A Humira lawsuit has been filed by a Montana woman who claims that the arthritis drug caused her to suffer permanent nerve damage.
The complaint was filed by Kara Mae Pletan, 32, in Circuit Court of Cook County, Illinois on April 26 against Abbott Laboratories, which manufactures the medication.
Pletan received Humira injections for three months in 2008 before she was diagnosed with small fiber peripheral neuropathy by doctors at the Mayo Clinic, the lawsuit claims. As a result, Pletan suffers from pain and hypersensitivity in her feet severe enough to cause her to give up outdoor activities and sell her family’s retail furniture business.
Humira was approved by the FDA in 2003 for the treatment of rheumatoid arthritis. It later gained approval as a treatment for several autoimmune diseases, including Crohn’s disease. The drug pulled in sales of $6.5 billion in 2010.
Pletan’s lawsuit claims that Abbott officials knew or should have known that Humira side effects included a risk of peripheral neuropathy before it received approval for autoimmune disease treatments, but says the company failed to warn doctors and patients about the risks. In 2006, French researchers reported that the drug could be linked to nerve damage.
Earlier this year, an FDA warning was issued for Humira and other bowel treatment drugs in a class of medications known as TNF blockers, indicating that the medications could be linked to a form of cancer known as Hepatosplenic T-Cell Lymphoma (HSTCL). Other drugs listed in the warning included Remicade, Enbrel, Cimzia and Simponi.
Two other women filed Humira cancer lawsuits earlier this year, alleging that Abbott Laboratories failed to adequately warn about these side effects.
In 2009, the FDA required black box warnings be placed on all TNF blockers warning of the increased risk of childhood cancer. The FDA found that incidents of cancer began to appear about 30 months after TNF blocker treatment in some children being treated for juvenile rheumatoid arthritis, psoriatic arthritis, plaque psoriasis, ankylosing spondylitis, inflammatory bowel disorder and Crohn’s disease.