DEAR DOCTOR LETTERS
in 21 C.F.R. § 200.5, it could have made strong arguments, especially
through an expert, that a proposed warning to be “very careful” does not
meet the requirements of a Dear Doctor letter. The lesson here is that
plaintiffs and defendants are both well-advised to have warning-defect
experts who are savvy about Dear Doctor letter and other FDA regulatory
requirements. If only one side or the other has such a knowledgeable
expert, that imbalance can tip the scale for the court’s analysis of whether a
Dear Doctor letter was feasible in the instant case.
The court also assumed, “for the sake of argument,” that plaintiff’s
doctors would have paid closer attention to a Dear Doctor letter than to
instructions included with the catheter.108 Nevertheless, the Kapps court
dismissed plaintiff’s failure-to-warn claim because he could not show that
his doctors “would have done anything differently” if Biosense had sent out
the proposed Dear Doctor letter.109
The District Court of Minnesota first critiqued plaintiff’s proposed
“[p]lease be very careful” warning as “content-free.”110 The court noted
that plaintiff’s expert testified that an instruction for extricating the
entrapped catheter “might” be: “if you get this thing entangled and it
doesn’t disentangle with a little clockwise torque, you would call a
surgeon.”111 But this did not help plaintiff’s warning claim, as his expert
said he was not going to render an opinion on what disentanglement
instruction “should have been included.”112 The court in Kapps further
assessed that plaintiff’s “content-free” Dear Doctor “would not have
changed anyone’s behavior.”113 After all, “[s]urely doctors know, based on
their training and common sense, that they must be ‘very careful’ when
manipulating an instrument inside a human heart.”114 The court in Kapps
thus cautions future plaintiffs to put specific content in their proposed Dear
Doctor letter that, at least on its face, sounds like it could make a difference
in the product’s use. The court in Kapps also encourages defendants to pin
down plaintiffs on their proposed Dear Doctor letter content, so they can
deconstruct and decimate it.
The court in Kapps then analyzed another glaring flaw in plaintiff’s Dear
Doctor letter argument: no one had deposed Dr. Wong, the doctor
manipulating the catheter when it became entrapped.115 Thus, as to Dr.
111. Id. (internal quotations and citation omitted).
112. Id. at 1157 (internal quotations and citation omitted).
113. Id. at 1156, 1157 (emphasis added).