PHILADELPHIA  – 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 program that 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 as 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.

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

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