Tuesday, September 21, 2010

A jury reportedly finds the risks of an FDA-approved drug outweighed its benefits, and an interesting appeal should follow

We have written several times before about the good and the bad pretrial rulings in Bartlett v. Mutual Pharmaceutical Co., No. 08-358 (D.N.H.). Faithful readers will recall that the plaintiff allegedly developed Stevens-Johnson Syndrome (SJS) after taking generic Sulindac, an NSAID. The court threw out the failure to warn claim because the provider never read the allegedly inadequate warning but allowed plaintiff to proceed to trial on a design defect claim. As we explained earlier, the design defect claim raises serious preemption issues because it asks the jury to second guess the FDA’s decision that the benefits of the drug outweigh its risks.

Bartlett went to trial, and unfortunately the jury returned a $21 million verdict in favor of the plaintiff earlier this month. For those of us not involved in the trial and not possessing a transcript, figuring out exactly what happened at a trial can be difficult. We often have nothing but the crowing of the winning attorneys, a prime example of how history is written by the victors, a turn of phrase attributed to Winston Churchill but perhaps not coined by him. Those post-trial statements are unreliable, and we take them with a big grain of salt, but they are all we have for now.

In any event, according to the statements the plaintiffs’ attorneys gave to the press after the trial, Bartlett showed at trial that Sulindac was unreasonably dangerous because its risks outweighed its benefits. A key part of plaintiff’s case, according to plaintiff’s counsel, was a report published after the drug was approved showing that Sulindac had a higher rate of SJS than any other NSAID. It appears from the published reports of the trial that plaintiff’s theory was that post-approval information showed that the drug should have been pulled from the market. But we can’t figure out from the post-verdict victory celebrations whether the post-approval reports were shared with the FDA, the extent to which the post-approval studies differed from the pre-approval studies, or many other relevant facts.

We assume that Mutual Pharmaceutical will file post-trial motions and an appeal, which should provide us with a clearer picture of exactly what happened at trial. We have previously complimented the trial judge on the thoroughness of his opinions, even though we have disagreed with some of his rulings. We look forward to his explanation of the trial evidence and his discussion of the relevant issues. This case is a long way from being over. This trial judge or the court of appeals should hold that conflict preemption does not allow a jury to ignore the FDA's approval and conclude under state law that an FDA-approved drug should never have been sold. If this verdict is allowed to stand, then they might as well abolish the FDA.

3 comments:

Justinian Lane said...

Any thoughts as to why Mutual didn't call a single witness?

FDA Compliance Guy said...

Good post. It certainly is an interesting case and one that shows the importance of ensuring FDA compliance amongst pharmaceutical manufacturing firms.

excessive sweating said...

It is an interesting article. I like your style of writing. Bartlett went to trial, and unfortunately the jury returned a $21 million verdict in favor of the plaintiff earlier this month.