Opinion ID: 856123
Heading Depth: 2
Heading Rank: 2

Heading: california protection of human subjects in

Text: MEDICAL EXPERIMENTATION ACT (“HUMAN SUBJECTS ACT”) CLAIM The California legislature enacted the Human Subjects Act “to provide minimum statutory protection for the citizens of [the] state with regard to human experimentation and to provide penalties for those who violate such provisions.” Cal. Health & Saf. Code § 24171. The Act lays out detailed guidelines for informed consent, which is required before a person can be “subjected to any medical experiment.” Id. § 24175(a); see id. § 24173. For purposes of the informed consent provisions, “medical experiment” is defined as follows: (a) The severance or penetration or damaging of tissues of a human subject or the use of a drug or device, as defined in Section 109920 or 109925, electromagnetic radiation, heat or cold, or a biological substance or organism, in or upon a human subject in the practice or research of medicine in a manner not reasonably related to maintaining or improving the health of the subject or otherwise directly benefiting the subject. (b) The investigational use of a drug or device as provided in Sections 111590 and 111595. (c) Withholding medical treatment from a human subject for any purpose other than PEREZ V . NIDEK CO ., LTD . 11 maintenance or improvement of the health of the subject. Id. § 24174. Perez’s claims do not fit the definition of “medical experiment” under either provision at issue here—§ 24174(a) or § 24174(b).
As to § 24174(a), there is no dispute that the laser eye surgeries involved the use of a device upon a human subject. Where the parties disagree is whether the surgeries were performed “in the practice . . . of medicine in a manner not reasonably related to maintaining or improving the health of the subject or otherwise directly benefiting the subject.”3 Only one published California case has addressed the interpretation of “medical experiment” under § 24174(a). Trantafello v. Medical Center of Tarzana, 182 Cal. App. 3d 315, 320 n.2 (Cal. Ct. App. 1986). In Trantafello, an orthopedic surgeon implanted a piece of acrylic in Trantafello’s neck to fill the space once occupied by a removed cervical disk. Id. at 318. The surgeon did not advise Trantafello that he planned to use an acrylic implant or that this was an innovative procedure not generally accepted in the United States. Id. at 319. In holding that the patient could not rely on the Human Subjects Act to extend the statute of limitations for his medical malpractice claim, the court stated in a footnote that the Act was “irrelevant” to 3 W ith regard to this and other claims, Nidek raises defenses that are unique to its corporate entities. Because we hold that Perez’s claims fail on grounds common to all of the defendants, we do not address Nidek’s other arguments. 12 PEREZ V . NIDEK CO ., LTD . Trantafello’s claim because the Act “deals with experiments on human subjects in the course of pure research. . . . Here [the doctor] used the acrylic implant not in the course of a medical research program but in a course of therapeutic treatment for plaintiff.” Id. at 320 n.2 (emphasis added). Perez quibbles with Trantafello’s restriction of the Act to experiments done in the course of pure research. According to Perez, “the fact that a procedure is meant to impart some benefit to a patient does not mean that it cannot also constitute a ‘medical experiment’ under the Act.” Without deciding whether there is any more play in the joints of § 24174(a) than Trantafello signals, the eye surgeries fell well outside the scope of subsection (a). Perez alleges that the procedures were undertaken “to attempt to correct [] farsightedness.” Perez admits that the surgeries had a therapeutic purpose. He does not claim that this therapeutic purpose was merely incidental to a broader research goal—in fact, he does not claim that there was any research goal whatsoever. Without doubt, the hyperopic surgeries at issue here were “reasonably related” to “improving [Perez’s] health” and “directly benefiting” him. See § 24174(a). Perez is unable to explain why his broad definition of “medical experiment” would not swallow up all off-label use. As the Supreme Court has recognized, “‘off-label’ usage of medical devices . . . is an accepted and necessary corollary of the FDA’s mission to regulate [in the area of medical devices] without directly interfering with the practice of medicine.” Buckman Co. v. Plaintiffs’ Legal Committee, 531 U.S. 341, 350 (2001). The legislative history of the Human Subjects Act reflects that California purposefully excluded therapeutic off-label use from the scope of § 24174. The Assembly Bill originally included off-label use and the use of a drug or PEREZ V . NIDEK CO ., LTD . 13 device for which an application had been denied or withdrawn by the FDA or the California Department of Health as falling within the definition of “medical experiment.” A.B. 1752, Assemb. Reg. Sess. (Cal. 1977–78) [revisions to AB 1752 as amended in Assembly, May 23, 1977] at 7; Assembly member Herschel Rosenthal, Letter to Governor Edmund G. Brown, Jr., re Assemb. Bill No. 1752 (1977–78 Reg. Sess.), June 28, 1978, at 2 [“Rosenthal Letter”]. Those provisions were deleted before the bill became law, at least in part in response to the California Medical Association’s opposition to the bill. Rosenthal Letter 2. Perez’s remaining arguments—that the eye surgeries were not “reasonably related” to improving the proposed class members’ health because the doctors performed the surgeries “to line their own pockets” and because the surgeries were elective—are unpersuasive. Both arguments attempt to import requirements into § 24174(a) that are not found in the text and have nothing to do with medical experimentation. The standard under § 24174(a) is objective, not subjective; the doctors’ alleged motivations do not come into play. Nor does the statute embody any requirement of altruism. A doctor’s desire to profit from a procedure hardly transforms that procedure from therapeutic to experimental. Finally, the elective nature of a procedure is not a component of the statutory definition. Many elective surgeries are performed to improve the patient’s health. The term often is used merely to distinguish emergency procedures from those that can be scheduled at the convenience of doctor and patient.4 4 The medical dictionary available through M edlinePlus, a service of the U.S. National Library of Medicine and the National Institutes of Health, defines “elective” as “beneficial for the patient but not necessary for 14 PEREZ V . NIDEK CO ., LTD . And even elective surgery that is not health related may be “reasonably related” to “directly benefiting” a patient. For example, elective cosmetic surgery that ostensibly has no health component, that is solely undertaken for aesthetic reasons, and that may be lucrative for certain physicians nonetheless may be performed to benefit a patient and thus fall outside of the Act. Perez is unable to advance a rationale that places these LASIK surgeries within the requirements of the Human Subjects Act.
The term “medical experiment” also includes, under § 24174(b), the “investigational use of a drug or device as provided in Sections 111590 and 111595.” These latter referenced sections, respectively, govern investigations, commonly dubbed clinical trials, conducted in accordance with the requirements of the FDCA, and investigations conducted under conditions specified by state law. Perez does not claim that he or any proposed class member was part of a clinical trial or that Physician Defendants performed their surgeries under the conditions specified in § 111595 (such as submitting reports to the state Department of Health Services). With respect to this claim, Perez’s undoing is that he affirmatively pled that he and the proposed class members were not participants in officially sanctioned clinical trials. The defendant doctor class is defined as “[a]ll physicians who performed Hyperopic LASIK and/or PRK in California with the Nidek Laser during survival”— for example, “an elective appendectomy.” Elective Definition, MedlinePlus, http://www.merriam-webster.com/medlineplus/elective (last visited Mar. 13, 2013). PEREZ V . NIDEK CO ., LTD . 15 the Class Period, other than during an approved FDA clinical trial.” According to the Complaint, those “Defendants knew and understood that the Lasers were being used on Plaintiffs and the Class without their informed consent to be subjected to the investigational use of the Laser, and without including them in a sanctioned clinical trial.” Perez cannot argue both that he was not included in clinical trials and that the procedure falls under the clinical trial provisions of the Human Subjects Act. See Huntman v. Danek Medical, Inc., No. 97-2155-IEG (RBB), 1998 WL 663362, at – (S.D. Cal. July 24, 1998) (explaining that because there was no evidence that the plaintiff was part of an Investigational Device Exemption, the defendant did not need to comply with the informed consent provisions of the IDE regulations). Perez’s allegation that the “Laser was being investigated . . . under FDA approved clinical trials by both NIDEK and independent physician groups” during the class period does not convert his own surgery—which falls outside of the provisions of sections 111590 and 111595—into part of a clinical trial. For this reason, Perez’s reliance on Daum v. Spinecare Medical Group, Inc., 52 Cal. App. 4th 1285 (Cal. Ct. App. 1997), is misplaced. The plaintiff in Daum was part of a clinical investigation conducted under the requirements of the FDCA. Id. at 1308. Although Perez may find it “perverse and inequitable,” as he puts it, to provide patients admitted to clinical trials with “more protection than those who are subjected to the same experimental procedures outside the gaze of the FDA,” § 24174(b), by its terms, applies only to investigations conducted under the requirements of the FDCA or state law. Perez was not subject to the “investigational use” of a device within the meaning of § 24174(b). 16 PEREZ V . NIDEK CO ., LTD .