There are currently lawsuits filed against the manufacturers of Pradaxa, Boehringer Ingelheim, for failing to warn consumers of the serious bleeding risks associated with the anticoagulant. Glenmark is attempting to grow their company and has already received 3 other approvals for drugs in the U.S. this year.
March 31, 2017 – Pradaxa Gains An Antidote With Praxbind In The UK
The UK has added Praxbind to the national antidote list. The drug is manufactured by German-owned Boehringer Ingelheim and is licensed for use in adults who are treated with the company’s anticoagulant Pradaxa. Praxbind is the only drug to be licensed in the UK as an antidote for oral anticoagulants that do not use vitamin K as a reversal agent. The drug was launched in December 2015 in the UK and the addition to the list means that hospital pharmacies need to make sure it is available to be used within one hour in case of emergency situations with patients.
February 24, 2017 – Daughter Blames Mother’s Death On Pradaxa
The daughter of an elderly woman is speaking out regarding her feelings on the blood thinner Pradaxa. After learning about the new anticoagulant as a part of a “patient familiarisation program” the 84-year-old patient eagerly switched from warfarin to Pradaxa. Unfortunately, the woman quickly developed a bleed and ended up in the hospital twice before deciding to switch back to warfarin. It was too late though according to her daughter, who found her mother underneath the dining room table. She believes she had a massive stroke and stated that she wished her mother had never heard about the new blood thinners.
January 30, 2017 – Unmet Need For Reversal Agent For New-Generation Anticoagulants
The new-generation anticoagulants have been developed as a replacement for the traditional blood thinner, warfarin. While there are several advantages to the Factor Xa Inhibitors many of the new blood thinners such as Pradaxa and Xarelto have hundreds of lawsuits filed against the manufacturers alleging personal injury and/or death due to side effects suffered from the use of the drugs. The traditional anticoagulants have the advantage of having a reversal agent in vitamin K while almost all of the new generation anticoagulants are still awaiting a reversal agent to be approved by the FDA. According to a Portola Pharmaceuticals sponsored article, mortality related to FXa-associated bleeding is seen in realworld registry data. Many are hopeful that a reversal agent will be approved in 2017, as the need for the use of FA inhibitors increases.
December 12, 2016 – In Combination With Some Statin Medications, Pradaxa Could Cause Serious Complications
A Canadian study suggests that Pradaxa taken with some statin medications could increase the chances of bleeding in patients. Dr. Andrew Rogrove, the medical director of stroke at Northwell Health’s Southside Hospital in Bay Shore, N.Y., pointed out that the authors of the study had identified a “potentially serious problem,” and that “there are alternate statin drugs that do not have this effect on Pradaxa.” Dr. Kevin Marzo, chief of cardiology at Winthrop-University Hospital in Mineola, N.Y., pointed out that “As many as 50% of patients on [Pradaxa] are also taking a statin.”
November 9, 2016 – POGO Calls FDA’s Drug Approval Of Pradaxa “Lax”
The Project on Government Oversight issued a report with several criticisms of the way in which the FDA handled the approval process and ongoing evaluation of the drug Pradaxa on October 15. The report incorporated interviews with patients and researchers and pages of summarized history of the drug that is public record. The report described the FDA’s approval process of the blood thinner as “lax” or “permissive” in terms of standards for drug safety and clinical trials. Some of the breaches mentioned included the granting of approval despite no antidote to counter side effects, the single trial performed was not “blinded”, and members of the FDA that reviewed Pradaxa had ties to the pharmaceutical industry.
October 24, 2016 – Summary Judgment Denied, Pradaxa Lawsuit Can Proceed To Trial
A wrongful death lawsuit that failed to be settled in the $650 million settlement agreement in 2014 is set to go to trial on December 5th in the U.S. District Court for the District of Massachusetts. This is expected to be the first case to go to trial regarding the side effects of blood thinner Pradaxa. Boehringer Ingelheim, the drug manufacturer, filed a motion for summary judgment but a federal judge rejected it last week.
September 29, 2016 – Despite Antidote Pradaxa Lawsuits Continue To Be Filed
A little more than two years ago Boehringer Ingelheim settled for $650 million with plaintiffs who alleged their blood thinner, Pradaxa, posed serious and life-threatening risks in 4,000 lawsuits consolidated into MDL. Yet despite the settlement, more lawsuits are being filed, which include class action suits, such as the one recently filed in Connecticut Superior Court, Hartford Judicial District. Only recently the FDA approved Praxbind, the reversal agent for Pradaxa. It continues to be the only new generation anticoagulant to have an available antidote for emergency bleeding events.
August 31, 2016- Latest Data On Pradaxa Safety & Effectiveness
The latest Pradaxa safety and effectiveness research has revealed that treatment with Pradaxa was linked with low incidents of stroke, bleeding and life-threatening bleeding. The results were presented from a trial of about 3,000 patients with non-valvular atrial fibrillation (NVAF) at the ESC Congress 2016 in Rome, Italy. There was another study that was recently launched by RE-VECTO, which captured data on Praxbind usage in clinical practice. Praxbind is a reversal agent that has been approved for use in emergency situations when there is a need to reverse the anticoagulant effect of Pradaxa.
July 13, 2016- Boehringer Not Allowed Extra Time For Pradaxa Patent
On July 6, 2016, a federal court ruled that Boehringer Ingelheim is no longer entitled to have a longer patent term extension for the time it lost while the FDA reviewed and approved of its blood thinner Pradaxa. Boehringer filed a lawsuit against the FDA stating that the FDA incorrectly determined the length of the patent term extension. A judge dismissed the case.
June 28, 2016- Praxbind Now Available In Hospitals To Stop Pradaxa Bleeding Problems
The recently approved Pradaxa reversal agent Praxbind is now available in numerous hospitals nationwide. Boehringer Ingelheim announced that Praxbind has been stocked in more than 2,200 hospitals all over the United States. There is also a Praxbind locator tool that is available on the manufacturer’s website which enables identification of facilities that have the drug in stock near health care providers and patients.
April 19, 2016- Industry Payments Under Scrutiny For Not Educating Doctors About New Drugs
A Pro Publica study released in March is providing vital insight into just how much influence industry payments are making on medications doctors prescribe. This industry payment of doctors is believed to influence the prescription of newer drugs like dabigatran also known as Pradaxa, that would have little known about rare or longer term harmful effects. In addition drugs like Pradaxa are said to not usually include older people and those with other serious health conditions in pre-market studies. This was the case with Pradaxa, an anticoagulant used to prevent strokes. The drug had no pre-market testing in people over 85, but it was quickly frequently prescribed to this particular age group leading to harmful adverse effects.