Nevada State Court Judge Says There’s a Hole in Mensing Preemption for Some “Dear Doctor” Letters

September 5, 2011

By Kurt R. Karst –      

In what appears to be the first instance in which a court has considered the U.S. Supreme Court’s decision in PLIVA, Inc. v. Mensing in the context of a preemption defense in a state tort-law failure-to-warn case, 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., et al., No. 08A575837, Megan T. Gasper, et al. v. Endoscopy Center of Southern Nevada, L.L.C., et al., No. 08A579660, Betty Hymas v. Endoscopy Center of Southern Nevada, L.L.C., et al., No. 08A582492, Nev. Dist., Clark Co.  In doing so, the court concluded that Mensing does not preempt the Plaintiffs’ claims that certain generic drug manufacturers could have sent a “Dear Doctor” or “Dear Healthcare Provider” letter warning against reuse of vials containing propofol (and that allegedly cause hepatitis infection).

In Mensing, the Court invoked the doctrine of impossibility preemption to hold 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 its decision, the Court deferred to FDA’s position, articulated the Agency’s brief to the Court, that the Changes Being Effected (“CBE”) procedures are not available to generic drug sponsors to add or strengthen label warnings.  (As we recently reported, Public Citizen has submitted a citizen petition to FDA requesting that the Agency amend its regulations to permit ANDA sponsors to revise their labeling through the CBE and Prior Approval Supplement procedures.) 

With respect to “Dear Doctor” letters, FDA said in its brief to the U.S. Supreme Court that they qualify as labeling and, therefore, must be “consistent with and not contrary to [the drug’s] approved . . . labeling.”  Thus, the Supreme Court, again deferring to FDA, 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.” 

In his decision, Judge Wiese writes that although “[t]his Court does not agree with the reasoning or the Supreme Court’s majority opinion in Mensing . . . . it is obligated to follow its decision.”  However, the Supreme Court did not, writes Judge Wiese,

indicate that “Dear Doctor” letters that were “consistent and not contrary” to the labeling, were preempted. . . .  While the FDA apparently believed that no liability may lie for failure to send such a letter unilaterally, the U.S. Supreme Court did not adopt this language, or set forth this holding as their own.  Consequently, it is not part of the Mensing ruling, and is not binding upon this Court. 

Continuing, Judge Wiese states that “[w]hile the U.S. Supreme Court may not have intended to leave this small argument available, the Court’s decision seems to indicate that a ‘Dear Doctor’ letter that is ‘consistent with and not contrary to the drug’s approved label,’ and which does not provide ‘substantially new’ or ‘additional’ warnings, would not be preempted under [Mensing].”  Judge Wiese is quick to note, however, that “[e]ven if the ability to send a ‘Dear Doctor’ letter is not precluded or preempted under Mensing, this Court is unclear with regard to the legal theory under which the Plaintiffs anticipate asserting a ‘duty’ to send a ‘Dear Doctor’ letter, since [Mensing] seems to hold that the state law failure to warn claim is preempted.”

It will be interesting to see whether this and other, let’s just call them “interesting,” arguments floating around out there will gain any traction in courts.