Perez v. Nidek Co.

• Citation: 711 F.3d 1109
• Decision Date: 25 March 2013
• Docket Number: No. 10–55577.,10–55577.
• Parties: 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.
• Court: United States Courts of Appeals. United States Court of Appeals (9th Circuit)

711 F.3d 1109

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.

Argued and Submitted Oct. 10, 2012.
Filed March 25, 2013.

[711 F.3d 1111]

James Richard Patterson, Patterson Law Group, APC, San Diego, CA; Duane A. Admire, Admire & Associates, Del Mar, CA; Alisa Ann Martin, Harrison Patterson & O'Connor LLP, San Diego, CA; Gene Joseph Stonebarger, Stonebarger Law, Folsom, CA; and Jon R. Williams, Boudreau Williams, LLP; San Diego, CA, for Plaintiffs–Appellants.

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 A. Kawesch, M.D., and Farzad Yaghouti, M.D.

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.

Appeal from the United States District Court for the Southern District of California, Barry T. Moskowitz, District Judge, Presiding. D.C. No. 3:08–cv–01261–BTM–JMA.
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.

[711 F.3d 1112]

Background¹

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 FDCA, as amended by the Medical Device Amendments of 1976 (“MDA”). 21 U.S.C. § 360c. For that reason, Nidek was required to get premarket approval (“PMA”) from the FDA before it could sell or distribute the Laser. 21 U.S.C. § 360e. Between 1998 and 2000, Nidek obtained three PMAs for treating nearsightedness with the Laser, but the Laser was not approved for treating farsightedness until October 2006. The PMAs restricted the Laser from being used for hyperopic corrections outside of approved investigations. During the class period, use of the Laser for farsightedness was being investigated in FDA-approved clinical trials, which required full disclosure of the device's experimental use and informed consent from patients receiving treatment.

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.

[711 F.3d 1113]

In 2001, the FDA sent two sets of warning letters to certain physicians after an investigator determined that the Lasers they were using for hyperopia were manufactured before Nidek's PMA was effective and that the Lasers contained software not approved for commercial distribution in the United States. The first letter stated, “Because an approved PMA or an approved IDE [Investigational Device Exemption] does not cover this laser, it is adulterated within the meaning of the Act. Therefore, you should not be using this laser to treat patients.” The second letter reiterated the information in the first letter and added that the modified lasers needed to be certified as in compliance with the federal laser product performance standard. In addition, the FDA published an Import Alert addressing the problem of Lasers with software not approved under the PMAs.

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.²See 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, 112 S.Ct. 2130 (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, 129 S.Ct. 1937 (“To survive a motion to dismiss, a complaint must contain sufficient factual matter,...