Table of contents
- Latest Remicade Stevens-Johnson Syndrome Lawsuit Updates
- October 1, 2026: Court Dismisses Kickback Case Against Janssen
- March 15, 2023: Court Approves Remicade Antitrust Settlement
- August 2, 2022: Court Grants Preliminary Approval
- September 4, 2008: FDA Asks for Stronger Fungal Infection Warnings
- What Is Stevens-Johnson Syndrome?
- Who May Be Affected?
- Reported Injuries or Damages
- Recall and Regulatory Background
- Evidence to Preserve
- Filing Deadlines
- Frequently Asked Questions
- Why Is There a Lawsuit Against Remicade?
- What Are the Symptoms of SJS and TEN?
- Does the Remicade Antitrust Settlement Cover Patients with SJS?
- What Does the Research Say About SJS and TEN?
Remicade (infliximab) is a Janssen Biotech drug whose label lists Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) among reactions reported after approval. Medical sources call both potentially fatal skin reactions.
Janssen is a Johnson & Johnson company. Doctors prescribe Remicade for Crohn’s disease, ulcerative colitis, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis and plaque psoriasis.
No federal Remicade SJS lawsuit, MDL or recall exists as of October 16, 2026. The Remicade litigation reported publicly concerns antitrust pricing and an alleged kickback scheme, not injuries from SJS or TEN.
Latest Remicade Stevens-Johnson Syndrome Lawsuit Updates
October 1, 2026: Court Dismisses Kickback Case Against Janssen
Law360 reported that a Massachusetts federal court dismissed a False Claims Act case against Janssen Biotech. A “large evidentiary hole” sunk a whistleblower’s claims that free consulting services to doctors were kickbacks [1].
The case is not about SJS. It is separate Remicade litigation, and the court rejected the whistleblower’s allegations rather than finding wrongdoing.
March 15, 2023: Court Approves Remicade Antitrust Settlement
Bloomberg Law reported that Johnson & Johnson won final approval from the Eastern District of Pennsylvania to pay $25 million and settle antitrust litigation over Remicade pricing [2].
The class bought or reimbursed Remicade, and plaintiffs had accused the company of stifling competition and raising prices for the drug.
August 2, 2022: Court Grants Preliminary Approval
A court memorandum shows the Eastern District of Pennsylvania granted preliminary approval of the Remicade antitrust class settlement. The case is In re Remicade Antitrust Litigation, No. 17-cv-04326 [3].
The class includes people and entities who indirectly purchased Remicade. The defendants agreed to deposit the settlement amount into a settlement fund.
September 4, 2008: FDA Asks for Stronger Fungal Infection Warnings
ABC News and HealthDay reported that federal health authorities asked the makers of four TNF-blocker drugs to strengthen boxed warnings on fungal infections. The FDA request covered Humira, Cimzia, Enbrel and Remicade [4].
SJS was not part of that request. The warnings concerned opportunistic fungal infections, which are a different risk from skin reactions.
What Is Stevens-Johnson Syndrome?
The Orphanet Journal of Rare Diseases review by Harr and French calls Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) severe drug skin reactions. Both are rare and are medical emergencies because they are potentially fatal [5].
The review treats them as two ends of one spectrum that differ by the extent of skin detachment. The Remicade label lists both among reactions reported after approval [6].
Who May Be Affected?
People treated with Remicade (infliximab) who developed SJS or TEN may be affected. Whether a person has a claim depends on the facts of treatment, diagnosis and recovery, and only an individual legal review can answer that.
SJS and TEN are severe reactions of the skin and mucous membranes. The Orphanet review says the mouth, genital or eye lining is involved in more than 90% of patients.
Reported Injuries or Damages
Stevens-Johnson syndrome and toxic epidermal necrolysis appear in the Remicade label’s list of postmarketing reactions. The label says such reactions are “reported voluntarily from a population of uncertain size.”
So it is not always possible to estimate their frequency or establish a causal relationship to the drug. Reports of this kind are not proof that Remicade caused any single case.
The Orphanet review by Harr and French cites a Yip study finding that 50% of TEN patients develop late eye complications.
Recall and Regulatory Background
No Remicade recall for SJS or TEN exists. The 2013 FDA label already listed SJS and TEN among postmarketing reactions [7].
Evidence to Preserve
Keep these records together, with dates wherever you have them:
- Medicine records: the name, dose and date of each Remicade infusion, plus the prescriber
- Symptom records: the date the rash, blisters or mouth and eye sores began
- Hospital and dermatology records, including eye exams
- Photographs of the skin taken over time
- A list of every other medicine taken
- Pharmacy receipts, insurance statements and medical bills
- Notes on missed work
A full medicine list matters because SJS and TEN are adverse reactions to drugs, according to the Orphanet review. Records of other medicines help show what a person took and when.
Filing Deadlines
Filing deadlines are set by state law and depend on where you live, when the reaction happened and when it was diagnosed.
Some states start the clock at diagnosis, not at the date of the reaction, so talk with a lawyer promptly to check the rule for your state.
Frequently Asked Questions
Why Is There a Lawsuit Against Remicade?
Why is there a lawsuit against Remicade? Plaintiffs including the National Employees Health Plan alleged in 2017 that Johnson & Johnson used exclusionary tactics with health insurers to block competition. That claim was resolved by settlement.
What Are the Symptoms of SJS and TEN?
What are the symptoms of SJS and TEN? According to the Orphanet review by Harr and French, the first symptoms can be unspecific and include fever, stinging eyes and discomfort upon swallowing.
Does the Remicade Antitrust Settlement Cover Patients with SJS?
Does the Remicade antitrust settlement cover patients with SJS? The settlement class covers people and entities that paid or reimbursed for Remicade between April 5, 2016 and February 28, 2022.
What Does the Research Say About SJS and TEN?
What does the research say about SJS and TEN? A review by Harr and French, published December 16, 2010, estimates that each condition affects about 1 or 2 people per 1,000,000 each year.