Thousands of people have experienced serious bleeding issues after using Pradaxa. More than 4,000 people will receive money from drug maker Boehringer Ingelheim as part of an MDL settlement related to Pradaxa.
Thousands of people who took Pradaxa suffered side effects, and hundreds of people died. These people and their families filed lawsuits for compensation.
More than 4,000 people who suffered damaging side effects from the blood thinner Pradaxa – including gastrointestinal, rectal and brain bleeding – filed lawsuits against the drug’s manufacturer, Boehringer Ingelheim Pharmaceuticals. Because Pradaxa was marketed heavily as safe and effective, doctors wrote millions of prescriptions for the new blood thinner after the U.S. Food and Drug Administration (FDA) approved it in October 2010.
But in 2011, more than 540 patients lost their lives after using Pradaxa, and thousands of other people reported suffering from serious side effects. One result of those fatalities and complications was the filing of claims against Boehringer Ingelheim. Many of these lawsuits were filed in federal court, and most were consolidated into a multidistrict litigation (MDL) in the U.S. District Court for the Southern District of Illinois.
U.S. District Court Judge David Herndon was to preside over more than one bellwether trial. But in May 2014, Boehringer Ingelheim announced it would pay $650 million to settle all 4,000 state and federal Pradaxa lawsuits.
“We are pleased that today’s settlement will bring justice and financial assistance to those hurt while taking Pradaxa,” Mikal Watts, a member of the 27-lawyer Plaintiffs’ Steering Committee, said in a statement. “We are proud of the settlement we have achieved, congratulate the company on doing the right thing, and look forward to distributing these funds to our clients as expeditiously as possible.”
In agreeing to the settlement, the company denied any wrongdoing.
“We continue to stand resolutely behind Pradaxa and believed from the outset that the plaintiffs’ claims lacked any merit,” Andreas Neumann, head of the Legal Department and general counsel for Boehringer Ingelheim worldwide, said in a statement.
“Notwithstanding our strong belief that we would prevail in these lawsuits, this settlement allows our company to avoid the distraction and uncertainty of protracted litigation over years and years.”
People Who Filed Pradaxa Lawsuits
Other people have already filed lawsuits. People like Berth Bivens, Helen and John Hawkins and Walter Daumler are representative of some of the claims made against Pradaxa’s manufacturer.
Bivens filed a claim in March 2012 in U.S. District Court for the Eastern District of Tennessee against Boehringer, alleging that Pradaxa led to the death of her mother, Nancy Brummett. The lawsuit claims that the company’s aggressive marketing did not take into account patient safety. “As a result of the defective nature of Pradaxa, persons who were prescribed and ingested Pradaxa for even a brief period of time, including Plaintiffs herein, were at increased risk for developing life-threatening bleeds,” according to the lawsuit.
In the same month, Helen and John Hawkins filed suit against Boehringer in U.S. District Court for the Eastern District of Kentucky. Helen Hawkins began taking Pradaxa in February 2011 to treat her atrial fibrillation. In March 2011, she was hospitalized for gastrointestinal bleeding, during which she underwent a blood transfusion. The suit blames Pradaxa for “severe and life-threatening injuries.”
Walter Daumler of Wisconsin watched his sister, Doris, bleed to death because of Pradaxa. Daumler told The New York Times that doctors told him there was nothing they could do because there is no antidote for the hemorrhaging caused by the blood thinner. Daumler said, “My No. 1 goal is to stop this insidious drug [and] to get this off the market, so others will not undergo or witness what I saw.”
Why Should You File A Pradaxa Lawsuit?
In some cases, filing a lawsuit is the only way to recoup money lost from hospital expenses, lost wages and, in the worst cases, funeral costs. Some people file Pradaxa lawsuits because they don’t want other families to suffer the way they have.
Walter Daumler of Wisconsin watched his sister, Doris, bleed to death because of Pradaxa. Daumler told The New York Times that doctors told him there was nothing they could do because there is no antidote for the hemorrhaging caused by the blood thinner. Daumler said, "My No. 1 goal is to stop this insidious drug [and] to get this off the market, so others will not undergo or witness what I saw."
People injured by Pradaxa allege drugmaker Boehringer Ingelheim willfully endangered the public through its use of deceptive marketing practices, failure to disclose risks and failure to provide adequate treatment methods for patients who experience severe bleeding events. Plaintiffs are also troubled by the fact Boehringer released the drug without an antidote.
In a statement released in February 2014, the company maintained: "We are certain that we can show in the legal cases that we have worked very carefully and responsibly in research, development and marketing of Pradaxa."
|Some other people who filed lawsuits include:|
|Roy Heady of Cookeville, TN was hospitalized for a brain hemorrhage after switching from warfarin (Coumadin) to Pradaxa.|
|Charles Jackson of Nashville, TN suffered intestinal bleeding after taking Pradaxa for only three weeks.|
|Harold Asher lost his wife, Barbara Jean, when she switched to Pradaxa. She was rushed to the hospital where she died because doctors couldn't stop the Pradaxa bleed.|
People injured by Pradaxa claim Boehringer Ingelheim:
- Marketed Pradaxa as safer and more convenient than warfarin, the standard blood thinning medication. In reality, studies showed that Pradaxa has the same or higher risk for bleeding events than warfarin. Also, there are antidotes for excessive bleeding suffered by warfarin patients, whereas, Pradaxa does not have an antidote.
- Misrepresented that Pradaxa was a "one-size-fits-all" drug, and did not require doctor check-ups to adjust dosage.
- Failed to adequately warn or disclose information regarding the risk of serious, excessive, uncontrollable and sometimes fatal bleeding.
- Failed to establish protocol or treatment methods for people who experience severe bleeding as a result of the drug.
- Failed to adequately research safety of the drug and establish variable factors in recommending doses of Pradaxa.
- Intentionally concealed the fact that Pradaxa was dangerous
- Failed in their duty to warn consumers
|In addition, lawsuits claim that Pradaxa's manufacturer did not adequately label the drug. Original labeling and prescribing information printed between October 2010 and March 2011 did not:|
|Include adequate dosing information with respect to patient's weight.|
|Provide adequate warnings about gastrointestinal bleeding, specifically in patients with gastrointestinal issues.|
|Provide adequate warnings about risk of bleeding in older patients and other at-risk populations.|
|Warn that there were no established methods for treating patients who suffered from excessive bleeding..|
There are many others who have reported severe bleeding injuries because of Pradaxa. If you or a loved one has suffered from internal bleeding because of this drug, you may have legal options.