As I reported here earlier this year, in PLIVA, Inc. v. Mensing, the US Supreme Court found that federal drug regulations applicable to generic drug manufacturers directly conflict with, and thus preempt, state tort-law claims based on drug manufacturers’ alleged failure to provide adequate warning labels for their products. As part of that decision, the Court said that a “[a] Dear Doctor letter that contained substantial new warning information would not be consistent with the drug’s approved labeling,” and concluded that “federal law did not permit the Manufacturers to issue additional warnings through Dear Doctor letters.”
Notwithstanding this ruling, the FDA law blog is reporting that Nevada State Court Judge Jerry Wiese II recently granted Plaintiff’s Motion for Partial Summary Judgment on Preemption Defense for Dear Doctor Liability in three propofol hepatitis infection cases – Carol Keck v. Endoscopy Center of Southern Nevada, L.L.C., Megan T. Gasper, et al. v. Endoscopy Center of Southern Nevada, L.L.C., and Betty Hymas v. Endoscopy Center of Southern Nevada, L.L.C.
According to the report, the court opined that the the Supreme Court did not indicate that “Dear Doctor” letters that were “consistent and not contrary” to the labeling, were preempted.
In other words, since a claim based on a manufacturer's failure to send a letter warning doctors of new risks would be preempted, the decision seems to say that there could be a claim based on one of two possible types of cases: when the manufacturer never sent a letter to begin with and, perhaps, when a manufacturer fails to send a letter reminding doctors of the information already available in past letters or other literature.
For more on this story go here. For more on PLIVA v Mensing, go here, here and here.
For a survey of cases on the subject since PLIVA go here.
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