Weiss v. American Academy of Ophthalmology, Inc.

District Court, N.D. California·Decided October 13, 2021·No. 3:20-cv-08124·Unknown

Opinion

JEFFREY N WEISS, Case No. 20-cv-08124-CRB

Plaintiff, ORDER GRANTING MOTION TO v. DISMISS

OPHTHALMOLOGY, INC., Defendant. Plaintiff Dr. Jeffrey Weiss, a Florida ophthalmologist, is suing Defendant American Academy of Ophthalmology, Inc. (“AAO”), a Minnesota not-for-profit corporation, of which he was formerly a member. Dr. Weiss alleges that AAO unlawfully investigated his conduct and terminated his membership. The Court granted AAO’s two prior motions to dismiss, holding that Dr. Weiss’s claims were not ripe because AAO’s Board of Trustees had not taken final action as to Dr. Weiss’ membership. Dr. Weiss’s second amended complaint alleges that AAO has now done so, and asserts violations of the Florida Deceptive and Unfair Trade Practices Act (“FDUTPA”) and California Business and Professions Code section 17200, as well as breach of contract and violation of the common-law right of fair procedure. AAO has moved to dismiss for failure to state a claim for which relief may be granted. Having concluded that oral argument is unnecessary, the Court grants AAO’s motion to dismiss. The Court denies Dr. Weiss leave to amend because amendment would be futile. A. Facts Dr. Weiss, a Florida resident, is an ophthalmologist and former member (“life fellow”) of the AAO. See Second Amend. Compl. (“SAC”) (dkt. 53) ¶ 3. AAO is a not- for-profit corporation organized under the laws of Minnesota. Id. ¶ 4. AAO’s governing documents include the Bylaws, which incorporate its Code of Ethics “to the same extent and with the same effect as though it were set forth verbatim.” Id. ¶ 7. Part B of the Code of Ethics sets forth mandatory “Rules of Ethics.” Id. ¶ 9; see Code of Ethics (dkt 53-2).1 Part C of the Code sets forth “Administrative Procedures” that govern how the AAO handles alleged violations of these Rules. Id. ¶ 14. The version of Rule 3 that was operative for all acts or omissions prior to 2020 stated: Research and innovation shall be approved by appropriate review mechanisms to protect patients from being subjected to or potentially affected by inappropriate, ill-considered, or fraudulent basic science or patient-oriented research. Basic science and clinical research are conducted to develop adequate information on which to base prognostic or therapeutic decisions or to determine etiology or pathogenesis, in circumstances in which insufficient information exists. Appropriate informed consent for research and innovative procedures must recognize their special nature and ramifications. In emerging areas of ophthalmic treatment where recognized guidelines do not exist, the ophthalmologist should exercise careful judgment and take appropriate precautions to safeguard patient welfare. SAC ¶ 10.2 Separately, federal law and Food and Drug Administration regulations require that programs funded by certain research grants be approved by Institutional Review Boards (IRBs), which “review biomedical and behavioral research involving human subjects.” 42 U.S.C. § 289; 45 C.F.R. §§ 46.101-46.124. At all times relevant here, Rule 13 has stated: Communications to the public must be accurate. They must not convey false, untrue, deceptive, or misleading information 1 The Court considers the Code of Ethics because the amended complaint incorporates the Code of Ethics by reference. See Khoja v. Orexigen Therapeutics, Inc., 899 F.3d 988, 998 (9th Cir. 2018). through statements, testimonials, photographs, graphics or other means. They must not omit material information without which the communications would be deceptive. Communications must not appeal to an individual’s anxiety in an excessive or unfair way; and they must not create unjustified expectations of results. If communications refer to benefits or other attributes of ophthalmic procedures that involve significant risks, realistic assessments of their safety and efficacy must also be included, as well as the availability of alternatives and, where necessary to avoid deception, descriptions and/or assessments of the benefits or other attributes of those alternatives. Communications must not misrepresent an ophthalmologist’s credentials, training, experience, or ability, and must not contain material claims of superiority that cannot be substantiated. If a communication results from payment by an ophthalmologist, this must be disclosed unless the nature, format or medium makes it apparent. SAC ¶ 13. When a violation of the Rules is alleged, the Ethics Committee investigates the member’s actions or omissions “objectively, without prejudgment, and in confidence.” Id. ¶¶ 14, 16; Code of Ethics (dkt. 53-2) § (C)(2)(c). The Committee determines whether the member “failed to observe the Rules of Ethics” and “recommend[s] an appropriate sanction to the Board of Trustees.” SAC ¶ 14; see Code of Ethics § (C)(4)(a)–(c). The Board of Trustees then decides whether the member failed to observe the Rules and may impose a sanction. SAC ¶ 14; Code of Ethics § (C)(4)(c), (e). A member may then appeal a finding of non-observance to the organization’s appellate body, which objectively reviews the facts found and the procedures followed. SAC ¶ 15; Code of Ethics § (C)(4)(f). The decision of the appellate body is binding on the Board of Trustees. Code of Ethics § (C)(4)(f). In 2013 and 2015, Dr. Weiss designed two studies investigating “whether the isolation of autologous bone marrow derived stem cells . . . and the transfer of those cells to the eyes” could improve the visual function of patients with retinal and optic nerve eye disease or damage. SAC ¶¶ 18, 19, 24; see Study Protocols (dkt. 53, ex. 3). These studies, the “SCOTS Trials,” were annually reviewed and approved by the International Cellular Medical Society’s IRB. SAC ¶¶ 19, 20. SCOTS Trials’ “IRB approval, participation fees, and monitoring and reporting adverse results, among other general issues.” Id. ¶ 24. After Dr. Weiss responded, on December 19, 2017, the Ethics Committee informed him that it wished to review his research to assess his compliance with the Rules of Ethics, including Rules 3 and 13. Id. ¶¶ 25–26. By the fall, the number of Dr. Weiss’ research participants dropped, and he went from performing 28 procedures per month to 5 procedures per month. Id. ¶ 27. Dr. Weiss alleges that the Committee’s investigation “became common knowledge in the medical community and even conveyed to Dr. Weiss’s patients,” in violation of its obligation to keep it confidential. Id. ¶ 28. Dr. Weiss alleges that Dr. Cherie Nau and Dr. Wendy Smith of the Mayo Clinic and Dr. Prem Subramanian of Johns Hopkins told patients and research participants “that the Academy was investigating Dr. Weiss’s stem cell research.” Id. He also states that “a number of [his] existing and prospective referral physicians, all members of Academy, improperly learned of the investigation, ceasing referrals.” Id. ¶ 29. On May 1, 2018, the Committee began a “formal Challenge” into Dr. Weiss’s compliance with the Code of Ethics. Id. ¶ 30. The Committee requested “raw data” and “data set analysis” relating to Dr. Weiss’ publications, but he did not prepare or provide the requested data set analysis because he “never had an obligation to do so.” Id. ¶ 31. Instead, he produced redacted medical charts for all of the study participants, which he contends contained the relevant data. Id. On October 22, 2020, the Ethics Committee gave Dr. Weiss notice that it would hold a virtual hearing on “Dr. Weiss’s alleged non-observance of Rules 3 and 13.” Id. ¶ 32. Dr. Weiss “did not attend the hearing” because he believed it “was meant to legitimize the Committee’s improper imposition of arbitrary standards to challenge” the SCOTS

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Weiss v. American Academy of Ophthalmology, Inc., (N.D. Cal. 2021).

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