Pennsylvania Record

Sunday, November 17, 2019

Conflict over encounter between plaintiff's doctor and pharma rep opens first Xarelto state court bellwether trial

By Nicholas Malfitano | Nov 8, 2017


PHILADELPHIA – The first Pennsylvania state bellwether trial connected to blood thinner drug Xarelto, which was set to begin Monday in the Philadelphia County Court of Common Pleas, was delayed due to a motion alleging an improper meeting between a plaintiff's doctor and a sales representative of the defense.

The first bellwether case is Hartman Et.Al v. Janssen Pharmaceuticals Et.Al, consisting of Lynn Hartman and Allen Hartman of Plymouth, Ind. against Janssen Pharmaceuticals, Bayer Corporation and their associated organizations.

That trial was due to begin Monday morning before Philadelphia County Court of Common Pleas Judge Michael Erdos, but controversy occurred over an alleged meeting between Lynn Hartman’s doctor, Timothy Aldridge, and a Janssen sales representative named Christine Derwent.

Plaintiff counsel asserts after a meeting between Aldridge and Derwent, the doctor became uncooperative and changed his story to not knowing that Hartman had suffered gastrointestinal bleeding – and furthermore, that they had not known of the meeting in question before deposing Aldridge, so they say did not have a chance to question him or Derwent before trial.

Michael M. Weinkowitz of Levin Fishbein Sedran & Berman in Philadelphia, a member of legal counsel for the Hartmans, could not be reached in connection with this story.

The defense countered that nothing improper occurred.

“The allegations that defendants acted improperly are completely without merit. Claims made by plaintiffs’ counsel on the day trial begins are simply meant to distract from the issues in this case,” Janssen spokesperson Sarah Freeman said.

A signed and sworn statement from Derwent, provided by Janssen and dated Nov. 6, explained she left materials with Aldridge’s assistant this past March 2 inviting him to attend a presentation about the treatment of atrial fibrillation, deep vein thrombosis or pulmonary embolism with Xarelto, being offered by a Dr. Ramon Mitra on June 13 in Culver, Ind.

“I did not speak with Dr. Aldridge on March 2, 2017 and had no conversation with him prior to that time. I documented the visit to Dr. Aldridge’s office in a call note dated the same day, pursuant to Janssen’s company policies,” Derwent said in the statement.

Derwent added, “My only interaction with Dr. Aldridge was saying hello when he attended the presentation by Dr. Ramon Mitra on June 13, 2017. Since that time, I have not spoken with Dr. Aldridge. I have never discussed any patient, this case or anything else related to this litigation with Dr. Aldridge.”

Given the alleged circumstances, plaintiff counsel asked the Court that Aldridge be prevented from testifying – a decision still pending with Erdos.

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.

According to court records, the bleeding was diagnosed by Aldridge in Rochester, Ind.

The Hartmans bring 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.

More than 1,540 lawsuits – 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 has 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.

Freeman added, “We will continue to defend against the allegations in this ongoing litigation as they contradict years of scientific data and the FDA’s repeated confirmation of Xarelto’s safety and efficacy. We believe 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.”

A Bayer representative also echoed those sentiments.

“With more than 31 million patients prescribed Xarelto worldwide, real world research continues to confirm that the benefit-risk profile remains favorable and consistent with clinical trials 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 vigorously defend it,” Bayer spokesman Chris Loder stated.

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. Judge 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 so far, juries have 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.

A fourth federal bellwether trial is scheduled for a Texas federal court in January.

Philadelphia County Court of Common Pleas case 160503416

From the Pennsylvania Record: Reach Courts Reporter Nicholas Malfitano at

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Philadelphia County Court of Common Pleas