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Ward v. Shamburek

United States District Court, D. Massachusetts

November 16, 2017



          F. Dennis Saylor IV United States District Judge

         This is 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.

         Ward 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. § 2679(d).

         Defendant 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.

         I. Background

         A. Factual Background

         1. The Parties

         Edmund 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. (Id.).

         Ernst 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).

         Robert 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).

         2. ACP-501

         The 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).[1]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).

         3. The Proposal to Ward

         According 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).

         The 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, 46).[2] 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, 46-47).[3]

         AlphaCore 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. ¶ 22).

         In 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.” (Id.).

         As of 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).

         4. The Protocol

         At some 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. ¶ 36(f)).

         A draft 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).

         The 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)).

         It 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 ...

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