Lawsuits blame blood thinner Pradaxa for thousands of injuries and hundreds of deaths. Affected patients and their surviving family members are suing the drug’s maker, Boehringer Ingelheim.
Lawyers are filing lawsuits in state court in Connecticut, where Boehringer Ingelheim Pharmaceuticals’ U.S. headquarters is located.
These claims are similar or identical to thousands of Pradaxa lawsuits settled in 2014. Many of the current cases involve injuries that happened after the $650 million settlement.
As of Oct. 9, 2018, there were 2,619 pending cases in Connecticut.
In all, more than 6,000 people have filed lawsuits against Boehringer Ingelheim over harm they say was caused by Pradaxa.
The drug is linked to dangerous side effects, including uncontrollable bleeding. Marketing campaigns pushed the idea that the medicine was easy to take and didn’t require monitoring. But internal company documents showed that employees tried to quash a research paper. They feared it would lead to a blood test requirement.
Bellwether Trials in Connecticut
The first three Connecticut bellwether trials concluded in March, May and October 2018. All yielded jury verdicts in favor of Boehringer Ingelheim. These so-called bellwether trials can give the parties an idea of how the rest of the cases may proceed.
That woman, Mary Boone, died on March 24, 2014, from an uncontrolled gastrointestinal bleed. Her doctor prescribed Pradaxa to lower her risk of stroke from atrial fibrillation.
Boehringer Ingelheim argued in court documents that the drug’s warnings were adequate. The company maintained that Boone’s doctor understood the risks.
On March 23, 2018, jurors handed up a verdict siding with the drug company. As of October 2018, that verdict was on appeal, according to a spokeswoman for the Connecticut judiciary.
The second bellwether trial involved Mary Lou Gallam’s lawsuit. Gallam’s doctor prescribed Pradaxa for atrial fibrillation in 2011. She suffered a “major bleeding event” on April 9, 2014, according to court filings.
On May 7, 2018, jurors in the Gallam case handed up their verdict in favor of Boehringer Ingelheim.
The third trial involved William Bedsole, who lives in Pensacola, Florida. He says in his lawsuit that he was prescribed the drug around Nov. 29, 2010, for atrial fibrillation. About eight months later, he suffered a severe internal bleed and was hospitalized for three days.
On Oct. 5, 2018, jurors ruled that the drug company was not liable for Bedsole’s injuries and did not have to pay any damages.
A fourth bellwether had been scheduled for February 2019 in the case of by Roanna Loftis-Bryant. But court records show she withdrew her lawsuit on Aug. 1, 2018.
The next bellwether is likely to begin in April or May of 2019, according to a court spokeswoman. The exact date had not been set as of Oct. 9, 2018.
Life-Threatening Bleeding Reported
The U.S. Food and Drug Administration approved the drug in 2010. More than 540 people who took Pradaxa died in 2011. Thousands of other people reported suffering from serious side effects that year.
Emergency room doctors and trauma surgeons reported patients suffering life-threatening bleeding that was difficult to reverse. Boehringer Ingelheim sold Pradaxa for five years without a bleeding remedy.
Lawsuits say the drug causes a higher rate of life-threatening bleeds than the strokes or systemic embolisms it is intended to prevent.
According to one lawsuit, from October 2010 until the end of March 2011, American doctors wrote approximately 272,119 prescriptions for the drug.
During that time, there were 932 Pradaxa- associated serious adverse event reports filed with the FDA, including at least 120 deaths and over 500 reports of severe, life-threatening bleeding.
The lawsuit adds that from April 1, 2011 until the end of June 2011, there were another 856 adverse event reports filed with the FDA involving the drug. These included at least 117 deaths and over 510 reports of severe, life-threatening bleeding.
- Gastrointestinal bleeding
- Rectal bleeding
- Brain bleeding
Accusations against Boehringer Ingelheim
Pradaxa lawsuits say Boehringer Ingelheim developed a bleeding remedy in 2010. But the company didn’t seek approval for the remedy until Feb. 19, 2015. The FDA first approved Praxbind, a fast-acting Pradaxa antidote, in October 2015.
Pradaxa is effective only if dosed properly for individual patients. Lawsuits assert that there is no accurate test to check drug levels.
Company Accused of Endangering Public
The lawsuits further claim Boehringer Ingelheim misled patients and their doctors about Pradaxa’s risks and benefits. Patients say the company endangered the public through deceptive marketing practices. Lawsuits claim it did not adequately label the drug.
The complaints allege the company made massive profits while hundreds of patients died and thousands suffered serious injuries.
In fiscal year 2011, Pradaxa sales around the world surpassed $1 billion, lawsuits say, giving the drug what the industry deems “blockbuster” status.
Boehringer Ingelheim announced a Pradaxa settlement plan on May 28, 2014. It said it would pay $650 million to settle 4,100 lawsuits that were pending at the time.
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.”
Company: Claims 'Lacked Merit'
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 are no longer able to file these lawsuits in federal court as a result of the settlement.
Federal Judge Closed Consolidated Action
Before the settlement, people filed thousands of cases in federal court. A judicial panel consolidated most of the lawsuits into a multidistrict litigation (MDL). A judge in the U.S. District Court for the Southern District of Illinois managed the Pradaxa MDL.
U.S. District Court Judge David Herndon planned to conduct four trials. The trials were to happen between August 2014 and February 2015.
Herndon selected the cases to help attorneys determine the effectiveness of their arguments. Two were wrongful death lawsuits. Two blamed the drug for severe injuries.
But the trials never started. Boehringer Ingelheim settled the cases instead. Herndon closed the MDL in December 2017 after the last case was resolved.
Lawyers continued to file individual lawsuits. If a large number of people claim the same drug injured them, a judicial panel may group the cases.
Took out following low-value sentences: “On a federal level, this is multidistrict litigation. In state courts, it’s complex litigation.”
Please seek the advice of a medical professional before making health care decisions.