Eli Lilly faces a product liability lawsuit brought by an Arkansas woman, who claims that she suffered a rare and disfiguring skin reaction known as Stevens-Johnson syndrome (SJS) from Cymbalta.
The complaint (PDF) was filed by Cristol Hutchison in the U.S. District Court for the Western District of Arkansas on March 7, alleging that Eli Lilly failed to provide adequate warnings about the risk that Cymbalta side effects may cause severe and potentially life threatening skin problems.
Stevens-Johnson Syndrome (SJS) is a reaction that can be caused by certain medications, where the skin begins to burn from the inside out, producing blisters, severe rash and the skin may separate from the body. When the skin lesions affect more than 30% of the body, the condition is typically referred to as toxic epidermal necrolysis (TEN).
Treatment for SJS or TEN typically involves inpatient care at a hospital Intensive Care Unit (ICU) or Burn Unit, and the conditions can be fatal in many cases.
Unaware that the drug was linked to SJS risk, Hutchison was prescribed the antidepressant drug in 2011. However, after her Cymbalta dose was increased in December 2011, she began suffering adverse skin reactions that included rashes, sores and peeling skin. Sores developed on her tongue, in her mouth and her right foot began to blister. She was diagnosed with SJS, which physicians said was caused by an adverse reaction to Cymbalta, the lawsuit claims.
As a result of the Cymbalta problems, Hutchison indicates that she eventually developed damage to her nervous system and has complex regional pain syndrome in her right leg, causing her to suffer a serious and permanent chronic pain condition.
According to allegations raised in the complaint, the FDA asked Eli Lilly as early as 2007 to investigate potential link between Cymbalta and SJS. However, the drug maker allegedly ignored that request and a number of other warnings by experts until July 2011, when the FDA issued a warning letter to the company about its failure to respond to Cymbalta skin complaints.
“The frequency of reports of severe skin reactions with Cymbalta (duloxetine) relative to the number of prescriptions has been five to ten times the rates observed with other commonly prescribed antidepressant drugs,” the agency noted in its letter.
The company finally relented and updated the label in September 2011. However, the Hutchison lawsuit argues that the changes did not come in time to provide adequate warning for her or her doctor, who put her on Cymbalta the next month. Her lawsuit accuses the company of negligence, strict product liability, failure to warn, failure to instruct, breach of warranty, and violating the Arkansas Deceptive Trade Practices Act, seeking punitive and compensatory damages.