United States District Court, D. Massachusetts
MEMORANDUM AND ORDER ON DEFENDANT'S MOTIONS TO
TRANSFER AND COMPEL AND PLAINTIFF'S MOTIONS TO AMEND AND
Dennis Saylor IV 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. §
Schaefer has moved to transfer the claims against him to a
Massachusetts medical malpractice tribunal and to compel
plaintiff to make an offer of proof in connection with that
tribunal. Plaintiff has moved to amend the complaint and to
have his deposition taken in light of his medical condition.
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
impairment.” In 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 course of treatment because
he would “get out of it what [he puts] into it.”
the beginning of 2013, Ward “was considered by his
physicians to be in kidney failure, ” and he was about
to receive regular dialysis. (Id. ¶ 21). Ward
postponed dialysis in order to participate in the trial.
(Id. ¶¶ 21, 41).
point (the complaint does not specify when), the NIH created
a clinical protocol for Ward's treatment. The protocol
was titled “Expanded access use of intravenous ACP-501
in one subject with Familial lecithin:cholesterol
acyltransferase [rhLCAT] Deficiency.” (Id.
¶ 36). It appears that AlphaCore and Auerbach played
some role in the creation of the protocol, although the
details of their roles are unclear. (See Pl. Ex. G).
Under the protocol, Dr. Shamburek was the principal
investigator, Dr. Remaley was the safety-review investigator,
and Dr. Schaefer was the medical monitor. (Id.
of the protocol provided for two study sites: one at the NIH
facility in Maryland, and another in Massachusetts where Ward
would be treated by his regular physician, Dr. Schaefer. (Pl.
Ex. E at 23). Under that draft of the protocol, Ward would
receive an initial phase of treatment at NIH in Maryland;
later, during the second phase, he would receive treatments
every few weeks in Massachusetts with additional treatments
at NIH every few months. (Id. at 26-27).
parties dispute whether that draft became the final operative
protocol or whether a later draft, which provided for only
one test site in Maryland, was in fact the final approved
protocol. (See 2d Auerbach Aff. Ex. B at 21; Pl.
Surreply at 6-7). It is undisputed that the protocol,
whichever version was adopted, did call for Dr. Schaefer to
monitor Ward while he was home in Massachusetts. (2d Auerbach
Aff. Ex. B at 21 (stating that Dr. Schaefer would
“monitor and treat [Ward's] renal dysfunction and
other disorders associated with his FLD” while in
Massachusetts); Pl Ex. E at 21 (stating that Dr. Schaefer
would monitor Ward)).
appears that in June and July 2013 there was some discussion
between Dr. Schaefer and Dr. Remaley concerning the
possibility of having ACP-501 sent to Massachusetts so that
Ward could be treated there. (Pl. Ex. H). However, it does