Relafen Stevens-Johnson Syndrome Lawsuit | 2025 Latest Updates

Relafen Stevens-Johnson Syndrome Lawsuit Overview

Relafen (nabumetone), a nonsteroidal anti-inflammatory drug (NSAID) manufactured by Carwin Pharmaceutical Associates, has been linked to severe cutaneous adverse reactions, including Stevens-Johnson Syndrome (SJS) and Toxic Epidermal Necrolysis (TEN). Lawsuits against Carwin allege that the company failed to adequately warn patients and healthcare providers about the risks of SJS/TEN, which can cause severe skin blistering, peeling, mucosal damage, and potentially fatal complications. Relafen was approved by the U.S. Food and Drug Administration (FDA) in 1991 for the treatment of rheumatoid arthritis and osteoarthritis. The drug’s labeling includes warnings about the potential for serious skin reactions, such as SJS and TEN, which can be fatal; however, plaintiffs argue these warnings were insufficient, delayed, or not prominently displayed to reflect the severity of the risks.

Related Article: Stevens-Johnson Syndrome Lawsuit

Latest Relafen Stevens-Johnson Syndrome Lawsuit Updates

As of April 2025 – Legal proceedings involving Relafen (nabumetone), a nonsteroidal anti-inflammatory drug (NSAID), and its alleged link to Stevens-Johnson Syndrome (SJS) and Toxic Epidermal Necrolysis (TEN) are ongoing, with new cases being filed nationwide. Lawsuits primarily target Carwin Pharmaceutical Associates, the manufacturer, alleging failure to adequately warn about the risks of SJS/TEN, severe cutaneous adverse reactions (SCARs) with mortality rates of 5–15% for SJS and 30–50% for TEN. While specific settlement figures or verdict amounts for Relafen-related SJS/TEN cases remain undisclosed in public records, comparable NSAID-related SJS/TEN lawsuits, such as a $63 million verdict against Johnson & Johnson for Motrin in 2013, demonstrate the potential for substantial compensation. Courts are evaluating evidence, including medical records, expert testimony linking Relafen to SJS/TEN, and the adequacy of the drug’s warning label, which states: “NSAIDs, including nabumetone tablets, can cause serious skin adverse events such as exfoliative dermatitis, Stevens-Johnson syndrome (SJS), and toxic epidermal necrolysis (TEN), which can be fatal.” Plaintiffs argue these warnings were insufficiently prominent or delayed, contributing to severe injuries or deaths.

FDA Reports and Statistics

Since Relafen’s approval by the U.S. Food and Drug Administration (FDA) in 1991, the FDA’s Adverse Event Reporting System (FAERS) has recorded adverse event reports for nabumetone (Relafen), a nonsteroidal anti-inflammatory drug (NSAID), though specific counts for Stevens-Johnson Syndrome (SJS) and Toxic Epidermal Necrolysis (TEN) are not publicly detailed in the provided data. SJS and TEN, severe cutaneous adverse reactions (SCARs) with mortality rates of 5–15% for SJS and 30–50% for TEN, are among the most serious reported events associated with Relafen. The FDA requires warnings on all NSAID labels, including Relafen, about the risk of serious skin reactions like SJS and TEN, reflecting the established link between NSAIDs and these conditions.

Relafen Injuries & Side Effects

Patients taking Relafen have reported severe and potentially life-threatening adverse reactions, particularly affecting the skin and mucous membranes.

• Stevens-Johnson Syndrome (SJS): A severe skin reaction causing rash, blistering, and detachment of the upper layer of skin
• Toxic Epidermal Necrolysis (TEN): A more severe form of SJS, affecting greater body surface area with higher mortality rates
• Exfoliative Dermatitis: Widespread inflammation of the skin with shedding of scales and loss of hair
• Other Hypersensitivity Reactions: Including fever, malaise, and multi-organ involvement

Do You Qualify for a Relafen Lawsuit?

You may qualify for a Relafen lawsuit if:

• You took Relafen as prescribed by your doctor
• You experienced Stevens-Johnson Syndrome or Toxic Epidermal Necrolysis after taking the medication
• Your symptoms required medical treatment or hospitalization
• You can provide medical documentation linking your injuries to Relafen use

Evidence Required for a Relafen Lawsuit

To build a strong case, you will need to provide:

• Medical records documenting your diagnosis of SJS or TEN
• Prescription records showing you were prescribed and took Relafen
• Documentation of the timeline between Relafen use and symptom onset
• Any photographs of your skin condition during the reaction
• Records of hospitalizations, treatments, and ongoing medical care

Damages You Can Recover

Victims of Relafen-induced SJS/TEN may be eligible to recover:

• Current and future medical expenses related to treatment
• Lost wages and reduced earning capacity
• Pain and suffering damages for physical and emotional trauma
• Permanent disfigurement and disability compensation
• Punitive damages against the manufacturer in cases of negligence

Relafen Stevens-Johnson Syndrome Recall Information

As of April 2025, no specific recall of Relafen (nabumetone), a nonsteroidal anti-inflammatory drug (NSAID), has been issued by the U.S. Food and Drug Administration (FDA) or its manufacturer, Carwin Pharmaceutical Associates, related to Stevens-Johnson Syndrome (SJS) or Toxic Epidermal Necrolysis (TEN). The FDA mandates warnings on all nabumetone product labeling about the risk of serious cutaneous adverse reactions. The Relafen label explicitly states: “NSAIDs, including nabumetone tablets, can cause serious skin adverse events such as exfoliative dermatitis, Stevens-Johnson syndrome (SJS), and toxic epidermal necrolysis (TEN), which can be fatal.” These warnings, in place since at least the early 2000s, reflect the recognized association between NSAIDs and SJS/TEN, though plaintiffs in lawsuits argue they are insufficiently prominent or were delayed, contributing to severe injuries or deaths.

Statute of Limitations for Relafen Stevens-Johnson Syndrome Lawsuits

The time limit for filing a Relafen lawsuit varies by state but generally ranges from 1-6 years from the date of injury or discovery of injury. Some states may apply the “discovery rule,” which starts the clock when you knew or should have known that Relafen caused your injury. Given these variations, consulting with an attorney promptly after diagnosis is crucial to preserve your legal rights.

FAQs

1. What is Relafen?

Relafen is a prescription nonsteroidal anti-inflammatory drug (NSAID) used to relieve symptoms of rheumatoid arthritis or osteoarthritis. The drug works by reducing hormones that cause inflammation and pain in the body. Relafen (nabumetone) was first approved by the FDA in 1991 and is manufactured by Carwin Pharmaceuticals Associates.

2. How can Relafen cause Stevens-Johnson Syndrome?

While the exact mechanism is not fully understood, it’s believed that altered drug metabolism in some patients triggers a T-cell–mediated cytotoxic reaction to drug antigens in skin cells. CD8+ T cells have been identified as important mediators of the blistering and skin detachment characteristic of SJS/TEN.

3. What are the early warning signs of SJS/TEN?

Early symptoms typically appear 1-3 weeks after starting Relafen and include malaise, fever, headache, cough, and conjunctivitis. These are followed by discolored spots on the face, neck, and upper trunk that can spread and develop into blisters.

4. How is Stevens-Johnson Syndrome treated?

Patients with suspected SJS should be transported to an emergency room immediately and will likely be treated in an intensive care burn unit. Treatment focuses on stopping the medication, wound care, fluid replacement, and preventing complications.

5. What is the mortality rate for SJS/TEN?

Studies indicate a 3-15% mortality rate in patients with untreated SJS. The mortality rate for TEN is significantly higher, with up to 40% of patients dying from complications.

6. Are there other risk factors for developing SJS/TEN?

Yes, the likelihood of developing SJS/TEN may be higher in bone marrow transplant recipients, HIV patients with Pneumocystis jirovecii infection, patients with systemic lupus erythematosus, and those with other chronic rheumatologic diseases.

7. How can I find a lawyer specializing in Relafen SJS lawsuits?

Search online directories, ask for referrals, or contact legal associations for recommendations on specialized attorneys. Choosing an experienced pharmaceutical litigation attorney is crucial for your case.

8. What compensation might I receive from a successful lawsuit?

Compensation varies based on case specifics but may include medical expenses, lost wages, pain and suffering, and sometimes punitive damages. The severity and permanence of injuries significantly impact settlement amounts.

9. How long does a typical Relafen lawsuit take?

The timeline varies greatly depending on case complexity, evidence strength, and whether the case settles or goes to trial. Most pharmaceutical litigation takes between 1-3 years, though some cases resolve sooner through settlements.

10. What if I took generic nabumetone instead of brand-name Relafen?

You may still have a case even if you took generic nabumetone. Recent court decisions have affected liability for generic manufacturers, but an experienced attorney can advise on your specific situation.

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See all related dangerous drug lawsuits our attorneys covered so far.

Take Action Now: Time-Sensitive Legal Claims

Time is limited to pursue legal action for Relafen-related Stevens-Johnson Syndrome. Many states only allow 1-2 years from the date of injury to file a claim, and this window may be closing on your case. At Schmidt & Clark, LLP, we offer:

• Free, confidential consultations to evaluate your case
• No upfront costs or fees for our services
• Payment only if we win your case and secure compensation

Don’t delay in seeking the justice and compensation you deserve. Contact our experienced pharmaceutical litigation team today.

Get a Free Relafen Stevens-Johnson Syndrome Lawsuit Evaluation With Our Lawyers

The Pharmaceutical Litigation Group at Schmidt & Clark, LLP law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in Relafen Stevens-Johnson Syndrome lawsuits. We are handling individual litigation nationwide and currently investigating potential settlements in all 50 states.

Again, if you or a loved one was diagnosed with Stevens-Johnson Syndrome (SJS) or Toxic Epidermal Necrolysis (TEN) after taking Relafen, you should contact our law firm immediately for a free case review. You may be entitled to compensation by filing a suit for legal fees and our dangerous drug lawyers can help with a free case evaluation.