A Florida federal judge has allowed a majority of the claims to proceed against Amgen Inc., Wyeth Inc., and Pfizer Inc. in an Enbrel injury case, finding plaintiffs adequately alleged design defect, failure to warn and breach of warranty.
On March 6th, Judge John E. Steele of the U.S. District Court for the Middle District of Florida found that because the drug’s warning label did not specifically warn of asymptomatic infections, “a determination as to the adequacy of such a broad warning of infection is best left for a later stage of the proceedings.”
According to Rebecca and Lawrence Small’s fourth amended complaint, Rebecca Small began receiving two subcutaneous injections of Enbrel each week in 2002 to treat her rheumatoid arthritis. She continued the treatment until August 29, 2008, when she was admitted to the hospital and diagnosed with a perforated bowel from a diverticulitis infection that was caused by her use of Enbrel, the suit says. Small claims she was symptomatic until a few days before her hospitalization.
Small alleges that she underwent multiple surgeries to treat the infection. After being discharged from the hospital, she visited her rheumatologist, Dr. Catherine Kowal. Dr. Kowal consulted with a sales representative regarding Enbrel, who assured the doctor that it was appropriate to resume Small’s treatment with Enbrel three months after the serious adverse effects had occurred.
Small says she experienced another round of complications associated with her use of Enbrel, requiring additional surgeries and treatment. On October 30, 2012, plaintiffs amended their complaint, which was dismissed as an impermissible shotgun pleading (legal jargon when a Plaintiff names numerous causes of action, or reasons for bringing the lawsuit, in hopes that one of them will win).
They now are relying on their Fourth Amended Complaint, which sets forth claims of strict liability based on a design defect, failure to warn, breach of express warranty, negligence, and loss of consortium. Plaintiffs allege that at no time prior to Small’s injuries were doctors and/or patients warned that Enbrel could cause asymptomatic, serious infections.
The prescription drug Enbrel is a “biologic” drug used to treat rheumatoid arthritis. Enbrel was originally developed by Amgen and was marketed and sold by both Amgen and Wyeth. Wyeth was acquired by Pfizer on October 15, 2009.
At the time of Small’s injuries, the Enbrel label included a boxed warning, stating the “infections, including serious infection leading to hospitalization or death, have been observed in patients treated with Enbrel” and that “in patients who develop a serious infection, Enbrel should be discontinued.” The drug’s medication guide advised patients that, “after starting Enbrel, if you get an infection, any signs of an infection including a fever, cough, flu-like symptoms, or have any open sores on your body, call your doctor right away. Enbrel can make you more likely to get infections or make any infection that you may have worse.”
Although warnings for Enbrel have mentioned “infections” since at least 2002, the U.S. Food and Drug Administration (FDA) has required that additional warnings covering histoplasmosis and other fungal infections be added to the label, Judge Steele noted.
Plaintiffs allege that defendants failed to adequately warn health care providers that Enbrel was associated with an increased risk of complications arising from serious and significant infection and failed to adequately instruct doctors and patients how to mitigate risks of infections, including asymptomatic infections, associated with the use of Enbrel.
The judge refused to dismiss all the claims except the negligence claim to the extent plaintiffs assert a negligence per se claim based on defendants’ alleged violations of FDA regulations. Judge Steele agreed with defendant that Florida law does not recognize a claim for negligence per se for the alleged violation of the Food, Drug and Cosmetic Act.
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