DEAR DOCTOR LETTERS
that because the FDA mandates label changes, the evidence fell within the
“superior governmental authority” exception to Rule 407.186
Even more recently, in Tietz v. Abbott Laboratories, Inc., et al., a Dear
Doctor letter not only wound up in front of an Illinois state court jury, but
also became “Exhibit A” in the plaintiff’s failure to warn case.187 Plaintiff
Tietz accused Abbott Laboratories, Inc. and AbbVie, Inc. (together,
“Abbott”) of failing to adequately warn doctors about the risks of
developing unrecognized histoplasmosis when taking the arthritis drug,
Humira.188 Tietz alleged that, as a result of taking Humira, his wife was
hospitalized and nearly died from a widespread histoplasmosis infection
that doctors struggled to diagnose in early May 2010. If Abbott had
adequately warned of the risk of developing a histoplasmosis infection
through a quickly distributed Dear Doctor letter, argued Tietz, doctors
could have diagnosed his wife’s condition sooner.
Abbott sent a Dear Doctor letter warning of this exact risk on May 17,
2010 (this letter ultimately ended up in front of the jury).189 The letter
provided that “Abbott would like to inform you... [of] the risk of
developing unrecognized histoplasmosis.”190 Tietz argued that Abbott
knew of the risk at least 20 months earlier (as evidenced by a FDA-mandated Risk Evaluation and Mitigation Strategy (“REMS”) concerning
Humira).191 According to Abbott, however, it could not be liable for failure
to send the Dear Doctor letter sooner because it met all FDA-imposed
deadlines concerning the REMS for Humira, including timely providing a
Dear Doctor letter to the FDA for its approval.192
Abbot’s Senior Director of Regulatory Affairs, Raymond Votzmeyer,
testified that Abbott could not have sent out the Dear Doctor letter before it
did because the letter needed FDA approval, which it did not have until
186. The “superior governmental authority” exception to Rule 407 provides that when
remedial measures are mandated by a governmental agency, they are not voluntary and Rule
407 is accordingly inapplicable. In re Levaquin Prods. Liab. Litig., No. 08-1943, 08-5743,
2010 U.S. Dist. LEXIS 124647 (D. Minn. Nov. 24, 2010).
187. Tietz v. Abbott Labs., Inc., No 12-L-002715 (jury verdict May 9, 2013).
188. Id.; see also James W. Huston, Ellen N. Adler & Joanna L. Simon, Client Alert:
Jury Buys Plaintiff’s Argument That Drug Manufacturer Should Have Distributed Dear
Doctor Letter Soon, Without Prior FDA Approval, MORRISON & FOERSTER LLP (May 15,
2013), available at http://www.mofo.com/files/Uploads/Images/130515-Dear-Doctor-
Letters.pdf [hereinafter Client Alert].
189. Robert Hoff, M.D., Senior Medical Director, Abbott Laboratories, to Healthcare
Providers (May 17, 2010), available at http://www.humirajustice.com/pdf/fda/11-Doctor_
191. See supra note 188, Client Alert.