Bartlett

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Last Friday we had a brief post about the new decision in Bartlett v. Mutual Pharmaceutical Co., 2010 WL 2765358 (D.N.H. July 12, 2010).  That was a tickler; we promised you a more fulsome discussion of the opinion later.
Well, later is now, so here goes.
Briefly, the product involved in Bartlett is generic Sulindac, an anti-inflammatory NSAID.  The plaintiff was prescribed Clinoral – the branded version of the drug – but in an increasingly common scenario, plaintiff’s pharmacist substituted generic Sulindac.  2010 WL 2765358, at *1.  Plaintiff came down with Stevens-Johnson Syndrome (“SJS”), a nasty condition that among other things left her permanently blind.
Plaintiff sued, and we suppose in the course of discovery, discovered FDA-related issues with the generic manufacturer’s ongoing post-marketing research – like there wasn’t any. The following facts were taken as true for purposes of the defendant’s summary judgment motion:

More than a year before these events [that is, plaintiff’s prescription], an international medical journal published a study of the link between NSAIDs and [SJS].  The study revealed that . . . Sulindac had 89 reported cases of [SJS] . . . more than any other NSAID on the market and all but four drugs of any kind.  [Defendant] was not aware of that study, however, because it had not been monitoring the medical literature for information about Sulindac’s safety risks.  [It] believed that the manufacturer of Clinoril, the brand-name version of the drug, was responsible for such monitoring.

2010 WL 2765358, at *2.
At the time of the prescription, the defendant’s FDA-approved label didn’t mention SJS by name, instead describing it as “hypersensitivity” – albeit specifically mentioning “severe skin reactions” and “fatalities.”  Id. Thus, the state of the labeling was something that, on the whole, tended to favor the plaintiff.Continue Reading Bartlett – Not All Pear-Shaped After All

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Anybody interested in generic drug preemption undoubtedly remembers Bartlett v. Mutual Pharmaceutical Co., 659 F. Supp. 2d 279 (D.N.H. 2009), as one of the earliest detailed examinations of such arguments post-Levine.  Whether one agrees with the conclusions of that decision or not (we mostly don’t), it certainly demonstrated that Judge Laplante was almost as thorough and conscientious an opinion writer as the late Ed Becker of the Third Circuit.  We do not make that comparison lightly.
Well, there’s now a second Bartlett opinion – Bartlett v. Mutual Pharmaceutical Company, Inc., 2010 U.S. Dist. Lexis 69825 (D.N.H. July 12, 2010), and not only is it just as detailed – but the defendant does considerably better (although not entirely so).  There are a lot of issues, so we’ll just highlight them here:
Adequacy of warning – The court refuses to hold as a matter of law that the warning was adequate – that “hypersensitivity” and “severe skin reactions” were the legal equivalent of a specific warning about Stevens-Johnson syndrome, which is frequently fatal.
Warning causation – Summary judgment is granted on warning claims based upon the prescriber’s admitted failure to read the defendant’s warnings.  There is a lengthy discussion of this recurring issue.Continue Reading A Second Significant Decision in Bartlett v. Mutual Pharmaceutical

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