Latest mass tort trial sees N.J. man allege that Xarelto caused his near-fatal gastrointestinal bleeding

By Nicholas Malfitano | Aug 13, 2018

PHILADELPHIA – In an environment in which recent statistics say only 16 percent of new pharmaceutical case plaintiffs reside in Pennsylvania, litigation continues to be heard in Philadelphia’s County Court of Common Pleas on the more than 1,800 cases surrounding blood thinning-drug Xarelto.

Through documents filed June 5 regarding which of the more than 1,800 Xarelto cases in Philadelphia’s Complex Litigation Center will be picked for trial, attorneys for Janssen Pharmaceuticals and Bayer Corp. say plaintiffs’ lawyers have been searching for a theory that will stem the early tide of defense verdicts in these lawsuits.

There can be no failure to warn of excessive bleeding if Xarelto’s label mentions bleeding more than 70 times, including “serious or fatal bleeding,” they claimed.

Next, Janssen and Bayer say they were accused of failing to instruct doctors to conduct certain testing – a theory rejected in the three federal MDL trials.

Other theories include that the label lacks sub-group data and data on concomitant aspirin use.

“All of this shape-shifting (including during the middle of trial) has led to numerous inefficiencies, including almost monthly amendments to expert reports, calls for additional discovery that should have been completed long ago, and two amendments to the master complaint,” defendants say.

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.

Currently, more than 1,860 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. In 2017, CLC stats show that figure jumped to an unprecedented 94 percent. Statistics recently released from the CLC for the first half of 2018 show the rate of out-of-state plaintiffs only dropped slightly, to 84 percent.

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.

After three consecutive verdicts for the defense in the federal court Xarelto bellwether trials, a Philadelphia court jury initially awarded a landmark $27.8 million amount to Xarelto plaintiffs Lynn and Allen Hartman of Plymouth, Ind. – however, that result was later overturned due to an issue with plaintiff Lynn Hartman’s prescribing doctor, notching four consecutive defense verdicts.

Another previous defense verdict in the case brought by New Jersey’s Daniel I. Russell made five.

Now, proceedings are being held on a sixth case, Cooney v. Janssen Research & Development, LLC Et.Al.

Cooney, 63, of Morristown, N.J, says he was prescribed Xarelto in 20 milligram-doses by Dr. Michael Scola of Regional Cancer Care Associates, also in Morristown, in November 2014. Cooney took the drug for approximately 13 months until December 2015, and claims that use year-plus-long use was the cause of his injuries.

In his June 2016 complaint, Cooney alleged he suffered “gastrointestinal bleeding requiring four days of hospitalization and transfusions of at least three units of packed red blood cells and an esophagogastroduodenoscopy” on Christmas Day 2015 an injury diagnosed by Dr. Kelly Ayre at Morristown Medical Center, in Morristown, N.J.

Originally, Cooney pursued claims of strict liability, manufacturing defect, design defect, failure to warn, negligence, breach of express warranty, breach of implied warranty, negligent misrepresentation, fraud and violations of Pennsylvania’s Unfair Trade Practices and Consumer Protection Law.

Through previous proceedings in the matter, only the “failure to warn” claim remains – predicated on what the defendants either knew or should have known at the time Cooney was prescribed Xarelto.

“To make it clear, the label today, 20 milligrams, is still the approved dose, still approved as safe and effective for the treatment of a pulmonary embolism or DVT. So, you know, and you'll learn in this trial that the way hematologists think about treatment versus prevention, you know, some possibly think about it differently, but what the label says is that 20 milligrams is still FDA-approved safe and effective for the treatment of those blood clots,” defense counsel Alexandra Walsh of Wilkinson Walsh & Eskovitz in Washington, D.C., said during recent court proceedings.

“Then what the label says is for the – for reduction in the risk of block, prevention of clots coming back, that 10 milligrams is the approved dose. But after a patient has been on a full strength blood thinner, which could be 20 milligrams or something else, for at least six months, so 10 milligrams even today, it's not approved until a patient has been on something else for at least six months.”

However, plaintiff counsel countered with claims that the defendant companies “manipulated the label-writing and regulatory process”, not wanting to “rock the boat and send the wrong signal to the FDA” regarding Xarelto by conducting a study of a lower dose or potentially lose valuable market share.

As a result, plaintiff counsel said, Cooney, a traveling salesman by trade, suffered near-fatal gastrointestinal bleeding.

But Walsh added that studies conducted showed no difference in actual major bleeding risks between 10-milligram and 20-milligram doses and there was internal concerns over the medication not working at a lower dose – claims vigorously disputed by plaintiff counsel.

Recently, a number of motions in limine being contested were decided by Philadelphia County Court of Common Pleas Judge Teresa M. Sarmina:

• Defendants’ Joint Motion No. 1: To exclude evidence or argument concerning developments post-dating plaintiff’s use of Xarelto was denied.

• Defendants’ Joint Motion No. 2: To exclude reference to Dr. David Madigan was granted, thereby preventing all parties from referring to Madigan or review of any statistical analyses conducted by Dr. David Kessler.

• Defendants’ Joint Motion No. 3: To exclude evidence and argument regarding Rocket AF US Sub-Group Data and related arguments was denied, preventing plaintiff from characterizing Xarelto as the “Worst-In-Class” novel oral anticoagulant.

• Defendants’ Joint Motion No. 4: To exclude evidence and argument regarding direct-to-consumer advertising was granted, preventing plaintiff from arguing or referencing such advertising for Xarelto.

• Defendants’ Joint Motion No. 5: To exclude evidence and argument concerning PT lab testing was granted, prohibiting plaintiff from arguing or referencing PT lab testing for Xarelto. Cooney is permitted to introduce evidence as to what his PT reading was when hospitalized in 2015, that his PT was elevated and what the upper limit of normal was. Furthermore, Cooney is prevented from introducing evidence characterizing him as a “high responder” in the PT lab test.

• Plaintiff’s Motion No. 6: To exclude evidence of compensation of expert witnesses for work not specific to the individual case being tried was granted. All counsel and witnesses are prohibited from “commenting on, referring to, introducing testimony or evidence about, attempting to elicit testimony about or arguing the amount of compensation received by any of plaintiff’s expert witnesses for their work on cases other than the case currently being tried, whether directly or indirectly.”

Philadelphia County Court of Common Pleas case 160602012

From the Pennsylvania Record: Reach Courts Reporter Nicholas Malfitano at

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