Abbott Sued Over Claim Humira Caused Fungal Infection

Abbott Laboratories (ABT) was sued by a Tennessee advertising executive who claimed its top-selling arthritis drug Humira caused a life-threatening fungal infection.

Frederick Delano, 69, was diagnosed in February 2009 with disseminated histoplasmosis, according to a complaint filed yesterday in federal court in Memphis, Tennessee. In a May 2010 warning letter to doctors, Abbott said some Humira patients are at risk of developing the fungal infection.

“In 2008, Fred and his physicians got no warning whatsoever that the medication which he thought would help could, in fact, kill him -- and nearly did,” Delano and his wife, Frances, said in the complaint.

In September 2008, 26 days before Delano’s first dose of Humira, according to his complaint, the U.S. Food and Drug Administration ordered the Abbott Park, Illinois-based drugmaker to warn patients and doctors of an increased risk of potentially fatal Humira-induced histoplasmosis.

The risk was highest for patients who lived in the Mississippi and Ohio River valleys and also took methotrexate, an immune-suppressant drug prescribed to Delano and thousands of other arthritis sufferers, the FDA said.

“Abbott stalled for more than a year and a half” before mailing warning letters to doctors, Delano said in his complaint, which seeks millions of dollars in actual and punitive damages. “Abbott opted for sales and chose not to” immediately issue the safety warning, he claimed.

‘Therapeutic Risks’

“Humira has more than 12 years of clinical and safety data and best-in-class efficacy,” Adelle Infante, an Abbott spokeswoman, said in a telephone interview today. “The therapeutic risks associated with Humira are well-known and documented in the prescribing label.”

“Abbott’s risk evaluation and mitigation strategy plan was submitted to the FDA in December 2008 and approved in April 2010,’’ Infante said regarding Delano’s claim that Abbott intentionally delayed warnings about the risk of fungal infections. “Abbott contacted health-care providers well within the timeframe required by the FDA,’’ she said.

Delano was diagnosed with histoplasmosis by a specialist at Memphis’s St. Francis Hospital after doctors at the local Veterans Administration hospital failed to pinpoint the cause of a “raging” infection he had had for a month, according to the complaint. VA doctors treated Delano’s psoriatic arthritis with numerous Humira injections during a 2 1/2-month period beginning in October 2008, he said.

Sales Leader

Humira, with 2010 sales of $6.55 billion, is expected to become the world’s most lucrative drug by 2016, according to a forecast by research company EvaluatePharma. The FDA approved Humira in 2003 to treat rheumatoid arthritis and has since approved the drug to treat five other auto-immune illnesses, including Crohn’s disease.

Delano’s lawyer, Andy Vickery of Perdue, Kidd & Vickery in Houston, has already sued Abbott claiming Humira caused cancer or peripheral nerve damage in patients from Texas, Massachusetts and Montana. He also represents a New York patient who claims the drug damaged her vision.

The case is Delano v. Abbott Laboratories, 2:11-cv-2475, U.S. District Court, Western District of Tennessee (Memphis).

To contact the reporters on this story: Laurel Brubaker Calkins in Houston at laurel@calkins.us.com; Margaret Cronin Fisk in Southfield, Michigan, at mcfisk@bloomberg.net.

To contact the editor responsible for this story: Michael Hytha at mhytha@bloomberg.net

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