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.
“Non-label” warning theories – summary judgment is granted on non-label warning claims: (1) should have been a medication guide claim is barred by the learned intermediary rule: (2) should have been a Dear Doctor letter is purely speculative, (3) black box warning is purely speculative, (4) educational campaign is purely speculative. Further, all the non-label theories lack supporting legal authority
Design defect – claims survives summary judgment, as comment k requires a drug’s unavoidably unsafe nature to be established on a case-by-case basis, and because the adequacy of the label cannot be decided as a matter of law to call comment k into play on summary judgment.
Fraud – summary judgment granted for lack of evidence of reliance.
Punitive Damages – the claim survives summary judgment because of what the court characterized as the defendant’s “admitted (though explained) failure to survey the medical literature” and the seriousness of the risk involved.
Negligence per se based on failure to survey medical literature – Summary judgment granted. The court held that there was an FDCA violation due to the generic manufacturer’s failure to conduct an ongoing survey of the medical literature. However, the violation could not be negligence per se mostly because: (1) New Hampshire does not allow negligence per se based upon violation of a mere regulation (as opposed to a statute); and somewhat because (2) the FDCA does not allow private enforcement of claimed violations.
Preemption – There’s no reason to reconsider the prior ruling.