Preview Newsletter
Hartman Verdict
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J&J, Bayer Ordered to Pay $28 Million in First Xarelto Loss
Dec 5, 2017 | Bloomberg
By Jef Feeley and Margaret Cronin Fisk
Johnson & Johnson and Bayer AG are responsible for a woman’s injuries tied to the blood-thinning drug Xarelto and must pay almost $28 million in damages, jurors concluded in the companies’ first loss at a trial over the medicine. -
Jury orders Bayer, J&J to pay $28 million in Xarelto lawsuit (UPDATE)
Dec 5, 2017 | Reuters
By Tina Bellon
A Philadelphia state court jury on Tuesday ordered Bayer AG and Johnson & Johnson to pay $27.8 million to an Indiana couple over the drugmakers’ failure to warn of internal bleeding risks from their blood thinner Xarelto. -
Washington Post Business Roundup
Dec 6, 2017 | Washington Post
Blurb on the verdict included in a Washington Post business roundup. Relevant portion included below. -
Phila. Jury Slams Makers of Xarelto With $27.8M Verdict
Dec 5, 2017 | The Legal Intelligencer
By Max Mitchell
A Philadelphia jury has awarded nearly $28 million to the plaintiffs in the first bellwether trial to take place in state court over the blood thinner Xarelto. The verdict comes after three straight losses for plaintiffs in federal court. -
BREAKING: J&J, Bayer Hit With $28M Verdict In 1st Xarelto Loss
Dec 5, 2017 | Law360
By Matt Fair
A Philadelphia jury delivered a first-of-its-kind verdict on Tuesday as it awarded almost $28 million in damages against a pair of Johnson & Johnson and Bayer AG units after finding the companies had provided inadequate warnings about the risks of bleeding associated with the blood thinner Xarelto. -
J&J, Bayer lose first Xarelto bleeding case, hit with $28M verdict
Dec 5, 2017 | FiercePharma
By Eric Sagonowsky
After three wins in cases over the risks of blockbuster blood thinner Xarelto, Bayer and Johnson & Johnson have encountered their first defeat. A jury in Philadelphia ordered the drugmakers to pay $28 million to plaintiff Lynn Hartman, but the companies plan to appeal. -
California Ranked No. 2 in Tort Reformers' Judicial Hellholes Report
Dec 5, 2017 | Law.com
By Amanda Bronstad
Brief mention of the verdict in article focused on an American Tort Reform Association report (highlighted below.) -
$28 Million Awarded to Indiana Couple in Xarelto Lawsuit Verdict
Dec 5, 2017 | ConsumerSafety.Org
By Curtis Weyant
Earlier today, a jury ordered two pharmaceutical megacorporations – Johnson & Johnson and Bayer – to pay $28 million to Lynn Hartman and her husband due to internal bleeding and other complications related to using the blood thinner Xarelto. -
Johnson & Johnson, Bayer Hit with $28 Million Xarelto Verdict
Dec 5, 2017 | DrugWatch
A Philadelphia jury ordered Johnson & Johnson and Bayer AG to pay nearly $27.8 million to an Indiana woman for failing to warn about bleeding risks associated with their blood thinner Xarelto. -
A Whopping Xarelto Verdict Landed The Same Day Philadelphia Was Called A 'Judicial Hellhole'
Dec 6, 2017 | Legal Newsline
By Nicholas Malfitano
The very day that a national report is issued naming the Philadelphia County Court of Common Pleas as a “Judicial Hellhole” where civil lawsuits are handled unfairly against businesses, the first win for plaintiffs in Xarelto litigation is secured with a near-$28 million verdict. -
Five things for pharma marketers to know: Wednesday, December 6, 2017
Dec 6, 2017 | Medical Marketing and Media
By Virginia Lau
Brief mention of the verdict and link to Bloomberg's coverage in a roundup of news on Medical Marketing and Media. -
Bloomberg Wake Up Call
Dec 6, 2017 | Bloomberg Law Business
By Rick Mitchell
Brief mention of the verdict in the Bloomberg Law Wake Up Call roundup of news. Relevant portion included below.
National Coverage
Trade Coverage
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J&J, Bayer Ordered to Pay $28 Million in First Xarelto Loss
Dec 5, 2017 | Bloomberg
By Jef Feeley and Margaret Cronin Fisk
Johnson & Johnson and Bayer AG are responsible for a woman’s injuries tied to the blood-thinning drug Xarelto and must pay almost $28 million in damages, jurors concluded in the companies’ first loss at a trial over the medicine.
Lynn Hartman said she took Xarelto, sold by J&J’s Janssen Pharmaceuticals unit, for more than a year before being hospitalized in 2014 with gastrointestinal bleeding she blamed on the drug. A Philadelphia jury on Tuesday ordered J&J and Bayer, which jointly developed the product, to pay $1.8 million in actual damages and $26 million in punitive damages, one of Hartman’s lawyers said after the verdict.
Johnson & Johnson and Bayer won the first three cases to come to trial in federal courts in Louisiana and Mississippi, after juries found the drug was safe and the companies properly warned about Xarelto’s bleeding risks. Plaintiffs had pinned their hopes on winning in state court in Philadelphia, which is known for having plaintiff-friendly juries. The companies still face more than 20,000 Xarelto suits.
“The plaintiffs needed to put a win on the board to keep these other cases alive,” said Carl Tobias, who teaches product-liability law at the University of Richmond in Virginia. “Otherwise, the rest of the cases may have been seen as having little value.”Appeal Plans
J&J and Bayer officials said Tuesday they’d appeal the jury’s finding that Xarelto posed a health risk. Xarelto’s labeling “has always warned of bleeding events” and provided information doctors need to make proper “treatment decisions,” Sarah Freeman, a Janssen spokeswoman, said by email.
“Bayer stands behind the safety and efficacy of Xarelto and believes there is no basis in fact or law for the verdict, including the punitive award,” Chris Loder, a Bayer spokesman, said in an emailed statement.
The companies still face more than 20,000 patent suits over Xarelto, which has been linked to at least 370 deaths, according to U.S. Food and Drug Administration reports. The number of Xarelto suits has grown by 27 percent this year, J&J said in an SEC filing.
The drug is Bayer’s top-selling product, generating $3.2 billion in sales last year and $2.5 billion in 2015 for the Leverkusen, Germany-based pharmaceutical company. Xarelto is J&J’s third-largest seller, bringing in $2.3 billion in 2016 as the New Brunswick, New Jersey, company seeks to replace revenue from its Remicade arthritis treatment, which lost patent protection a year ago.
Xarelto belongs to a class of drugs aimed at replacing Bristol-Myers Squibb Co.’s Coumadin, which has thinned patients’ blood since the 1960s. Other new thinners include Pradaxa made by Boehringer Ingelheim GmbH, a German company that paid $650 million in 2014 to settle thousands of suits claiming it hid the medicine’s bleeding risks.
“Xarelto is the worst in class of the new blood thinners,” Michael Weinkowitz, a Philadelphia attorney who represents Hartman, said Tuesday in an emailed statement. “The serious health complications suffered by thousands of patients could have been avoided if physicians were properly instructed about the risks.”
Hartman, 75, argued she had to have four blood transfusions to counteract Xarelto’s bleed-out effects, which caused her pain and worry. She switched to another blood thinner and hasn’t had similar problems, according to court filings.
During the trial, ex-FDA Chief David Kessler told the Philadelphia Common Pleas Court jury the companies’ Xarelto warning labels understated the drug’s bleeding risks and didn’t warn doctors that some patients would be at higher risks for bleed outs.
The case is Lynn Hartman v. Janssen Pharmaceuticals Inc., Case No. 160503416, Court of Common Pleas of Philadelphia County, Pennsylvania.
(A previous version of this article was corrected for the amount of the damage award.)
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Jury orders Bayer, J&J to pay $28 million in Xarelto lawsuit (UPDATE)
Dec 5, 2017 | Reuters
By Tina Bellon
A Philadelphia state court jury on Tuesday ordered Bayer AG and Johnson & Johnson to pay $27.8 million to an Indiana couple over the drugmakers’ failure to warn of internal bleeding risks from their blood thinner Xarelto.
The jury slapped the companies, which jointly developed the blockbuster drug, with $1.8 million in compensatory and $26 million in punitive damages, according to the couple’s lawyer.
The verdict marks the first trial loss in litigation over Xarelto. Bayer and J&J have won three previous cases in federal court.
Bayer in a statement said it believed there was no basis for the verdict, including the punitive damages award, and said it was going to appeal the verdict.
Janssen, J&J’s pharmaceutical subsidiary, in a statement also said it was going to appeal the verdict, adding that it contradicted years of scientific data and repeated confirmations of Xarelto’s safety by the U.S. Food and Drug Administration.
“Xarelto is the worst in class of the new blood thinners,” Michael Weinkowitz, the couple’s lawyer, said in a statement. “The serious health complications suffered by thousands of patients could have been avoided if physicians were properly instructed about the risks.”
Lynn Hartman and her husband had sued the drugmakers in 2015.
Hartman was prescribed Xarelto to prevent strokes as a result of atrial fibrillation, an irregular heartbeat. She took the drug for approximately one year and in June 2014 was hospitalized with severe gastrointestinal bleeding, which she blamed on Xarelto. She has since recovered.
The trial was the first of roughly 1,400 Xarelto cases pending in the Philadelphia court.
More than 18,500 cases are pending in federal court, where they are consolidated in a multidistrict litigation at the U.S. District Court for the Eastern District of Louisiana.
Federal juries have cleared the companies of liability in three previous trials. The latest verdict in the federal litigation came down in August in the case of a Mississippi woman.
Xarelto is Bayer’s best-selling drug and in 2016 contributed 2.9 billion euros ($3.41 billion) in revenues to the German group’s pharmaceutical business.
J&J in 2016 reported $2.2 billion in revenues from Xarelto.
The U.S. Food and Drug Administration approved Xarelto in 2011. The drug is prescribed for people with atrial fibrillation and to treat and reduce the risk of deep vein thrombosis and pulmonary embolisms.
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Washington Post Business Roundup
Dec 6, 2017 | Washington Post
Johnson & Johnson and Bayer are responsible for a woman’s injuries tied to the blood-thinning drug Xarelto and must pay almost $28 million in damages, jurors concluded in the companies’ first loss at a trial over the medicine. Lynn Hartman said she took Xarelto for more than a year before being hospitalized in 2014 with gastrointestinal bleeding she blamed on the drug. On Tuesday, a Philadelphia jury ordered Johnson & Johnson and Bayer, which jointly developed the product, to pay $1.8 million in actual damages and $26 million in punitive damages, one of Hartman’s lawyers said after the verdict.
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Phila. Jury Slams Makers of Xarelto With $27.8M Verdict
Dec 5, 2017 | The Legal Intelligencer
By Max Mitchell
A Philadelphia jury has awarded nearly $28 million to the plaintiffs in the first bellwether trial to take place in state court over the blood thinner Xarelto. The verdict comes after three straight losses for plaintiffs in federal court.
The jury handed up the verdict against Bayer and Janssen Pharmaceuticals late morning Tuesday, awarding plaintiff Lynn Hartman $1.8 million in compensatory damages and $26 million in punitive damages. The verdict came after nearly one month of trial before Philadelphia Court of Common Pleas Judge Michael Erdos.
Lead trial counsel for the plaintiffs, Gary Douglas of Douglas and London, said the verdict was “vindication.”
“This was a great verdict for Mrs. Hartman and a great win for exposing the pharmaceutical industry,” he said.
In an emailed statement, Levin Sedran & Berman attorney Michael Weinkowitz, a lead attorney for the plaintiffs, said he was pleased with the verdict.
“Xarelto is the worst in class of the new blood thinners. The serious health complications suffered by thousands of patients could have been avoided if physicians were properly instructed about the risks, and if patients were given the choice to switch to Eliquis and Pradaxa, which are safer and far more effective,” he said.
Bayer spokesman Christopher Loder said in an emailed statement that the company plans to appeal.
“Bayer stands behind the safety and efficacy of Xarelto, believes there is no basis in fact for the verdict, including the punitive award, and plans to appeal,” he said. “Xarelto’s safety and efficacy is supported by both real-world experience with 31 million patients and expert health regulators in 130 countries, and its FDA-approved label provides accurate and science-based information on the medicine’s benefits and risks.”
A spokeswoman for Janssen, Sarah Freeman, said in an emailed statement that Janssen also plans to appeal.
“This verdict contradicts years of scientific data and the FDA’s repeated confirmation of Xarelto’s safety and efficacy,” she said. “Hartman is the fourth Xarelto trial and the first state trial to date. In each of the three federal multidistrict litigation Xarelto trials, juries returned decisions in favor of the company.”
The defendants were represented at trial by Wilkinson Walsh + Eskovitz attorney Beth Wilkinson.
Hartman was the first bellwether trial to begin in state court. Over the summer, defendants won all three cases that went to trial from the consolidated litigation being handled in federal court. More than 18,000 cases are pending in the federal multidistrict litigation over Xarelto, which makes it the second largest litigation nationwide, second only to the consolidated pelvic mesh litigation. More than 1,500 Xarelto cases are pending in Philadelphia.
The mass tort is focused on claims that the drugmakers failed to adequately warn about the danger of suffering a severe bleed, especially when patients took Xarelto in combination with Aspirin.
Hartman was closely watched by attorneys given the difficult time plaintiffs have had in federal court, and, although most of the trial focused on the label and the drug’s ability to cause Hartman’s bleed, the litigation took a few contentious and unexpected turns over the past month.
The start of the trial was delayed after the plaintiffs alleged a Janssen sales representative had improperly contacted a witness prior to an important deposition. Although the judge allowed parties to depose the sales rep, the judge ultimately denied the plaintiffs’ requests, and declined to block the witness’s testimony.
Also, during closing arguments, the trial took a political turn, with attorneys from both sides referencing fake news, growing xenophopbia and even a quote from Michelle Obama.
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BREAKING: J&J, Bayer Hit With $28M Verdict In 1st Xarelto Loss
Dec 5, 2017 | Law360
By Matt Fair
A Philadelphia jury delivered a first-of-its-kind verdict on Tuesday as it awarded almost $28 million in damages against a pair of Johnson & Johnson and Bayer AG units after finding the companies had provided inadequate warnings about the risks of bleeding associated with the blood thinner Xarelto.
The verdict, which credited claims from an Indiana woman who said she suffered a serious gastrointestinal bleed while using the medication, comes after juries in federal multidistrict litigation sided with the drugmakers in three bellwether cases earlier this year over the drug’s risks.
Lynn Hartman’s case is one of more than 1,500 pending as part of a mass tort program in the Philadelphia County Court of Common Pleas to consolidate Xarelto-related product liability claims.
Her trial centered around claims that Janssen Pharmaceuticals Inc. and Bayer Healthcare Pharmaceuticals Inc. failed to include information in Xarelto’s warning label indicating that the rate of bleeding events observed in a clinical trial was significantly higher among patients in the United States than patients elsewhere in the world.
According to evidence in the case, the rate among participants in the United States was 8.1 percent annually versus 3.6 percent annually among participants globally.
Hartman’s attorneys have also accused the companies of failing to adequately warn about the higher risk of bleeds when using the drug alongside aspirin, and of failing to inform doctors that some patients end up with significantly higher levels of the medication in their blood than others.
Her attorneys argued that the risk of adverse events associated with Xarelto was significantly higher than that of competitors Eliquis and Pradaxa.
“Xarelto is the worst in class of the new blood thinners,” said Michael Weinkowitz, an attorney with Levin Sedran & Berman representing Hartman. “The serious health complications suffered by thousands of patients could have been avoided if physicians were properly instructed about the risks, and if patients were given the choice to switch to Eliquis and Pradaxa which are safer and far more effective.”
The plaintiff’s case was bolstered by testimony from former Food & Drug Administration chief David Kessler, who told jurors that he believed the Xarelto warning label had lacked key information about the severity of the potential bleeding risk associated with the drug.
The drugmakers, whose trial team was led by Beth Wilkinson of Wilkinson Walsh & Eskovitz, focused their defense on the clear and unequivocal language in the Xarelto label warning that the medication “can cause serious and fatal bleeding.”
“There isn’t a more serious warning you could give,” Wilkinson told jurors during closing arguments on Friday.
The defense also pointed to testimony from Hartman’s physician that she would not have changed her decision to prescribe the drug even with the additional information she said should have been included on the label.
A second case is scheduled to go to trial in Philadelphia in January, according to court records.
Bayer spokesman Christopher Loder told Law360 in a statement that the company maintained that Xarelto was a safe and effective medication.
“Bayer stands behind the safety and efficacy of Xarelto, believes there is no basis in fact or law for the verdict, including the punitive award, and plans to appeal," he said. "Xarelto’s safety and efficacy is supported by both real-world experience with 31 million patients and expert health regulators in 130 countries, and its FDA-approved label provides accurate and science-based information on the medicine’s benefits and risks."
Sarah Freeman, a spokeswoman for Janssen, said the company vowed to appeal.
"At Janssen, nothing is more important to us than the health and safety of the patients who use our medicines," she said. "This verdict contradicts years of scientific data and the [FDA] repeated confirmation of Xarelto's safety and efficacy. We will appeal this verdict and will continue to defend against the allegations made in this litigation."
Hartman is represented by Gary Douglas of Douglas & London PC, Michael Weinkowitz and Frederick Longer of Levin Sedran & Berman, Ned McWilliams of Levin Papantonio, and Laura Feldman of Feldman & Pinto.
The defendants are represented by Beth Wilkinson and Brian Stekloff of Wilkinson Walsh & Eskovitz, David Abernethy, Chanda Miller, Susan Sharko and Rodney Hudson of Drinker Biddle & Reath LLP, Kim Moore and Timothy Daniels of Irwin Fritchie Urquhart & Moore LLC, and Albert Bixler and Leslie Hayes of Eckert Seamans Cherin & Mellott LLC.
The case is Hartman v. Janssen Pharmaceuticals Inc. et al., case number 160503416, in the Court of Common Pleas of Philadelphia County, Pennsylvania. -
J&J, Bayer lose first Xarelto bleeding case, hit with $28M verdict
Dec 5, 2017 | FiercePharma
By Eric Sagonowsky
After three wins in cases over the risks of blockbuster blood thinner Xarelto, Bayer and Johnson & Johnson have encountered their first defeat. A jury in Philadelphia ordered the drugmakers to pay $28 million to plaintiff Lynn Hartman, but the companies plan to appeal.
In a statement to FiercePharma, Michael Weinkowitz, an attorney for the plaintiff, said his team is "grateful" for the jury's decision. Hartman argued that her Xarelto use—prescribed to prevent strokes associated with atrial fibrillation—caused severe gastrointestinal bleeding, according to Reuters.
"Xarelto is the worst in class of the new blood thinners," Weinkowitz said via email. "The serious health complications suffered by thousands of patients could have been avoided if physicians were properly instructed about the risks."
But J&J and Bayer contend that Xarelto's label does disclose its risks. Sarah Freeman, a Janssen spokesperson, said the "verdict contradicts years of scientific data and the U.S. Food and Drug Administration’s repeated confirmation of XARELTO’s safety and efficacy."
Freeman said Xarelto's label "has always warned of bleeding events—a known risk associated with anticoagulation—and appropriately informs physicians of the information that they need to make treatment decisions with their patients."
A representative for Bayer added that his company "believes there is no basis in fact or law for the verdict, including the punitive award, and plans to appeal." He noted that Xarelto's "safety and efficacy is supported by both real-world experience with 31 million patients and expert health regulators in 130 countries, and its FDA-approved label provides accurate and science-based information on the medicine’s benefits and risks."
The case was the first to go to trial in state courts over Xarelto bleeding risks, according to Freeman. It follows several significant victories in federal court for the pharma partners as J&J and Bayer previously prevailed in three bellwether suits in Mississippi and New Orleans.
The company faces thousands more liability cases, 21,400 in fact, according to J&J's most recent quarterly filing. About 1,400 are pending in Philadelphia, Reuters reports.
First approved by the FDA in 2011, Xarelto was Bayer’s top-selling drug last year at $3.24 billion and ranked third for J&J at $2.5 billion in sales.
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California Ranked No. 2 in Tort Reformers' Judicial Hellholes Report
Dec 5, 2017 | Law.com
By Amanda Bronstad
California landed right behind Florida in the No. 2 spot in the annual Judicial Hellholes report this year.
The Tuesday report, published by the American Tort Reform Association since 2002, cited four Florida Supreme Court rulings in medical malpractice lawsuits among the primary reasons for ranking it the least business-friendly courts in the nation for the first time. Other top venues included New York, Pennsylvania and New Jersey.
In a statement accompanying the annual report’s release, ATRA president Tiger Joyce called California a “perennial hellhole … where lawmakers, prosecutors and plaintiff-friendly judges inexorably expand civil liability at the expense of businesses, jobseekers and those desperately in need of affordable housing.”
“The good news is the U.S. Supreme Court in June reversed a California high court decision that we criticized in last year’s report,” said Joyce of the High Court’s decision in Bristol-Myers Squibb v. Superior Court of California. “Had it been allowed to stand, California’s courthouse doors would have been thrown open even wider to out-of-state plaintiffs suing out-of-state defendants over alleged out-of-state injuries,” he said.
American Association for Justice spokesman Peter Knudsen took aim at the report’s general criticism of the courts.
“The authors of this report seem to think that our Seventh Amendment right to seek justice in court is something to be condemned. But that right is protected by the Constitution, just like their right to trot out this same stunt every year in an effort to help corporations avoid accountability.”
Here’s a look at some of the eight venues that made the list:Florida
According to the report, Florida Supreme Court’s medical malpractice cases appeared to disregard the intent of the state’s legislature. The first decision granted patients access to medical records. Two other decisions pushed back against limits on attorney fees and damages. The court also upheld the privacy rights of patients.
Fort Lauderdale plaintiffs lawyer Scott Schlesinger chastised the report as “fiction” and “meaningless.” He said it’s harder than ever for plaintiffs to get compensated for malpractice committed by their doctors.
“Medical care is pretty much worse than it’s ever been and more dangerous than ever, but nobody wants to be held accountable,” said Schlesinger, of Schlesinger Law Offices. “The powers that be are able to ram through special interest legislation, and it’s the neutral courts that say, wait, this is unfair, or unconstitutional or unlawful legislation.”
The report also noted recent crackdowns on insurance fraud among Florida’s plaintiffs’ bar, some of which have landed plea agreements. And it referenced $9.2 million in sanctions against two Jacksonville plaintiffs firms for “unprofessional conduct” in tobacco cases.
“Our state has a vibrant justice system that is working to keep Floridians safe and deter insurance companies and big corporations from taking advantage of people and small businesses,” wrote Florida Justice Association spokesman Ryan Banfill. “That’s good for consumers and for business, too.”California
The report cited California’s Private Attorneys General Act and public nuisance law as among the reasons the state ranked No. 2. In particular, the report mentioned an appeals court decision upholding liability in a $1.15 billion lead paint judgment.
The report acknowledged some defense wins in California, both involving alleged links between Johnson & Johnson’s baby powder and ovarian cancer and mesothelioma. And it praised the U.S. Supreme Court’s reversal of the U.S. Court of Appeals for the Ninth Circuit’s 2016 ruling in the Bristol-Myers Squibb case.
New York
In New York, the report focused on the city’s asbestos docket, which ranked No. 4 due to a case management order issued this year that allowed claimants to pursue punitive damages.
Joyce called it “a great disappointment for defendants.”Missouri
St. Louis topped the list last year but moved to No. 3 after the governor signed legislation designed to reign in large verdicts based on what tort reformers called “junk science.” Juries in St. Louis have awarded double-digit awards against Johnson & Johnson over baby powder. The report cited those reforms, Bristol-Myers and an appeals court’s reversal of a $72 million talc verdict as reasons for St. Louis to drop in rank.Pennsylvania
The Philadelphia Court of Common Pleas ranked No. 5 due to a surge of new lawsuits and big verdicts particularly involving pelvic mesh, antipsychotic drug Risperdal and blood thinner Xarelto. The most recent was the first Xarelto trial in Philadelphia that ended in a$27.8 million verdict on Tuesday.New Jersey
The state ranked No. 6, primarily due to an appeals court ruling reviving more than 2,000 lawsuits over acne drug Accutane that had been dismissed based on scientific experts.
The report also flagged several venues to watch out for, such as Georgia, for its “growing list of outrageous verdicts.” It also chastised the Connecticut Supreme Court for upholding a $41.7 million award against a private school after a student was bit by a tick while on a class trip in China—though the judges were less than enthusiastic about their opinion.
Justice Andrew McDonald wrote in a concurring opinion: “Indeed, while the damages award in the present case shocks my conscience, our existing standard does not provide a recognized basis to conclude that the trial court’s conclusion to the contrary was improper.”
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$28 Million Awarded to Indiana Couple in Xarelto Lawsuit Verdict
Dec 5, 2017 | ConsumerSafety.Org
By Curtis Weyant
Earlier today, a jury ordered two pharmaceutical megacorporations – Johnson & Johnson and Bayer – to pay $28 million to Lynn Hartman and her husband due to internal bleeding and other complications related to using the blood thinner Xarelto.
Filed in the Philadelphia Court of Common Pleas, this Xarelto case is the first time that a jury has chosen to hold the two drug companies accountable for the extremely dangerous side effects of Xarelto, which can include severe bleeding and even death.
The Hartman Xarelto Case
In 2013, Lynn Hartman began taking Xarelto in an attempt to treat atrial fibrillation, a form of erratic heartbeat that can lead to strokes, heart attacks, pulmonary embolisms, and other health problems.
However, about a year after taking the blood thinner, Hartman began to experience severe gastrointestinal bleeding. She was hospitalized in 2014, but thankfully after being taken off the drug, she eventually recovered her health and stopped experiencing the bleeding problems.
In 2015, Hartman and her husband brought a Xarelto lawsuitagainst Janssen Pharmaceutical, a division of the multinational drug and consumer products company Johnson & Johnson that makes the anticoagulant. The couple, who live in Indiana, also sued Bayer, which markets the product alongside J&J.
The Hartmans’ suit became the first in a state court to be tried a bellwether trial. Bellwether trials often set precedents for similar cases and can signal to both companies and future plaintiffs the types of arguments that juries are likely to respond to.
The Hartmans had to wait more than two years from the time they file their initial complaint to the trial itself. Once the trial was ready to start, they experienced yet another setback when it was discovered that the plaintiffs’ doctor had allegedly met with a sales representative from Janssen pharmaceuticals. After that meeting, the doctor changed his testimony, claiming that he was not aware of the gastrointestinal bleeding experienced by Lynn Hartman in 2014. As a result, the Hartman’s lawyers requested that the doctor not be allowed to testify.
Later during the trial, however, the pharmaceutical companies were beset by a former commissioner of the U.S. Food & Drug Administration, who claimed that Xarelto’s drug label was inadequate to warn patients of potential problems with the Drug. Kessler had testified in previous Xarelto trials, as well.
Understanding the $28 Million Xarelto Verdict
Before the Hartman case, J&J and Bayer had won all three of the federal court bellwether trials. Given that track record, the companies undoubtedly believed that they would win this state court trial as well, but as it happened, the jury sided with the plaintiff.
In total, the jury awarded the Hartmans $27.8 million. This compensation breaks down into:$1.8 million in compensatory damages $26 million in punitive damages
While the Hartmans could no doubt use the money to pay for medical bills and other expenses that have racked up during the trial, the money will likely continue to be tied up while the drug companies appeal the verdict. After the jury’s decision, Chris Loder, a spokesperson for Bayer, stated, “Bayer stands behind the safety and efficacy of Xarelto and believes there is no basis in fact or law for the verdict, including the punitive award.”
Given that there are more than 20,000 lawsuits against the companies – at least 18,500 in federal court and another 1,500 in the Philadelphia court where the Hartmans filed their claim – it’s understandable why the drug companies will persist in their attempts to paint Xarelto as a legitimate medication.
However, there is more to it than just the cost of the trials and potential future payouts. Xarelto is Bayer’s top-selling product, which has generated nearly $6 billion for the company in the last two years. And that’s only a fraction of the total amount brought in to large pharmaceutical corporations from blood thinner drugs, which include Bristol-Myers Squibb’s Coumadin and Boehringer Ingelheim’s Pradaxa – which has also seen its share of lawsuits due to severe bleeding.
What Makes Xarelto So Dangerous
The reason that J&J and Bayer find themselves in their current predicament is that Xarelto does not have an “antidote” that will counteract the effects of the prescription medication. Patients who take other blood thinners like Coumadin can be given vitamin K to help the body resume its normal coagulation of blood. For individuals who take Xarelto, however, even a small cut or bruise can become extremely dangerous – or even deadly.
Because of this, Johnson & Johnson has found itself defending against thousands of lawsuits claiming that the company knew about the dangers of its drug but failed to warn patients. While it won a few early victories, this latest verdict could signal a change in the landscape. Whether that change endures for both the Hartmans and others who are still awaiting trial remains to be seen.
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Johnson & Johnson, Bayer Hit with $28 Million Xarelto Verdict
Dec 5, 2017 | DrugWatch
A Philadelphia jury ordered Johnson & Johnson and Bayer AG to pay nearly $27.8 million to an Indiana woman for failing to warn about bleeding risks associated with their blood thinner Xarelto.
It was the fourth trial of lawsuits over the blockbuster drug and the first time the companies lost in court. The three previous Xarelto trials had been in federal court as part of a massive multidistrict litigation (MDL) involving more than 19,000 lawsuits. Tuesday’s verdict came in a Pennsylvania state court.
The jury hit the companies with $1.8 million in actual damages for Lynn Hartman and her husband. Jurors tacked on another $26 million in punitive damages. Punitive damages are awarded to punish defendants when jurors determine those defendants’ behavior was especially problematic. Bayer and Johnson & Johnson had worked together to develop the drug.
“Bayer stands behind the safety and efficacy of Xarelto and believes there is no basis in fact or law for the verdict, including the punitive award,” Chris Loder, a Bayer spokesman said in a statement. The company, along with Johnson & Johnson, has promised to appeal the decision.
Hartman had taken Xarelto for more than a year before she was hospitalized in 2014 for gastrointestinal bleeding. She told the court she required four blood transfusions as doctors tried to figure out the cause.
Former FDA Chief Testified at Xarelto Trial
Former U.S. Food and Drug Administration Commissioner Dr. David Kessler testified on Hartman’s behalf during the nearly month-long trial. He told the court that label warnings about Xarelto’s bleeding risk had been inadequate.
He testified that Xarelto won FDA approval in 2011 largely based on the results of the ROCKET-AF study. The study found only fewer than 4 percent of people globally given Xarelto experienced bleeding complications. But in the U.S., the number was more than twice that rate.
“It’s a clinically significant adverse event, it’s a demographic characteristic and it should be on the label,” said Kessler, who served as FDA commissioner under the first Bush and the Clinton administrations.
The FDA Adverse Events Reporting System (FAERS) public dashboard shows the agency has received more than 68,000 reports of serious complications associated with Xarelto, including more than 14,000 reports of gastrointestinal hemorrhage — the same complication Hartman filed a lawsuit over. At least 370 deaths have been directly attributed to taking Xarelto.
Xarelto Among a Class of Powerful Blood Thinners
Xarelto is part of a new class of blood thinners called novel oral anticoagulants (NOACs). The drugs are part of a new generation of drugs designed to replace warfarin, sold under the brand name Coumadin, to prevent blood clots. In addition to Xarelto, other NOACs include Eliquis, Pradaxa and Savaysa.
“Xarelto is the worst in class of the new blood thinners,” Michael Weinkowitz, Hartman’s lawyer, told Bloomberg in an emailed statement. “The serious health complications suffered by thousands of patients could have been avoided if physicians were properly instructed about the risks.”
Anticoagulants, including NOACs, are used to prevent blood clots that could damage the lungs or heart. But they can be associated with serious bleeding and it can make it more difficult for doctors to stop or slow bleeding. Unlike warfarin, Xarelto does not have an antidote that allows blood to resume clotting to stop bleeding.
Another NOAC, Pradaxa, has also been targeted in more than 2,500 lawsuits claiming its maker hid bleeding risks from patients and doctors. Manufacturer Boehringer Ingelheim GmbH paid $650 million in 2014 to settle most of those cases.
Bayer, Johnson & Johnson Face Thousands More Xarelto Lawsuits
Hartman’s lawsuit was the first of more than 1,500 Xarelto lawsuits filed in a consolidated litigation in Pennsylvania state courts that have been centralized in Philadelphia. Another 19,000 lawsuits from around the U.S. have been consolidated in a multidistrict litigation in Louisiana federal court. In filings with the federal government, Johnson & Johnson reports the number of lawsuits over Xarelto has increased by more than 25 percent just this year.
Three previous federal trials ended in verdicts favoring Bayer and Johnson & Johnson. The most recent one wrapped up in August. Legal experts say Hartman’s win in state court keeps hopes of a settlement alive for people who have sued over injuries suffered after taking Xarelto.
Xarelto is Bayer’s best-selling drug, bringing in $3.2 billion in sales for the German company in 2016. It is Johnson & Johnson’s third-biggest seller, worth $2.3 billion last year.
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A Whopping Xarelto Verdict Landed The Same Day Philadelphia Was Called A 'Judicial Hellhole'
Dec 6, 2017 | Legal Newsline
By Nicholas Malfitano
The very day that a national report is issued naming the Philadelphia County Court of Common Pleas as a “Judicial Hellhole” where civil lawsuits are handled unfairly against businesses, the first win for plaintiffs in Xarelto litigation is secured with a near-$28 million verdict.
The verdict was rendered Tuesday in the first Xarelto bellwether case to reach a Pennsylvania state court, whose jury decided after almost one month of proceedings that warnings from manufacturers Janssen Pharmaceuticals (a subsidiary of Johnson & Johnson) and Bayer of the drug’s risks for internal bleeding were inadequate.
The verdict joins others from Philadelphia's Risperdal programthat have led to a flood of cases from out-of-state plaintiffs. Though verdicts have been somewhat evenly split between plaintiffs and Janssen, one plaintiff was awarded an eye-popping $76 million judgment for the alleged side of effect of gynecomastia – the growth of female breast tissue in males.
Xarelto plaintiff Lynn Hartman was awarded nearly $2 million in compensatory damages and $26 million in punitive damages through the verdict.
Hartman, 75, was prescribed Xarelto by Dr. Josephine Randazzo in Plymouth, Ind. and took the drug from March 2013 to June 2014 – at that time, Hartman says she suffered gastrointestinal bleeding on June 26, 2014, which caused her to stop taking the drug.
The Food & Drug Administration (FDA) approved Xarelto in 2011 for prescription to patients suffering from a rhythmic heart disorder called atrial fibrillation and to prevent blood clots that can lead to heart attacks, strokes and pulmonary embolisms.
Plaintiffs and their counsel charge Xarelto’s manufacturers with failing to properly warn patients that Xarelto use presented increased risks for cranial and gastrointestinal bleeding when taken once daily and not properly monitored.
The Hartmans brought the following claims asserted in the Xarelto amended master long-form complaint: Strict liability, manufacturing defect, design defect, failure to warn, negligence, breach of express warranty, breach of implied warranty, negligent misrepresentation, fraud and violation of consumer protection laws in both Indiana and Pennsylvania, plus loss of consortium.
Reaction to the verdict from the defendants was swift.
“At Janssen, nothing is more important to us than the health and safety of the patients who use our medicines. This verdict contradicts years of scientific data and the U.S. Food and Drug Administration’s (FDA) repeated confirmation of Xarelto’s safety and efficacy. We will appeal this verdict and will continue to defend against the allegations made in this litigation,” Janssen spokesperson Sarah Freeman said.
Freeman added the company had been victorious in three bellwether trials at the federal level in multi-district litigation (MDL), and a fourth trial that had been slated for January in a Texas court was voluntarily dismissed by its own plaintiffs with prejudice.
Xarelto’s FDA-approved labeling has always warned of bleeding events – a known risk associated with anticoagulation – and appropriately informs physicians of the information that they need to make treatment decisions with their patients. Patients should take Xarelto as prescribed and not discontinue use without first discussing with a physician,” Freeman stated.
Bayer representative Christopher Loder echoed similar sentiments.
“Bayer stands behind the safety and efficacy of Xarelto, believes there is no basis in fact or law for the verdict, including the punitive award, and plans to appeal," Loder said.
"Xarelto’s safety and efficacy is supported by both real-world experience with 31 million patients and expert health regulators in 130 countries, and its FDA-approved label provides accurate and science-based information on the medicine’s benefits and risks. Juries in three federal bellwether trials reached verdicts in favor of Bayer and Janssen and rejected claims substantially similar to those in Hartman, and a fourth case has been dismissed with prejudice."
A separate group of more than 18,000 Xarelto lawsuits have been consolidated through the federal court system’s MDL process, which utilizes bellwether trials to establish evidence and determine any settlement value for similar plaintiff claims.
The federal Xarelto MDL is listed as Case No. 2592, consolidating individual actions filed against Bayer, Janssen and Johnson & Johnson. Judge Fallon presided over the initial three federal bellwether trials, two of which took place in New Orleans, plus another in Jackson, Miss.
In all three previous federal bellwether trials, juries cleared Xarelto’s manufacturers of liability relating to claims that the drug caused internal bleeding, which plaintiff attorneys allege led to severe injuries or deaths in patients who used it.
The American Tort Reform Association had just named the Philadelphia court a “Judicial Hellhole”
As to the national report in question, issued annually by the American Tort Reform Association (ATRA), it lists the Philadelphia County Court of Common Pleas as No. 5 on its list of “Judicial Hellholes” and names the court as a longtime “national center” for products liability litigation.
“The court’s Complex Litigation Center (CLC) hosts a mass torts program that attracts drug, medical device and asbestos cases from across the county. The CLC had undertaken reforms and, in recent years, seemed to become less welcoming to out-of-state plaintiffs. But a surge of new lawsuits and a string of multimillion dollar verdicts have sadly returned ‘The City of Unbrotherly Torts’ to the ranks of Judicial Hellholes,” the report states.
When rescinding of tolling agreements took place earlier this year, it led to a massive spike in out-of-state filings for such mass tort lawsuits as those centered around anti-psychotic drug Risperdal and blood thinner Xarelto.
The percentage of claims belonging to out-of-state plaintiffs has traditionally been in the high 80s. In 2016, the percentage for pharmaceutical lawsuits dropped to 74 percent.
However, in 2017, the most recent CLC stats show that figure has jumped to an unprecedented 94 percent.
Currently, more than 6,400 cases have been filed in the Risperdal mass tort litigation in Philadelphia and likewise, more than 1,560 cases in Xarelto mass tort litigation for Philadelphia, as well.
Furthermore, landing on ATRA’s “Watch List” to observe closely moving forward was the Supreme Court of Pennsylvania.
“Pennsylvania’s Supreme Court has been regarded as generally balanced in the past, but that balance has shifted since 2016 after several newly elected justices supported by the plaintiffs’ bar joined the bench. Now it seems the high court is more easily persuaded to expand liability, as it has done with decisions affecting asbestos litigation, medical liability, workers’ compensation and ‘bad faith’ claims against insurers. On the bright side, the court upheld a longstanding statutory remedy for victims of lawsuit abuse,” the report reads.
The head of Pennsylvania's trial lawyers group - the Pennsylvania Association for Justice (PAJ) - finds no credibility in ATRA's report.
“ATRA has always been putting out the Judicial Hellholes report every year, and we find that this is just a PR campaign that they do,” PAJ director of public affairs Tom Previc said.
“Unfortunately, while ATRA may believe in the bottom line of profits, we have always believed in justice for all and the rule of law. We respect what the judiciary does on a daily basis, and I have to believe ATRA does not.”
Previc reiterated his confidence in the judicial branch and the jury process, as well as his viewpoint that the report’s purpose was to discredit the judiciary.
“That is something that doesn’t really have a place right now. I think we all should have belief in our institutions,” Previc stated.
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Five things for pharma marketers to know: Wednesday, December 6, 2017
Dec 6, 2017 | Medical Marketing and Media
By Virginia Lau
1. The FDA approved Novo Nordisk's diabetes drug Ozempic, a once-weekly injection set to compete with other GLP-1 therapies such as Eli Lilly's Trulicity. (Reuters)
2. Walgreens is rebranding itself to reach female millennial and Gen X consumers with an updated mobile app, loyalty program, and website in the wake of mergers, including CVS Health and Aetna.The drugstore chain is partnering with Med Express to launch urgent care centers in four states, as part of a pilot test. (CNBC)
3. Drugmakers are increasingly transparent about their clinical trial data, with public availability of results up in 505 trials for 19 novel drugs, a new study found. Johnson & Johnson and Sanofi/Genzyme had high transparency marks, while Valeant was at the bottom. (Endpoints News)
4. Drugmakers such as GlaxoSmithKline, Merck, and AstraZeneca plan to invest in Britain post-Brexit, as part of the country's Life Sciences Sector Deal. GSK will invest $54 million in genomic research, and Merck plans to expand its research operations in Britain. (Reuters)
5. A Philadelphia jury ordered Bayer and Johnson & Johnson to pay $27.8 million in damages to a patient taking blood-thinning drug Xarelto, concluding the drug was responsible for her being hospitalized for gastrointestinal bleeding. The drugmakers plan to appeal the verdict. (Bloomberg)
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Dec 6, 2017 | Bloomberg Law Business
By Rick Mitchell
Legal Actions
• Johnson & Johnson and Bayer AG are responsible for a woman’s injuries tied to the blood-thinning drug Xarelto and must pay almost $28 million in damages, a Philadelphia jury concluded in the companies’ first loss at a trial over the medicine. (Bloomberg)
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