The Xarelto blood-thinner litigation is MDL No. 2592, not 2738 as it is sometimes miscited. (MDL 2738 is the separate Johnson & Johnson talc proceeding; the two get confused because both involve J&J subsidiaries.) The Xarelto MDL 2592 settlement resolved roughly 25,000 lawsuits in March 2019 through a $775 million fund paid by Bayer and Johnson & Johnson, with no admission of liability from either company.1PR Newswire. Settlement Reached Resolving Xarelto Multidistrict Litigation Claims Enrollment and filing deadlines closed in early 2019, so the practical window for new claims has been shut for years.
What the Lawsuits Alleged
Xarelto is the brand name for rivaroxaban, a prescription anticoagulant designed to prevent strokes and blood clots. Bayer manufactures it, and Janssen Pharmaceuticals, a Johnson & Johnson subsidiary, markets it in the United States.1PR Newswire. Settlement Reached Resolving Xarelto Multidistrict Litigation Claims Plaintiffs said the companies failed to warn patients and prescribers adequately about the risk of severe, uncontrolled bleeding. The practical heart of the complaint was that, unlike warfarin, Xarelto had no available antidote to reverse its effects during an emergency bleed.
Reported injuries included severe gastrointestinal hemorrhage, intracranial bleeding, and other internal bleeding events requiring hospitalization. Claims were filed as product liability actions alleging design defect, failure to warn, and negligence. The Judicial Panel on Multidistrict Litigation consolidated the cases on December 12, 2014, sending them to U.S. District Judge Eldon E. Fallon in the Eastern District of Louisiana.2GovInfo. In re Xarelto (Rivaroxaban) Products Liability Litigation Order and Reasons
The reversal-agent problem eventually closed. On May 3, 2018, the FDA approved Andexxa for emergency reversal of anticoagulation in patients treated with rivaroxaban or apixaban.3U.S. Food & Drug Administration. Package Insert – ANDEXXA By then, most of the alleged injuries had already occurred and the litigation was well underway.
Before settlement, the MDL ran a series of bellwether trials. Every one went for the defense. The first federal bellwether verdict came on May 3, 2017; a second federal bellwether and two Philadelphia state cases followed with the same result, for five defense verdicts in a row.4United States District Court, Eastern District of Louisiana. MDL – 2592 Xarelto Products Liability Litigation Even with that trial record, the volume of pending cases — around 25,000 — pushed both sides toward a global resolution.
How the Settlement Was Structured
The $775 million agreement was a voluntary opt-in program. Eligible plaintiffs could accept an award through a claims process instead of proceeding to individual trial. A claims administrator and special master reviewed medical records, applied the settlement criteria, and assigned each claim a point value that determined the payout. Bayer and J&J reserved the right to walk away if participation rates were not met.5Bayer. Bayer Reaches Settlement to Resolve Xarelto Litigation
Eligibility turned on three things: what drug you took, when you took it, and how badly you were injured. A claimant generally needed documented Xarelto use and a qualifying injury such as a severe bleeding event, stroke, or other cerebrovascular event. More serious injuries drew higher point values and larger awards.
To participate at all, a plaintiff had to have retained counsel to investigate a Xarelto claim before March 11, 2019, register the claim by March 28, 2019, and file a civil action by April 4, 2019.1PR Newswire. Settlement Reached Resolving Xarelto Multidistrict Litigation Claims Missing any of these dates could disqualify a claimant from the program.
Why Some Awards Were Reduced or Capped
Two date cutoffs pulled significant value out of otherwise eligible claims. Awards were substantially reduced if the first Xarelto prescription was dated on or after December 1, 2015, or if the first alleged injury occurred on or after March 1, 2016.1PR Newswire. Settlement Reached Resolving Xarelto Multidistrict Litigation Claims Those dates line up with the period when the manufacturers updated the drug’s warning label. Once updated warnings were in place, the failure-to-warn theory was harder to sustain, so post-cutoff claims were treated as less valuable.
A hospitalization cap also applied. Claimants who were hospitalized for two consecutive days or less received capped payments,1PR Newswire. Settlement Reached Resolving Xarelto Multidistrict Litigation Claims on the reasoning that a shorter stay generally reflected a less severe bleeding event.
What Plaintiffs Who Didn’t Settle Had to Do
Anyone who didn’t opt into the settlement fell under Case Management Order No. 11, which moved remaining cases toward individual trial with concrete evidentiary deadlines.6United States District Court Eastern District of Louisiana. Case Management Order No. 11A – Supplemental Docket Control Order
The centerpiece requirement was a case-specific expert report from a licensed physician qualified to give a causation opinion. The physician had to state, to a reasonable degree of medical probability, that the plaintiff’s injury was caused by taking Xarelto as directed.7United States District Court Eastern District of Louisiana. CMO 11 Deadlines and Obligations Plaintiffs also had to produce all medical records tied to their Xarelto prescription, use, and treatment. Retaining a qualified physician to review records and draft a causation report is expensive, and many remaining cases collapsed at this step.
Deadlines under CMO 11 depended on filing date. Existing plaintiffs — those who filed on or before March 11, 2019 — had until January 2, 2020 to produce both the expert report and the medical records. Later filers had either that date or 120 days after their case was docketed, whichever came later.7United States District Court Eastern District of Louisiana. CMO 11 Deadlines and Obligations
What Comes Out of a Settlement Check
A claimant’s gross award is not what lands in the bank. Three deductions applied.
Common Benefit Fee
In March 2020, Judge Fallon set the common benefit fee at 12% of settlement funds, plus a 2.75% cost reimbursement assessment for expenses incurred by common benefit counsel. The 12% came out of the plaintiff’s own attorney’s fee rather than on top of it. On a standard 33⅓% contingency, the plaintiff’s lawyer received 21⅓% and common benefit counsel received 12%. Two groups were exempt: claimants who enrolled in the Alternative Resolution Program and those whose total award was $5,000 or less. The total common benefit fee came to less than $93 million from the overall fund.8GovInfo. In re Xarelto Products Liability Litigation – Allocation of Common Benefit Attorneys Fees and Costs Reimbursement
Medicare Liens
Claimants on Medicare had a further deduction. Any Medicare payment for treatment related to the Xarelto injury — emergency care, hospitalization, follow-up — was conditional, meaning Medicare had a statutory right to recoup it from the settlement.9Office of the Law Revision Counsel. 42 USC 1395y – Exclusions From Coverage and Medicare as Secondary Payer The Medicare Secondary Payer statute required reporting the case to the Benefits Coordination & Recovery Center; for pharmaceutical exposure claims, the recovery period ran from first exposure through the date of settlement.10CMS. Medicare’s Recovery Process After settlement, claimants had 30 days to respond to a conditional payment letter. For an extended hospitalization, Medicare’s claim could reach tens of thousands of dollars. Lien amounts were often negotiated down but never simply ignored.
Taxes
Most of the settlement was not federally taxable. Under 26 U.S.C. § 104(a)(2), damages received on account of personal physical injuries or physical sickness are excluded from gross income, punitive damages aside.11Office of the Law Revision Counsel. 26 USC 104 – Compensation for Injuries or Sickness The IRS treats compensatory damages — including lost wages — for a personal physical injury as excludable.12Internal Revenue Service. Tax Implications of Settlements and Judgments Interest earned while funds sat in escrow is fully taxable. Emotional distress damages are taxable unless they don’t exceed the amount the claimant paid for medical care tied to that distress.
Can You Still File a Xarelto Claim?
Not through this MDL. The settlement enrollment deadlines closed in early 2019, and the CMO 11 expert report deadlines passed in early 2020. Any plaintiff who had not retained counsel before March 11, 2019 was outside the settlement program, and any non-settling plaintiff who failed to produce a causation expert report by the CMO 11 date faced dismissal.
As of October 2022, the court was still handling a small number of severed cases where attorneys had not paid filing fees. Judge Fallon issued sanctions warnings with a November 21, 2022 compliance deadline.4United States District Court, Eastern District of Louisiana. MDL – 2592 Xarelto Products Liability Litigation The MDL is in its administrative wind-down. No new trials or settlement programs are anticipated.