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Pradaxa is a prescription, blood-thinning medicine used to reduce the risk of stroke and blood clots in people with atrial fibrillation. Pradaxa bleeding events are alleged to have resulted in thousands of injuries, some resulting in fatal bleeding deaths. More than 4,000 lawsuits were filed as a result of the adverse side effects.
October 17, 2018 - A West Virginia jury awarded $1.2 million to the family of Betty Knight, a woman who died while taking the blood thinner, Pradaxa. The verdict is the first to award to a consumer alleging injuries from the drug.
The jury found that Boehringer Ingelheim committed fraud by misrepresenting facts, according to an article on Law360. The jury's award included $1 million in punitive damages.
May 29, 2014 - THL announced the settlement of nearly 4,000 cases filed by individuals who claimed they were injured by Pradaxa usage. The manufacturer, Boehringer Ingelheim, admits no wrongdoing. Tor Hoerman was a co-lead attorney in the litigation that leads to this settlement of $650 million.
"This settlement allows those who believe they were injured by Pradaxa to receive fair compensation for their claims. We appreciate that the defendants did the right thing, we congratulate the lawyers that worked so hard to achieve this settlement, and we look forward to continuing our work to see that the plaintiffs receive the compensation to which they are entitled under the terms of the settlement," Hoerman said.
The Pradaxa settlement will compensate plaintiffs who allege that they were injured from severe bleeding events caused by Pradaxa and in most cases, the doctor was unable to control these bleeds.
January 30, 2014 - In a dissent that reads like an angry mother grounding a child for complaining about punishments provided by dad, Judge Hamilton tells Boehringer Ingelheim (hereinafter Boehringer) that the petitioner-defendants use of a procedure referred to as a "writ of mandamus" was weak-kneed.
A "writ of mandamus" is an extraordinary court order that asks a higher court to direct a lower court to act in a certain way. Traditionally, courts don't like to rule on writs of mandamus because these rulings are not on the merits of a case. In this specific case, the writ asks the Court of Appeals to tell a District Judge that he has overstepped his boundaries in ordering a specific sanction.
In the lawsuit, the petitioner-defendant is Boehringer Ingelheim, the manufacturer of prescription blood thinner Pradaxa. Boehringer finds itself in a court in the Southern District of Illinois. Judge Herndon presides over the consolidated Pradaxa litigation, in which injured victims allege that Boehringer failed to warn the public about the risk of bleeds due to blockbuster Pradaxa.
The lawsuit is now in the discovery stage, during which each side of the lawsuit is entitled to fully investigate the other side's position. As is typical with all large consolidated cases, the judge set out very specific instructions guiding the expectations for both the plaintiffs and the defendants during the lawsuit. As was noted by both the district court and the court of appeals, the defendants simply were not complying with Judge Herndon's orders and their discovery obligations.
Although it is not common for a judge to impose fines and sanctions on a party, Judge Herndon has imposed sanctions on Boehringer on two separate occasions, warning the defendants that he will not tolerate the disregard of discovery rules and court orders. The last set of sanctions was handed out in December when Judge Herndon ordered Boehringer to pay a fine of almost $1 million and directed the defendants to bring certain employees to New York City for future depositions, rather than requiring the plaintiffs to travel to Amsterdam to depose these key witnesses.
Both the majority and dissenting Seventh Circuit opinions noted that, in light of the cumulative effect of the defendant's repeated and serious failures, the district court's inferences of bad faith were reasonable and well supported. However, the majority and dissenting opinions disagreed on whether Judge Herndon had the right to order thirteen depositions moved from Amsterdam to New York.
Although the majority agrees that the unjustifiable delays imposed on discovery warrants sanctions, the court takes issue with the form of the sanctions ordered by Judge Herndon. Specifically, the majority concluded that ordering the thirteen depositions moved to New York would violate the federal legal limitations on compelled discovery in foreign countries and would punish the witnesses for the actions of their employer (Boehringer). The majority concludes that Judge Herndon exceeded his authority in ordering the location of the depositions changed and orders the district court to revisit the entire sanctions package "now that this relatively mild sanction about deposition location has been removed."
Like the angry mother, the Seventh Circuit Court of Appeals does what every good parent-team would do - send the weak-kneed kid back to dad for further punishment with the warning that they may regret ever second guessing the first round of punishment.
September 18, 2013 - "I have never seen a litigation with so many ongoing problems. There has been a simple disregard of court orders that have frustrated the Court beyond comprehension."
Judge Herndon directed these words at corporate officers of Boehringer Ingelheim Pharmaceuticals and their defense counsel who were ordered to appear in U.S. District Court for the Southern District of Illinois so the Court could impress upon the parties the importance of compliance with its orders.
Prior to the conference, Judge Herndon asked the plaintiff's attorneys to list all of the discovery violations to date. After listening to arguments from both plaintiff and defense counsel with regards to these specific discovery violations In re:Pradaxa MDL No. 2385, Judge Herndon agreed with the plaintiff's counsel that the totality of the circumstances is what counts in this circumstance rather than any one specific violation, and that the defendant's behavior was not acceptable. To that end, Judge Herndon adopted the entire list provided by plaintiffs' counsel finding that each item was a violation made by the defense, who have established a pattern of failing to meet either the letter or the spirit of court orders with respect to discovery.
Judge Herndon noted that, despite apologies from Boehringer Ingelheim General Counsel, Marla Perskey, it is hard to determine where the fault lies in these violations and identified that fault might lie with outside counsel, the defendant, or their employees. Paul Schmidt, lead counsel for Boehringer Ingelheim, noted that defense was not in court today to beg forgiveness and he insisted that the defendants are taking actions to demonstrate that they are taking the court's warning seriously. In the end, Judge Herndon ruled that regardless of whether these were deliberate violations, gross negligence or a corporate leadership failure, remedy for these violations does not require a determination of fault or motive.
The defense attempted to explain the violations individually, but the Court ruled that the violations were so numerous and ongoing that they amounted to a pattern that prejudiced the plaintiffs and demonstrated a low regard for the court and its authority. Judge Herndon noted that defense can't continue to fail-then-apologize, then start from scratch as in this litigation. He noted that conduct is what counts and it has a cumulative effect.
For these reasons, Judge Herndon ordered Boehringer Ingelheim to pay sanctions in the amount of $29,540 and imposed a number of mandatory injunctions upon the defendants that are designed to keep the case moving forward without continued delays due to discovery violations. Although this is not a significant fine for a company that has already spent over $24 million on the Pradaxa litigation, it should serve as a warning that this court will take violations and delays seriously.
October 5, 2012 - A courtroom full of attorneys gathered in the Southern District of Illinois Court for the initial conference in the multidistrict litigation for Pradaxa in front of Chief Judge David Herndon.
In Case Management Order Number 6 – Unified Case Management Plan there were five bellwether trial dates selected for the summer and fall of 2014, a time that THL referred to as the "bellwether season."
Bellwether cases are chosen to represent all the plaintiffs (which as of October 2012 included over 130 plaintiffs in the Pradaxa MDL) in an effort to determine common claims or theories. While this doesn’t mean that every case will be decided at the end of the bellwether season, the results from the bellwether cases will be critical information in evaluating the strength of this case.
September 27, 2012 - Chief Judge David R. Herndon of the Southern District of Illinois, the judge who presided over the federal Pradaxa litigation, announced the plaintiffs’ leadership counsel who oversaw the interests of the plaintiffs in the Pradaxa litigation. Tor Hoerman was named as Co-Lead Counsel and Steven Davis was named as Co-Liason Counsel.
Tor was proud to be named to leadership and welcomed the opportunity to work with the following other exceptional attorneys, each of whom was also co-lead counsel:
In addition, the court appointed an exceptionally highly qualified executive and steering committee.
August 2012 – The Joint Panel on Multidistrict Litigation, a panel of federal judges that manages the coordination of mass cases, entered an order consolidating all current and future federally-filed Pradaxa cases in front of Judge David R. Herndon, chief judge of the Southern District of Illinois.
Given the complexity of this litigation and anticipated resource demands that accompany "mass tort" (multiple plaintiffs injured in a similar fashion by a defective product) cases, the consolidation is intended to allow the litigation to move forward in an efficient, organized and timely manner.
Although the order originally identified 21 actions pending in eleven district courts, the number grew tremendously.
The attorneys at TorHoerman Law worked diligently to move the Pradaxa litigation forward. TorHoerman Law cases were among the first filed cases in the Southern District of Illinois. Earlier, Judge Herndon ruled in favor of our plaintiffs by denying motions to dismiss filed by Boehringer Ingelheim.
Pradaxa (dabigatran) is a prescription medication used to prevent strokes in atrial fibrillation patients. Atrial fibrillation affects more than five million people in the U.S. It is a dangerous condition – a type of cardiac arrhythmia that greatly increases the risk of stroke.
The medication was designed to prevent strokes by thinning the blood enough to prevent a blood clot from forming in the heart and traveling to the brain. Manufactured by German company Boehringer Ingelheim, the drug was approved for use by the U.S. Food & Drug Administration (FDA) in October 2010. Although Pradaxa has only been on the market since 2010, its hype began long before.
Pradaxa gained momentum as the result of an “RE-LY Clinical trial” (Randomized Evaluation of Long-term anticoagulant therapy) sponsored by Boehringer Ingelheim Pharmaceuticals. The RE-LY trial concluded that vitamin K antagonists such as warfarin are cumbersome to use, because of their multiple interactions with food and drugs, and they require frequent laboratory monitoring. Oral Vitamin K antagonists, such as warfarin, have been used in various indications for more than 50 years.
The RE-LY Clinical trial, sponsored by Boehringer Ingelheim Pharmaceuticals, went on to suggest that there was a need for new anticoagulant agents that are effective, safe, and convenient to use. The marketing materials suggested that Pradaxa represented a therapeutic simplification and therapeutic progress because it did not require patients to undergo periodic monitoring with blood tests.
Boehringer Ingelheim’s marketing strategy RE-LYs very heavily relied on the findings of their clinical trial and it has paid off – Pradaxa was predicted to become one of the leading therapies in the atrial fibrillation drug market.
But, one year after its FDA approval, Boehringer Ingelheim acknowledged 260 deaths associated with the use of Pradaxa.
Unfortunately, there are too many instances where products prove to be more dangerous than the company-sponsored studies indicated. Further, history is filled with examples of companies responding improperly when negative safety information comes to light about potential blockbuster products. It is inherently difficult for companies to make the right decision when profits can be so marginalized by disclosure of safety risks.
Unfortunately, as of November 14, 2014, 35,549 reports of a serious adverse event identified Pradaxa as the primary suspect drug causing the event.
According to voluntary reports to the FDA from health professionals and consumers, in 2011, Pradaxa surpassed all other monitored drugs in several categories, including the overall number of reports (3,781), deaths (542), hemorrhage (2,367), acute renal failure (291) and stroke (644).
In October 2015, the FDA approved an antibody, Praxbind (idarucizumab), which has been shown to reduce the anticoagulation effects of Pradaxa.
Did you suffer from the following side effects while taking Pradaxa?
Please contact your doctor to consider whether Pradaxa may currently, or will, cause an issue.
If you have any questions regarding a Pradaxa lawsuit, please contact the Pradaxa lawyers at TorHoerman Law.
April 12, 2016 - A single 5g dose of Praxbind immediately reversed the anticoagulant effects of the blood thinner Pradaxa in all patients evaluated, according to an ongoing phase III RE-VERSE AD patient study presented at the American College of Cardiology 65th Annual Scientific Session and Expo in Chicago on April 2.
RE-VERSE AD is an ongoing study involving patients taking Pradaxa who have uncontrolled bleeding events or require emergency procedures. Since May 2014, researchers in this study have been evaluating the effectiveness of idarucizumab for the types of patients healthcare professionals treat in real-world emergency situations – those with uncontrolled or life-threatening bleeding complications, and those requiring emergency surgery or an invasive procedure.
The U.S. Food and Drug Administration (FDA) approved Praxbind (idarucizumab) in October 2015 as the first specific reversal agent created for Pradaxa and works by binding to the drug compound to neutralize its effect. The approval was based on three randomized, placebo-controlled trials enrolling a total of 283 healthy volunteers who received either dabigatran and idarucizumab or dabigatran and placebo.
Reversing the effects of Pradaxa exposes patients to the risk of blood clots and stroke from their underlying disease, and the medication's labeling recommends patients resume their anticoagulant therapy as soon as medically appropriate, as determined by their health care provider.
October 9, 2013 - Complaints about the safety of blood-thinner Pradaxa spread overseas. The families of four elderly people who died while taking Pradaxa filed complaints against France's drug safety body and Germany-based drug maker Boehringer Ingelheim. These complaints allege that Pradaxa was put on the market without adequate testing on the elderly population. Furthermore, like the plaintiffs in the cases filed in the United States, the French families allege that the pharmaceutical company failed to provide proper warnings about the product's potential dangers. Although prescribed to prevent strokes, Pradaxa can cause severe internal bleeding and has been linked to a number of deaths.
The French lawsuits involve individuals that were between the ages of 70 and 83 and died in the beginning of 2013 while taking Pradaxa. Their complaints allege that Boehringer Ingelheim did not sufficiently study the side effects of Pradaxa in the elderly. In addition, the complaints allege that, unlike some other anti-clotting drugs, there is no antidote to Pradaxa, and therefore there is no way to stop or control bleeding once it starts.
December 20, 2012 - The FDA warned that the anticoagulant dabigatran (also known by its brand name Pradaxa) should not be prescribed to prevent stroke or thromboembolic events in patients with mechanical (also known as mechanical prosthetic) heart valves. The warning was also issued to European doctors by the European Medicines Agency (EMEA).
The warning was announced just two weeks after the FDA's decision to stop the RE-ALIGN trial. RE-ALIGN was a global, Phase II trial that was created to evaluate the safety and pharmacokinetics of Pradaxa in 400 patients who have mechanical heart valves. The 12-week study compared three doses of Pradaxa to warfarin in patients with both aortic valve replacements and mitral valve replacements. Investigators stopped RE-ALIGN because the Pradaxa users were more likely to experience strokes, heart attack, and thrombosis forming on the mechanical heart valves than were users of warfarin. There was also more bleeding after valve surgery in the Pradaxa users, according to the FDA.
May 18, 2012 - According to Dr. Mark Wurster, M.D., the problem with dabigatran is that it has been presented as a "fire-and-forget" medicine. That is, the doctor can write a prescription and not think about it again. But anticoagulation is not like that. Just because patients on dabigatran don't need to have regular INR measurements doesn't mean they don't need monitoring.
Dr. Wurster made this statement after he presented preliminary results from his study “Dabigatran in the Real World” at the Thrombosis & Hemostasis Summit of North America (THSNA) in Chicago. This study, done over the course of more than a year, followed each of 113 patients for six months after each had been switched from warfarin to Pradaxa.
According to Dr. Wurster, there were 13 total incidents of serious adverse reactions to Pradaxa, including a death resulting from a Pradaxa-related bleeding incident, as compared to a single incident of warfarin toxicity resulting from warfarin treatment.
While Dr. Wurster is reluctant to call Pradaxa a “bad drug”, he has concerns regarding appropriate patient selection and regarding monitoring of those who use Pradaxa. His results indicate that Pradaxa's adverse effects appear more frequently in elderly populations and in female populations. The mean age for adverse event suffers was 73.4, and 71% of adverse event suffers were female.
He adds that the price of Pradaxa exacerbates this problem. "Many patients will start cutting the tablets in half or stop taking them altogether because of the expense. And that will be a big problem. If a patient was not compliant on warfarin, they will fare worse on these new drugs."
The study is only one more item in a string of bad news reports for Boehringer Ingelheim since Pradaxa hit the market in late 2010.
April 4, 2012 - A study published in the Journal of Clinical Neuroscience highlighted the substantial problem of emergency surgery for individuals taking Pradaxa (dabigatran). Pradaxa's effect, acting as an anticoagulant, cannot be rapidly reversed in order to perform emergency surgery, causing uncontrollable bleeding.
The study identified the pros and cons of Pradaxa, weighing the usefulness of this drug, marketed as a better alternative to Warfarin, against its severe risks. Determining that the risks of Pradaxa are great, the authors concluded:
"It is only a matter of time before we see case reports of irreversible bleeding during dabigatran-treated surgical emergencies and urgent attention must be paid to the provision of an effective, rapidly acting antidote. Surely it is irresponsible of any pharmaceutical company to release such a drug into the market and promote it extensively as a potential life-saving replacement for existing therapies without fully detailing the very real risk of irreversible hemorrhagic complications following trauma or at emergency surgery, no matter how small the numbers at such risk may be. These patients cannot be regarded simply as collateral damage."
March 20, 2012 - Boehringer Ingelheim (BI) was accused of intentionally misusing their medical-professional-only website. An anonymous general practitioner accused the company of intending to market Pradaxa to the general public through their site that is supposedly intended only for medical professionals.
The Prescription Medicines Code of Practice Authority (PMCPA) is a British organization responsible for monitoring the promotion of prescription medicines to health professionals and the provision of information to the public about prescription-only medicines.
Although the PMCPA did not find that BI's medical professionals' website was being used to target the public, it did cite BI for not providing a clear, prominent statement as to where the prescribing information can be found. This was a direct violation of clause 4.6 of the Code of Practice.
March 5, 2012 - A group of hematologists in New Zealand, concerned by what they were witnessing in the short time Pradaxa had been available there (since July 1, 2011), sparked a review that was done in collaboration with the Haematology Society of Australia and New Zealand. The review was published online on February 1, 2012, at the Journal of the American College of Cardiology. The review panel identified 78 bleeding episodes over the two-month review period, including 44 cases handled by the panelists. Of the 44 cases with which the panelists were intimately familiar, 12 were severe.
One of the major factors in these bleeding episodes, according to the panelists, is prescriber error. Those errors include prescribing Pradaxa for patients with impaired renal function, which is also identified as another of the four major factors contributing to the episodes. The impaired renal function makes it difficult for the body to clear the active, blood-thinning agents from the body, which increases the chance that a bleed will become severe. In the RE-LY trial, which serves as the basis for the FDA approval of Pradaxa and the label information, less than 20% of the participants had impaired renal function, while 58% of the New Zealand review population had at least moderate renal impairment.
A third factor identified by the panelists is patient age. While the average age in the RE-LY trial was 71 years of age, and less than one-third of the RE-LY participants were more than 80 years of age. Among the population reviewed by the panelists, more than two-thirds of the patients were over 80 years old. This is significant because moderate renal impairment is reported in half of all patients with atrial fibrillation (the chief indication for Pradaxa) who are over the age of 80, and as discussed above, renal impairment increases the chance that a bleed will become severe.
The fourth factor identified by the panelists is a complication arising from the lack of a reversal agent. If a patient being treated with warfarin begins to bleed, doctors can administer agents designed to counter-act warfarin, allowing the blood to clot and reducing the risk that the bleed will continue. No such reversal agent exists with Pradaxa. Doctors are not able to reverse its effects once a bleed is identified. This complication is compounded in patients who suffer from an impaired renal function; in such a patient, it may be days before the body can cleanse itself from Pradaxa and allow the body's natural clotting function to resume. Of course, many of these patients won't have the days required for the clearance to occur.
Because the population reviewed in New Zealand has demographic properties different from the population studied in the RE-LY trial, the panelists encourage post-marketing surveillance and adverse-event reporting, and they encourage those that prescribe Pradaxa to change risk-benefit discussions with their patients in light of these new post-marketing reports, especially in patients over 80 or with impaired renal function.
January 12, 2012 - Reports of adverse events continue to mount among users of Pradaxa, a drug approved to reduce the risk of stroke by inhibiting blood coagulation. A study identified more than 500 reports of fatal, disabling, or other severe hemorrhages.
Following on the heels of the other reports, the Institute for Safe Medication Practices (ISMP), a nonprofit organization educating the healthcare community and consumers about safe medication practices, suggests that "Pradaxa's adverse effects in high-risk patients deserves to be a national priority" as a result of its examination of the FDA MedWatch Reports from the first quarter of 2011 for dabigatran (Pradaxa).
ISMP publishes "Quarter Watch", an independent publication that monitors all domestic serious adverse drug events reported to the FDA. As we reported last month, the FDA asked anyone experiencing adverse events involving Pradaxa to contact the FDA MedWatch program and fill out a voluntary form under the Adverse Event Reporting System (FAERS) that could be used to help the FDA could make an informed decision about the safety of Pradaxa. The information provided by individuals supplements the adverse event information the FDA collects from health professionals and from the manufacturer.
ISMP analyzed 932 serious adverse event reports specifically coded as "serious" and submitted to the FDA under this process from the first quarter of 2011. According to ISMP, of the 932 serious cases involving Pradaxa, 120 cases resulted in death to the patient, 25 cases resulted in permanent disability and 543 cases required hospitalization.
ISMP saw evidence suggesting that some of the oldest patients may experience severe bleeds resulting in harm, rather than benefits, because of the one-size-fits-all dosing regimen of Pradaxa. The evidence gathered suggests that the oldest patients may require a lower dosage, which is currently unavailable. Furthermore, Pradaxa does not offer tools to individualize blood levels, patients are not routinely monitored to see if they are getting too much drug, and there is no readily available antidote like vitamin K for warfarin overdoses.
Boehringer Ingelheim has gained market share with Pradaxa as a therapeutic simplification compared to warfarin. A drug that is easier to use because it doesn't require weekly or monthly laboratory tests to individualize doses may be appealing to physicians and patients, but it certainly appears to be less safe for some, and it is time for the FDA to prioritize safety oversimplification.
January 10, 2012 - According to a Cleveland Clinic study evaluating the risk of acute coronary events, Pradaxa was associated with a greater occurrence of myocardial infarction (MI) or acute coronary syndrome when compared to other similar treatments such as warfarin, enoxaparin or a placebo.
The Cleveland Clinic information comes not from a single study, but from seven separate randomized controlled trials that included 30,514 patients, and not one of which included more than 3,500 patients. Furthermore, the patients were studied for six months or less in each of the studies. The authors of the Cleveland Clinic study could not explain the higher risk of a heart attack with Pradaxa (dabigatran) use. It may have been an issue with Pradaxa, but the authors suggest that it is possible that warfarin and the other drugs are possibly just better at preventing MI.
Boehringer Ingelheim does not agree with the Cleveland Clinic analysis and points to the original RE-LY trial which, it claims, found that the increased risk of heart attack was not statistically significant.
Although the RE-LY trial included more than 18,000 patients for more than two years, it is difficult to ignore the obvious large profit incentive involved. The RE-LY trial, which concluded that Pradaxa offers patients a therapeutic simplification, was funded by Boehringer Ingelheim, which is predicted to earn $1.3 billion in sales of Pradaxa by 2018.
There are issues with both studies, and more complete studies are needed to assess the safety of Pradaxa.
In an editorial accompanying the Cleveland Clinic analysis released in the Archives of Internal Medicine yesterday, Jeremy Jacobs, MBBS, and Jochanan Stessman, MD of Hadassah-Hebrew University Medical Center in Jerusalem, wrote:
"Uchino and Hernandez suggest that physicians step back for a moment, take their own pulse, and retain a critical view as a powerful new drug enters clinical use on a potentially massive scale.... The Robust finding that dabigatran is associated with increased rates of MI is alarming and emphasizes the need for continued critical appraisal of new drugs after phase III trials."
January 2012 - The number of reported injuries arising from the use of Pradaxa continued to grow at an unparalleled pace and yet financial and pharmaceutical analysts celebrated Boehringer Ingelheim as profits on its blockbuster drug, Pradaxa, continued to surge.
In the last three months of 2011, the FDA collected 3,000 reports of adverse events for Pradaxa, earning Boehringer Ingelheim's blockbuster drug the fifth spot on the Top Ten Drugs with the Most Adverse Reports List for 2011 Q4. Of those 3,000 reported adverse events, 459 deaths, 69 disabilities, and 1,331 hospitalizations resulted – making it the drug with the most associated deaths for the quarter.
Meanwhile, Boehringer Ingelheim enjoyed an increase in after-tax profits by 66% and sales increases of 5% as the financial and pharmaceutical journals attribute a large percentage of the increased sales to Pradaxa which officially graduated to "blockbuster" status as a result (blockbuster status is defined as generating annual sales of $1 billion or more).
Where was the disconnect? Why was this drug selling at such a high rate given all the negative press out there?
Thomas, Katie. "Study of Drug for Blood Clots Caused a Stir, Records Show." The New York Times, The New York Times, 5 Feb. 2014, www.nytimes.com/2014/02/06/business/study-of-blood-clot-drug-pradaxa-unnerved-its-maker-documents-suggest.html.
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