Abbott Labs Sued on Claims Humira Caused Permanent Eye Damage
Abbott Laboratories (ABT) was sued by a New York Web designer who claimed its top-selling drug Humira, which she took for Crohn’s disease, permanently damaged her optic nerves.
The doctor who treated Jamie Bixby at the New York Eye and Ear Infirmary in Brooklyn in 2008 said Bixby’s optic neuritis was “related to her use of Humira,’’ according to the lawsuit, which was filed May 20 in Chicago federal court, near the drugmaker’s headquarters in Abbott Park, Illinois.
Bixby said she was told by a nurse on the company’s telephone helpline that the eye pain she began experiencing after a month of Humira treatments wasn’t related to the drug. An eye doctor diagnosed Bixby with permanent damage to the myelin sheath of her optic nerves a month later, after she sought emergency treatment when vision in one eye became blurry with black holes.
If Abbott had warned Bixby or her gastroenterologist “that Humira could be the source of her eye pain, she would have immediately discontinued taking the drug and would have immediately obtained proper emergency medical treatment,’’ Bixby said in the complaint.
Humira, which had reported 2010 worldwide sales of $6.5 billion, is expected to outsell Roche Holding AG (ROG)’s Avastin cancer medicine by 2016 to become the world’s most lucrative drug, according to a May 2010 forecast by research company EvaluatePharma.
‘Safety Data’
“Humira has more than 12 years of clinical and safety data and best-in-class efficacy,’’ Adelle Infante, an Abbott spokeswoman, said in an e-mail today. “The therapeutic risks associated with Humira, including disorders of the nervous systems, are well known and documented in the prescribing label.’’
Bixby’s lawyer, Andy Vickery of Vickery, Waldner & Mallia LLP in Houston, has already sued Abbott claiming Humira caused cancer or peripheral nerve damage in patients from Texas, Massachusetts and Montana.
Humira was originally approved in 2003 as a treatment for rheumatoid arthritis. The U.S. Food and Drug Administration has since approved it to treat five additional autoimmune diseases, including Crohn’s.
Bixby said Abbott should have known Humira could damage the coatings of optic nerves before it began marketing the drug to Crohn’s patients in 2007. She said an article in a leading arthritis journal detailed a series of patients who developed deterioration of their optic nerves’ myelin sheaths after taking Enbrel and Remicade, similar drugs made by competitors.
‘Specific Warning’
“Other competitor drugs in the same class have a specific warning about the risks of optic nerve damage,’’ Bixby said in the complaint. “Humira does not.’’
This year, two arthritis patients in Massachusetts and Texas sued Abbott claiming Humira gave them lymphoma. In April, a Montana Crohn’s patient sued on claims Humira caused lasting nerve damage in her feet.
In all four cases, the patients are seeking both economic and punitive damages.
The case is Bixby v. Abbott Laboratories, 1:11-cv-3414, U.S. District Court, Northern District of Illinois (Chicago).
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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