4 Key Plaintiff Experts Admitted in Next Weeks' Xarelto Trial

Former FDA Commission David A. Kessler, M.D., will testify in the Xarelto trial.
Former FDA Commission David A. Kessler, M.D., will testify in the Xarelto trial.

Ruling in several Daubert motions, US District Judge Eldon E. Fallon admitted four of the plaintiff’s key expert witnesses in two upcoming bellwether trials (test cases), the first of which starts next week in the Eastern District of Louisiana.

Judge Fallon is supervising 16,285 cases in MDL 2592, IN RE: Xarelto (Rivaroxaban) Products Liability Litigation.

Defendants Janssen and Bayer are scrambling to exclude or limit testimony from key plaintiff experts — unsuccessfully. The Judge admitted said three important plaintiff witnesses passed muster:

  • Dr. Suzanne Parisian. She is one of the few people who specializes in the complexities of FDA regulation. Based in Phoenix, AZ, Dr. Parisian will assist the jury in understanding the regulatory requirements applicable to pharmaceutical manufacturers and drug labeling within the context of the FDA.

She is a former Chief Medical Officer of the Food and Drug Administration (FDA), as well as physician, Board Certified Pathologist, past researcher in genetics and developmental biology, author of FDA Inside and Out, and President of Medical Device Assistance, Inc., a regulatory and clinical consulting firm.

  • Dr. Laura Plunkett. She will testify about drug pharmacology, general causation, regulatory matters and the adequacy of labels for both prescription and non-prescription drugs.

Dr. Plunkett is a pharmacologist and toxicologist who has substantial experience as an expert witness. She is a Diplomate of the American Board of Toxicology and a registered patent agent. She is neither a medical doctor nor a regulatory agent for the FDA, but has extensive experience consulting and advising as to regulatory matters, including label content.

  • Dr. David Kessler. He is uniquely qualified to offer opinions on the conduct of pharmaceutical companies.

He is a medical doctor, the former Commissioner of the Food and Drug Administration, a professor of food and drug law, and an advisor to pharmaceutical companies. He has testified before Congress on multiple occasions and has published many articles in legal, medical, and scientific journals on the federal regulation of drugs and medical devises as well as the intersection of federal regulation and state law. Currently, Dr. Kessler is a senior advisor to a global private equity firm that owns pharmaceutical and biomedical companies and serves on the boards of two pharmaceutical companies. He advises corporates on the proper standard of care under both state and federal law.

  • Dr. Nathaniel Winstead. He will testify that the probable cause of the plaintiff’s gastrointestinal bleed was Xarelto.

Dr. Nathaniel Winstead, MD, is a general gastroenterologist and hepatologist with clinical experience with Warfarin, and is double-board-certified in gastroenterology and internal medicine. In researching for and writing his expert report, Dr. Winstead attests that he used the same methods he uses to evaluate and treat his patients. From 2008-2013, Dr. Winstead was the Director of Gastroenterology Research and the Medical Director of the Inflammatory Bowel Disease Center at Ochsner. He was the principal investigator or sub-investigator in multiple clinical trials for various drug manufacturers, including Defendant Janssen.

Some rulings for the defense

The court also allowed the plaintiffs’ expert witnesses to express opinions that if physician monitored the concentration of Zarelto in their patients, bleeding risk would be reduced. “Because of Xarelto’s short half-life and the variability in patients, some patients will retain more Xarelto in their system and will be subject to a greater bleeding risk,” the judge said.

Judge Fallon also excluded defense expert Dr. James A. Reiffel, who would have testified that patients might have abruptly stopped taking Xarelto due to attorney advertising.

Ruling for the defense, the judge said that its experts could testify about what might have happened to the plaintiffs if they had taken a different anticoagulant. The court also allowed defense expert D. J. Michael Gaziano to testify.

Gaziano has been a physician for 30 years. He received his MD from Yale and his MPH with a concentration in cardio-epidemiology from Harvard. He is a cardiologist in Boston where he teaches and sees patients including those who require anticoagulant therapy.

The testimony of defense experts Drs. Scott Boniol and William Franklin Peacock IV was limited to exclude opinions about the early detection of cancer because of anticoagulant-related bleeding events.

 

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