VIRGINIA BEACH, Va. (CN) - A man claims Amgen's arthritis drug Enbrel gave him cancer, and that Amgen and its affiliates hid the extent of the drug's side effects from doctors and their patients.
Wayne Stone Sr. says he was healthy and cancer-free when he began getting Enbrel injections for rheumatoid arthritis. Now, Stone says, he is disabled and forced to live a life filled with pain and hospital visits. He claims that his doctor would not have prescribed the drug had he known of its side effects.
Also sued in City Curt are Immunex, Pfizer, Wyeth, and John Doe distributors of the drug.
Stone says the FDA approved Enbrel (etanercept) on Nov. 2, 1998, "for a discrete population who had an inadequate response to one or more disease-modifying anti-rheumatic drugs."
Within 5 months of its licensing, Stone says, "post-marketing reports documented 30 serious infections, including six deaths. Information provided by the defendants indicated that a large proportion of cases occurred in people with one or more potential risk factors of serious infections, including diabetes, active infections, and a history of chronic recurrent infections."
Stone says Immunex funded a double-blind, placebo-controlled study of the drug from March 18 to June 21, 1999, but an independent Data and Safety Monitoring Board "recommended that the study be halted because of futility. More than half of the discontinuations of the study were for death (approximately 14 percent of the population), and there was a trend suggesting a dose-response," according to the complaint.
On Feb. 29, 2000, Stone says, a director of the Center for Biologics Evaluation and Research wrote a letter "admonishing Immunex for violations of 21 CFR 312.7(a) and 301(b)," federal food and drug laws.
The Enbrel label was changed in July 2001, but Stone says the warning was inadequate in many ways.
After the FDA issued a warning in January 2002, "about serious nervous system problems caused by Enbrel, involving demyelination, producing MS and other conditions," Stone says, the defendants "produced a video called 'The Enbrel Effect.' ...
"Defendants' video minimized the seriousness of potential CNS [central nervous system] disorders by failing to refer to them as serious disorders and by making it appear that the results of developing a nervous system disorder will be limited and cease if Enbrel is discontinued."
Stone says the defendants sent an "Important Product Information" warning on a calendar it sent to Enbrel users in February 2003. But he adds, "The 'Important Product Information' included in the calendar failed to note such known serious side effects of Enbrel use as lupus, MS, optic neuritis, polymyostitis, swelling of the brain, meningitis, encephalitis, sepsis and death.
"Despite the serious, debilitating and deadly side effects that defendants were aware that Enbrel can cause or to which it can be a substantial contributing factor, defendants widely advertised and promoted Enbrel.
"Additionally, defendants jointly and/or severally created, financed, supported and participated in aggressive advertising campaigns throughout the United States that glamorized the success and safety of Enbrel for the treatment of rheumatic arthritis while minimizing the risks."
Stone says he got lymphoma from Enbrel. He demands punitive damages for fraud, negligence, product liability, breach of warranty, negligent misrepresentation, fraudulent misrepresentation and fraud by concealment.
He is represented by Stephen Swain with Shuttleworth, Ruloff, Swain, Haddad & Morecock of Virginia Beach.
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