This post comes from the Cozen O’Connor side of the blog.

Last week, the New York Appellate Division upheld a preemption decision in a medical device case involving alleged off-label promotion. Pitkow v. Lautin, 2016 WL 2746469 (N.Y. App. Div. May 12, 2016). While the Appellate Division’s opinion was only three-paragraphs long, it affirmed the trial court’s ruling in every respect, making the trial court’s lengthier opinion that much more important. We obtained a copy, and here it is.

The plaintiff’s claims were based on complications that arose after her use of an injectable product, Sculptra, for cosmetic purposes, which was an off-label use. Plaintiff sued the doctors who injected her and the manufacturers of Sculptra. Among other things, she alleged that the manufacturers had improperly promoted off-label use of Sculptra.

After discovery, the manufacturers moved for summary judgment, arguing that all of plaintiff’s claims were preempted. The trial court agreed and, quite effectively, walked through the manner in which both Riegel and Buckman preempted plaintiff’s claims as well as the deficiencies of plaintiff’s attempts at parallel violation claims.

First up was Riegel preemption, since Sculptra was approved under the FDA’s PMA process:

Sculptra is a Class III medical device that was undeniably approved through the PMA process. What is more, all of the plaintiff’s claims against the [manufacturers] regard the safety and effectiveness of the device or require a finding that Sculptra’s design, labeling, and/or manufacturing process should have differed from that approved by the FDA via the PMA process . . . . Thus, the claims are preempted by the federal law.

Slip. Op. at 8-9.

The trial court had at least as much to say about plaintiff’s parallel violation claims. Plaintiff alleged “that the defendants promoted an off-label use of Sculptra that was contrary to the representations of the [manufacturers] made to the FDA during the PMA process.” Id. at 9. The court, however, found that plaintiff pointed to no violation of an FDA requirement or state law that paralleled that requirement: “plaintiff has failed to cite a specific federal regulation that was violated, or an obligation existing under state law that was ‘identical’ or ‘generally equivalent’ to a specific obligation imposed by federal law.” Id.

The trial court went further in taking out plaintiff’s parallel violations claims. The court held that Buckman prohibits the broad use of state law to enforce FDA requirements, in particular for fraud on the FDA, and made the important point that the Riegel case itself involved allegations of off-label claim promotion:

What is more, any claims based on alleged off-label promotion and/or misrepresentations to the FDA during the PMA process are barred by Buckman Co. v. Plaintiffs’ Legal Comm., 531 U.S. 341 (2001). The Supreme Court there indicated that only the FDA, and not private litigants, may sue based on alleged noncompliance with the Medical Device Amendments, stating (at 347) that the FDA is “amply empower[ed] to police fraud against the Administration, and policing the fraud is not a field the States have traditionally occupied.” The Court explained that while the doctrine may be read to allow for some state-law claims that are parallel to the requirements under the MDA, “it does not and cannot stand for the proposition that any violation of the FDCA will support a state law claim.” Id. at 353.

The Court rejects plaintiff’s claim here (at ¶42) that Buckman should not be applied because the fraud on the FDA allegedly committed by the Sculptra Defendants was of greater magnitude than usual. Buckman makes no such distinction. What is more, the plaintiff in Riegel had alleged that the medical device was used in an off-label and contra-indicated manner, similar to plaintiff’s claims here, but those claims did not escape preemption.

Id. at 9-10. Given plaintiff’s arguments, the trial court also had to explain, very quickly, why Wyeth v. Levine (prescription drugs, no Medical Device Amendments’ preemption clause) and Medtronic v. Lohr (§510k process, not PMA process) did not apply.

With that, the trial court, now with a stamp of approval from the Appellate Division, made it much more difficult for New York plaintiffs to state parallel violation claims based on off-label promotion. New York plaintiffs face a significant challenge in identifying an FDA requirement that would be violated by such off-label promotion and, more important, a parallel New York law that also prohibits it.