United States District Court, D. Massachusetts
MEMORANDUM AND ORDER ON DEFENDANTS SHAMBUREK AND
REMALEY'S MOTION TO SUBSTITUTE THE UNITED STATES AS
Dennis Saylor IV United States District Judge
a tort and Bivens action arising out of the use of a
drug in a compassionate-use protocol. Plaintiff Edmund Edward
Ward suffers from a rare genetic deficiency that has resulted
in, among other things, severe kidney disease. He alleges
that he was fraudulently induced to participate in what he
contends was a non-therapeutic, experimental drug trial. He
alleges that he was led to believe that the drug, ACP-501,
would reverse his kidney disease, but that defendants'
true purpose in treating him was to gain data that would be
beneficial in selling the company that produced the drug.
has filed suit against two physicians with the National
Institutes of Health, Dr. Robert Shamburek and Dr. Alan
Remaley, who were involved in the treatment protocol.
Shamburek and Remaley have moved to dismiss the claims
against them and substitute the United States as defendant
pursuant to the Westfall Act, 28 U.S.C. § 2679(d). For
the reasons stated below, that motion will be granted in part
and denied in part.
facts, as alleged in the complaint, are set out fully in the
Court's prior Memorandum and Order on Defendants'
Motions to Dismiss for Failure to State a Claim and for Lack
of Personal Jurisdiction. As is relevant here, the facts are
Edward Ward was born with an extremely rare genetic
deficiency of a bloodstream enzyme, called
lecithin-cholesterol acyltransferase (“LCAT”).
(Compl. ¶ 9). As a result of his deficiency, referred to
as “familial LCAT deficiency” or “FLD,
” Ward produces virtually no cholesterol. (Id.
¶ 9). He also suffers from other associated health
conditions, including kidney disease. (Id.). He is
in stage 5 kidney failure, and receives dialysis treatment
three times a week. (Id.).
Robert Shamburek and Alan Remaley are physicians employed by
the United States Department of Health and Human Services,
National Institutes of Health (“NIH”), in
Bethesda, Maryland. (Id. ¶ 4).
complaint alleges that defendants induced Ward to participate
as the only subject in an experimental trial of a drug,
ACP-501. (Id. ¶¶ 22). According to the
complaint, defendants misrepresented to Ward that the drug
would reverse his advanced kidney disease, while hiding their
true motivations of establishing the drug's safety and
efficacy in increasing the production of high-density
lipoprotein cholesterol (“HDL-C”)-the so-called
“good cholesterol”-in order to facilitate the
sale of the drug to a large pharmaceutical company, from
which the defendants allegedly stood to benefit financially.
(Id. ¶¶ 11, 22, 23, 45-47). The complaint
alleges that Ward's kidney function ultimately
deteriorated, and that he withdrew from the trial at the
advice of his treating physician. (Id. ¶¶
filed the complaint in this action in July 2016, in
Massachusetts state court. The complaint alleges claims for
fraud (Count One); lack of informed consent (Count Two);
unjust enrichment (Count Three); violations of the Due
Process Clause of the United States Constitution, the
Massachusetts Declaration of Rights, and the Nuremberg Code
(Count Four); violation of the Massachusetts Civil Rights Act
(Count Five); and civil conspiracy (Count Six) against all
December 16, 2016, defendants Shamburek and Remaley removed
the action to this Court pursuant to the Westfall Act, 28
U.S.C. § 2679(d)(2). On February 23, 2017, Shamburek and
Remaley moved, again pursuant to the Westfall Act, to
substitute the United States as the proper defendant. For the
reasons stated below, that motion will be granted in part and
denied in part.
Westfall Act provides that the remedy against the United
States under the Federal Tort Claims Act (“FTCA”)
“for injury . . . arising or resulting from the
negligent or wrongful act or omission of any employee of the
Government while acting within the scope of his office or
employment is exclusive of any other civil action or
proceeding for money damages by reason of the same subject
matter against the employee whose act or omission gave rise
to the claim . . . .” 28 U.S.C. § ...