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Hey, trial lawyers! The FDA is watching you!

Friday, April 18, 2014
posted by Douglas Keene

im-watching-youAnd they want you to stop abusing their Adverse Event Reporting System (FAERS). We’ve worked a number of cases recently where FDA warnings were used as evidence at trial and were very interested to see this article in the American Journal of Gastroenterology. And the answer to the skeptic’s question is “no”. No, we don’t accept that a medical journal, clearly an outlet for industry points of view, is blind to their own interests.

The author uses the example of the drug, Isotretinoin (also known as Accutane). The FDA and Hoffman La Roche issued warnings of a “possible causal association between isotretinoin and inflammatory bowel disease” and litigation ensued. According to the author, hundreds of lawsuits were filed and paid out substantial awards for damages due to the use of this medicine. The author lists examples of $10.5M for ulcerative colitis, $25.16M for inflammatory bowel disease, and two $9M awards for bowel disease. In 2009, “as the number of adverse events reported to the FDA and lawsuits from patients continued to grow”, La Roche recalled Accutane from the market–not because they believed it was dangerous (according to their public statements) but because generic medications were taking a large share of the market.

So, what’s the problem, you may wonder. Well. It turns out there is strong evidence Accutane doesn’t actually cause inflammatory bowel disease. There is another side to the story. The early warning system (FAERS) was used as a method to recruit Plaintiffs, who went to court and prevailed. Now evidence from a “large pharmaco-epidemiologic database” is being published that seems to exonerate Accutane.

A new French study of 7,593 patients with inflammatory bowel disease (including ulcerative colitis, Crohn’s Disease, and indeterminate colitis), and 30,372 control subjects who had been exposed to isotretinoin but had not developed the diseases has just been completed. The study concludes the use of Accutane/Isotretinoin is “not associated with increased ulcerative colitis risk but was associated with a decreased Crohn’s Disease risk”.

The author thinks the litigation system and the FDA both try to protect consumers. The litigation system works to compensate for harm caused by defective products and the FDA sets rules and enforces regulation, says the author. He believes the problem comes in when instead of operating independently, trial lawyers use warnings issued by the FDA to assign blame to specific drugs when research has not yet been done to ascertain responsibility for harm done by the specific drug. He says the FAERS was developed for hypothesis testing–not to establish blame. His solution is for pharmaceutical manufacturers to be shielded from state tort law. “By inhibiting trial lawyer misuse of science, especially the FAERS, there will be a decrease in wasteful, expensive, premature litigation.” The adverse affects are listed because they were observed to some degree in clinical trials, but a research study large enough to determine causation, as opposed to association, can’t be done until the drug is taken by much larger numbers than are typical for routine clinical trials. The FDA required the disclosure in order for the extremely profitable drug to be marketed.

So– what are Plaintiffs supposed to do? Should they wait the decade or so until a large-scale study can be done? Or should more testing be required up front prior to new medicines being released?

It is undisputed that the cost of large-scale impact testing would be prohibitively expensive and exert a huge impact on drug development and availability. And it is inevitable that drugs that cause long-term changes in metabolism and human biochemistry have impacts on organ systems that are not anticipated. If the risks were deemed significant, Hoffman could have requested a more limited indication for the drug, perhaps in cases of exceptionally severe or prolonged acne, rather than using it for routine and embarrassing conditions. What is clear, and not unexpected in a medical journal, is that the pharmaceutical industry wants to have a long litigation-free window to market and sell the product before anyone can sue for damage that might have happened during the first year it was released. I can’t blame them, but does that sound like justice?

Tenner S (2014). Editorial: Isotretinoin and inflammatory bowel disease: trial lawyer misuse of science and FDA warnings. The American Journal of Gastroenterology, 109 (4), 570-1 PMID: 24698863

Racine A, Cuerq A, Bijon A, Ricordeau P, Weill A, Allemand H, Chosidow O, Boutron-Ruault MC, & Carbonnel F (2014). Isotretinoin and risk of inflammatory bowel disease: a French nationwide study. The American Journal of Gastroenterology, 109 (4), 563-9 PMID: 24535094


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