Robert Perez and others sought and received Laser in Situ Keratomileusis (“LASIK”) eye surgery with a Nidek EC–5000 Excimer Laser System 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 their proposed class action lawsuit, had they known, they would not have consented to the surgeries.
The Laser is a Class III medical device under the FDCA, as amended by the Medical Device Amendments of 1976. For that reason, Nidek was required to get premarket approval 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, 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 alleged 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 the physicians 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.
The lawsuit alleged 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. The Ninth Circuit Court of Appeals has now held that the claim of omission is expressly preempted by the preemption provision in the federal Medical Device Amendments (“MDA”). Furthermore, the court also held that, the claim was also impliedly preempted because it amounts to an attempt to privately enforce the FDCA. Perez v. Nidek Co., Ltd., — F.3d —- (9th Cir. March 25, 2013).
The court of appeals found that the disclosure requirement at issue is “different from, or in addition to” the requirements applicable to the Laser under the MDA. § 360k(a)(1). The Laser was subject to device-specific requirements by the FDA—including that it was not to be used for hyperopic corrections and was not permitted to be introduced into commerce for such corrections unless it was used in connection with an approved investigational use. The claim asserted by Perez depends on a requirement that is “in addition to” those federal requirements. According to the court of appeals “Perez effectively seeks to write in a new provision to the FDCA: that physicians and medical device companies must affirmatively tell patients when medical devices have not been approved for a certain use. We do not pass judgment on whether this would be a wise rule for the FDA to adopt. It is sufficient for our inquiry that it has not done so.”
Even without express preemption, the Ninth Circuit ruled that Perez’s fraud by omission claim is also impliedly preempted because it conflicts with the FDCA’s enforcement scheme. The FDA is responsible for investigating potential violations of the FDCA. Although citizens may petition the FDA to take administrative action, private enforcement of the statute is barred.
Although Perez would not be barred from bringing any fraud claim related to the surgeries, the court found that he cannot bring a claim that rests solely on the non-disclosure to patients of facts tied to the scope of the FDA’s premarket approval. While courts have acknowledged that some fraud and false advertising claims related to FDA status may go forward, the court found no support for allowing a plaintiff to bring suit solely for failure to disclose lack of FDA approval.
Agreeing with the Eight Circuit, the court of appeals noted that a claim must fit within a “narrow gap” to escape preemption by the FDCA: a plaintiff must be suing for conduct that violates the FDCA but the plaintiff must not be suing because the conduct violates the FDCA.
At Heygood, Orr & Pearson, we have extensive experience litigating defective pharmaceutical and medical device lawsuits. In fact, we recently have resolved nearly 200 claims against Johnson & Johnson relating to their defective medical products. To receive a free legal consultation and find out if you are eligible to file a case, please call our toll-free number at 1-877-446-9001, or by filling out our free case evaluation form located on this page.