A Philadelphia jury last week found in favor Lynn Hartman
against the manufacturers of the anticoagulant Xarelto. The jury came back from
a little over a day of deliberations with an award of $27.8 million. The main
defendants in the case were Johnson & Johnson and Bayer AG. The award
included roughly $26 million in punitive damages. Hartman suffered serious
gastrointestinal bleeding while on the medication. She was an Indiana resident
who began taking the drug in 2013.
As part of her claims, Hartman argued that the defendants
should have included additional warnings over excessive bleeding risks and that
the warnings were inadequate. The
three-week trial centered around arguments that the drug's warning label
originally excluded information that the rate of bleeds observed in a clinical
trial was significantly higher among patients in the United States than
patients elsewhere in the world. Her attorneys proffered evidence that the rate
among participants in the United States was 8.1 percent annually versus 3.6
percent annually among participants globally. The information was later added
to the drug's labeling in September 2015 as part of the FDA’s efforts to
standardize labeling for all of the so-called novel oral anticoagulant
medications that have been approved in recent years.
The plaintiff’s case was bolstered by testimony from former
Food & Drug Administration chief David Kessler, who told jurors that he
believed the Xarelto warning label had lacked key information about the
severity of the potential bleeding risk associated with the drug.
Her case is one of about 1,500 pending as part of a consolidated mass tort program in Philadelphia County. The Bayer and Janssen defendants had won defense verdicts in three previous Xarelto injury cases tried out of a multidistrict litigation program in Louisiana federal court earlier this year. Those cases focused on arguments that drugmakers should have encouraged doctors to conduct laboratory testing on their patients to more precisely determine their risk of bleeding from Xarelto. The defense won those cases largely on the learned intermediary doctrine, under which drugmakers must provide all necessary warnings to prescribing physicians in order to properly weigh the risks and benefits of a medication.
The defendants in the Philadelphia trial have vowed to appeal and have already presented the learned-intermediary arguments to the trial court as part of a motion for a directed verdict in the case.
Her case is one of about 1,500 pending as part of a consolidated mass tort program in Philadelphia County. The Bayer and Janssen defendants had won defense verdicts in three previous Xarelto injury cases tried out of a multidistrict litigation program in Louisiana federal court earlier this year. Those cases focused on arguments that drugmakers should have encouraged doctors to conduct laboratory testing on their patients to more precisely determine their risk of bleeding from Xarelto. The defense won those cases largely on the learned intermediary doctrine, under which drugmakers must provide all necessary warnings to prescribing physicians in order to properly weigh the risks and benefits of a medication.
The defendants in the Philadelphia trial have vowed to appeal and have already presented the learned-intermediary arguments to the trial court as part of a motion for a directed verdict in the case.
A second case in the consolidated actions is scheduled to go
to trial in Philadelphia in January.
Pittman, Dutton & Hellums, P.C., is currently
investigating Xarelto cases. If you or a loved one were prescribed Xarelto and
suffered an irreversible internal bleeding that lead to hospitalization and/or
death, contact Booth Samuels at toll free 1-866-515-8880 or by email at booths@pittmanudutton.com.
