Opinion ID: 856123
Heading Depth: 1
Heading Rank: 1

Heading: analysis

Text: Perez sued two groups of doctors: the two doctors who performed surgery on the named plaintiffs, and named and unnamed doctors who performed no surgery on the named plaintiffs, but who allegedly performed surgery on other individuals in the proposed class. With respect to the first group, standing is not at issue, but the second group raises a serious standing question.2 See Easter v. Am. W. Fin., 381 F.3d 948, 961–62 (9th Cir. 2004) (holding that borrowers of second mortgage loans had no standing to sue those investment trusts that did not hold a named plaintiff’s note because they could not trace the alleged injury in fact to those defendants’ actions). Perez apparently endeavors to sidestep the traceability hurdle for the second group of doctors through his allegations of conspiracy and aiding and abetting. A look at those allegations reveals virtually nothing because they are no more than conclusory and bare bones words and phrases without any factual content. Such vacuous claims are insufficient to establish standing or to survive a motion to dismiss. See Lujan, 504 U.S at 561 (explaining that the elements of standing “must be supported in the same way as any other 2 Although Perez, as the party invoking federal jurisdiction, has the burden of establishing Article III standing, Lujan v. Defenders of Wildlife, 504 U.S. 555, 561 (1992), he did not respond to the argument that he had no standing to sue the second group of doctors. PEREZ V . NIDEK CO ., LTD . 9 matter on which the plaintiff bears the burden of proof, i.e., with the manner and degree of evidence required at the successive stages of the litigation”); Iqbal, 556 U.S. at 678 (“To survive a motion to dismiss, a complaint must contain sufficient factual matter, accepted as true, to ‘state a claim to relief that is plausible on its face.’” (citation omitted)). Because Perez’s substantive claims fail, amendment would be futile. For the same reason, we do not need to reach the more difficult chicken-and-egg question of whether class certification should be decided before standing. See Easter, 381 F.3d at 962 (explaining that the district court correctly addressed standing before class certification and that Ortiz v. Fibreboard Corp., 527 U.S. 815 (1999), “does not require courts to consider class certification before standing”). Nor does Perez have standing to sue any of the defendants under the CLRA. The Complaint requests only injunctive relief under that statute. Perez has not demonstrated that he faces “a real or immediate threat of an irreparable injury.” Hangarter v. Provident Life & Acc. Ins. Co., 373 F.3d 998, 1021 (9th Cir. 2004) (emphasis in original) (citation and internal quotation marks omitted); see also Los Angeles v. Lyons, 461 U.S. 95, 105 (1983). Perez does not allege that he intends to have further hyperopic surgery and, more importantly, the Laser has been approved for hyperopic use since 2006. No post-2006 conduct is alleged. Although the district court dismissed the CLRA claim on the basis of preemption, we affirm on the alternate ground of standing, which is a threshold determination. See Thompson v. Paul, 547 F.3d 1055, 1058–59 (9th Cir. 2008) (explaining that we can affirm a dismissal under Rule 12(b)(6) “on any ground supported by the record”); Bates v. United Parcel Serv., Inc., 10 PEREZ V . NIDEK CO ., LTD . 511 F.3d 974, 985 (9th Cir. 2007) (en banc) (“Standing is a threshold matter central to our subject matter jurisdiction.”).
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 .
Perez also alleges a common-law fraud by omission claim. The theory is that the defendants misled the proposed class by failing to disclose that the Laser was not FDA approved for hyperopic surgeries, even though Nidek and the doctors knew or should have known that the proposed class members believed the Laser was FDA approved for such surgeries. This claim of omission is expressly preempted by the preemption provision in the Medical Device Amendments (“MDA”). Even if it were not, it is impliedly preempted because it amounts to an attempt to privately enforce the FDCA.
The FDCA has long provided for premarket approval of new drugs. Medtronic, Inc. v. Lohr, 518 U.S. 470, 475 (1996). Before 1976, states were left to supervise the introduction of new medical devices. See Riegel v. Medtronic, Inc., 552 U.S. 312, 315 (2008). California was among a number of states that adopted regulatory measures governing devices. Id. In 1976, Congress enacted the Medical Device Amendments to the FDCA, which “swept back some state obligations and imposed a regime of detailed federal oversight.” Id. at 316. These amendments include an express preemption provision: Except as provided in subsection (b) of this section, no State or political subdivision of a State may establish or continue in effect with respect to a device intended for human use any requirement— PEREZ V . NIDEK CO ., LTD . 17
any requirement applicable under this chapter to the device, and
of the device or to any other matter included in a requirement applicable to the device under this chapter. 21 U.S.C. § 360k(a). An implementing regulation provides that state and local requirements are only preempted by the MDA when the FDA “has established specific counterpart regulations or there are other specific requirements applicable to a particular device under the act, thereby making any existing divergent State or local requirements applicable to the device different from, or in addition to, the specific Food and Drug Administration requirements.” 21 C.F.R. § 808.1(d). A trio of Supreme Court cases address preemption under the MDA: Lohr, Buckman, and Riegel. Lohr and Riegel involved the MDA’s express preemption provision, and Buckman involved implied preemption. As we explained in a recent en banc decision, the “rule that emerges from these cases is that the MDA does not preempt a state-law claim for violating a state-law duty that parallels a federal-law duty under the MDA.” Stengel v. Medtronic, Inc., 704 F.3d 1224, 1228 (9th Cir. 2013) (en banc). In Lohr, the Court held that plaintiffs’ common-law claims stemming from a pacemaker failure were not preempted under § 360k. The allegations included claims that Medtronic had violated FDA regulations, and “[n]othing in § 360k denies Florida the right to provide a traditional 18 PEREZ V . NIDEK CO ., LTD . damages remedy for violations of common-law duties when those duties parallel federal requirements.” 518 U.S. at 495 (emphasis added). Although a plurality of the Court emphasized the generality of the state laws giving rise to the plaintiffs’ claims, “five Justices concluded that common-law causes of action for negligence and strict liability do impose ‘requirement[s]’ and would be pre-empted by federal requirements specific to a medical device.” Riegel, 552 U.S. at 323–24 (citing Lohr, 518 U.S. at 512 (opinion of O’Connor, J., joined by Rehnquist, C.J., and Scalia and Thomas, JJ.); id. at 503–05 (opinion of Breyer, J.)). None of the federal laws or regulations at issue imposed devicespecific requirements. Lohr, 518 U.S. at 492–94, 500–01. In contrast, the Court in Riegel held that § 360k preempted common-law claims challenging the safety and effectiveness of a medical device that had received premarket approval from the FDA. Unlike the federal laws and regulations at issue in Lohr, premarket approval imposes device-specific requirements. Id. at 322–23. Because the state common-law claims related to the safety and effectiveness of the device and because the plaintiffs alleged that the device violated state tort law notwithstanding compliance with the federal requirements, the state claims were preempted. Id. at 323, 330. It did not matter that the common-law claims involved general tort duties of care applicable to other products besides medical devices. Id. at 327–29. In Stengel, we “clarified preemption law under the MDA.” 704 F.3d at 1233. Plaintiffs’ proposed negligence claim for failure to warn the FDA was not preempted “insofar as the state-law duty parallels a federal-law duty under the MDA.” Id. We distinguished an Eighth Circuit case holding PEREZ V . NIDEK CO ., LTD . 19 plaintiffs’ claims were preempted because, in that case, “plaintiffs sought to enforce state-law requirements that would have required Medtronic ‘to give additional warnings, precisely the type of state requirement that is “different from or in addition to” the federal requirement.’” Id. at 1232 (quoting In re Medtronic, Inc., Spring Fidelis Leads Products Liability Litigation, 623 F.3d 1200, 1205 (8th Cir. 2010)) (citation and internal quotation marks omitted). In a