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Xarelto Morning Media Report
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Bayer and J&J win big, Microsoft lags because of Intel, Apple turns over information
Jan 10, 2018 | Yahoo Finance
Brief mention of the overturned verdict in a Yahoo Finance roundup of news, highlighted below. -
Bayer, J&J win reversal of $28 million verdict in Xarelto lawsuit
Jan 9, 2018 | Reuters
By Nate Raymond and Tina Bellon
A Pennsylvania state court judge on Tuesday overturned a $27.8 million jury award to an Indiana couple who accused Bayer AG and Johnson & Johnson of failing to warn of internal bleeding risks of their drug Xarelto, the companies said. -
Judge reverses plaintiffs' $27.8M Xarelto jury verdict in Philadelphia court
Jan 11, 2018 | Pennsylvania Record
By Nicholas Malfitano
Late Tuesday, a state court judge reversed a near-$28 million jury verdict in product liability litigation surrounding the blood thinner Xarelto, a decision that overturned what had been the first win nationally for plaintiffs and included a landmark punitive damages award. -
Pennsylvania judge overturns $27.8M Xarelto decision against J&J, Bayer
Jan 11, 2018 | Becker's Hospital Review
By Leo Vartorella
A judge in Pennsylvania overturned a $27.8 million jury award against Johnson & Johnson and Bayer AG over claims their blood thinner Xarelto caused internal bleeding, according to EquitiesFocus.com. -
Judge punishes lawyer for using hashtag #killinnazis, tosses $27.8M Xarelto verdict on other grounds
Jan 11, 2018 | ABA Journal
By Debra Cassens Weiss
A Pennsylvania judge on Tuesday overturned a $27.8 million verdict against the makers of the blood thinner Xarelto in a lawsuit by an Indiana woman who claimed the drug caused severe gastrointestinal bleeding. -
Plaintiff's Xarelto victory is short-lived as judge overturns $28M verdict against Bayer and J&J
Jan 10, 2018 | FiercePharma
By Eric Sagonowsky
The first verdict to go against Bayer and Johnson & Johnson over Xarelto's bleeding risks didn't stand up to court scrutiny. A U.S. judge overturned the $28 million award on grounds it was an unreasonable result. -
Phila. Trial Judge Throws Out $28M Verdict in Xarelto Case
Jan 10, 2018 | Legal Intelligencer
By Max Mitchell
The nearly $28 million verdict awarded last month in the first Xarelto case to be tried in state court has been reversed. Philadelphia Court of Common Pleas Judge Michael Erdos on Tuesday granted the defense’s motion for judgment notwithstanding the verdict, which eliminates the $27.8 million award a jury handed up Dec. 5. The award was the first win for plaintiffs in the Xarelto litigation after four consecutive losses in federal court. -
A Pennsylvania state court judge has overturned an Indiana couple's $27.8 million award in a lawsuit against rivaroxaban (Xarelto) drugmakers Bayer AG and Johnson & Johnson, Reuters reports.
Jan 10, 2018 | Equities Focus
By David Roper
A state court judge in Pennsylvania overturned a jury award on Tuesday of $27.8 million to a couple from Indiana who had accused Johnson & Johnson and Bayer AG of not warning of the risks of internal bleeding from Xarelto a drug the two companies developed, said both companies. -
Judge Reverses $28 Million Xarelto Award (Reuters)
Jan 10, 2018 | MedPage Today
A Pennsylvania state court judge has overturned an Indiana couple's $27.8 million award in a lawsuit against rivaroxaban (Xarelto) drugmakers Bayer AG and Johnson & Johnson, Reuters reports. -
Pa. Judge Junks $28M Xarelto Verdict Against J&J, Bayer
Jan 9, 2018 | Law360
By Matt Fair
A Pennsylvania state judge agreed late Tuesday to throw out a $28 million verdict finding that a pair of Johnson & Johnson and Bayer AG units had failed to properly warn about the risks of internal bleeding from the anticoagulant medication Xarelto. -
Philly judge tosses $28M verdict in Xarelto blood-thinner case
Jan 10, 2018 | Philadelphia Inquirer
By Sam Wood
A judge in Philadelphia has thrown out a $28 million jury verdict awarded last monthto an Indiana woman who had accused Bayer AG and Johnson & Johnson subsidiary Janssen Pharmaceuticals of failing to adequately warn about the risks of the blood-thinner Xarelto. -
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Jan 10, 2018 | NBC Columbia, MO
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Bayer and J&J win big, Microsoft lags because of Intel, Apple turns over information
Jan 10, 2018 | Yahoo Finance
Here’s a look at some of the companies the Yahoo Finance team will be watching for you today.
A big win in the pharma space. Bayer and Johnson & Johnson (JNJ) are no longer to blame in an internal bleeding case involving their drug Xarelto. A judge overturned a $28M jury award to an Indiana couple after the physician for the plaintiff testified that additional warnings would not have changed her decision to prescribe the drug.
Microsoft (MSFT) says its new software patches that guard against security threats are slowing down people’s PCs. The tech giant released the chips after last week’s bombshell news that almost all chips were vulnerable to hacking. Shares of chipmakers Intel and AMD also fell on the news.
Apple (AAPL) is finally giving in to China. The iPhone maker says it will turn over its iCloud operations to a Chinese partner. The move complies with Chinese law that says customer data must be collected and stored on the mainland. In exchange for letting China monitor its citizens, Apple is expected to have more freedom to improve services in the country.
Toyota (TM) and Mazda are headed south. The Japanese automakers have chosen Alabama for the location of their new auto plant. The new Limestone County factory is expected to start operations in 2021 and employ about 4,000 people. The $1.6 billion plant will be funded equally by Toyota and Mazda. They’ll work together on projects including electric car innovations.
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Bayer, J&J win reversal of $28 million verdict in Xarelto lawsuit
Jan 9, 2018 | Reuters
By Nate Raymond and Tina Bellon
A Pennsylvania state court judge on Tuesday overturned a $27.8 million jury award to an Indiana couple who accused Bayer AG and Johnson & Johnson of failing to warn of internal bleeding risks of their drug Xarelto, the companies said.
Judge Michael Erdos, in the Philadelphia County Court of Common Pleas, ruled following a hearing on the drugmakers’ motion to reverse the December verdict, which was their first trial loss in litigation over the blood thinner, the companies said.
J&J’s Janssen Pharmaceuticals Inc unit and Bayer, which jointly developed Xarelto, in separate statements welcomed the decision and said they will continue to defend against the allegations in related litigation.
“Bayer stands behind the safety and efficacy of Xarelto and will continue to vigorously defend it,” Bayer said in a statement.
The verdict came in a lawsuit by Lynn Hartman, who was prescribed Xarelto to prevent strokes as a result of atrial fibrillation, an irregular heartbeat.
Hartman said that 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.
Hartman and her husband sued the drugmakers in 2015. A jury in December awarded $1.8 million in compensatory damages and $26 million in punitive damages.
The lawsuit was one of around 21,400 that J&J says are pending in federal and state courts blaming injuries on Xarelto. The trial was the first to result from roughly 1,400 Xarelto cases pending in the Philadelphia court.
Michael Weinkowitz, a lawyer for the couple, said the decision related to a “very narrow issue related to Mrs. Hartman’s prescribing physician.” He said he looked forward to trying the next series of Xarelto-related cases in Philadelphia.
The U.S. Food and Drug Administration approved Xarelto in 2011. It is prescribed for people with atrial fibrillation, a common heart rhythm disorder, and to treat and reduce the risk of deep vein thrombosis and pulmonary embolisms.
But plaintiffs contend Xarelto was unreasonably dangerous and that J&J and Bayer failed to warn patients about a serious risk of uncontrollable, irreversible bleeding in emergencies.
Bayer and J&J contend Xarelto’s label adequately warns of bleeding risks.
Federal juries have cleared the companies of liability in three previous trials. The latest verdict in the federal litigation came in August in the case of a Mississippi woman.
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Judge reverses plaintiffs' $27.8M Xarelto jury verdict in Philadelphia court
Jan 11, 2018 | Pennsylvania Record
By Nicholas Malfitano
Late Tuesday, a state court judge reversed a near-$28 million jury verdict in product liability litigation surrounding the blood thinner Xarelto, a decision that overturned what had been the first win nationally for plaintiffs and included a landmark punitive damages award.
Janssen Pharmaceuticals spokesperson Sarah Freeman expressed satisfaction with Philadelphia County Court of Common Pleas Judge Michael Erdos’s reversal of the verdict.
“We are pleased with the court’s decision to reverse the jury verdict reached in Hartman and enter judgment in favor of Janssen. Nothing is more important to us than the health and safety of the patients using our medicines,” Freeman stated.
“Xarelto’s FDA-approved labeling has always warned of bleeding events – a known risk associated with anti-coagulation – 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. We will continue to defend against allegations made in this litigation.”
Bayer shared Janssen’s affirmation of the verdict being overturned.
“Bayer is pleased that the Court has entered judgment in favor of the defendants. Today’s ruling and the defense verdicts in the first three federal court trials support 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 spokesperson Chris Loder said.
“With more than five years on the U.S. market and 33 million patients prescribed worldwide in over 130 countries, real-world experience continues to confirm the favorable benefit-risk profile of Xarelto for patients who have a high risk of life-threatening blood clots that may cause strokes and other serious medical complications. Bayer stands behind the safety and efficacy of Xarelto and will continue to vigorously defend it.”
Michael M. Weinkowitz of Levin Fishbein Sedran & Berman in Philadelphia, a member of legal counsel for plaintiffs Lynn and Allen Hartman, explained the reversal had to do with Lynn Hartman’s prescribing doctor.
“The dismissal was based on a very narrow issue related to Mrs. Hartman’s prescribing physician. However, the court also ruled that the jury’s punitive damages verdict was appropriate and that sufficient evidence existed for the jury to find that the defendants acted with reckless disregard for human life,” Weinkowitz said.
“This ruling regarding the defendants’ wrongful conduct – which resulted in the jury awarding $26 million in punitive damages – has far broader implications for the Xarelto litigation as a whole. We look forward to trying the next series of cases in Philadelphia.”
The $27.8 million verdict was the first one reached in the Philadelphia County Court of Common Pleas and through its Complex Litigation Center, which is handling more than 1,600 Xarelto cases.
After three consecutive verdicts for the defense in the federal court Xarelto bellwether trials, a Philadelphia court jury recently awarded the landmark $27.8 million amount to Xarelto plaintiffs Lynn and Allen Hartman of Plymouth, Ind.
$26 million of that amount consisted of punitive damages, while the remaining $1.8 million were to compensate the plaintiffs for alleged injuries. The case pitted the Hartmans against Janssen, Bayer and their associated organizations.
Lynn 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 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.
Currently, more than 1,620 cases – most from out-of-state plaintiffs – will be handled in Philadelphia’s Complex Litigation Center. The CLC has several mass tort programs, including cases over asbestos and Risperdal, and 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 jumped to an unprecedented 94 percent.
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 which 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.
Plaintiff counsel believe the PT test, which has been used to identify patients with bleeding risks for years, would have been beneficial to plaintiffs negatively affected by the drug. In contrast, counsel for Xarelto’s manufacturers countered that the PT test isn’t scientifically reliable.
The reversal of the jury verdict was the second decision Erdos made in the case on Tuesday, with the first one related to the issuing of sanctions to two members of plaintiff counsel for improper photos and social media posts connected to the trial.
Earlier on Tuesday, Erdos ruled to rescind the pro hac vice admission status of plaintiff attorney Ned McWilliams of Levin Papantonio Thomas Mitchell Rafferty Proctor in Pensacola, Fla. Further, Erdos ruled fellow member of plaintiff counsel Emily Jeffcott of The Lambert Firm in New Orleans, La. must perform 25 hours of community service in Philadelphia, and fined her $2,500.
McWilliams and Jeffcott’s punishments are a result of their taking photos in the courtroom while the Xarelto trial was in progress and publishing them on social media, with the one taken by McWilliams specifically being accused of stoking anti-German bias.
Defense counsel, including that for Bayer Corporation, which is based in Leverkusen, Germany, contended McWilliams had posted on Instagram, a popular social media mobile app used to share photographs, and hashtagged a photo taken in the empty trial courtroom with the phrase “#KillinNazis”.
Jeffcott had taken a courtroom photo with Erdos on the bench, which she also posted to Instagram. Though it did not include the “#KillinNazis” hashtag, it was later downloaded and re-published in other media reports on the trial.
Plaintiff counsel believed the social media posts were “taken out of context” and jurors did not see them. However, the photography and subsequent social media posts violate courtroom rules and both attorneys apologized to Erdos.
Neither McWilliams nor Jeffcott could be reached for comment on the matter.
Additionally, the defense argued plaintiff counsel used “xenophobic and offensive remarks” directed at their client during the trial’s closing arguments.
Weinkowitz denied any xenophobic conduct transpired.
“The jury found by clear and convincing evidence that the defendants engaged in willful and wanton conduct by not warning about Xarelto’s serious risk, despite mounting evidence that thousands of people are being harmed, including Mrs. Hartman. There was absolutely no attempt by any lawyer associated with Mrs. Hartman to raise any sentiment about nationality at trial,” Weinkowitz said.
Freeman communicated a different perspective on behalf of Janssen, towards both the photographs and alleged closing argument remarks.
“We believe the posts made by plaintiff’s counsel on social media are inappropriate, insensitive and similar to egregious statements they made during trial,” Freeman said.
Erdos had allowed for the “#KillinNazis” hashtag to be entered into official evidence for consideration by the Superior Court of Pennsylvania.
A separate group of more than 18,000 Xarelto lawsuits have been consolidated through the federal court system’s multi-district litigation (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. U.S. District Court Judge Eldon E. Fallon presided over the initial three federal bellwether trials, two of which took place in New Orleans, La., plus another in Jackson, Miss.
In all three 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.
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Pennsylvania judge overturns $27.8M Xarelto decision against J&J, Bayer
Jan 11, 2018 | Becker's Hospital Review
By Leo Vartorella
A judge in Pennsylvania overturned a $27.8 million jury award against Johnson & Johnson and Bayer AG over claims their blood thinner Xarelto caused internal bleeding, according to EquitiesFocus.com.
In December, a jury awarded Lynn Hartman $1.8 million in compensatory damages and $26 million in punitive damages after she claimed taking Xarelto for her atrial fibrillation caused gastrointestinal bleeding. The lawsuit is just one of nearly 21,400 Johnson & Johnson and Bayer AG are facing over Xarelto, but this was the first to award any damages.
In three previous cases, federal judges cleared the companies of any liability. Both companies noted the drug's label adequately warns customers of any internal bleeding risk.
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Judge punishes lawyer for using hashtag #killinnazis, tosses $27.8M Xarelto verdict on other grounds
Jan 11, 2018 | ABA Journal
By Debra Cassens Weiss
A Pennsylvania judge on Tuesday overturned a $27.8 million verdict against the makers of the blood thinner Xarelto in a lawsuit by an Indiana woman who claimed the drug caused severe gastrointestinal bleeding.
Judge Michael Erdos issued a judgment notwithstanding the verdict because of testimony by the prescribing doctor for plaintiff Lynn Hartman, report the Legal Intelligencer (sub. req.) and Law360.
Erdos rejected an alternate ground for overturning the verdict that was based on an Instagram photo by a lawyer for the plaintiff that used the hashtag #killinnazis. Erdos nonetheless scolded and punished the lawyer for the post, the Legal Intelligencer (sub. req.) reports in another story.
Hartman’s case is among about 1,500 Xarelto suits pending in Philadelphia County. Xarelto makers previously won three lawsuits filed in Louisiana federal court.
Hartman’s lawyers had argued the drug companies should have warned that U.S. patients taking Xarelto had a higher rate of bleeding than patients in other countries, and that some patients had higher levels of Xarelto in their blood than others.
The lawyers maintained that the doctor would have informed Hartman about increased risks if she had tested Hartman for blood coagulation levels, and Hartman wouldn’t have taken Xarelto based on the information. Erdos found the argument was too speculative.
The doctor testified that she didn’t discuss percentages with patients, and she wouldn’t concede that the tone of her conversation with Hartman would have been any different, Erdos said.
Lawyers for the drug companies, Germany-based Bayer and Janssen Pharmaceuticals, had suggested an additional basis to overturn the verdict: a lawyer’s Instagram photo of the courtroom using the hashtag #killinnazis. The defense had claimed the hashtag and closing arguments pointed to plaintiffs’ attempt to link the defendants to Nazi Germany.
Erdos said the ‘killinnazis’ hashtag on the court photo was “beneath the dignity of the legal profession.”
Lawyer Ned McWilliams had posted the photo. Erdos punished McWilliams by revoking his pro hoc vice status, which had allowed the Florida lawyer to handle the Xarelto lawsuit in Pennsylvania.
Erdos ordered another lawyer, Emily Jeffcott, to pay $2,500 and perform 25 hours of community service for posting a courtroom photo with Erdos on the bench to Instagram. The photo was later used in promotional materials for Jeffcott’s firm.
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Plaintiff's Xarelto victory is short-lived as judge overturns $28M verdict against Bayer and J&J
Jan 10, 2018 | FiercePharma
By Eric Sagonowsky
The first verdict to go against Bayer and Johnson & Johnson over Xarelto's bleeding risks didn't stand up to court scrutiny. A U.S. judge overturned the $28 million award on grounds it was an unreasonable result.
In the case of Lynn Hartman, Judge Michael Erdos in Philadelphia this week entered a judgment notwithstanding the verdict, which is a finding that a no reasonable jury could have reached the same conclusion.
Hartman brought the case in Pennsylvania, arguing her Xarelto use—prescribed to prevent strokes associated with atrial fibrillation—caused severe gastrointestinal bleeding, according to Reuters. The case was the first to go to trial in state courts over Xarelto bleeding risks, a J&J spokesperson previously said.
Representatives for both Bayer and J&J said the companies are "pleased" with the decision and that they will continue defending their product in court.
Michael Weinkowitz an attorney for Hartman, said the "dismissal was based on a very narrow issue related to Mrs. Hartman’s prescribing physician." He said the court determined the jury's punitive damages award was "appropriate and that sufficient evidence existed for the jury to find that the defendants acted with reckless disregard for human life."
"This ruling regarding the defendants' wrongful conduct—which resulted in the jury awarding $26 million in punitive damages—has far broader implications for the Xarelto litigation as a whole. We look forward to trying the next series of cases in Philadelphia. "
The original verdict in December was the first case to go against Bayer and J&J in their defense of the blockbuster blood thinner, which has come under legal attacks claiming it can cause serious bleeding and that the drugmakers didn't appropriately warn patients and physicians. For their part, both companies contend the med's label discloses its risks.
"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," a J&J spokesperson said via email late Tuesday.
J&J faces about 21,400 Xarelto liability cases, as of its most recent quarterly filing. About 1,400 are in Philadelphia, Reuters reports. First approved by the FDA in 2011, Xarelto was Bayer’s top-selling drug last year, with $3.24 billion in revenues. It ranked third for J&J at $2.5 billion in sales.
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Phila. Trial Judge Throws Out $28M Verdict in Xarelto Case
Jan 10, 2018 | Legal Intelligencer
By Max Mitchell
The nearly $28 million verdict awarded last month in the first Xarelto case to be tried in state court has been reversed.
Philadelphia Court of Common Pleas Judge Michael Erdos on Tuesday granted the defense’s motion for judgment notwithstanding the verdict, which eliminates the $27.8 million award a jury handed up Dec. 5. The award was the first win for plaintiffs in the Xarelto litigation after four consecutive losses in federal court.
According to a transcript of the proceedings, Erdos based his decision on the testimony of plaintiff Lynn Hartman’s prescribing doctor, focusing on whether the plaintiffs established that the doctor would have still prescribed Xarelto if Hartman had taken a PT, or prothrombin test, to assesses coagulation levels in a person’s blood, which is a test plaintiffs contended should have been required.
Hartman’s counsel had argued that the prescribing doctor, Dr. Josephine Randazzo, would have told Hartman about the increased risks if she had performed the test and Hartman would have then refused to take the medication. However, Erdos said that argument was based on speculation.
“I think it is speculative to say that based on [the PT test] she would have communicated the increased risks with respect to the other issues, particularly in light of her answers about not discussing percentages generally,” Erdos said. “In fact she would not even concede that the tone and demeanor of the conversation would have been any different. She was never asked specifically if she would have communicated the new information to Mrs. Hartman as opposed to just generally.”
Randazzo’s testimony was not live before the jury, but rather had been videotaped and played for the jury. The testimony has been a point of contention throughout the litigation, and following the verdict, several court watchers said the issue was one the defendants were likely to focus on. However, defense motions based on Randazzo’s videotaped testimony had also previously been denied on several occasions, including in a motion for summary judgment that Philadelphia Judge Arnold New denied in October and as part of the defendants’ motion for compulsory nonsuit at the end of the plaintiff’s case.
In an emailed statement a spokeswoman for Janssen said the company was pleased that the court reversed the verdict.
“Nothing is more important to us than the health and safety of the patients using our medicines,” spokeswoman Sarah Freeman said.
A spokesman for Bayer said the company was also pleased with the ruling.
“Today’s ruling and the defense verdicts in the first three federal court trials support both the safety and efficacy of Xarelto and that its [U.S. Food and Drug Administration]-approved label contains accurate, science-based information on the benefits and risks of this life-saving medicine,” spokesman Chris Loder said in an emailed statement.
In an emailed statement Levin Sedran & Berman attorney Michael Weinkowitz, who is co-liaison counsel for the plaintiffs, said the court also determined there was sufficient evidence to support the jury’s multimillion-dollar punitive damages award, which, he said, has implications for the 1,600 cases pending in Philadelphia’s Xarelto mass tort program.
“This ruling regarding the defendants’ wrongful conduct—which resulted in the jury awarding $26 million in punitive damages—has far broader implications for the Xarelto litigation as a whole,” he said. “We look forward to trying the next series of cases in Philadelphia.”
The ruling Tuesday adds one more wrinkle to the already contentious litigation, which has seen disputes arise over allegedly unsavory tactics involving a witness, improper comments during closing arguments, and social media posts that eventually resulted in two attorneys being punished for the conduct on Tuesday.
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Jan 10, 2018 | Equities Focus
By David Roper
A state court judge in Pennsylvania overturned a jury award on Tuesday of $27.8 million to a couple from Indiana who had accused Johnson & Johnson and Bayer AG of not warning of the risks of internal bleeding from Xarelto a drug the two companies developed, said both companies.
Judge Michael Erdos ruled after a hearing that was requested by the drug makers to reverse the verdict in December, which was the first loss in trial over the popular blood thinner, said the companies.
Janssen Pharmaceutical, a unit of J&J and Bayer, which developed Xarelto jointly, welcomed the court’s decision in separate statements saying they would continue defending against allegation in other related litigation.
Bayer remains behind the efficacy and safety of Xarelto and continued to defend it vigorously said Bayer in its statement.
The court’s verdict came in a suit filed by Lynn Hartman. She was prescribed the drug to prevent strokes due to atrial fibrillation, which is an irregular heartbeat.
She said she took the medication for nearly one year and was hospitalized during June of 2014 with gastrointestinal bleeding, which she said was caused by Xarelto. She since has recovered.
She and her husband sued the two drug makers and were awarded in December of a jury $1.8 million for compensatory damages and punitive damages of $26 million.
The lawsuit is just one of close to 21,400 J&J is facing in state and federal courts that blame injuries on the drug. The verdict was the first that resulted from close to 1,400 that are pending in the court.
The attorney representing the couple said that the judge’s decision was related to a narrow issue involving Hartman’s physician who prescribed the drug.
The United States Food and Drug Administration gave its approval to Xarelto during 2011. It is used for people that have atrial fibrillation, which is a common disorder of the heart rhythm and to treat as well as reduce risk of pulmonary embolisms and deep vein thrombosis.
However, plaintiffs contend that the drug is unreasonably dangerous and both Bayer and J&J did not warn patients sufficiently about the risk of irreversible, uncontrollable bleeding.
Both J&J and Bayer contend that the label on Xarelto adequately warns users about the risks of bleeding.
Federal juries cleared the two companies of any liability in a total of three previous lawsuits. The most recent verdict came this past August in litigation of a case involving a woman from Mississippi.
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Judge Reverses $28 Million Xarelto Award (Reuters)
Jan 10, 2018 | MedPage Today
A Pennsylvania state court judge has overturned an Indiana couple's $27.8 million award in a lawsuit against rivaroxaban (Xarelto) drugmakers Bayer AG and Johnson & Johnson, Reuters reports.
The couple had accused the companies of failing to warn about the risk of internal bleeding with the drug. Plaintiff Lynn Hartman was prescribed rivaroxaban to prevent strokes resulting from atrial fibrillation, and one year later was hospitalized with severe gastrointestinal bleeding, which she blamed on the drug.
The award had been the companies' first trial loss in litigation over the blood thinner. There are about 21,400 lawsuits pending in federal and state courts relating to rivaroxaban injuries.
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Pa. Judge Junks $28M Xarelto Verdict Against J&J, Bayer
Jan 9, 2018 | Law360
By Matt Fair
A Pennsylvania state judge agreed late Tuesday to throw out a $28 million verdict finding that a pair of Johnson & Johnson and Bayer AG units had failed to properly warn about the risks of internal bleeding from the anticoagulant medication Xarelto.
Judge Michael Erdos in the Philadelphia County Court of Common Pleas junked the verdict after hearing arguments from Janssen Pharmaceuticals Inc. and Bayer Healthcare Pharmaceuticals Inc. that a physician for plaintiff Lynn Hartman had testified that additional warnings would not have changed her decision to prescribe the drug.
The ruling, which a Janssen spokesperson confirmed to Law360 on Tuesday evening, voids the lone win that plaintiffs had managed to rack up in four trials over internal bleeding allegedly caused by the blockbuster medication.
Hartman’s three-week trial centered around arguments that the drug's warning label originally excluded information that the rate of bleeds 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. The information was later added to the drug's labeling in September 2015 as part of the U.S. Food and Drug Administration's efforts to standardize labeling for all of the so-called novel oral anticoagulant medications that have been approved in recent years.
Hartman's attorneys also accused the companies of failing to adequately warn about the higher risk of bleeds when using the drug along with 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 case is one of about 1,500 pending as part of a mass tort program in Philadelphia County.
Hartman’s victory came after Bayer and Janssen won defense verdicts in a trio of Xarelto injury cases tried out of a multidistrict litigation program in Louisiana federal court earlier this year.
The ruling came after a marathon hearing on Tuesday aimed at addressing a slew of post-trial motions in the Hartman case.
Beth Wilkinson, an attorney with Wilkinson Walsh & Eskovitz representing the drugmakers, said testimony from Hartman’s prescribing physician did not pass muster under the so-called learned intermediary doctrine, under which drugmakers must provide all necessary warnings to prescribing physicians in order to properly weigh the risks and benefits of a medication.
“There’s nothing here to suggest that she believed that she would have given a different warning or had a different conservation with Mrs. Hartman,” she said.
Frederick Longer, an attorney with Levin Sedran & Berman representing the plaintiff, countered that the physician’s ultimate prescribing decision had to be considered alongside the possibility that Hartman may not have consented to take the drug if she’d gotten an additional warning.
“If she had given this information to Mrs. Hartman, we know from the testimony that Mrs. Hartman would have said, ‘I don’t want this drug,’” he said.
While Judge Erdos ultimately nixed the liability verdict, he ruled earlier in Tuesday’s hearing that there had been enough evidence to support an award of punitive damages in the case.
Michael Weinkowitz, another attorney with Levin Sedran & Berman representing Hartman, focused on that ruling in a statement to Law360.
“While the dismissal was based on a very narrow issue related to Mrs. Hartman’s prescribing physician, the court ruled the jury’s verdict with respect to punitive damages was appropriate and sufficient evidence existed for the jury to find the defendants acted with reckless disregard for human life,” he said. “The ruling with regard to punitive conduct — which resulted in the jury awarding $26 million in punitive damages — has far broader implications for the litigation as a whole. As a result, we look forward to trying the next series of cases in Philadelphia.”
Sarah Freeman, a spokeswoman for Janssen, praised the decision in a statement to Law360.
“We are pleased with the court’s decision to reverse the jury verdict reached in Hartman and enter judgment in favor of Janssen,” she said. “Nothing is more important to us than the health and safety of the patients using our medicines. 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.”
She said the company would continue to fight future claims over the drug.
A spokesperson for Bayer did not immediately return a message seeking comment.
The ruling came after Judge Erdos took two members of Hartman’s legal team to task for courthouse photos taken during the course of the trial that were posted to social media.
The judge removed Levin Papantonio Thomas Mitchell Rafferty & Proctor PA partner Ned McWilliams from working on the Hartman case after castigating the Pensacola, Florida-based attorney’s conduct — which included Instagram posts of the courtroom and one photo that featured a juror along with the hashtag “#killinnazis” — as “well beneath the dignity of the legal profession.”
McWilliams is also facing the prospect of having his authority to practice in Philadelphia revoked in a second Xarelto case scheduled to go to trial later this year.
A second attorney on the plaintiff’s side, Lambert Firm PLC partner Emily Jeffcott, was slapped with a $2,500 fine and ordered to complete 25 hours of community service after she was identified as having taken a photo of Judge Erdos on the bench during jury deliberations in the case last month.
Both McWilliams and Jeffcott declined to comment after Judge Erdos announced the disciplinary measures on Tuesday morning.
Bayer had taken the position in post-trial motions that posts from members of Hartman’s legal team with the “#killinnazis” hashtag showed a willful effort to try and prejudicially link Berlin-based Bayer with Nazi Germany in the minds of jurors during closing arguments.
Wilkinson said the use of the hashtag provided context for portions of Hartman’s legal team’s closing arguments allegedly alluding to Nazi Germany.
She pointed to comments during closings from Gary Douglas, an attorney with Douglas & London PC representing Hartman, urging jurors to “wield that mighty sword and let those folks know in Berlin, Germany, when they planned to sell this drug to us Americans to make their billions.” She also referenced McWilliams’ comment during closing arguments that “bodies are literally piling up and they know it” as he talked about Bayer’s failure to include information in the original warning labels for Xarelto about a heightened rate of serious bleeds seen among patients in a clinical trial in North America.
Hartman is represented by Gary Douglas of Douglas & London PC, Michael Weinkowitz and Frederick Longer of Levin Sedran & Berman, Laura Feldman of Feldman & Pinto, and others.
Bayer and J&J are represented by David Abernathy, Chandra Miller, Susan Sharko and Rodney Hudson of Drinker Biddle & Reath LLP, Albert Bixler and Leslie Hayes of Eckert Seamans Cherin & Mellott LLC, Kim Moore and Timothy Daniels of Irwin Fritchie Urquhart & Moore LLC, and Beth Wilkinson, Brian Stekloff and Alexandra Walsh of Wilkinson Walsh & Eskovitz.The case is Hartman v. Janssen Pharmaceuticals Inc. et al., case number 160503416, in the Court of Common Pleas of Philadelphia County, Pennsylvania.
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Philly judge tosses $28M verdict in Xarelto blood-thinner case
Jan 10, 2018 | Philadelphia Inquirer
By Sam Wood
A judge in Philadelphia has thrown out a $28 million jury verdict awarded last monthto an Indiana woman who had accused Bayer AG and Johnson & Johnson subsidiary Janssen Pharmaceuticals of failing to adequately warn about the risks of the blood-thinner Xarelto.
The verdict, overturned on Tuesday, had granted $1.8 million in compensatory damages and $26 million in punitive damages to Lynn Hartman, who began taking Xarelto in 2013 to prevent strokes. Less than a year later, she was hospitalized with severe gastrointestinal bleeding she attributed to the drug.
Common Pleas Judge Michael Erdos reversed the decision “based on a very narrow issue related to Mrs. Hartman’s prescribing physician,” said Hartman’s attorney, Michael Weinkowitz, who said he would appeal the decision. About 370 deaths have been linked to the medication, according to the FDA.
Xarelto is most commonly prescribed to prevent strokes as a result of an irregular heartbeat, a condition called atrial fibrillation. Nationwide, there are more than 18,000 Xarelto cases pending. About 1,800 of those have been filed in Philadelphia, earning the city the title of “Judicial Hellhole” from the American Tort Reform Foundation. Four more trials involving the medication are set for the Court of Common Pleas through May.
A spokeswoman for Janssen said the company was pleased with the court’s decision. Xarelto’s labeling “has always warned of bleeding events — a known risk associated with anticoagulation,” said Sarah Freeman. “We will continue to defend against allegations made in this litigation.”
According to Bloomberg, the drug is Bayer’s top-selling product, generating $3.24 billion in sales last year and $2.5 billion in 2015 for the German pharmaceutical company. Xarelto is J&J’s third-largest seller, bringing in $2.29 billion in 2016.
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Jan 10, 2018 | NBC Columbia, MO
View clip here: https://app.criticalmention.com/app/#clip/view/31824803?token=dc6526b6-6a46-4cf6-8b90-17901f24eef7
Rough transcript: here's a story that's trending this morning... a pennsylvania judge overturned a 27.8 million dollar jury award to an indiana couple who accused pharmaceutical companies bayer and johnson & johnson of failing to warn of internal bleeding risks to their drug xarelto. this was as a result of the drugmakers' motion to reverse the december verdict, which was their first trial loss in litigation over the blood thinner. lynn hartman who was prescribed xarelto to prevent strokes as a result of an irregular heartbeat originally sued the companies, after she was hospitalized with severe gastrointestinal bleeding, which she blamed on xarelto that she had been taking for a year prior. bayer and j&j contend xarelto's label adequately warns of bleeding risks.
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