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NAME: MANJOT KAUR
PROFESSOR: Dr. SHERI CLARK
COURSE NUMBER: HCM 5300
COURSE NAME: HEALTH CARE LAW
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Case Overview:
Xarelto Products Liability Litigation
Facts of the Case:
Xarelto (Rivaroxaban) exists as a prescription anticoagulant which obtained US Food and
Drug Administration approval for deep vein thrombosis (DVT) and pulmonary embolism
(PE) prevention and stroke reduction in people with non-Valvular Atrial fibrillation. The
medication found its use among patients getting knee or hip replacement surgery. Xarelto
serves as a current alternative to Warfarin (Coumadin) under Bayer Healthcare
manufacturing with Janssen Pharmaceuticals as the marketing division of Johnson &
Johnson.
Xarelto generated substantial health dangers for patients because they experienced life-
threatening bleeding episodes which led to both long-term disabilities and fatality. Xarelto
contains a U.S. Food & Drug Administration black-box warning specifying how spinal
bleeding after procedures or traumas can cause permanent paralysis to patients1. Older
patients faced increased susceptibility towards bleeding in their cranium as well as severe
adverse effects after taking Xarelto.
A massive number of 32,000 lawsuits were filed against Bayer and Johnson & Johnson by
patients who argued that the companies should have provided better warnings about Xarelto
side effects and the lack of a reversal agent. A Indiana couple received a $28 million verdict
from a court decision in November 2017 but the appeal judges later invalidated it. The
increasing number of lawsuits resulted in Bayer and Johnson & Johnson consenting to a $775
million settlement during March 2019.
Defect:
The main defect in this case stemmed from Xarelto's insufficient warnings about dangerous
bleeding side effects and the lack of a medicine that could stop this bleeding.
Company Response:
Bayer together with Johnson & Johnson resolved the issue by reaching a $775 million
settlement to compensate patients injured from using the drug. The companies reinforced
Xarelto's prescribing label by introducing more robust warning notices about its severe
bleeding hazards.
Personal Approach:
During my leadership of this matter I would first require companies to run extensive clinical
trials to uncover all possible risks which would be transparently disclosed to medical experts
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and patients. I would establish methods to generate safety backup products that would protect
patients from severe bleeding incidents.
Fault:
Bayer and Johnson & Johnson bear the responsibility for not supplying proper warnings and
coagulation reversal solutions for Xarelto. The court found these companies responsible by
directing them to give a large settlement combined with new warning statements.
Foreseeability:
The risks for dangerous harm were foreseeable to a reasonable extent and could have been
predicted. The companies should have foreseen the dangerous bleeding risks from
anticoagulant medications so they needed to implement proper risk reduction strategies.
Tort Committed: Product Liability
Defective Product
The main defect in the Xarelto product liability case resulted from insufficient labeling about
dangerous bleeding risks together with the absence of a medication to reverse these adverse
effects.
The Xarelto case includes problems with both design and manufacturing processes of the
medication. The designers planned Xarelto without an essential antidote while failing to warn
both patients and health providers about its harmful side effects.
Failure to Warn
Plaintiffs maintained that Bayer and Johnson & Johnson supplied insufficient warning
information about serious bleeding possibilities and the unavailable reversal agent. Warning
deficiencies in product distribution are considered a fundamental requirement under product
liability laws.
Several legal complaints asserted that the drug companies deliberately misrepresented
Xarelto safety statistics to make patients believe the medication was more secure than proven
data demonstrated.
Causation
The plaintiffs needed to prove through evidence how the medical device defect of inadequate
warnings and lack of a reversal agent caused their injuries. The legal case needed to prove
Xarelto directly caused all severe bleeding incidents suffered by users of the drug.
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Legal standards for proximate cause established that injuries emerged naturally from the
product's defects.
Damages
The plaintiffs filed claims for both compensatory damages which included medical costs with
wage losses together with suffering pain and additional associated expenses. Some plaintiffs
requested punitive damages which aimed to charge the companies with negligence and to
prevent additional incidents of misconduct.
The $775 million sum designated for compensation served to reimburse victims for their
injuries. The plaintiffs received their payments according to their individual injury severity
levels and personal situation-specific details.
Settlements
The March 2019 settlement totaling $775 million between Bayer and Johnson & Johnson
promised to handle more than 25,000 outstanding Xarelto lawsuits. Through this settlement
Bayer and Johnson & Johnson compensated victims whose severe bleeding incidents together
with long-term disabilities and serious health complications resulted from the drug.
Repository funds went to plaintiffs based on the extent of their harm and case-specific
aspects.
The agreement contained details to revise Xarelto medication labels with enhanced warning
statements about its risks especially concerning the absence of a bleeding counter medication.
The settlement marked a critical achievement to enhance understanding about medication
risks between future patients and healthcare providers.
