Bartlett v. Mutual Pharmaceutical Company, Inc.: Living in a Post-Wyeth v. Levine World.

Ever since the Supreme Court’s decision in Wyeth v. Levine, drug manufacturers have found themselves at increased risk from state tort claims. On July 12, 2010, the United States District Court for the District of New Hampshire issued an opinion in Bartlett v. Mutual Pharmaceutical Company, Inc., 2010 U.S. Dist. LEXIS 69825 (D.N.H. July 12, 2010).  This case arises from an incident where a plaintiff, seeking treatment for pain in her right shoulder, was prescribed a non-steroidal, anti-inflammatory drug (“NSAID”) called Clinoril. The prescription was filled with the generic version of the drug, which was manufactured by the defendant. Weeks later, the plaintiff developed Stevens-Johnson Syndrome ("SJS") progressing to toxic epidermal necrolysis ("TEN"), a potentially fatal condition. The plaintiff sued defendant and alleged, among other things, that the defendant’s drug’s safety risks outweighed its medical benefits, making it an unreasonably dangerous product and that the defendant should have strengthened the drug’s safety warning in light of a certain reports in the medical literature about the connection between the drug and SJS/TEN. Both parties moved for summary judgment on various points.

In his opinion, Judge Lapalante found the following:


  1. Adequacy of the Safety Warning. The court refused to grant summary judgment on whether defendant’s drug label adequately warned doctors of the risk of SJS/TEN. The court reasoned that given the severity of SJS/TEN and a study indicating that the drug had more reported cases than most NSAIDs, the decision should be left to the jury.
  1. Causation. On various issues of causation, the court found as follows:

A.                            Reliance on Warning Labels. The court granted summary judgment in favor of the defendant on the issue of whether the defendant’s alleged failure to issue a stronger warning caused plaintiff’s injuries on the basis that the plaintiff’s doctor never reviewed the label warnings.


B.                             Non-Label Theories. The court granted summary judgment in favor of the defendant on the issue of whether a stronger warning by the defendant could have reached the physician’s attention through some other means apart from the label and found that the plaintiff did not provide enough evidence to establish the presence of a trial-worthy issue as to whether the defendant 's alleged failure to warn caused her injuries.


C.                            Defective Design Claims. On the issue of design defect, the court concluded that the plaintiff presented enough evidence (in the form of expert testimony) to create a trial-worthy issue as to whether defendant’s drug is unreasonably dangerous and whether that defective condition caused her injuries.


  1. Fraud. The court granted summary judgment in favor of the defendant on the issue that the defendant committed fraud, because neither the plaintiff nor the plaintiff’s physicians relied on the drug’s label.
  1. Punitive Damages.  The claim for punitive damages survived summary judgment because a reasonable jury could conclude that the defendant recklessly created a risk of great harm to consumers.


  1. Negligence for Failure to Survey Medical Literature. Although the defendant conceded that it did not survey medical literature, the violation of an FDA regulation requiring surveillance did not amount to negligence per se and the Food Drug and Cosmetic Act did not provide private enforcement of such violations.  Thus, plaintiff’s request for summary judgment was denied.
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