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Ward v. Schaefer

United States District Court, D. Massachusetts

July 10, 2017

EDMUND EDWARD WARD, Plaintiff,
v.
ERNST J. SCHAEFER, M.D.; ROBERT D. SHAMBUREK, M.D.; and ALAN T. REMALEY, M.D., Defendants.

          MEMORANDUM AND ORDER ON DEFENDANTS SHAMBUREK AND REMALEY'S MOTION TO SUBSTITUTE THE UNITED STATES AS DEFENDANT

          F. Dennis Saylor IV United States District Judge

         This is 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.

         Ward 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.

         I. Background

         A. Factual Background

         The 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 as follows.

         Edmund 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.).

         Defendants 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).

         The 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. ¶¶ 59, 61).

         B. Procedural Background

         Ward 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 defendants.

         On 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.

         II. Legal Standard

         The 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. § ...


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