[Drug and Device Law] Breaking News - Post-2002 NJ Accutane Labels Adequate As A Matter Of Law
This just in – after many years of litigation, the post April 10, 2002 warnings on Accutane were determined to be adequate as a matter of law by the New Jersey judge tasked with overseeing this mass tort. A copy of today's opinion is here.
Most of the opinion is factual. Legally, the determination is made under New Jersey law, since the 800+ plaintiffs chose to come to that forum. New Jersey law, of course, has a presumption of adequacy of FDA approved labels. Accutane, slip op. at 18-19. Only certain types of proof can overcome the presumption, and plaintiffs failed to produce such evidence, despite repeated opportunities.. Id. at 19. Thus:
Taken as a whole, the warning system crafted by Defendants conveys a meaning as to potential risks and consequences that is unmistakable. It is inconceivable to this court that the reasonable dermatologist (or any physician, generally) of ordinary education, training and experience could examine the materials comprising the warning literature and not immediately conclude that Accutane has been associated with life-altering side effects, including IBD [Inflammatory Bowel Disease]. At multiple points, IBD is explicitly communicated to the prescribing physician as a potential risk of Accutane ingestion.
Id. at 20. Various rulings by the prior judge supervising this mass tort were inoperative, because that court “did not have the benefit” of more recent New Jersey appellate authority. Id. at 4 (citing Deboard v. Wyeth, 28 A.3d 1245 (N.J. Super. App. Div. 2011)).
The Accutane plaintiffs have only one shot left – they can try to escape New Jersey law, despite voluntarily coming to the forum, by alleging that some other state’s law applies that: (1) avoids the learned intermediary rule (very few states, in our estimation), (2) does not allow warning adequacy to be decided as a matter of law (we know of none that preclude such a determination no matter what the facts), or (3) imposes a “heavier burden of proof” than New Jersey. Id. at 21. We predict that most plaintiffs will try to open door #3, due to the statutory presumption of adequacy – but we doubt the underlying standard of adequacy (putting aside the presumption) will vary very much.
It is likely that the New Jersey Accutane plaintiffs are approaching the end of their rope.
Snip snip.
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Posted By Bexis to Drug and Device Law at 4/02/2015 04:35:00 PM --
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