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Philadelphia County Court of Common Pleas
other-fatigue; other-transfusion; arterial/vascular-blood loss; arterial/vascular-internal bleeding; pulmonary/respiratory-respiratory
Products Liability – Pharmaceutical, Failure to Warn, Strict Liability
In Re: Xarelto® Products Liability Litigation,
December 5, 2017
Lynn Hartman (Female, 70s),
Laura A. Feldman;
Feldman & Pinto;
Lynn Hartman, Allen Hartman ■ Gary J. Douglas;
Douglas & London, P.C.;
Lynn Hartman, Allen Hartman ■ Frederick S. Longer;
Levin Sedran & Berman Attorneys at Law;
Lynn Hartman, Allen Hartman ■ Michael M. Weinkowitz;
Levin Sedran & Berman Attorneys at Law;
Lynn Hartman, Allen Hartman ■ Neil E. “Ned” McWilliams Jr.;
Levin Papantonio Thomas Mitchell Rafferty & Proctor, P.A.;
Lynn Hartman, Allen Hartman
J. Miles; M.D.; Cardiology; Philadelphia,
PA called by:
Laura A. Feldman, Gary J. Douglas, Frederick S. Longer, Michael M. Weinkowitz ■ David Kessler; M.D.; FDA Regulatory Affairs; San Francisco,
CA called by:
Laura A. Feldman, Gary J. Douglas, Frederick S. Longer, Michael M. Weinkowitz ■ Rotonya Carr; M.D.; Gastroenterology; Philadelphia,
PA called by:
Laura A. Feldman, Gary J. Douglas, Frederick S. Longer, Michael M. Weinkowitz
Bayer Pharma AG,
Janssen Ortho LLC,
Johnson & Johnson,
Bayer Healthcare AG,
Bayer Healthcare LLC,
Janssen Pharmaceuticals Inc.,
Janssen Research & Development LLC,
Bayer Healthcare Pharmaceuticals Inc.
Beth A. Wilkinson;
Wilkinson Walsh + Eskovitz;
Bayer Corp., Bayer Pharma AG, Janssen Ortho LLC, Johnson & Johnson, Bayer Healthcare AG, Bayer Healthcare LLC, Janssen Pharmaceuticals Inc., Janssen Research & Development LLC, Bayer Healthcare Pharmaceuticals Inc. ■ Timothy F. Daniels;
Irwin Fritchie Urquhart & Moore LLC;
Bayer Corp., Bayer Pharma AG, Janssen Ortho LLC, Johnson & Johnson, Bayer Healthcare AG, Bayer Healthcare LLC, Janssen Pharmaceuticals Inc., Janssen Research & Development LLC, Bayer Healthcare Pharmaceuticals Inc.
In 2013, plaintiff Lynn Hartman, in her 70s, started taking Xarelto, an anticoagulant medication, after she was diagnosed with atrial fibrillation. Her physician had prescribed the drug. In June 2014, Hartman suffered from gastrointestinal bleeding which resulted in hospitalization. She was then switched to another blood-thinner which caused no negative health issues. Hartman asserted that Xarelto’s label failed to adequately warn of the risks of bleeding. The drug was manufactured by Bayer AG and sold by Johnson & Johnson subsidiary Janssen Research & Development, LLC. Hartman sued Bayer, Johnson & Johnson, and Janssen, alleging failure to warn under theories of strict liability and negligence. According to Hartman’s counsel, Xarelto was part of a new class of blood-thinning drugs meant to replace older anticoagulants like Coumadin/warfarin. Whereas a patient who takes Coumadin requires periodic monitoring and dose adjustments, a patient taking Xarelto does not. Bayer and Janssen touted the drug as a one-size-fits-all, so patients need not undergo regular blood tests or a change of diet, and require overall less management. The companies championed Xarelto as a major breakthrough and a miracle replacement for Coumadin, Hartman’s counsel argued. Hartman’s expert in FDA regulatory affairs testified that although the drug’s label describes a risk of bleeding, it does so in a misleading manner. He said that while the document accompanying the drug does warn 70 times about to the risk of bleeding, it states that users are at risk of bleeding of 3.6 percent per year. This percentage is misleading, because the 3.6 percent figure represents the worldwide risk, not the U.S. risk, which is much higher, at 8.1 percent. However, the 8.1 percent is not in the Xarelto label. Additionally, the label also does not take into account interpatient variability, meaning that each patient is different, as some are at a much higher risk of bleeding than others taking the same dose. The expert noted that the FDA required Bayer and Janssen to change the Xarelto label to reflect the 8.1 percent risk in 2015. He also stated that the FDA is not perfect in regulating the approximately 17,000 drugs it oversees, and that the agency relies on the drug manufacturers to provide accurate clinical trials. Hartman’s cardiology expert testified that the Xarelto label fails to adequately warn of bleeding risks when taking aspirin concurrently. Many users, including Hartman, take aspirin for preventing a heart attack and/or for blood clot reduction generally, and a synergistic interaction between Xarelto and aspirin results in a higher risk of bleeding. Hartman’s counsel provided internal documents from Bayer and Janssen to demonstrate that the companies knew about the synergism, and that they had documented an approximately 6 percent increase in bleeding by taking Xarelto with aspirin, but did not disclose this information to the public or in the Xarelto label. Her counsel maintained that Eliquis, another new-class anticoagulant, quantifies on its label the increased risk of bleeding if taking the drug with aspirin. According to Hartman’s counsel, Bayer and Janssen stacked the deck in clinical trials to yield favorable results. Through internal emails and documents, her counsel argued that the companies conducted clinical trials in countries where medicine is not as advanced, like Romania, Czechoslovakia, and countries in South America. Since Coumadin management is not as efficient in these countries, the outcome of bleeds on Coumadin was higher than in the United States, where Coumadin management is better, and therefore Xarelto appeared no worse than Coumadin with respect to the bleeding risk when the worldwide results were pooled together. Hartman’s expert in cardiology also testified that from a prescribing physician’s point of view, he needs to know all the details on a drug’s label in order to ensure it is the right fit for a patient. The 8.1 percent U.S. risk, information about interpatient variability, and a quantification of the bleeding risk when Xarelto is taken concurrently with aspirin is all vital information that should have been disclosed on the label so that a physician could make an informed decision and get an informed consent from a patient, the expert opined. Since learning about Bayer and Janssen’s internal findings, the expert stated that he has changed his prescribing habits. Bayer and Janssen maintained that the Xarelto was adequate and safe, since it had been approved by the FDA. The companies’ experts in cardiology opined that the label was sufficient. According to the experts, the information about 8.1 percent U.S. risk was not important, since it was only a small subgroup analysis, and such an analysis can be misleading. The only necessary statistic is the worldwide-risk percentage, which Xarelto label properly stated, and therefore the U.S.-risk percentage should not be in the label. Moreover, the increased risk of bleeding by taking aspirin with an anticoagulant is widely known, and so that information does not need to be quantified in the label, the experts concluded. Bayer and Janssen’s experts in cardiology confirmed that the Xarelto label was adequate, and that it is well-known in the medical community that taking aspirin with an anticoagulant increases bleeding. The experts stated that, as prescribing physicians, they do not want to know the U.S.-risk data because it is dangerous to base the information on subgroups and not on a worldwide study.
On June 19, 2014, Hartman, who lives in Plymouth, IN., began feeling faint and fatigued, and expericned shortness of breath. Over the next week, she consulted with her cardiologist and physician. Her condition continued to worsen, and on June 26, she presented to a hospital, where it was determined that she had suffered severe gastrointestinal bleeding, having lost 40 percent of her blood volume. She emergently received two units of packed red-blood cells, and three days later two more units. She was discharged on June 30. During the ensuing weeks, Hartman recuperated at home. She switched cardiologists and was eventually put on Eliquis. Hartman made a full recovery and has had no further complications. She testified about the pain she experienced leading up to her hospitalization, and how she feared for her life once she discovered how much blood she had lost. She sought damages for pain and suffering, in addition to punitive damages. Hartman’s husband had withdrawn a claim for loss of consortium, prior to trial. Hartman’s expert in gastroenterology determined that her taking Xarelto caused her internal bleeding, and not the aspirin she had been taking. Aspirin is a negligible risk of bleeding while anticoagulants are very dangerous, the expert stated. Hartman’s counsel asserted that Bayer and Janssen deliberately kept the risk of increased bleeding off the Xarelto label in pursuit of profits. The companies knew that if they had fully disclosed all of the hazardous effects, the anticoagulant would never become the blockbuster, billion-dollar drug it later became. Counsel presented Xarelto’s sales in Indiana: $140,000 in 2011, $14.94 million in 2013, and $13.1 million from Jan. 1, 2014, to June 30, 2014. The defendants had a combined net worth of $26.6 billion. Bayer and Janssen’s expert in gastroenterology testified that it was Hartman’s use of aspirin that caused her internal bleeding, and not the Xarelto, which does not cause bleeding. The expert cited how the drug was FDA-approved and that any risk of bleeding was minimal, as properly warned on the label.
The jury found that the defendants were negligent with respect to the Xarelto warning label, and that their negligence was a responsible cause of harm to Hartman. Compensatory damages of $1.8 million were awarded. Jurors also found that the defendants engaged in willful and wanton misconduct and awarded punitive damages of $26 million. Hartman was determined to receive total damages of $27.8 million.
Lynn Hartman: $26,000,000 Personal Injury: Punitive Exemplary Damages; $1,800,000 Personal Injury: compensatory damages
Michael E. Erdos
This report is based on information that was provided by plaintiffs’ counsel. Defense counsel did not respond to the reporter’s phone calls.