Stevens-Johnson Syndrome

Stevens-Johnson syndrome is a dermatological disorder (a disorder of the skin) due to an infection (herpes simplex and mycoplasma), allergy, or hypersensitivity to medication.

Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) are uncommon yet severe skin and mucous membrane reactions. Their occurrence is estimated at two to seven cases per million people annually, with SJS being three times more common than TEN.

Some conditions increase the risk of Steven-Johnson syndrome, including HIV infection and systemic lupus. More recently, genetic susceptibility has been suggested to predispose some people to Stevens-Johnson syndrome.

Calling it a “skin disorder” does not do it justice. SJS is a life-threatening drug-induced cutaneous reaction that can “kill or severely disable previously healthy people.” Roujeau, J., Medication Use and the Risk of Stevens-Johnson Syndrome of Toxic Epidermal Necrolysis, N.E. J. MED. 1995. The pathology is still unknown, but the disorder may involve damage to the skin’s blood vessels followed by skin tissue damage.

Early recognition of SJS and TEN is critical due to their high risk of severe health complications and fatality.  The failure to properly diagnose and treat is the foundation of most SJS medical malpractice lawsuits.

• Research published in JAMA Dermatology on June 21, 2023, suggests that standardized systems and a diagnostic test for SJS could better help identify SSJ

Drug-Induced Stevens-Johnson Syndrome: Which Drugs?

Medications that often give rise to Stevens-Johnson Syndrome include barbiturates, penicillins, phenytoin, and sulfonamides, among others. Barbiturates (e.g., pentobarbital and phenobarbital) are a class of drugs derived from barbituric acid which act on the central nervous system as depressants, having sedative effects, and also used as anticonvulsants.

Barbiturates have, in large part, been replaced by benzodiazepines in medical practice. Penicillins are a group of antibiotics from Penicillium fungi that are widely used, though many bacteria have become resistant to this group of antibiotics. Phenytoin sodium (marketed under trade names Phenytek, Dilantin Kapseals, and Dilantin Infatabs) is an anti-epileptic drug but may also be used as an antiarrhythmic medication.

Sulfonamides (also referred to as sulfa or sulpha drugs) are synthetic antimicrobial drugs. However not all sulfonamide drugs have antibacterial effects (e.g., sultiame, an anticonvulsant; sulfonylureas and thiazide diuretics). Specific drugs that have been the subject of lawsuits include Levaquin, Dilantin, Accutane, Aloprim, and, this year after a $10 million verdict, Children’s Motrin. Treatment and Consequences of Stevens-Johnson Syndrome

Symptoms of Stevens-Johnson Syndrome include fever, itchy skin, feeling ill, achy joints, multiple skin lesions, mouth sores, vision problems, dry eyes, bloodshot eyes, eye burning, itching and discharge, and eye pain. Diagnosis is generally based on the appearance of lesions and tests, including Nokolsky’s sign and microscopic examination of skin lesion biopsies.

Treatment options include infection prevention, treating symptoms, and controlling the illness causing the condition. In severe cases, antibiotics are often administered to control skin infections; corticosteroids are used to control inflammation, and intravenous immunoglobulins (IVIG) are used to stop the disease process and possible hospitalization in intensive care or burn units.

Where large areas of the body are affected, skin grafting may be required. Immune complex hypersensitivity stemming from Stevens-Johnson Syndrome may be the worst side effect, causing toxic epidermal necrolysis involving multiple large blisters that come together, followed by a sloughing of most skin and mucous membranes. Other complications include sepsis, shock, skin infection, permanent skin damage and scarring, and lesions of internal organs leading to heart, lung, kidney, or liver inflammation. Mortality rates of Stevens-Johnson Syndrome are estimated to be 5-15%. One thing is for sure: prompt diagnosis of SJS and identification of the medication causing the reaction is imperative in reducing the risk of injury and death.

Stevens-Johnson Syndrome Verdicts and Settlements

Stevens-Johnson Syndrome and Toxic Epidermal Necrolysis are severe reactions often associated with medical treatments or pharmaceutical products.

Legal cases surrounding these conditions typically fall into two primary categories: medical malpractice and product liability lawsuits.

Medical malpractice lawsuits concerning SJS and TEN arise when healthcare professionals fail to diagnose, treat, or manage these conditions properly, leading to worsened patient outcomes. This can include misdiagnosis, delayed treatment, or inadequate care in managing the patient’s symptoms.

On the other hand, product liability lawsuits involve claims against pharmaceutical companies or manufacturers. Victims’ lawyers in these lawsuits are based on the argument that a drug or product was inherently dangerous or lacked sufficient warnings about potential severe side effects, such as SJS or TEN. Plaintiffs in these cases often allege that they were not adequately informed about the risks associated with a medication or product, leading to unexpected and severe health complications. Both types of lawsuits hinge on the intricate details of patient care, drug administration, and the duty of care owed to the patient by medical professionals and pharmaceutical companies.

• 2023, New Hampshire: $21,000,000 Verdict. A 51-year-old woman developed severe skin reactions and internal injuries due to Stevens-Johnson Syndrome and toxic epidermal necrolysis. These conditions occurred after she took a generic version of the anti-inflammatory drug Clinori (Sulindac). The woman’s severe reaction to the medication resulted in blindness and permanent damage to her throat, stomach, and lungs. She was hospitalized for 112 days in a burn unit due to a skin ailment affecting 65% of her skin. Her lawsuit argued that the generic drug Sulindac had the highest reported instances of SJS/TENS among all NSAIDs available.
• 2022, Pennsylvania: $125,000 Settlement. A 71-year-old woman died from Stevens-Johnson Syndrome and/or toxic epidermal Necrolysis. She was taking Diflucan for oral thrush. Her SJS malpractice lawyers filed a lawsuit in Bucks County claiming the prescribing doctor failed to document her medical history correctly, neglected to note that the medication had been prescribed, inadequately evaluated the patient’s complaints, did not properly warn the patient about the risks or side effects of Diflucan (including SJS/TEN), misdiagnosed a drug reaction, and did not sufficiently perform a physical examination of the patient’s skin. The parties ultimately reached a settlement amount of $125,000, with 80% attributed to wrongful death and 20% to survivorship. The deceased was survived by her spouse and their four grown children.
• 2018, Illinois: $3,000,000 Verdict. A man was wrongly prescribed Bactrim. He suffered from Stevens-Johnson Syndrome, which led to kidney damage. The man now permanently required dialysis. His SJS medical malpractice lawsuit claimed his physician negligently prescribed the medication despite knowing the man was allergic to it and failed to offer alternatives. The jury awarded the man $3,000,000.
• 2018, New York: $1,500,000 Verdict. A woman took Bactrim for several years. She developed Stevens-Johnson Syndrome, which caused facial rashes and mucosal erosion. The woman alleged that her physician’s failure to stop prescribing Bactrim caused her injuries. She claimed he prescribed a medication that failed to treat her condition and caused an allergic reaction. A jury awarded her a $1,500,000 verdict.
• 2017, New York: $710,000 Settlement. A 3-year-old girl presented to the hospital with symptoms that suggested Kawasaki disease. The hospital staff gave her ibuprofen. The girl subsequently suffered photosensitivity and vision loss in one eye. Her mother alleged that the hospital staff’s negligence caused these permanent injuries. She claimed they failed to timely diagnose Stevens-Johnson syndrome, prevent her condition from deteriorating, and discontinue ibuprofen administration. This case settled for $710,000.
• 2013, California: $89,290 Verdict. A woman sought a dermatologist for mild hand dermatitis. She was diagnosed with a fungal infection and prescribed Lamisil. The woman experienced an allergic reaction that caused a full-body rash with skin peeling. She eventually discovered that her anti-hypertensive medications caused her initial rash. The woman alleged that the dermatologist’s failure to properly diagnose her with Stevens-Johnson Syndrome caused her injuries. She claimed this led him to prescribe the wrong medication, that worsened her condition. The jury awarded the woman an $89,290 verdict.
• 2013, Massachusetts: $63,000,000 Verdict. A 7-year-old girl was prescribed Children’s Motrin for her fever. She developed Stevens-Johnson syndrome. The girl was left with learning difficulties, chronic fatigue, and permanent eye, skin, lung, liver, and reproductive organ damage. She could no longer eat or breathe on her own. The girl was now legally blind. Her mother alleged that Johnson & Johnson’s failure to issue sufficient warnings on Motrin caused these permanent injuries. Johnson & Johnson denied liability. They argued that the Motrin did not cause the girl’s injuries and that its label contained sufficient warnings. The jury awarded a $63,000,000 verdict.

Potential Stevens-Johnson Syndrome Lawsuits

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List of Studies on Stevens-Johnson Syndrome

• Kridin, K., et.al (2021). Assessment of Treatment Approaches and Outcomes in Stevens-Johnson Syndrome and Toxic Epidermal Necrolysis: Insights From a Pan-European Multicenter Study. JAMA Dermatology, 157(10), 1182-1190.
• SJS/TEN: Stern & Bigby, An Expanded Profile of Cutaneous Reactions to Nonsteroidal Anti-inflammatory Drugs, JAMA 252:1433-7 (1984).
• Bigby & Stern, Cutaneous Reactions to Nonsteroidal Anti-inflammatory Drugs, J AM. ACAD DERM 12:866-76 (1985).
• Roujeau, Toxic Epidermal Necrolysis J AM. ACAD DERM 23:1039-58 (1990)
• Strom, Using a Claims Database to Investigate Drug-Induced Stevens-Johnson Syndrome, STATISTICS IN MED 10:565-76 (1991)
• Strom, A Population-Based Study of Stevens-Johnson Syndrome, ARCH DERMATOL 127:831-8 (1991)
• Halpern, Ibuprofen Toxicity. A Review of Adverse Reactions and Overdose, TOXICOL REV, 12: 107-28 (1993)
• Halpern & Volans, Cutaneous Toxicity of Ibuprofen, ARCH DERM 130: 259-60 (1994), Roujeau & Stern, Severe Adverse Cutaneous Reactions to Drugs, NEW ENGLAND J MED 331:1272-85 (1994)
• Lesko & Mitchell, An Assessment of the Safety of Pediatric Ibuprofen, JAMA 273:929-33 (1995)
• Power et al., Analysis of the Acute Ophthalmic Manifestations of the Erythema Mulitforme/Stevens-Johnson Syndrome/Toxic Epidermal Necrolysis Disease Spectrum, OPTHAMOL 102: 1669-76 (1995)
• Salomon et al., Five Cases of Toxic Epidermal Necrolysis Treated by Intravenous Innumoglobulins with Favorable Results, ANN DERMATOL VENEREOL 124 (Suppl):S216-7 (1997)
• Lebargy, Pulmonary Complications in Toxic Epidermal Necrolysis: A Prospective Clinical Study, INT. CARE MED. 23:1237-1244 (1997)
• Viard, Inhibition of Toxic Epidermal Necrolysis by Blockade of CD95 with Human Intravenous Immunoglobulin, SCIENCE 282:490-93 (1998)
• Srivastava, Drug-Associated Acute-Onset Vanishing Bile Duct and Stevens-Johnson Syndromes in a Child, GASTROENTEROL 115: 743-46 (1998)
• Garcia-Doval, Toxic Epidermal Necrolysis and Stevens-Johnson Syndrome: Does Early Withdrawal of Causative Drugs Decrease the Risk of Death?, ARCH DERMATOL 136:323-7 (2000)
• Morelli & O’Brien, Stevens-Johnson Syndrome and Cholestatic Hepatitis, DIGEST DIS SCI 46:2385-88 (2001)
• Spies, Treatment of Extensive Toxic Epidermal Necrolysis in Children, PEDIATRICS 108:1162-68 (2001)
• Sheridan, Long-Term Consequences of Toxic Epidermal Necrolysis in Children, PEDIATRICS 109: 74-78 (2002)
• Taghian, Acute Vanishing Bile Duct Syndrome After Ibuprofen Therapy in a Child, J PEDIATRICS 145:273-76 (2004)
• Neuman & Nicar, Apoptosis in Ibuprofen-induced Stevens-Johnson Syndrome, TRANSLATIONAL RESEARCH 149:254-259 (2007)
• Dore & Salisbury, Morbidity and Mortality of Mucocutaneous diseases in the Pediatric Population at a Tertiary Care Center, J BURN CARE RES. 28:865-870 (2007)
• Sanmarkan, Retrospective Analysis of Stevens-Johnson Syndrome and Toxic Epidermal Necrolysis Over a Period of Ten Years, INDIAN J DERMATOL 56:25-9 (2011).