Dear Doctor Letters: Lessons in Statutory
Interpretation, Preemption, Proximate Causation,
and Subsequent-Remedial Measures
James W. Huston,*
Ellen Nudelman Adler** & Joanna L. Simon***
Dear Doctor letters (also referred to as Dear Healthcare Provider or
“DHCP” letters) are an important avenue of communication between
pharmaceutical manufacturers and the professionals who prescribe and
administer drugs. The letters were developed as a tool for manufacturers to
effectively provide healthcare professionals with key information about a
drug. But how are Dear Doctor letters used by drug manufacturers in
practice—to properly relay new black box warnings, or to (improperly)
advertise new drug uses? Where do Dear Doctor letters fit into the FDA’s
regulatory scheme—and is FDA approval required before sending out such
letters (we say yes)? What impact might a Dear Doctor letter have on
litigation? Could it be seen as an admission that the drug label was
This article first discusses the applicable FDA regulations and guidance
material, including the standards for when, how, and to whom Dear Doctor
letters should be issued. Next, the article reviews the extent to which
federal preemption principles apply to Dear Doctor letters as outlined by the
Supreme Court in the landmark generic case Pliva v. Mensing. The article
B. A., University of South Carolina, 1975; J.D., University of Virginia School of Law,
1984. Mr. Huston is a partner in the San Diego office of Morrison & Foerster LLP, and is
chair of the firm’s Trial Practice Group. Mr. Huston’s practice focuses on product liability
matters, contract disputes, and appeals.
** B. A., University of Texas Law School, 2001; J.D., Stanford Law School, 2004; Clerk to
the Hon. Michael Daly Hawkins, Ninth Circuit Court of Appeals. Ms. Adler is an associate
in the San Diego office of Morrison & Foerster LLP. Ms. Adler’s practice focuses on
product liability and complex commercial litigation, with an emphasis on aviation and
*** B. A., Northeastern University, 2007; J.D. University of San Diego School of Law, 2010.
Ms. Simon is an associate in the San Diego office of Morrison & Foerster LLP.
Ms. Simon’s practice involves product liability and complex commercial litigation, with an
emphasis on aviation and pharmaceutical defense.