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Xarelto Makers Ordered to Pay $27.8 Million for Failure to Warn About Risks

xarelto pill bottleIn early December, a Philadelphia state court ruled against the makers of the anticoagulant Xarelto, ordering them to pay $27.8 million in damages due to their failure to warn patients and the medical community about the drug’s potential to cause internal bleeding.

Drug makers Bayer AG and Johnson & Johnson have said they will appeal the ruling.

The $27.8 million in damages was split into compensatory damages of $1.8 million and punitive damages of $26 million, according to Reuters.

Risks of Xarelto internal bleeding cited

The case involved a suit by an Indiana couple, the Hartmans. In 2013, Mrs. Lynn Hartman was prescribed Xarelto for her atrial fibrillation (AF). AF is a heart arrhymia that can increase the risk of heart attacks, strokes, pulmonary embolism, and related health concerns. Anticoagulants such as Xarelto are frequently prescribed for AF treatment.

After roughly a year of Xarelto treatment, Mrs. Hartman developed severe bleeding in her gastrointestinal tract. She was hospitalized for internal bleeding. The symptoms stopped when she stopped taking Xarelto.

Controversial meeting between drug company rep and plaintiff’s doctor

In an interesting development, the trial was initially delayed due to a motion filed by the plaintiff’s counsel alleging that the plaintiff’s doctor had abruptly changed his testimony following a meeting with a Janssen Pharmaceuticals sales rep. Plaintiff’s counsel alleged that after a meeting with Janssen sales rep Christine Derwent, doctor Timothy Aldridge changed his testimony, denying that he had known about Hartman’s gastrointestinal bleeding.

According to court records, Aldridge had diagnosed Hartman with gastrointestinal bleeding on June 26, 2014.

In her sworn testimony, Janssen drug rep Derwent claimed, “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.”

20,000 Xarelto lawsuits await trial

The Hartman case is the first to be tried as part of a bellwether set of trials. Bellwether trials are often used when there are multiple cases expected to have broadly similar sets of facts and circumstances. Their outcomes can provide grounds for settlement negotiations between parties in pending Xarelto lawsuits.

Currently, there are roughly 20,000 cases pending against Xarelto, 18,500 in the federal system and 1,500 in state court systems.

The Hartmans sued Janssen Pharmaceutical, a division of Johnson & Johnson, and Bayer in 2015.

Xarelto is Bayer’s top-selling drug, responsible for more than $3.4 billion in revenue last year.

This most recent case was the first in which the drug manufacturers have lost. Three federal cases have ended with rulings in favor of the defendants.

Further Reading on $28 Million Xarelto Case:

  1. “Bayer, Johnson & Johnson Ordered to Pay $27.8 Million in Xarelto Lawsuit -Reuters.” December 6, 2017. Fox Business News.
  2. Weyant, Curtis. “$28 Million Awarded to Indiana Couple in Xarelto Lawsuit Verdict.” December 5, 2017. Consumer Safety.
  3. Penn Record, Conflict over encounter between plaintiff’s doctor and pharma rep opens first Xarelto state court bellwether trial,