Xarelto

  • Xarelto Medical Record Review & Outsourcing Services

Xarelto (Rivaroxaban) is an anticoagulant that got its U.S. Food and Drug Administration (FDA) approval in November 2011. Xarelto is manufactured by Bayer and jointly marketed by Johnson & Johnson's subsidiary Janssen Pharmaceuticals. It works by blocking certain clotting proteins in the blood and was promoted as a replacement for Warfarin, a blood thinner that had been on the market for a number of years.

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.

Serious Alleged Injuries may include:

  • Rectal bleeding
  • Intestinal bleeding
  • Brain hemorrhaging
  • Death caused by uncontrolled bleeding

FDA Safety Warnings:

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.

Legal Updates:

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.

Evidence:

  • Indication of Usage in Medical and Pharmacy Records
  • Duration of Usage
  • Complications and their treatment after intake

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.

Accreditations

HIPAA

Neural IT has successfully implemented HIPAA for securing Health records....

ISO 27001 Certification

Neural IT has successfully passed the ISMS re-certification audit and is now ISO 27001:2013 certi...

NSIC - CRISIL

NSIC-CRISIL has assigned a "SE 2A" rating to Neural IT, indicating a company with High Performanc...

Associations

CAALA

CAALA - "Neural IT is proud to be associated with CAALA (Consumer Attorneys Association of Los An...

CAOC

CAOC - "Neural IT is proud to be associated with CAOC (Consumer Attorneys of California) as a Ven...

NYSTLA

NYSTLA - "Neural IT is proud to be associated with NYSTLA (New York State Trial Lawyers Associati...

News & Events

MTMP April 2019
Neural IT shared presence with Mike Papantonio at the spectacular 3-day conferenc
1st Quarter 2019 ‘Rewards & Recognition Program
Neural IT celebrated Employee Appreciation Day on April 5, 2019, by rewarding its star performers
Best HRMS Vendor 2019
The Neural IT team was felicitated with the 'Best HRMS Vendor 2019' award for

Latest Tweets