Xarelto is indicated in Atrial fibrillation for people who have just had hip or knee replacement surgery to reduce the risk of forming a blood clot, and also to treat Deep Vein Thrombosis (DVT) and Pulmonary Embolism (PE). It is the first orally administered active direct factor Xa inhibitor slowing down blood clot formation. It was heavily marketed, and equivalently the usage also increased, until it was noticed that it causes uncontrollable bleeding. As Xarelto has no antidote that can help stop the bleeding, it led to unexpected serious injuries leading to death.
August 2013: A black box warning for spinal bleeding, blood clot, DVT risks.
January 2014: Warning out about the lack of antidote and risks to patients with prosthetic heart valves.
March 2014: Provided healthcare providers with additional direction for limiting spinal bleeding.
December 2014: The drug makers were ordered to add details of new adverse reactions including hepatitis and thrombocytopenia that could increase the potential risk of bleeding.
May 2016: Update warnings of increased bleeding risk related to SSRI and SNRI antidepressant use.
October 2016: Healthcare providers updated about precautions for preventing spinal bleeding.
May 2017: Warnings for spinal/epidural hematoma have occurred in patients treated with Xarelto, who are receiving neuraxial anesthesia or undergoing spinal puncture. These hematomas may result in long-term or permanent paralysis.
February 2018: Included risks for pregnant or nursing women, advised patients to take medication with food, and added the results of the EINSTEIN CHOICE study advocating for lower doses with an extended treatment of VTE.
May 2018: A reversal agent for Xarelto approved by the FDA named Andexxa.
June 2018: Shared information regarding the new reversal agent available to Xarelto users.
October 2018: FDA approved Xarelto to reduce the risk of major cardiovascular (CV) events, such as CV death, myocardial infarction (MI) and stroke, in people with chronic coronary or peripheral artery disease (CAD/PAD). As of Oct. 2018, Xarelto became the first and only Factor Xa inhibitor approved for patients living with these conditions.
The FDA never issued any sort of Xarelto recall despite the numerous safety label updates.
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Defendants: Bayer AG and J&J and its subsidiary Janssen Pharmaceuticals Inc.
Defendant Law Firm:
For Bayer: Arnold & Porter Kaye Scholer, LLP; Chaffe McCall, LLP; Wilkinson Walsh Eskovitz; Nelson Mullins Riley & Scarborough.
For Janssen, Drinker Biddle & Reath LLP; Barrasso Usdin Kupperman Freeman & Sarver.
Co-Lead Defense Counsel:
Susan M. Sharko - Drinker Biddle & Reath LLP
Steven Glickstein - Kaye Scholer LLP
Allegations:
Failing to properly warn patients about increased risks for cranial and gastrointestinal bleeding when taken once daily and not properly monitored.
Strict liability
Manufacturing & design defect
Failure to warn
Negligence & negligent misrepresentation
Breach of express warranty, implied warranty
Fraud & violation of consumer protection laws where permitted by state statutes
Loss of consortium when possible.
Plaintiff Steering Committee:
Andy D. Birchfield, Jr.- Beasley Allen (Co-Lead Counsel)
Brian H. Barr - Levin Papantonio (Co-Lead Counsel)
Russell T. Abney - Lawyerworks
Jeffrey S. Grand - Seeger Weiss
Roger C. Denton - Schlichter Bogard & Denton
Michael Goetz - Morgan & Morgan
Dr. Mark Alan Hoffman - Ross Feller Casey
Bradley D. Honnold - Bartimus Frickleton Robertson Rader
Frederick Longer - Levin Sedran & Berman
Dianne M. Nast - NastLaw LLC
Neil D. Overholtz - Witkin, Kreis & Overholtz, PLLC: Weitz & Luxenberg
Ellen Relkin - Weitz & Luxenberg/W&L
Lawsuit Status:
2014: Louisiana MDL Docket
A multidistrict litigation (MDL No. 2592) was created in December 2014, in the Eastern District of Louisiana overseen by U.S District Judge Eldon Fallon. Case Management order No. 6 signed by Judge Fallon announced the selection and discovery for 1200 cases to comprise Wave 1 and Wave 2 cases.
Wave 1 to consist of 600 cases: 200 cases selected by PSC, 200 cases selected by
Defendants, and 200 cases selected by the Court by random selection. Eligible for Plaintiffs who have met the core requirements for the Plaintiff Fact Sheet on or before January 31, 2018.
Wave 2 shall consist of 600 cases: 200 cases selected by PSC, 200 cases selected by
Defendants, and 200 cases selected by the Court by random selection. Eligible for Plaintiffs who have met the core requirements for the Plaintiff Fact Sheet on or before March 30, 2018.
2015: Philadelphia Docket
On January 20, 2015, a Xarelto Litigation Mass Tort Program Case No. 2349 was created in the Philadelphia County Court of Common Pleas.
2016: Xarelto California JCCP Docket
On February 22, 2016, Judicial Council Coordinated Proceedings (JCCP) was created for all Xarelto cases in the state courts, JCCP Case No. 4862. Judges: Emilie H. Elias, Kenneth R. Freeman, and William F. Highberger.
As of December 2018, federal and state cases combine to more than 20,000 Xarelto Lawsuits
Important Verdicts & Settlements
May 2017
1st Xarelto bellwether trial
U.S. District Court for the Eastern District of Louisiana
Plaintiff: Joseph Boudreaux, Jr.,
Boudreaux, Jr. et al v. Janssen Research & Development LLC (Case No. 2:14-cv-02720).
This case resulted in a defense verdict.
June 2017
2nd Xarelto bellwether trial
U.S. District Court for the Eastern District of Louisiana.
Plaintiff:Joseph Orr (husband of a woman who died of a cerebral hemorrhage)
Joseph Orr v. Janssen Research, Case No. 2:15-CV-3708
This case resulted in a defense verdict.
August 2017
3rd Xarelto bellwether trial
Plaintiff: Dora Mingo
U.S. District Court for the Eastern District of Louisiana.
Dora Mingo vs. Janssen Research & Development, LLC et al. Case No. 2:15-cv-03469
This case resulted in a defense verdict.
December 2017
4th Xarelto trial (first Philadelphia Xarelto Trial)
Plaintiff: Lynn Hartman
Philadelphia County Court of Common Pleas
Xarelto Products Liability Litigation, Lynn Hartman, et al. v. Janssen Pharmaceuticals, Inc., No. 160503416
Verdict: Plaintiff awarded $28 Million in damages against J&J and Bayer.
January 2018
Bayer & J&J win reversal of $28 million verdict by Judge Michael Erdos, in the Philadelphia County Court of Common Pleas
Case: Xarelto Products Liability Litigation, Lynn Hartman, et al. v. Janssen Pharmaceuticals, Inc., No. 160503416
August 2018
5th Xarelto trial (2nd Philadelphia Xarelto Trial)
Plaintiff Daniel Russell
Philadelphia Court of Common Pleas jury
XARELTO Case No. 2349 Philadelphia Court of Common Pleas briefcase
This case resulted in a defense verdict.
March 2019
Bayer AG and Johnson & Johnson's subsidiary Janssen Pharmaceuticals annpuned to pay $775 million to resolve more than 25,000 lawsuits pendin in the U.S. courts.
Medical Record Review and claim validation of Xarelto case should take approximately 4 hours in most instances; however, this approximation may vary in cases based on the volume of records.
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