Thousands of patients who say they’ve been harmed by Xarelto (rivaroxaban) are suing drug companies for compensation. Potential awards or settlements are unknown. Loved ones of those who have died are suing, too.
In all, more than 18,000 suits allege companies are getting rich while putting “American citizens at risk of severe bleeds and death.”
Xarelto, approved in 2011, is described as “the first and only one-a-day prescription blood thinner” for patients with a common heart condition called atrial fibrillation not caused by a heart-valve problem.
The drug is designed to reduce stroke risks. But it doesn’t require the hassle of routine blood monitoring. Such tests are required for users of a much older blood thinner, warfarin (Coumadin).
According to Johnson & Johnson’s annual report, Xarelto brought in over $2 billion for the company in 2016 alone. It’s on track to become the 19th-best-selling drug in the world by 2018 with global sales of $3.7 billion. J&J subsidiary Janssen Pharmaceuticals markets Xarelto in the U.S. Bayer is the manufacturer.
Why Are People Filing Lawsuits?
People filing Xarelto lawsuits say the drug is dangerous because it can be tricky to administer and it can complicate wound healing.
The drug has a narrow therapeutic index, meaning there is small window between a safe dose and a dangerous one. That makes it is easy for a person to get too much or too little of Xarelto, attorney Ellen Relkin told Drugwatch. There is no antidote.
Xarelto does not require blood tests for monitoring. That’s why patients say the drug is defective and dangerous, said Relkin, a Weitz & Luxenberg attorney who sits on a panel overseeing federal lawsuits in Louisiana.
“In other words, it can be safe at a certain point and dangerous within a very close range,” Relkin said. “Someone can be 110 pounds or 200 pounds, old or young [and] with varying kidney functions and get the same dose and have a very different impact.”
“Someone can be 110 pounds or 200 pounds, old or young [and] with varying kidney functions and get the same dose and have a very different impact.”
– Ellen Relkin, Weitz & Luxenberg attorney
Relkin said people filed claims against Johnson & Johnson (Janssen) and Bayer because Xarelto warnings aren’t strong enough. Many patients were unaware Xarelto had no antidote, she said. J&J and Bayer, she said, promoted the drug’s benefits and downplayed risks.
Another issue with Xarelto is its link to wound infections. Since blood thinners reduce clotting, cuts take longer to heal. The risk of an infection increases the longer wounds are left exposed.
Relkin said Xarelto increases “wound leakage” and infections by more than 10 times.
Doctors have other safer ways to prevent blood clots, including aspirin, compression stockings and getting patients “up and walking,” Relkin said.
She said some doctors are prescribing alternative drugs because of Xarelto’s risks.
In a lawsuit, the family of a Xarelto victim who died said manufacturers “misinformed patients and their health care providers” about routine blood monitoring. Manufacturers “have created a new drug, Xarelto, that is not better than warfarin from a safety perspective, and at best, is only perhaps slightly easier to use and administer,” the lawsuit said.
Victims say drug companies misrepresented the safety and effectiveness of Xarelto. The companies are also accused of not adequately warning patients and doctors about the severe side effects, despite knowing about them.
The victims say drug companies put profits over patients. “Xarelto is unreasonably dangerous and defective as formulated, putting consumers… at an unreasonable risk of suffering needless injuries and death,” a lawsuit says.
Victims say drug companies failed to:
- Use “due care” in the Xarelto’s development
- Adequately test, research and study Xarelto
- Provide adequate warnings about Xarelto safety risks, specifically uncontrolled, irreversible bleeding
- Adequately warn that it is impossible to measure Xarelto’s affect
- Warn patients and doctors about not having an antidote
- Provide adequate warning that seniors are at increased risk of Xarelto bleeds
- Adequately warn of the increased risk of gastrointestinal bleeds, especially in patients with a history of gastrointestinal issues
- Adequately train health care providers about how to use Xarelto
- Include a boxed warning — the FDA’s most serious warning — about serious bleeding with Xarelto
- Inform the FDA, the health care industry and the public at large about dangers of Xarelto
- Remove Xarelto from the market when they knew, or should have known, of side effects and injuries
Who Are the Plaintiffs?
Victims filed lawsuits because they say the drug left them seriously injured or led to the death of a loved one.
The common allegations include failing to warn about bleeding risks, failing to warn about a lack of a bleeding antidote and misleading the public about the effectiveness and safety of the drug.
The victims want money for expenses from injuries or deaths. They also want to punish drug companies.
Plantiffs include the following people:
In June 2014, Nancy Packard filed a Xarelto lawsuit on behalf of her husband, William N. Packard Jr., who died after taking Xarelto. In January 2012, her husband began taking Xarelto for atrial fibrillation as his doctor told him. In June of the same year, he suffered a fatal subdural hemorrhage (a collection of blood outside of the brain).
Packard said her husband would not have taken Xarelto if drug companies had “properly disclosed the risks associated with its use, as safer alternatives… were available,” her suit says.
Packard’s wrongful death suit also stated that the companies had a duty to protect him “against reasonably foreseeable harms” and they “breached that duty.”
In 2014, Ruth McGowan filed a lawsuit on behalf of her father, Thomas Dunkley, who died after taking the drug to reduce his risk of stroke.
He suffered serious bleeding in his brain after taking Xarelto for about a month. The lawsuit accuses Janssen and Bayer of concealing safety risks and not properly testing the drug.
They did that to “defraud or deceive” the public and the health care community. She stated that their actions were “callous, reckless and willful” and showed a “depraved indifference” to patients, ultimately resulting in her father’s suffering and death.
Frank Peck filed a lawsuit on behalf of his wife, Ann Peck, who died after taking the drug one month in 2013. The suit alleges she suffered internal bleeding and a hemorrhagic stroke (bleeding on the brain) that ultimately took her life on May 4, 2013.
Peck stated that the “severe and permanent personal injuries, pain, suffering [and] emotional distress” contributed to his wife’s death. He also said the companies did not mention Xarelto could lead to irreversible bleeds and that an antidote was not available. She wouldn’t have taken Xarelto if she knew about the risks, the suit says.
Peck’s suit says drug companies haven’t taken steps to remove the drug, provide strong warnings or create an antidote. The suit says companies “promoted and continue to promote Xarelto as a safe and effective treatment…”
Harry and Joseph Griggs
Harry and Joseph Griggs filed a lawsuit on behalf of their father, Charles Griggs, who died in 2013. He took Xarelto and suffered from bleeding in August 2013. He died of his injuries on December 6, 2013. The sons say Xarelto led to their father’s suffering and eventual death. The lawsuit said companies failed to warn about Xarelto’s dangers. They didn’t tell anyone that Xarelto bleeding may be irreversible, permanently disabling and life threatening, the suit says.
Consolidated Xarelto Lawsuits
There are currently more than 18,000 cases that have been consolidated in Louisiana for efficiency. U.S. District Court Judge Eldon E. Fallon is in charge. Hundreds of other lawsuits are also currently pending in state courts. Fallon appointed a 12-member panel headed by attorneys Andy Birchfield, Jr. and Brian H. Barr to coordinate legal procedures.
The panel includes:
- Ellen Relkin, Weitz & Luxenberg, New York
- Bradley Honnald, Bartimus Frickleton, Kansas City
- Frederick Longer, Levi, Fishbein, Sedran & Berman, Philadelphia
- Russell Abney, Ferrer, Poirot & Wansbrough, Atlanta
- Dianne Nast, Nast Law, Philadelphia
- Roger Denton, Schlicter, Bogard & Denton, St. Louis
- Sindhu Daniel, SeegerWeiss, Newark, New Jersey
- Michael Goetz, Morgan and Morgan, Tampa
- Neil Overholtz, Aylstock, Witkin, Kreis & Overholtz, Pensacola
Judge Fallon gathered about 40 cases for the initial bellwether trials, according to court documents. Three of these trials have already occurred, ending with victories for drug companies. A fourth is set for 2018.
Results from bellwether trials can set the tone for future outcomes of Xarelto lawsuits, as well as possible settlement negotiations.
A second group of consolidated Xarelto lawsuits is currently pending in Philadelphia’s Complex Litigation Center (CLC). The CLC is designed to handle several mass tort programs. About 1,300 cases are pending with Judge Arnold New presiding. The first trial is set to begin in November 2017.
Bellwether Trials Give Companies Victories
The first trial in a series of test trials was conducted on a lawsuit filed by Joseph Boudreaux of Louisiana in April 2017.
The jury heard how the 75-year-old was prescribed Xarelto in 2014 to treat his heart condition, and subsequently suffered gastrointestinal bleeding that led to his hospitalization and numerous blood transfusions.
“The jury’s verdict affirms both the safety and efficacy of Xarelto, and that its FDA-approved label contains accurate, science-based information on the benefits and risks of this life-saving medicine.”
- Bayer said following the first trial in a series of test trials in 2017
Meanwhile, lawyers for Boudreaux said that they were “disappointed, but would press on in similar cases,” according to Reuters.
On May 30, 2017, the court moved forward with the second bellwether trial, this time filed by a patient’s widower, Joseph Orr, who claimed that his wife, Sharyn Orr of Louisiana, died in May 2015 after taking Xarelto. Orr said drug companies were responsible for his wife’s death from hemorrhagic stroke (bleeding on the brain). She was in a coma for 10 days before dying. The jury sided with Janssen and Bayer.
A third bellwether trial took place in August 2017. The plaintiff, Dora Mingo, developed a DVT after hip surgery, and doctors prescribed her Xarelto. Mingo blames the blood thinner for gastrointestinal bleeding and acute blood loss she experienced after taking the drug. Her lawsuit alleges her doctor would have acted differently had the drug companies provided adequate instructions. Therefore, she says, her injuries could have been avoided or diminished. A Mississippi jury sided with Bayer and J&J.
A fourth bellwether trial is expected to begin in January 2018 in Texas. The plaintiff in that case is James Henry.
Similar Blood Thinner Settlements
The Xarelto litigation is currently underway and Johnson & Johnson and Bayer have yet to offer a settlement. Some experts were hopeful settlement talks would begin in 2016. However, since the parties have not reached an agreement, the cases proceeded to trial in 2017.
Similar cases involving Boehringer Ingelheim’s blood thinner Pradaxa (dabigatran) ended with settlements.
The company settled 4,000 Pradaxa lawsuits for $650 million in May 2014. The FDA reported hundreds of people lost their lives to the drug, and thousands complained of bleeding side effects in situations consistent with those seen in patients taking Xarelto.
Attorneys refer to the Pradaxa cases as a possible model for Xarelto litigation and settlement possibility. The size of Xarelto litigation is already more than four times the size the Pradaxa litigation was at the time of settlement.
Kristin Compton is a medical writer with a background in legal studies. She has experience working in law firms as a paralegal and legal writer. She also has worked in journalism and marketing. She’s published numerous articles in a northwest Florida-based newspaper and lifestyle/entertainment magazine, as well as worked as a ghost writer on blog posts published online by a Central Florida law firm in the health law niche. As a patient herself, and an advocate, Kristin is passionate about “being a voice” for others.