Robert PEREZ; Nancy Art; Brett Harbach, on behalf of themselves and all others similarly situated, Plaintiffs-Appellants, v. NIDEK CO., LTD.; Nidek Incorporated; Nidek Technologies Incorporated; Manjov V. Motwani, M.D.; Gary M. Kawesch, M.D.; Linda Vu, M.D.; Joseph Lee, M.D.; Farzad Yaghouti, M.D.; Randa M. Garrana, M.D.; Thomas S. Tooma, M.D.; Paul C. Lee, M.D.; Keith Liang, M.D.; Antoine L. Garabet, M.D.; William Ellis, M.D.; Gregg Feinerman, M.D.; Michael Rose, M.D.; John Kownacki, M.D.; Steven Ma, M.D.; Estate of Glenn A. Kawesch, M.D.; TLC Vision Corporation, dba TLC Laser Eye Center, Inc.; California Center for Refractive Surgery, a medical corporation; Laser Eye Center Medical Office, Inc.; Southwest Eye Care Center Inc.; Does, 1 through 1000, inclusive, Defendants-Appellees.
No. 10-55577.
United States Court of Appeals, Ninth Circuit.
March 25, 2013.
711 F.3d 1109
Argued and Submitted Oct. 10, 2012.
Thomas S. Arthur and Thomas M. Robins, III, Frandzel Robins Bloom & Csato, Los Angeles, CA, for Defendant-Appellee Nidek, Inc.
James J. Wallace, II, La Follette Johnson De Haas Fesler & Ames, APC, San Diego, CA, for Defendants-Appellees Manjov V. Motwani, M.D., and Keith Liang, M.D.
Lisa W. Cooney, Rita R. Kanno, John Takashi Tsumura and Craig T. Mann, Lewis Brisbois Bisgaard & Smith LLP, San Diego, CA, for Defendant-Appellee Gary M. Kawesch, M.D.
Gregory Dale Werre, Bonne, Bridges, Mueller, O‘Keefe & Nichols, Los Angeles, CA, for Defendants-Appellees William Ellis, M.D., Gregg A. Feinerman, M.D., Randa M. Garrana, M.D., Joseph Lee, M.D., and Linda Vu, M.D.
Daniel S. Belsky and Gabriel M. Benrubi, Belsky & Associates, San Diego, CA; Kenneth R. Pedroza and Matthew S. Levinson, Cole Pedroza, LLP, Pasadena, CA, for Defendants-Appellees Estate of Glenn
Albert E. Cressey, III, Reback, McAndrews, Kjar, Warford & Stockalper, Manhattan Beach, CA, for Defendant-Appellee Thomas S. Tooma, M.D.
H. Steven Schiffres, Rosoff, Schiffres & Barta, Los Angeles, CA, for Defendant-Appellee Michael Rose, M.D.
Gregory M. Hulbert, Gonzalez and Hulbert, LLP, Glendale, CA, for Defendant-Appellee John Kownacki, M.D.
Before: STEPHEN S. TROTT, ANDREW J. KLEINFELD, and M. MARGARET McKEOWN, Circuit Judges.
OPINION
McKEOWN, Circuit Judge:
We are asked to decide whether patients who suffered no injuries but who were subject to the off-label use of a medical device for eye surgeries may bring suit solely because the Food and Drug Administration (“FDA“) status of the device was not disclosed to them. The Third Amended Complaint (“the Complaint“) does not state a claim under the California Protection of Human Subjects in Medical Experimentation Act (“the Human Subjects Act“) because the surgeries were not “medical experiments” subject to the protection of the Act. Robert Perez does not have standing to sue for injunctive relief under the California Consumers Legal Remedies Act (“CLRA“), and his other substantive claim is preempted by the Federal Food, Drug, and Cosmetic Act (“FDCA“). We affirm the district court‘s dismissal of the Complaint.
Robert Perez, Nancy Art, and Brett Harbach (collectively, “Perez“) each sought and received Laser in Situ Keratomileusis (“LASIK“) eye surgery with a Nidek EC-5000 Excimer Laser System (“the Laser“) to correct farsightedness. They claim that, at the time of their surgeries, they did not know the FDA had not approved the Laser for this use. According to the Complaint, had they known, they would not have consented to the surgeries.
Perez sued on behalf of himself and a class of similarly situated individuals who received hyperopic surgery (surgery to correct farsightedness) with the Laser between February 1996 and October 2006. Perez does not allege any injury stemming from surgery. Nor does Perez claim that his or any other surgery was ineffective. Instead, he asserts claims under the Human Subjects Act and the CLRA, as well as common-law claims of fraud by omission, civil conspiracy, and aiding and abetting. Perez brought these claims against various Nidek corporate entities (“Nidek“), named and unnamed physicians who allegedly used the Laser for unapproved purposes on individuals in the purported class (“Physician Defendants“), named and unnamed medical centers where these procedures were allegedly performed, and other unnamed persons and entities who allegedly participated in the conduct at issue. Of the named Physician Defendants, only two performed LASIK surgery on the named plaintiffs.
The Laser is a Class III medical device under the
Perez alleges that the defendants engaged in a nationwide scheme to modify the approved Laser to enable it to correct farsightedness before it was approved for that purpose. He claims that Physician Defendants used the modified Lasers to perform hyperopic surgeries without informing patients that the Laser was not approved for that use outside of approved clinical trials, and that Nidek knew about the improper use of the Laser. Perez further alleges that the defendants conspired and aided and abetted each other in their unlawful conduct.
The FDA was aware of claims that the Laser was being put to unauthorized uses, and it took steps to halt abuses. In late 2000, the FDA sent Nidek a letter expressing concern that chips in Laser units were being replaced with chips that enable the device for “unapproved applications, such as hyperopia.” The letter addressed allegations that Nidek employees were providing the replacement chips and that Nidek had fired at least one employee for doing so. It also noted that Nidek had waited several months after becoming aware that some Lasers had been tampered with before reporting the problem, in violation of the PMA conditions.
Perez alleges that, “[d]espite these actions by [the] FDA, Defendants continued to sell, distribute, lease, use, service, and market the Lasers in the United States with the capacity to perform hyperopic procedures.” He alleges that Nidek “continued to install, service and enable the Lasers to perform hyperopic corrections outside of sanctioned clinical trials” and that Nidek falsified many service records indicating that it had removed the software. In October 2006, the Laser was approved for hyperopic use with improved and updated software and treatment parameters.
ANALYSIS
I. STANDING
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 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
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, 103 S.Ct. 1660, 75 L.Ed.2d 675 (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
II. CALIFORNIA PROTECTION OF HUMAN SUBJECTS IN 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.”
(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 or109925 , 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 and111595 .(c) Withholding medical treatment from a human subject for any purpose other than maintenance or improvement of the health of the subject.
A. SECTION 24174(a)
As to
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
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, 121 S.Ct. 1012, 148 L.Ed.2d 854 (2001). The legislative history of the Human Subjects Act reflects that California purposefully excluded therapeutic off-label use from the scope of
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
B. SECTION 24174(b)
The term “medical experiment” also includes, under
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
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
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,”
III. FRAUD BY OMISSION CLAIMS
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
A. EXPRESS PREEMPTION
The
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—
(1) which is different from, or in addition to, any requirement applicable under this chapter to the device, and
(2) which relates to the safety or effectiveness of the device or to any other matter included in a requirement applicable to the device under this chapter.
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
In contrast, the Court in Riegel held that
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 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., Sprint Fidelis Leads Products Liability Litigation, 623 F.3d 1200, 1205 (8th Cir. 2010) (citation and internal quotation marks omitted)). In a concurring opinion joined by six other judges, Judge Watford explained that, had the plaintiffs predicated their claim on a failure to warn doctors directly—an action not required by FDA regulations—that claim would have been preempted because it would have been an addition to the federal requirement. Stengel, 704 F.3d at 1234 (Watford, J., concurring).
The teachings from the Supreme Court cases plus our application of MDA preemption in Stengel lead to an obvious result: Perez‘s fraud by omission claim is expressly preempted by
B. IMPLIED PREEMPTION
Perez faces another hurdle—even without express preemption, Perez‘s fraud by omission claim is impliedly preempted because it conflicts with the
In Buckman, the Court held that the plaintiffs’ “fraud-on-the-FDA” claims were impliedly preempted by the
Like the fraud-on-the-FDA claims in Buckman, Perez‘s fraud by omission claim “exist[s] solely by virtue of the FDCA ... requirements,” 531 U.S. at 353, with respect to approved use of the Laser. As in Buckman, “the existence of these federal enactments is a critical element in their case.” Id. Although Perez is not barred from bringing any fraud claim related to the surgeries, he cannot bring a claim that rests solely on the non-disclosure to patients of facts tied to the scope of PMA approval. While courts have acknowledged that some fraud and false advertising claims related to FDA status may go forward,5 Perez cites to no case
The FDA knew about the allegations that the Laser was being used for unapproved hyperopic use and took steps to address the allegations by issuing warning letters and an Import Alert, but it did not take final action against the defendants. The district court explained that
[w]hether Defendants’ use of the laser was in violation of the FDCA depends on, among other things, the scope of the PMAs, whether the Lasers were modified so that they were “adulterated” under section 501(f)(1)(B) of the FDCA, whether Defendants were engaged in a permissible “off-label” use of the Laser, and whether re-certification of the device was required under
21 C.F.R. § 1040.10 . All of these matters rest within the enforcement authority of the FDA, not this Court.
The Eighth Circuit has aptly described the “narrow gap” through which a state-law claim must fit to escape preemption by the
AFFIRMED.
M. MARGARET McKEOWN
UNITED STATES CIRCUIT JUDGE