An Arkansas woman has filed a lawsuit against Eli Lilly & Co. for failing to adequately warn doctors and consumers that its antidepressant, Cymbalta, can cause serious skin reactions, including Stevens-Johnson syndrome.
The March 7th complaint filed in the U.S. District Court for the Western District of Arkansas says Eli Lilly ignored several requests from the U.S. Food and Drug Administration (FDA) to include these warnings in the Cymbalta labeling and patient medical safety guides.
“Eli Lilly promoted and marketed Cymbalta to be used in doses that were known to cause harmful side effects which outweighed any potential utility,” the suit says.
According to the lawsuit, Christol Hutchison was prescribed Cymbalta in October 2011 to treat her depression and anxiety. Hutchison’s doctor increased her dosage because she reported an increase in chronic back pain.
Cymbalta is a selective serotonin and norepinephrine reuptake inhibitor that was initially approved in 2004 for the treatment of major depressive disorder and pain associated with diabetic peripheral neuropathy in 2004.
Hutchison says she began to experience adverse skin reactions, including rashes, sores and peeling skin, the complaint states, and she developed sores in her mouth and tongue and experienced blistering on her right foot. She was diagnosed with Stevens-Johnson syndrome caused by an adverse reaction to Cymbalta.
“Hutchison began receiving treatment for Stevens-Johnson syndrome; however, she further developed severe, throbbing pain, primarily in her lower right leg, right foot and fingertips. These areas became extremely hypersensitive and swollen,” she alleges. “The pain Hutchison experienced in her lower right leg and foot continued to worsen; approximately one month after receiving the diagnosis of Stevens-Johnson syndrome, the pain in Hutchison’s right lower leg and foot was so unbearable that she was forced to use a wheelchair or walker to avoid bearing weight on this extremity.”
Hutchison was eventually diagnosed with complex regional pain syndrome of her right lower extremity, which resulted from the blistering rash on her right foot caused by Cymbalta, the suit says. Hutchison claims her use of Cymbalta as prescribed, resulted in overexposure to the drug, which has caused her to suffer serious, permanent and disabling injuries.
“If Eli Lilly had provided an adequate warning of the adverse side effects of Cymbalta, including that Cymbalta caused or could cause severe skin reactions, including Stevens-Johnson syndrome, Hutchison’s physician would not have prescribed the drug to Hutchison if he knew of its actual risks,” Hutchison alleges.
The suit says that in 2008 the FDA asked Lilly to add the risk of serious skin reactions to the Warnings and Precautions section of the Cymbalta labeling. The drug maker, however, ignored requests from the FDA to revise the product label to include a warning for serious skin disorders, Hutchison reported.
The suit states, “For years, Lilly pushed to expand the indication for Cymbalta and encouraged doctors to use the drug to treat conditions for which it was not approved.” It goes on to say, “On Sept. 21, 2007, and again on Jan. 7, 2010, the FDA issued warnings to Eli Lilly for misrepresenting the efficacy and capabilities of Cymbalta without adequately communicating the risks associated with its use.”
After Lilly received a warning letter from the FDA in July 2011 requesting additional safety information to be included in Cymbalta’s labeling, the drug maker submitted a supplemental new drug application, agreeing to change the warning in its label. The FDA approved Lilly’s “severe skin reactions” warning in September 2011. However, Lilly failed to incorporate the new warnings regarding severe skin reactions in a timely manner in the package inserts and medication guides, the suit says.
“The Cymbalta package insert, medication guide and instructions for use were confusing and misleading as to the proper dosage for patients, especially for patients being treated for both major depressive order and chronic low back pain,” Hutchison asserts. “Even though Lilly marketed a maximum dose of 120 mg/day for major depressive disorder, it knew that there was no evidence that the additional dose of 120 mg/day for major depressive disorder, it knew that there was no evidence that the additional dosage conferred any additional benefit. Eli Lilly also knew that an increased dosage to 120 mg/day significant increased the change of an adverse reaction, such as Stevens-Johnson syndrome.”
The complaint lists claims of negligence, strict products liability, failure to warn, failure to instruct, breach of implied warranties, and violation of the Arkansas Deceptive Trade Practices Act.
Once again, these pharmaceutical companies put their profits before the safety of consumers. They need to be held accountable for their negligence.
For more information, contact one of our Gacovino Lake attorneys at 1-800-246-HURT (4878).