Table of contents
- Latest Stevens-Johnson Syndrome Lawsuit Updates
- November 28, 2023: FDA Requires New DRESS Warnings
- April 25, 2018: FDA Requires Lamotrigine HLH Warning
- June 24, 2013: Supreme Court Reverses Bartlett Verdict
- February 13, 2013: Jury Returns Reckis Motrin Verdict
- What Is Stevens-Johnson Syndrome?
- Who May Be Affected?
- Reported Injuries or Damages
- Recall and Regulatory Background
- Evidence to Preserve
- Filing Deadlines
- Potential Compensation
- Frequently Asked Questions
- How Long Does Stevens-Johnson Syndrome Last?
- Which Gene Raises the Risk of Stevens-Johnson Syndrome?
- What Does the Research Say About Stevens-Johnson Syndrome?
- Can a Family Member File a Stevens-Johnson Syndrome Lawsuit After a Death?
- How Common Is Stevens-Johnson Syndrome?
People who developed Stevens-Johnson syndrome or toxic epidermal necrolysis after taking a medicine have brought drug-injury lawsuits. They allege failure to warn and design defects. The reactions can cause severe skin loss, blindness and death.
The reactions are rare and can follow almost any medicine. These claims are filed one patient at a time. No MDL or class action names Stevens-Johnson syndrome. Two jury verdicts involved the condition, and the Supreme Court later reversed one.
One case involved generic sulindac and the other Children’s Motrin. The FDA’s November 28, 2023 warning on levetiracetam and clobazam concerns DRESS, a different reaction from SJS.
Latest Stevens-Johnson Syndrome Lawsuit Updates
November 28, 2023: FDA Requires New DRESS Warnings
FDA warned that the antiseizure medicines levetiracetam (Keppra) and clobazam (Onfi) can cause DRESS, a rare but serious reaction. It required new warnings in the prescribing information and patient Medication Guides [1].
Early DRESS symptoms such as fever or swollen lymph nodes can appear without a visible rash. That differs from SJS and TEN, where a rash appears early.
April 25, 2018: FDA Requires Lamotrigine HLH Warning
FDA warned that the seizure and bipolar medicine lamotrigine (Lamictal) can cause hemophagocytic lymphohistiocytosis (HLH). HLH is an excessive immune reaction that can lead to hospitalization and death. FDA required a new warning in the drug labels [2].
FDA identified eight cases worldwide in 24 years. HLH is a different reaction from SJS, which is marked by blistering and skin loss.
June 24, 2013: Supreme Court Reverses Bartlett Verdict
The U.S. Supreme Court ruled 5-4 in Mutual Pharmaceutical Co. v. Bartlett that state-law design-defect claims turning on a generic drug’s warnings are pre-empted by federal law. The case was argued on March 19, 2013 [3].
The ruling reversed a New Hampshire verdict of over $21 million. Karen Bartlett developed toxic epidermal necrolysis after taking generic sulindac.
February 13, 2013: Jury Returns Reckis Motrin Verdict
A jury in Plymouth Superior Court in Massachusetts awarded Samantha Reckis and her parents $63 million, or $109 million with interest. The defendants were Johnson & Johnson and McNeil-PPC [4].
The verdict followed toxic epidermal necrolysis after Children’s Motrin. The family alleged failure to warn. The company said it disagreed with the verdict.
What Is Stevens-Johnson Syndrome?
According to the National Organization for Rare Disorders (NORD), Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) are rare, severe skin reactions to drugs. They form a spectrum, sorted by body surface involved [5].
By body surface, SJS is under 10%, overlap is 10% to 30% and TEN is over 30%. Both can be life-threatening.
Who May Be Affected?
Many kinds of medicine have been tied to SJS and TEN. NORD lists allopurinol, sulfonamide drugs, NSAIDs, nevirapine, anti-TB drugs and antibiotics such as minocycline. It also lists anticonvulsants such as phenytoin, carbamazepine, lamotrigine and phenobarbital.
Almost any medicine, including over-the-counter and herbal products, can cause it. Symptoms characteristically begin one to eight weeks after exposure. About 75% of cases are caused by medications and about 25% by infections or unknown causes.
The conditions can affect any age. People who took a generic drug should know that Bartlett limited design-defect claims against generic makers.
Whether a claim fits your situation takes an individual legal review. Diclofenac, an NSAID, is covered on the Diclofenac SJS Lawsuit page.
Reported Injuries or Damages
In the Bartlett opinion, 60 to 65 percent of Karen Bartlett’s body surface deteriorated after generic sulindac. She spent months in a medically induced coma, had 12 eye surgeries, was tube-fed for a year and is nearly blind.
The Reckis family’s attorney said Samantha lost 90 percent of her skin, was blinded, had brain damage and has 20 percent lung capacity. Those are the family’s claims, not findings.
NORD reports a mortality rate of 10% to 30% for SJS/TEN. Most survivors suffer long-term emotional and physical complications.
Medscape says mortality depends mainly on skin loss. It is about 1-5% with under 10% sloughing, and 25% to 35% above 30%, possibly as high as 50% [6].
MedPage Today reported an FDA review of adverse event reports on DRESS that found 32 serious levetiracetam cases through March 2023. All patients were hospitalized and two died [7].
The review also found 10 serious clobazam cases through July 2023, with no deaths. DRESS is not SJS, and reports do not prove a drug caused each case.
Recall and Regulatory Background
FDA has acted on these drugs through label changes, not recalls. The levetiracetam and clobazam warnings cover Keppra, Keppra XR, Elepsia XR, Spritam, Onfi and Sympazan.
For lamotrigine, FDA told patients to “contact your doctor right away” if they have symptoms of HLH. DRESS and HLH differ from SJS, and a warning does not prove that a drug caused any one person’s injury.
Evidence to Preserve
Records that may matter in a drug-triggered skin reaction include:
- Medication names, doses, pharmacy labels and prescriptions, with start and stop dates
- The package insert or Medication Guide for the drug you took
- Photographs of the rash, blisters and skin loss over time
- Hospital, burn-unit and eye-care records, including discharge papers
- The diagnosis (SJS, TEN or overlap) and any biopsy results
- Bills, lost-wage records and a symptom diary kept as you recover
- Messages with doctors and pharmacies about the medicine and the reaction
Filing Deadlines
Filing deadlines exist for drug injury claims, and they come from state law, so no single date applies to every person.
They depend on where a person lives, when the reaction began and when the diagnosis was made. Some states start the clock at diagnosis.
A late filing can end a claim, however strong the facts. Talk to a lawyer soon so the dates in your own case are checked.
Potential Compensation
A drug-injury claim may seek damages for medical expenses, lost income, pain and suffering, and loss of enjoyment of life. Which damages apply depends on the facts of each case.
The Bartlett jury’s award was set aside when the Supreme Court reversed. In the Reckis case, the Massachusetts jury awarded damages to Samantha and to each of her parents.
Compensation amounts vary by case. Past results do not guarantee future outcomes. Potential compensation is judged claim by claim, on the facts of each person’s injury.
Frequently Asked Questions
How Long Does Stevens-Johnson Syndrome Last?
How long Stevens-Johnson syndrome lasts varies by person. Medscape says individual lesions typically heal within 1-2 weeks and skin regrowth is usually complete within 3 weeks. Survivors may have long-term effects, and the most disabling are those of the eye.
Which Gene Raises the Risk of Stevens-Johnson Syndrome?
A gene variant called HLA-B*15:02 raises the risk of Stevens-Johnson syndrome in some people. NORD says this applies to people of Chinese or Southeast Asian ancestry taking carbamazepine. Genetic screening before prescribing is not routine practice in North America and Europe.
What Does the Research Say About Stevens-Johnson Syndrome?
Research on Stevens-Johnson syndrome and related reactions includes the FDA review of DRESS, as reported by MedPage Today. In 25 of 29 levetiracetam cases with discontinuation data, symptoms resolved when the drug was stopped. DRESS differs from SJS, so this finding concerns a related reaction.
Can a Family Member File a Stevens-Johnson Syndrome Lawsuit After a Death?
A family member may be able to file a Stevens-Johnson syndrome lawsuit after a death. That depends on state law and on who is allowed to sue. A lawyer can say who qualifies in your state.
How Common Is Stevens-Johnson Syndrome?
Stevens-Johnson syndrome is rare. NORD reports an incidence in western societies of 1-2 per 1,000,000 people in the general population. The incidence is much higher in older people than in younger ones.