Jan. 12 (Bloomberg) -- Abbott Laboratories was sued by a Texas rheumatoid arthritis sufferer who claims she developed lymphoma after taking its drug Humira in a company-sponsored clinical trial in 2005.
“Abbott had the data in its possession by January 2005 to alert people to the three- to fivefold potential risk of cancer for patients taking Humira,’’ Andy Vickery, the plaintiff's attorney, said in a lawsuit filed yesterday in Houston federal court. “Abbott did nothing to warn patients directly about the risks of Humira-induced cancers’’ until federal regulators required it in 2009.
Gayathri Murthy, a Houston hospital worker, began taking Humira as part of a clinical trial in early 2005, for treatment of rheumatoid arthritis, according to the complaint. Her doctor warned her the drug increased the risk of tuberculosis and said other side effects were similar to the “side effects of aspirin.’’
She remained on the drug until she was diagnosed with lymphoma in February 2006, according to the complaint.
Humira is expected to outsell Roche Holding AG’s Avastin cancer medicine by 2016 to become the world’s most lucrative drug, according to a May forecast by research company EvaluatePharma. Revenue from Humira will increase about 9 percent annually to $10.1 billion in 2016 from $5.6 billion in 2009, London-based EvaluatePharma said in a May 3 statement.
“Humira has more than 12 years of clinical and safety data and best-in-class efficacy,’’ Adelle Infante, Abbott’s spokeswoman, said in a brief phone interview today. “The therapeutic risks associated with Humira are well-known and documented in the prescribing label.’’
Humira’s full warning label, which was inserted in packaging provided to doctors rather than patients, warned in July 2004 that patients in clinical trials of the same class of drugs as Humira developed a small number of cancers not seen in patients receiving other rheumatoid arthritis treatments, according to the complaint.
The class of drugs, known as tumor necrosis factor-blockers, prevent the body’s cancer-killing cells from working.
Neither this package warning nor her doctor’s relationship as a “paid clinical investigator for Abbott’’ were disclosed in the informed-consent form Murthy signed upon entering the Humira trial, according to the complaint. A company-provided video shown to all clinical study participants at that time similarly painted “a rosy picture of therapy with Humira and does little if anything to alert the patient to the very real risk of life-threatening Humira-induced cancer,’’ Vickery said in the complaint.
2010 FDA Guide
In the U.S. Food and Drug Administration’s September 2010 Patient Medication Guide, Abbott states: “For children and adults taking TNF-blocker medicines, including Humira, the chances of getting lymphoma or other cancers may increase,’’ according to the complaint.
Murthy sued Abbott for breach of contract over how it conducted the 2005 Humira clinical trial, product liability, negligence and failure to warn. She requested unspecified punitive damages.
Murthy also asked that Abbott be required to pay for lifetime medical monitoring and full medical care should her cancer, which is in remission following chemotherapy, ever recur.
The case is Murthy v. Abbott Laboratories, 4:11-cv-00105, U.S. District Court, Southern District of Texas (Houston).
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