Between February 1996 and October 2006, patients sought and received Laser in Situ Keratomileusis (“LASIK”) eye surgery with a Nidek EC–5000 Excimer Laser System (“the Laser”) to correct farsightedness, also known as hyperopic surgery. At the time of the patients’ surgeries, the FDA had not approved the Laser for this use.
The Laser is a Class III medical device under the Federal Food, Drug, and Cosmetic Act (FDCA), as amended by the Medical Device Amendments of 1976 (“MDA”). For that reason, Nidek was required to get premarket approval (“PMA”) from the FDA before it could sell or distribute the Laser. Between 1998 and 2000, Nidek obtained three PMAs for treating nearsightedness with the Laser. 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. The Laser was not approved for treating farsightedness until October 2006.
The patients filed a putative class action alleging that, at the time of their surgeries, they did not know the FDA had not approved the Laser for this use and had they known, they would not have consented to the surgeries. The patients alleged that the manufacturer of the Laser had conspired with physicians to use the Laser to correct farsightedness, despite lack of premarket approval (PMA) by the FDA in violation of the FDCA, the Human Subjects Act, and the California Consumers Legal Remedies Act (CLRA). The patients also brought common-law claims of fraud by omission, civil conspiracy, and aiding and abetting. The United States District Court for the Southern District of California dismissed the suit.
The Ninth Circuit U.S. Court of Appeals affirmed. First, the court held that the named plaintiffs lacked standing to bring claims against unnamed doctors who had allegedly performed surgery on other proposed class members, but not on the named plaintiffs themselves, absent sufficient factual support tracing allegations of injury to them.
Second, the court held that the named plaintiffs lacked standing to pursue violations of the CLRA. To establish standing under the CLRA, plaintiffs must demonstrate a real or immediate threat of an irreparable injury. There was no evidence that the named plaintiffs intended to have further hyperopic surgery. Moreover, since its approval in 2006, such surgery was no longer prohibited by the FDA.
Third, the court held that use of the Laser did not constitute a “medical experiment” within the meaning of the informed consent statute. Under California law, use of the Laser to correct farsightedness was reasonably related to improving patients' health, and thus did not constitute “medical experiment” within the meaning of the statute requiring informed consent before subjecting persons to any medical experiment, where the Laser was not being used for any investigational purpose.
Fourth, the patients’ California common-law fraud by omission claim was expressly pre-empted by the MDA to the FDCA. Resolving the state law claim depended on a determination that the FDCA had been violated.
Finally, even if not expressly pre-empted, the patients’ state law claims were impliedly pre-empted since they amounted to an attempt to privately enforce the FDCA. Although citizens may petition the FDA to take administrative action, private enforcement of the statute is barred. A plaintiff cannot bring suit solely for failure to disclose lack of FDA approval. 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. Whether the 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 the FDCA, whether the defendants were engaged in a permissible off-label use of the Laser, and whether re-certification of the device was required under federal regulations, and all of these matters rest within the enforcement authority of the FDA, not the federal courts.
See: Perez v. Nidek Co., Ltd., 2013 WL 1189098 (C.A.9 (Cal.), March 25, 2013) (not designated for publication).
See also Medical Law Perspectives, April 2012 Report: Using Medical Devices Off-Label: False Claims, Overpromotion, Malpractice, and Other Dangerous Territory