Ward v. Schaefer

91 F.4th 538

Virginia Cora WARD, as the administratrix of the estate ofEdmund Edward Ward, Plaintiff, Appellant, v. Ernst J. SCHAEFER, MD, Defendant, Appellee.

No. 22-1547

United States Court of Appeals, First Circuit

January 29, 2024

APPEAL FROM THE UNITED STATES DISTRICT COURT FOR THE DISTRICT OF MASSACHUSETTS [Hon. F. Dennis Saylor, IV, U.S. District Judge]

Timothy Cornell, with whom Cornell Dolan, P.C. was on brief, for appellant.

Tory A. Weigand, with whom Morrison Mahoney, LLP was on brief, for appellee.

Before Rikelman, Selya, and Howard, Circuit Judges.

SELYA, Circuit Judge.

Although this appeal arises out of an experimental protocol undertaken at a site famed for the development of new cures and treatments, the appeal itself hinges on familiar fare: the persuasiveness vel non of the appellant's claims of trial error. After careful consideration of a scumbled record, we conclude that the appellant's claims of error lack force. Accordingly, we affirm the judgment below as to the remaining appellee.¹

I

We briefly rehearse the relevant facts and travel of the case. We take the facts in the light most congenial to the verdict, consistent with record support. See United States v. Kilmartin, 944 F.3d 315, 323 (1st Cir. 2019).

Edmund Edward Ward was born with a rare genetic deficiency that caused his body to refrain from producing a blood enzyme called lecithin-cholesterol acyltransferase (LCAT), which is critical to cholesterol production. The disease process resulting from this enzyme deficiency — familial LCAT deficiency (FLD) — may cause kidney failure, which requires either regular dialysis or kidney transplantation. The doctor who initially treated Ward for his kidney damage believed that he had LCAT deficiency and referred him to a specialist practice. After consulting several physicians about his condition, Ward met Dr. Ernst J. Schaefer (who is the appellee here). Dr. Schaefer confirmed a diagnosis of FLD and developed a creative approach to Ward's medical care.

Bereft of any good treatment options, Dr. Schaefer enlisted the National Institutes of Health (NIH) and AlphaCore Pharma, LLC (ACP) to see if Ward might be a candidate for experimental enzyme therapy. Ward's condition at the time was deteriorating, and the prospect of dialysis loomed. Although Ward alleges that he was promised a potential cure, Dr. Schaefer insists that Ward was warned about the "unchart[ed] territory" that they would be exploring. If successful, the upshot would be delaying dialysis, not a cure.

An NIH researcher, Dr. Robert Shamburek, and ACP employees proceeded to write an expanded access protocol for ACP's recombinant enzyme known as ACP-501.² Dr. Schaefer testified that he was not involved in drafting the ACP-501 protocol, but he did lobby for approval of the protocol's expanded access use (which the United States Food and Drug Administration ultimately granted).

Dr. Shamburek testified that — before commencing the ACP-501 protocol — he twice reviewed with Ward (himself a lawyer) the detailed consent form that had been written specifically for this protocol. He also testified that he advised Ward to discuss the consent form with family and other doctors before signing it. The signed consent form was admitted into evidence at the trial. Ward testified, though, that he did not recognize the form, did not recall discussing it with Dr. Shamburek, and did not remember signing it.

Nevertheless, it is undisputed that Ward traveled periodically from his home in Massachusetts to the NIH facility in Bethesda, Maryland, so that he could receive infusions of the recombinant enzyme. And Dr. Schaefer continued to monitor Ward in Massachusetts.

The experiment produced underwhelming results: the drug failed to ameliorate Ward's condition, and his suffering allegedly worsened because he was compelled to delay more effective dialysis treatments. Thus, Ward began regular dialysis, departed from the ACP-501 protocol, and concluded that the only conceivable outcome was prolonged pain and suffering. With the protocol consigned to the scrap heap, Ward repaired to the courts. He sued Dr. Schaefer; Dr. Shamburek; Dr. Alan Remaley (an NIH physician who had worked closely with Dr. Shamburek); ACP and one of its principals, Dr. Bruce Auerbach; MedImmune, LLC (MedImmune), which had acquired ACP; and AstraZeneca Biopharmaceuticals, Inc. (AstraZeneca), MedImmune's parent, in a Massachusetts state court. Drs. Shamburek and Remaley removed the suit to the United States District Court for the District of Massachusetts. See 28 U.S.C. § 2679(d)(2). The United States later was substituted for Drs. Shamburek and Remaley as to certain claims. See id. The district court, in separate orders, dismissed the claims against ACP and Dr. Auerbach; the United States; and MedImmune and AstraZeneca. See Ward v. Schaefer, No. 16-12543, 2018 WL 1096829 (D. Mass. Feb. 27, 2018) (dismissing claims against Drs. Remaley and Shamburek and United States); Ward v. Auerbach, No. 16-12543, 2017 WL 2724938 (D. Mass. June 23, 2017) (dismissing claims against Dr. Auerbach and pharmaceutical companies).

The claims of fraud and failure to obtain informed consent against Dr. Schaefer went to trial. Ward's theory was that Dr. Schaefer fraudulently induced him to participate in the ACP-501 protocol and otherwise failed to obtain informed consent for his participation in the protocol. The jury disagreed and returned a take-nothing verdict in favor of Dr. Schaefer on all claims. The district court denied Ward's motion for a new trial in a text order.

This timely appeal ensued. Ward died during its pendency, and Virginia Cora Ward, his sister and the administratrix of his estate, was substituted in his place and stead. See Fed. R. App. P. 43(a). We refer to her throughout as the appellant.

II

Before us, the appellant argues that Drs. Remaley and Shamburek represented that Ward's kidney function was improving materially while he was taking the drug, even though the data were ambiguous at best and he had switched to a lower dose of the drug due to a supply shortage. She also argues that Ward's nephrologist advised him that proceeding without dialysis was no longer medically acceptable.

The appellant's assignments of error, though, do not hinge on the substance of these arguments. Instead, her flagship contention as to the evidence is that the district court erred in excluding the ACP-501 patent.

We review a preserved objection to the district court's admission or exclusion of evidence for abuse of discretion. See Kilmartin, 944 F.3d at 335. A discretionary decision, however, "cannot be set aside by a reviewing court unless it has a definite and firm conviction that the court below committed a clear error of judgment in the conclusion it reached upon a weighing of the relevant factors." Schubert v. Nissan Motor Corp., 148 F.3d 25, 30 (1st Cir. 1998) (quoting In re Josephson, 218 F.2d 174, 182 (1st Cir. 1954)). We add, moreover, that abuse of discretion is not a monolithic standard. See United States v. Padilla-Galarza, 990 F.3d 60, 73 (1st Cir. 2021). It "encompasses 'de novo review of abstract questions of law, clear error review of findings of fact, and deferential review of judgment calls.' " Id. (quoting United States v. Lewis, 517 F.3d 20, 24 (1st Cir. 2008)).

The district court refused to allow the introduction of the ACP-501 patent, concluding that the patent was inadmissible because it had been offered without any foundation and, in all events, had "nothing . . . to do with the medical issues" before the jury. The appellant contends that this ruling constituted an abuse of discretion because "the development, effects, and properties of [ACP-501] were the central issues in the trial." Inasmuch as claim one of the patent describes "a method for decreasing the amount of cholesterol in arteries of a human subject not suffering from [LCAT deficiency]," the appellant urges that the patent makes pellucid that the drug was not formulated to treat Ward's condition or the resulting kidney damage. She further urges that administering the drug to Ward was especially inappropriate considering that none of his doctors had bothered to review the patent.

Dr. Schaefer offers a number of responses. First, he submits that Ward neither made an offer of proof nor provided any evidentiary basis for introducing the patent at trial. Second, he submits that the patent is of no relevance to claims of fraud and failure to obtain informed consent.

We start with the patent's relevance and with the application of Federal Rule of Evidence 403. Dr. Schaefer contends that the appellant's arguments for admissibility are meritless because the patent was offered without foundation and "any possible tangential relevancy was minimal and substantially outweighed by the . . . risk of confusion [due to] technical complexity." In our view, an analysis under Rule 403 disposes of the matter.³ Accordingly, it would be superfluous to consider Dr. Schaefer's other arguments regarding the admission of this evidence.

Under Rule 403, a "court may exclude relevant evidence if its probative value is substantially outweighed by a danger of . . . unfair prejudice, confusing the issues, misleading the jury, undue delay, wasting time, or needlessly presenting cumulative evidence." Fed. R. Evid. 403; see United States v. Leoner-Aguirre, 939 F.3d 310, 321 (1st Cir. 2019) ("A district court may exclude evidence when its probative value is substantially outweighed by the danger of unfair prejudice."). Applying this standard, we agree with the district court that the probative value of the patent is difficult to fathom. The requirements for obtaining patent protection are demanding, see 35 U.S.C. §§ 101-103 (requiring, inter alia, that invention be useful, novel, and non-obvious for patent protection), but completely different from the medical issues here, such as the efficacy and risks of a drug. What was distinct about ACP-501 for patent...