Weiss v. American Academy of Ophthalmology, Inc.

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

Opinion

1 2 3 4 7 8 JEFFREY N WEISS, Case No. 20-cv-08124-CRB

9 Plaintiff, ORDER GRANTING MOTION TO 10 v. DISMISS

OPHTHALMOLOGY, INC., 12 Defendant. 13 14 Plaintiff Dr. Jeffrey Weiss, a Florida ophthalmologist, is suing Defendant American 15 Academy of Ophthalmology, Inc. (“AAO”), a Minnesota not-for-profit corporation, of 16 which he was formerly a member. Dr. Weiss alleges that AAO unlawfully investigated his 17 conduct and terminated his membership. 18 The Court granted AAO’s two prior motions to dismiss, holding that Dr. Weiss’s 19 claims were not ripe because AAO’s Board of Trustees had not taken final action as to Dr. 20 Weiss’ membership. Dr. Weiss’s second amended complaint alleges that AAO has now 21 done so, and asserts violations of the Florida Deceptive and Unfair Trade Practices Act 22 (“FDUTPA”) and California Business and Professions Code section 17200, as well as 23 breach of contract and violation of the common-law right of fair procedure. AAO has 24 moved to dismiss for failure to state a claim for which relief may be granted. Having 25 concluded that oral argument is unnecessary, the Court grants AAO’s motion to dismiss. 26 The Court denies Dr. Weiss leave to amend because amendment would be futile. 27 2 A. Facts 3 Dr. Weiss, a Florida resident, is an ophthalmologist and former member (“life 4 fellow”) of the AAO. See Second Amend. Compl. (“SAC”) (dkt. 53) ¶ 3. AAO is a not- 5 for-profit corporation organized under the laws of Minnesota. Id. ¶ 4. 6 AAO’s governing documents include the Bylaws, which incorporate its Code of 7 Ethics “to the same extent and with the same effect as though it were set forth verbatim.” 8 Id. ¶ 7. Part B of the Code of Ethics sets forth mandatory “Rules of Ethics.” Id. ¶ 9; see 9 Code of Ethics (dkt 53-2).1 Part C of the Code sets forth “Administrative Procedures” that 10 govern how the AAO handles alleged violations of these Rules. Id. ¶ 14. 11 The version of Rule 3 that was operative for all acts or omissions prior to 2020 12 stated: Research and innovation shall be approved by appropriate 13 review mechanisms to protect patients from being subjected to or potentially affected by inappropriate, ill-considered, or 14 fraudulent basic science or patient-oriented research. Basic science and clinical research are conducted to develop 15 adequate information on which to base prognostic or therapeutic decisions or to determine etiology or pathogenesis, 16 in circumstances in which insufficient information exists. Appropriate informed consent for research and innovative 17 procedures must recognize their special nature and ramifications. In emerging areas of ophthalmic treatment 18 where recognized guidelines do not exist, the ophthalmologist should exercise careful judgment and take appropriate 19 precautions to safeguard patient welfare. 20 SAC ¶ 10.2 Separately, federal law and Food and Drug Administration regulations require 21 that programs funded by certain research grants be approved by Institutional Review 22 Boards (IRBs), which “review biomedical and behavioral research involving human 23 subjects.” 42 U.S.C. § 289; 45 C.F.R. §§ 46.101-46.124. 24 At all times relevant here, Rule 13 has stated: Communications to the public must be accurate. They must 25 not convey false, untrue, deceptive, or misleading information 26 1 The Court considers the Code of Ethics because the amended complaint incorporates the Code of 27 Ethics by reference. See Khoja v. Orexigen Therapeutics, Inc., 899 F.3d 988, 998 (9th Cir. 2018). through statements, testimonials, photographs, graphics or 1 other means. They must not omit material information without which the communications would be deceptive. 2 Communications must not appeal to an individual’s anxiety in an excessive or unfair way; and they must not create 3 unjustified expectations of results. If communications refer to benefits or other attributes of ophthalmic procedures that 4 involve significant risks, realistic assessments of their safety and efficacy must also be included, as well as the availability 5 of alternatives and, where necessary to avoid deception, descriptions and/or assessments of the benefits or other 6 attributes of those alternatives. Communications must not misrepresent an ophthalmologist’s credentials, training, 7 experience, or ability, and must not contain material claims of superiority that cannot be substantiated. If a communication 8 results from payment by an ophthalmologist, this must be disclosed unless the nature, format or medium makes it 9 apparent. 10 SAC ¶ 13. 11 When a violation of the Rules is alleged, the Ethics Committee investigates the 12 member’s actions or omissions “objectively, without prejudgment, and in confidence.” Id. 13 ¶¶ 14, 16; Code of Ethics (dkt. 53-2) § (C)(2)(c). The Committee determines whether the 14 member “failed to observe the Rules of Ethics” and “recommend[s] an appropriate 15 sanction to the Board of Trustees.” SAC ¶ 14; see Code of Ethics § (C)(4)(a)–(c). The 16 Board of Trustees then decides whether the member failed to observe the Rules and may 17 impose a sanction. SAC ¶ 14; Code of Ethics § (C)(4)(c), (e). A member may then appeal 18 a finding of non-observance to the organization’s appellate body, which objectively 19 reviews the facts found and the procedures followed. SAC ¶ 15; Code of Ethics 20 § (C)(4)(f). The decision of the appellate body is binding on the Board of Trustees. Code 21 of Ethics § (C)(4)(f). 22 In 2013 and 2015, Dr. Weiss designed two studies investigating “whether the 23 isolation of autologous bone marrow derived stem cells . . . and the transfer of those cells 24 to the eyes” could improve the visual function of patients with retinal and optic nerve eye 25 disease or damage. SAC ¶¶ 18, 19, 24; see Study Protocols (dkt. 53, ex. 3). These studies, 26 the “SCOTS Trials,” were annually reviewed and approved by the International Cellular 27 Medical Society’s IRB. SAC ¶¶ 19, 20. 1 SCOTS Trials’ “IRB approval, participation fees, and monitoring and reporting adverse 2 results, among other general issues.” Id. ¶ 24. After Dr. Weiss responded, on December 3 19, 2017, the Ethics Committee informed him that it wished to review his research to 4 assess his compliance with the Rules of Ethics, including Rules 3 and 13. Id. ¶¶ 25–26. 5 By the fall, the number of Dr. Weiss’ research participants dropped, and he went from 6 performing 28 procedures per month to 5 procedures per month. Id. ¶ 27. 7 Dr. Weiss alleges that the Committee’s investigation “became common knowledge 8 in the medical community and even conveyed to Dr. Weiss’s patients,” in violation of its 9 obligation to keep it confidential. Id. ¶ 28. Dr. Weiss alleges that Dr. Cherie Nau and Dr. 10 Wendy Smith of the Mayo Clinic and Dr. Prem Subramanian of Johns Hopkins told 11 patients and research participants “that the Academy was investigating Dr. Weiss’s stem 12 cell research.” Id. He also states that “a number of [his] existing and prospective referral 13 physicians, all members of Academy, improperly learned of the investigation, ceasing 14 referrals.” Id. ¶ 29. 15 On May 1, 2018, the Committee began a “formal Challenge” into Dr. Weiss’s 16 compliance with the Code of Ethics. Id. ¶ 30. The Committee requested “raw data” and 17 “data set analysis” relating to Dr. Weiss’ publications, but he did not prepare or provide 18 the requested data set analysis because he “never had an obligation to do so.” Id. ¶ 31. 19 Instead, he produced redacted medical charts for all of the study participants, which he 20 contends contained the relevant data. Id. 21 On October 22, 2020, the Ethics Committee gave Dr.

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