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Ward v. Auerbach

United States District Court, D. Massachusetts

June 23, 2017



          F. Dennis Saylor IV United States District Judge.

         This is a tort 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 the company that originally produced the drug (AlphaCore Pharma, LLC), as well as one of its officers (Bruce Auerbach); the company that later purchased AlphaCore (Medimmune, LLC); a related company (AstraZeneca Biopharmaceuticals, Inc.); and the doctors involved in his treatment (Ernst Schaefer, Robert Shamburek, and Alan Remaley).[1]

         Defendants MedImmune, LLC and AstraZeneca Biopharmaceuticals, Inc., have moved to dismiss the claims against them for the failure to state a claim upon which relief can be granted. Defendants AlphaCore Pharma, LLC and Auerbach have moved to dismiss the claims against them for lack of personal jurisdiction. For the reasons stated below, both motions will be granted.

         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.).

         Bruce Auerbach is a Michigan resident. He is an officer and principal of defendant AlphaCore Pharma, LLC (“AlphaCore”), a limited liability company based in Ann Arbor, Michigan. (Id. ¶ 2). As of 2012, AlphaCore was the sole patent licensee of a form of recombinant human LCAT (“rhLCAT”) called ACP-501. (Id. ¶ 13). The relevant patent, concerning the “Use of Lecithin-Cholesterol Acytransferase [sic] LCAT) to Reduce Accumulation of Cholesterol, ” is owned by the United States. (Id. ¶ 14).

         Defendant Ernst Schaefer 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).

         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).

         Defendant AstraZeneca Biopharmaceuticals, Inc. (“AstraZeneca”) is a corporation with a usual place of business in Delaware. (Id. ¶ 7). MedImmune, LLC is a limited liability company and a subsidiary of AstraZeneca. (Id.).

         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).[2]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 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). Defendants Shamburek and Remaley collaborated with Auerbach 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 Shamburek, 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 individual defendants 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). According to the complaint, the individual defendants 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 a large pharmaceutical company. (Id. ¶¶ 23, 46-47).

         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 phase two, 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 not appear that any ACP-501 treatments took place in Massachusetts.

         5. The Trial

         Ward was admitted to the NIH facility in Maryland on January 6, 2013. (Id. ¶ 28). According to the complaint, Ward did not receive and sign the NIH's Consent to Participate in a Clinical Research Study until January 24, after he had already been subjected to several days of study. (Id. ¶ 29). The complaint further alleges that the consent form was inadequate, because it failed to fully disclose defendants' financial interests in ACP-501. (Id. ¶ 35).

         The regimen which Ward underwent was “painful, grueling, and confining.” (Id. ¶ 28). For example, from January 24 to February 27, 2013, Ward remained in one NIH hospital room for 24 hours a day. (Id.). He had two intravenous lines continuously inserted, one to administer ACP-501 for one hour in the morning, and the other to draw blood as many as 32 times per day. (Id.). From February 27 to June 28, Ward travelled from Massachusetts to Maryland every Tuesday. At NIH, he would check into a hospital room, and Dr. Shamburek would administer ACP-501 on Wednesday morning and then draw his blood six times on Wednesday and another six times on Thursday. (Id. ¶ 38).

         According to the complaint, Drs. Shamburek and Remaley both told Ward that the ACP-501 was materially improving his kidney function, even though the data as to the drug's effects was at best ambiguous. (Id. ¶¶ 39-40). Throughout the trial, at the counseling of Drs. Shamburek and Remaley, Ward did not receive dialysis. (Id. ¶ 41).

         In April or May 2013, Ward's nephrologist, Dr. Valerie Price, told him that he could no longer go without dialysis. (Id. ¶ 50). Nonetheless, he continued with the regimen.

         In June 2013, the supply of ACP-501 at NIH was running low. (Id. ¶ 52). Drs. Shamburek and Remaley convinced Ward to continue the trial at a lower dose. (Id.). That lower dose caused Ward's HDL-C to plummet. (Id. ¶ 53). He expressed a desire to drop out of the trial if he could not continue to receive the higher dose. (Id.). According to the complaint, Drs. Shamburek and Remaley induced him to remain in the trial with false promises of a new shipment of ACP-501, meaning a return to the higher dose, and reversing his kidney disease. (Id. ¶¶ 54, 56).

         From July to September 2013, Ward again travelled from Massachusetts to Maryland every Tuesday for treatment with the lower dose of ACP-501. (Id. ¶ 58). According to the complaint, his kidney function deteriorated on the lower dose. (Id. ¶ 59). In September, at the urging of Drs. Price and Schaefer, Ward decided to withdraw from the trial in order to receive needed dialysis. (Id. ¶¶ 59, 61). The complaint alleges that Dr. Shamburek then tried to convince Ward to remain in the trial by telling him he had “interesting new information” and that the lower dose was working to improve kidney function. (Id. ¶ 60). In October, Dr. Shamburek allegedly called Ward and told him that he could not “just leave the program” and that he had to “come back to the NIH.” (Id. ¶ 61). According to the complaint, in early fall 2013, Ward “learned that the only effect of the ACP-501 experimentation on his kidney condition was to delay, for many months, critical dialysis treatment.” (Id. ¶ 41).

         It appears that AlphaCore reimbursed Ward for his travels to and from Maryland, as well as for any lab work conducted in Massachusetts in connection with the trial. (Pl. Ex. D).

         6. The Sale of AlphaCore

         In April 2013, during the course of the trial, MedImmune purchased AlphaCore for $20, 000, 000. (Id. ¶ 43). According to the complaint, the sale was “based” principally on . . . Ward's HDL-C results.” (Id.). It further alleges that Ward was not made aware of sale until 2014, almost a year after he had withdrawn from the trial. (Id. ¶ 43, 49).

         The complaint alleges that the individual defendants, “acting in concert, ” were AlphaCore shareholders, owned AlphaCore options or warrants, or “otherwise benefitted materially from the sale of [AlphaCore] to [AstraZeneca] in secret.” (Id. ¶ 45).

         7. Allegations as to MedImmune and Astra Zeneca

         The allegations of the complaint as to the involvement of MedImmune ...

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