Harold Asher never thought to ask why his wife’s doctors prescribed Boehringer Ingelheim GmbH’s blood thinner Pradaxa after she recovered from a stroke.
Barbara Jean Asher took Pradaxa for three months to cut her risk of suffering another stroke. Then, in June 2011, she was rushed to a hospital with internal bleeding that proved fatal, her family said in a lawsuit blaming Ingelheim, Germany-based Boehringer for her death. Asher, 72, a grandmother from a suburb of Palm Springs, California, died when doctors couldn’t stop the hemorrhaging, the family said.
“My generation, you do what your doctor tells you,” Harold Asher, 77, said in a telephone interview on her switch to Pradaxa from an older type of blood thinner. “You don’t ask any questions.”
Hundreds of patients and their families are questioning whether Boehringer executives knew Pradaxa posed a deadly risk to some patients when they brought the drug to the U.S. market in October 2010. Unlike older blood thinners, researchers said, Pradaxa has no antidote to reverse its effects, which can lead to so-called bleed-out deaths.
Pradaxa has generated more than $1 billion in sales worldwide for closely held Boehringer, the world’s biggest family-owned drugmaker. Researchers have found it more effective at preventing strokes than older competitors, including Bristol-Myers Squibb Co.’s Coumadin.
Pradaxa has been linked to more than 500 U.S. deaths over a two-year period, and Boehringer now faces more than 150 suits over claims that it sold the drug knowing the medicine could cause bleed-outs among some patients, plaintiffs’ lawyers said.
The drugmaker probably will face thousands more claims over the medicine in coming years, the attorneys said.
Boehringer reported Oct. 2 that 120 suits had been filed in federal court by then. Another 34 federal cases have been added since, most in southern Illinois, according to court records. About a dozen additional Pradaxa claims are pending in state courts.
Boehringer officials acted “appropriately and responsibly” when developing and marketing Pradaxa and believe the drug has a “positive benefit-risk profile,” Emily Baier, a U.S. spokeswoman, said in an e-mailed statement
“Boehringer Ingelheim believes the product liability lawsuits filed against the company regarding Pradaxa are without merit,” she said. The company will defend every case, she said.
The U.S. Food and Drug Administration approved Pradaxa in 2010 as a safe and effective alternative to 58-year-old Coumadin, a brand of warfarin, for preventing strokes caused by blood clots.
Doctors routinely relied on aspirin and warfarin to help prevent strokes in 2.2 million Americans with an irregular heartbeat known as atrial fibrillation, for example. Warfarin, developed as a rat poison, was approved by the FDA as a medication in June 1954.
Bristol-Myers began selling it as a blood thinner under the name Coumadin. The drug is now sold cheaply as a generic. Doctors were eager for an alternative that didn’t require regular blood tests to ensure correct dosing.
Since Pradaxa doesn’t require as much monitoring, sales skyrocketed. It has racked up about 1.13 billion euros ($1.48 billion) in sales worldwide over almost two years starting in 2011, Boehringer executives said in earnings reports and an e-mailed statement.
In April, the company said operating income in 2011 rose 20 percent, from 1.9 billion euros to 2.27 billion euros as Pradaxa sales increased.
Concerns about Pradaxa’s safety surfaced soon after U.S. doctors began prescribing it. FDA officials said they received reports of 542 deaths and 3,781 side-effect incidents tied to the drug in 2011.
The drug generated more reports of injury or death than any of the 800 medicines monitored by the Institute of Safe Medication Practices, a Horsham, Pennsylvania-based nonprofit group that studies medication use.
Boehringer acknowledged in November 2011 that Pradaxa had been linked to 260 deaths worldwide after a German magazine reported European regulators received reports of 256 deaths tied to the drug.
Three doctors in New Zealand sent a letter to the New England Journal of Medicine in March saying a two-month audit of medical records in that country found 78 bleeding incidents tied to Pradaxa. The drug went on the market in New Zealand in 2011.
In August, Japanese regulators ordered Boehringer officials to warn physicians that patients using the version of Pradaxa sold in that country faced bleeding risks and no antidote was available to reverse its anti-coagulation effects.
The lack of an antidote makes Pradaxa “a truly defective drug,” said Hunter Shkolnik, a New York-based lawyer who has sued Boehringer on behalf of Pradaxa patients and their families. “There’s no way you can reasonably market this as a safer alternative to other blood thinners.”
Giving warfarin patients Vitamin K can reverse the drug’s effects and help stop bleed-out deaths, according to a report published by the National Institutes of Health.
Suits filed against Boehringer in federal courts across the country have been consolidated for pretrial information exchanges before U.S. District Judge David Herndon in East St. Louis, Illinois.
Tor Hoerman, a Chicago lawyer on a five-member plaintiffs’ steering committee in the cases before Herndon, said the judge has set the first case for trial in March 2014.
Other committee members include Mikal Watts, a Texas-based plaintiffs’ lawyer, and Michael London, a New York-based lawyer for Pradaxa patients. Watts represents Asher’s family in its suit against Boehringer over Pradaxa.
Hoerman said the drugmaker can expect to face as many as 4,000 suits comprising those before Herndon and in state courts in Delaware, California, Illinois and Connecticut.
“The federal judge overseeing these cases understands the need for an early trial, so he has put us on a fast track,” Hoerman said. “That may help us get a quicker resolution of claims that this drug harmed people.”
Boehringer officials said they have toughened warnings about Pradaxa’s bleeding risks and point to reports issued in October by the FDA and European health regulators backing Pradaxa’s safety profile.
FDA regulators found the drug didn’t pose a higher bleeding risk to patients than those faced by people taking warfarin. European Medicines Agency officials have said they believe Pradaxa’s benefits in reducing the chances of a stroke outweigh its bleeding risks.
On a website about Pradaxa, Boehringer executives said that some patients, including those older than 75 or those with kidney problems, are at a higher bleeding risk while on the drug. “Pradaxa can cause bleeding, which can be serious and sometimes lead to death,” the drugmaker said on the site.
Boehringer is likely negotiate a global settlement to resolve the claims, Carl Tobias, who teaches product-liability law at the University of Richmond in Virginia, said in a phone interview.
“International drugmakers don’t have that much familiarity with the U.S. justice system, and that means that many times they aren’t as comfortable taking cases to trial as U.S.-based pharma companies might be,” Tobias said.
“That often prompts companies like Boehringer to be more quick to settle,” he said. “It will all come down to how much Boehringer has to pay to make these Pradaxa claims go away.”
The case is In re Pradaxa Products Liability Litigation, 12-MD-2385, U.S. District Court, Southern District of Illinois (East St. Louis).