Pradaxa is a drug that is intended to reduce the risk of stroke by treating blood clots. The drug is used by those who are prone to these blood clots since they have atrial fibrillation. Pradaxa is an anticoagulant that is supposed to keep the blood flowing freely through the body. However, there have been significant side effects that have been associated with the drug. Severe bleeding is a possibility, especially in the gastrointestinal area. This complication has resulted in a large number of lawsuits against the maker of the drug, Boehringer Ingelheim Pharmaceuticals. Although the company settled a large number of these lawsuits in 2014, there have been bellwether lawsuits going to trial in 2018 and 2019 brought by plaintiffs who were not part of the original settlement or lawsuits. Recently, plaintiffs won their first victories in the bellwether cases, possibly setting the stage for further settlements.
Pradaxa has been in use since it was approved by the FDA in 2010. Pradaxa was the first drug to market in its class, and the market for anticoagulants has been growing in recent years. While Pradaxa is one of the major drugs in the class, the market leader in terms of sales is Xarelto. About four years after the drug was first approved, studies were released showing that there was an increased risk of heavy bleeding associated with Pradaxa. One study showed that nearly one in ten people taking Pradaxa experienced heavy bleeding.
There were thousands of lawsuits filed against Boehringer Ingelheim, seeking compensation for injuries allegedly caused by Pradaxa. By 2014, there were approximately 4,000 cases in state and federal courts. Boehringer Ingelheim Pharmaceuticals entered into a settlement agreement for all of these cases, agreeing to pay a total of $650 million to settle all of the cases. The settlement followed sanctions against the company for abuses during the early part of the litigation. The company continued to maintain that the product was completely safe and that it entered into the settlement agreement to avoid the distraction of costly litigation.
However, the settlement agreement did not completely erase the prospect that Boehringer Ingelheim Pharmaceuticals would face future litigation relating to Pradaxa. There were thousands of users who had not filed suit yet at the time that the settlement agreement was reached. Further, the suit was settled for approximately $162,000 per claimant, and plaintiffs had the right to opt out of the settlement agreement and continue to pursue their claims in court.
As a result, the company still faced thousands of lawsuits stemming from the bleeding issue.
As what happens with many large scale product liability lawsuits against pharmaceutical companies, the remaining lawsuits were consolidated into multi-district litigation in federal court in Connecticut. The cases proceed down a common track for discovery. After that, the court will select several bellwether cases to be tried first. Once that happens, both the plaintiffs and the defendant will have an idea of how the jury views the merits of the cases and can act accordingly. Many times, companies who lose the bellwether cases feel the need to settle the cases to reduce their litigation risk.
2019 has seen plaintiffs’ fortunes begin to shift in these cases. In 2018, one plaintiff received a $1.25 million verdict from a jury in West Virginia when his spouse died from the bleeding. This trial was outside of the multidistrict litigation. In this case, the jury slapped Boehringer Ingelheim Pharmaceuticals with punitive damages for its gross and reckless failure to warn of the effects of the drug.
However, Boehringer Ingelheim Pharmaceuticals soon won several of the first bellwether cases in the multidistrict litigation, placing plaintiffs’ ability to recover from the company in doubt. Recently, a plaintiff had the first win in one of these multi-district bellwether cases. A Connecticut jury awarded the plaintiff $542,000 for the injuries that he suffered after using Pradaxa. This verdict is noticeably larger than the average settlement amount. Approximately $42,000 of the award was to compensate the plaintiff for his past medical bills. The rest of the verdict was for the plaintiff’s pain and suffering. In addition, the jury decided that the company should be assessed further punitive damages for its conduct. Like the case in West Virginia, this jury was seemingly bothered by the egregiousness of the company’s conduct in failing to warn patients and doctors about the potential for severe bleeding.
The next developments likely will involve appeals of both the previous verdict as well as the one in Connecticut. There are an additional 3,000 cases that are awaiting trial, and they may soon begin being heard in court. Now that the company has previously settled thousands of cases and has lost two recent cases, it may feel the need to enter into settlement discussions with the plaintiffs. The makers of Xarelto recently settled thousands of cases related to excessive bleeding for $775 million.
Another development in the Pradaxa cases was a California court’s dismissal of a number of lawsuits related to the drug. The cases were dismissed on grounds of jurisdiction as opposed to anything related to the merits of the cases. In other words, a jury did not find the maker of the drug not responsible. The reason why these lawsuits were dismissed was because neither the plaintiffs nor the defendants were California residents, and the drugs were not purchased in the state.
Anyone who has been injured by Pradaxa has a limited amount of time to bring a lawsuit before the statute of limitations expires.
Learn more about Pharmaceutical Lawsuits.