Alleging a diagnosis of cancer and accusing drugmakers of hiding Enbrel side effects, Wayne Stone Sr. is suing Immunex, Pfizer, Wyeth, and so-called “John Doe” distributors of the drug, reported Courthouse News. Amgen and Pfizer market Enbrel for rheumatoid arthritis and psoriasis.
Stone Sr. claims Enbrel gave him lymphoma and the severity of Enbrel side effects were hidden from physicians and patients, arguing that he was cancer-free and in good health prior to receiving Enbrel injections for his rheumatoid arthritis, said Courthouse News. Today, says Stone Sr., he is disabled, in pain, and enduring hospital visits. He also alleges that his physician never would have prescribed Enbrel had he been aware of all of the side effects, added Courthouse News.
According to Stone Sr., the U.S. Food and Drug Administration (FDA) approved the drug on November 2, 1998 “for a discrete population who had an inadequate response to one or more disease-modifying anti-rheumatic drugs,” quoted Courthouse News. Within five months, said Stone Sr., “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,” wrote Courthouse News, quoting the Enbrel lawsuit.
Stone alleges that a “double-blind, placebo-controlled” study of Enbrel funded by Immunex from March 18 to June 21, 1999 received a recommendation “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,” by the Data and Safety Monitoring Board, wrote Courthouse News, quoting the complaint. On February 29, 2000, a director of the Center for Biologics Evaluation and Research also wrote a letter “admonishing Immunex for violations of 21 CFR 312.7(a) and 301(b),” federal food and drug laws, said Stone.
The FDA issued a warning in January 2002, “about serious nervous system problems caused by Enbrel, involving demyelination, producing MS and other conditions,” and the defendants, said Stone,” produced a video called ‘The Enbrel Effect,’ quoted Courthouse News. The complaint alleges, “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.”
Although the defendants sent Enbrel users an “Important Product Information” warning on a calendar in February 2003, The information “failed to note such known serious side effects” including “lupus, MS, optic neuritis, polymyostitis, swelling of the brain, meningitis, encephalitis, sepsis and death” and that, “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” and “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.”
We have long covered Enbrel side effects on this blog. For example, we recently wrote that The Institute for Safe Medication Practices issued an adverse event report for last year’s third quarter that indicated that Enbrel was cited 495 times. And, in 2009, we wrote that federal regulators released more information regarding cancers associated with drugs like Enbrel. Just prior to that, the FDA mandated that the Black Box Warnings on these drugs “known as TNF blockers” highlight their possible association with lymphoma and other cancers in children and teens.
Stone is demanding “punitive damages for fraud, negligence, product liability, breach of warranty, negligent misrepresentation, fraudulent misrepresentation, and fraud by concealment,” said Courthouse News.