PHILADELPHIA – 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.

Philadelphia County Court of Common Pleas case 160503416

From the Pennsylvania Record: Reach Courts Reporter Nicholas Malfitano at nickpennrecord@gmail.com

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