United States District Court, D. Massachusetts
MEMORANDUM AND ORDER ON DEFENDANTS' MOTION TO
Dennis Saylor, United States District Judge.
an 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 further
contends 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 the doctors involved in his treatment,
including Dr. Ernst Schaefer, Dr. Robert Shamburek, and Dr.
Alan Remaley. The United States has been substituted as
defendant as to certain claims against Dr. Shamburek and Dr.
Remaley pursuant to the Westfall Act, 28 U.S.C. §
United States and Drs. Shamburek and Remaley (collectively,
the “government defendants”) have moved to
dismiss the complaint for lack of subject-matter jurisdiction
pursuant to Fed.R.Civ.P. 12(b)(1) and for failure to state a
claim under Fed.R.Civ.P. 12(b)(6). For the foregoing reasons,
the motion will be granted.
Edward Ward is a Massachusetts resident and a lawyer. (Compl.
¶ 1; 2d Auerbach Aff Ex. A at 498). Ward was born with
an extremely rare genetic deficiency of a bloodstream enzyme,
called lecithin-cholesterol acyltransferase
(“LCAT”). (Id. ¶ 9). LCAT is
associated with high-density lipoprotein cholesterol
(“HDL-C”), often referred to as the “good
cholesterol.” (Id. ¶ 11). As a result of
his deficiency, referred to as “familial LCAT
deficiency” or “FLD, ” Ward produces
virtually no cholesterol. (Id. ¶ 9). Ward 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.
Schaefer, M.D., is a Massachusetts resident. He is a
physician at the Tufts University School of Medicine and
Boston Heart Diagnostics. (Id. ¶ 3). Dr.
Schaefer is one of Ward's regular treating physicians.
(Id. ¶ 18).
Shamburek, M.D., and Alan Remaley, M.D., are physicians
employed by the United States Department of Health and Human
Services, National Institutes of Health (“NIH”),
in Bethesda, Maryland. (Id. ¶ 4).
claims of the patent for ACP-501 involve “a method for
decreasing accumulation of cholesterol in arteries in a human
subject not suffering from . . . LCAT . . . deficiency
syndrome.” (Id. ¶ 14). In 2011, Dr.
Schaefer and several other physicians published a paper in
the Journal of Clinical Lipidology about LCAT deficiency. (2d
Auerbach Aff. Ex. A at 498).The paper concluded that
“[i]n the future, the use of recombinant LCAT may be of
value in patients who develop significant renal
2012, in collaboration with the NIH, AlphaCore (the company
that originally produced the drug) conducted a clinical trial
of ACP-501 to determine the safety and tolerability of a
single injection of the drug in 16 to 18 patients with stable
coronary artery disease. (Compl. ¶ 15). Dr. Shamburek
and Dr. Remaley collaborated with Bruce Auerbach, an officer
at AlphaCore, in running the trial, and reported that a
single injection of ACP-501 was safe and tolerated by the
subjects. (Id. ¶ 16).
The Proposal to Ward
to the complaint, sometime in 2012, Ward was introduced to
Dr. Shamburek, Dr. Remaley, and Auerbach by his treating
physician, Dr. Schaefer, as a potential “ideal research
subject for ACP-501.” (Id. ¶ 18).
complaint alleges that the four individuals induced Ward to
participate as the only subject in a long-term trial of
ACP-501 by misrepresenting that the drug would reverse his
advanced kidney disease. (Id. ¶¶ 22,
According to the complaint, they withheld their true
motivation for the study, which was to test the effect of
ACP-501 on the production of HDL-C in an LCAT-deficient
patient, “hoping the drug would be considered a
potential breakthrough in the prevention of cardiovascular
disease, ” as well as to acquire long-term safety data,
in order to accelerate the sale of AlphaCore to MedImmune,
LLC, an affiliate of AstraZeneca Biopharmaceuticals, Inc., a
large pharmaceutical company. (Id. ¶¶ 23,
was granted an “orphan drug” designation for
ACP-501 and a “compassionate use” protocol was
approved. (Id. ¶ 20). AlphaCore donated to the
NIH the ACP-501 needed for the trial. (Id. ¶
January 2013, Ward travelled from Massachusetts to the NIH in
Maryland to begin treatment. (Id. ¶ 27). At the
outset of the trial, Auerbach met with Ward and allegedly
told him that the process of using ACP-501 to reverse his
kidney failure would take a long time, and that he should
remain in the trial for the full ...