DEAR DOCTOR LETTERS
Dr. Kuhn testified that he did not recall ever reviewing Stryker’s pump
instructions or speaking with a Stryker sales representative.83 A nurse
would simply deliver the pump to Dr. Kuhn in the operating room, “without
any packaging or the instructions for use.”84 Thus, plaintiff faced a
“causation problem”: he had “no evidence that, even if Stryker had placed
the proposed warning in the instructions or given it through a sales
representative, the warning would have reached Dr. Kuhn or would have
prevented the injury.”85
As the Sixth Circuit put it, plaintiff tried to “sidestep” the causation
problem by “add[ing]” that defendants should have warned physicians
through a Dear Doctor letter or a label directly on the pain pump.86 Both of
these arguments suffered three main flaws.
First, plaintiff had not pled the Dear Doctor letter or direct label theories
in his complaint—he only claimed that defendants should have provided
“adequate” warnings.87 “If these warnings were the only ‘adequate’ ones in
this setting, it was Rodriguez’s burden to argue that and provide evidence
showing that.”88 Thus, future plaintiffs are now on notice that it would be
wise to plead the Dear Doctor letter (or any other alternative warning)
argument in their complaint, and likely present some expert testimony as to
why only that kind of warning would be “adequate.” Presumably, with
respect to Dear Doctor letters, that would require some analysis of the 21
C.F.R. § 200.5 “important” information standard and FDA policies and
practices with respect to Dear Doctor letters.
Second, the Sixth Circuit in Rodriguez criticized the plaintiff for raising
the Dear Doctor letter and direct label options in connection with his “FDA
arguments”—relating to the manufacturer’s duty to warn—89 rather than in
the causation context. The plaintiff argued that “Stryker should have
known that it needed to ‘revise its instructions or at least circulate a Dear
Doctor Letter’ when the FDA rejected its requests to approve the pump
specifically for use in a joint.”90 But, the court had already concluded that
the FDA position in response to Stryker’s 510(k) requests did not indicate
in any way that using the pain pump in a joint was unsafe.91 Thus, if
85. Id. at 576.
89. Plaintiff argued that defendants should have known that the pain pump was not safe
to use in a joint because the FDA had denied permission to market the pump for that use. Id.
90. Id. at 576 (citation omitted).