A judge in the District of Massachusetts recently questioned whether Congress intended to criminalize off-label promotion through misbranding and adulteration statutes. In an order denying a Rule 29 motion brought by two former Acclarent executives, U.S. District Judge Allison D. Burroughs wrote, “It seems clear that the statutory and regulatory scheme needs to be rethought. Currently there is no statute that specifically prohibits off-label marketing and yet the Government continues to prosecute the conduct by patching together the misbranding and adulteration regulations, thereby criminalizing conduct that it is not entirely clear Congress intended to criminalize.” Although the court ultimately rejected the defendants’ arguments for acquittal, it opined that, “where a conviction can result in exclusion from healthcare programs, likely a death knell for any company, it is also important for the regulatory and law enforcement regime to clearly spell out what is and is not prohibited conduct.” Though this opinion does not carry the force of law, it could signal a shift in how federal judges view off-label promotion cases.

Misbranding and Adulteration vs. Off-Label Promotion

Class III medical devices can take two different routes to market entry. First, a company can obtain an FDA-approved premarket approval application, which requires the manufacturer to demonstrate the device’s safety and efficacy. Alternatively, a company may seek 510(k) clearance, which allows it to expedite bringing a device to market by demonstrating the device has the same intended use or technological characteristics, or is as safe and effective as, an already-approved device.

Adulteration or misbranding occurs when a medical device is sold without either of these two types of approvals. A device is adulterated if, among other things, it was required to, but did not, receive premarket approval for an intended use from the FDA. Similarly, a device is misbranded if it was sold without 510(k) clearance for an intended use. Adulteration and misbranding, in their misdemeanor forms, are strict liability offenses — meaning the government needs only to prove the defendant sold the improperly labeled devices. To convict a defendant of felony adulteration or misbranding, the government must prove that a defendant acted with the specific intent to mislead or defraud.

Courts have acknowledged that the Federal Food, Drug, and Cosmetic Act (FDCA) “and its accompanying regulations do not expressly prohibit the ‘promotion’ or ‘marketing’ of drugs for off-label use.” United States v. Caronia, 703 F.3d 149, 154 (2d Cir. 2012). Even so, the government often argues that off-label promotional speech is evidence of an intent to sell an adulterated or misbranded product. Though the government concedes that truthful and non-misleading off-label promotion serves an evidentiary purpose and is not a crime in and of itself, courts have become increasingly wary of prosecutions that blur the line between criminalizing this promotional speech and advocating that this speech is evidence of intent to sell an adulterated or misbranded product. This is especially true with strict liability criminal statutes, such as the misdemeanor provisions of the FDCA.

United States v. Facteau

The tension between adulteration and misbranding and truthful, non-misleading off-label promotion has never been more pronounced than it was in United States v. Facteau, No. 15-cr-10076-ADB (D. Mass.). There, the government charged two Acclarent executives with 10 counts of both felony and misdemeanor adulteration and misbranding based on the off-label promotion of a medical device manufactured by Acclarent. With respect to misbranding, the government alleged three theories: false and misleading labeling, lack of adequate directions for use, and lack of required premarket approval for intended use. After a six-week trial, the jury acquitted the defendants of the felony charges, but convicted the defendants on only one theory of the misdemeanor misbranding charges: the lack of required premarket approval for intended use.

In their Rule 29 motion, the defendants argued that their convictions violated the First Amendment, because they relied on evidence of truthful, non-misleading speech. Facteau, 2020 WL 5517573 (D. Mass. Sept. 14, 2020). Noting that “[t]he First Circuit has not yet considered the line between off-label promotion that is truthful and non-misleading and the FDA’s ability to regulate speech relative to off-label promotion,” the court relied on Second Circuit precedent — Caronia and Amarin Pharma, Inc. v. FDA, 119 F. Supp. 3d 196 (S.D.N.Y. 2015) — which recognizes “a distinction between truthful, non-misleading off-label speech on its own, and speech in connection with the act of mislabeling for an unapproved intended use.” Facteau, at *13. The court concluded that, unlike in Caronia, its instructions to the jury made clear that jurors could not convict the defendants simply for making truthful, non-misleading off-label statements and, therefore, following the “almost invariable assumption of the law that jurors follow [] instructions . . . the [d]efendants’ speech cannot be assumed to be the basis for the conviction.” Id. at *14.

The Facteau Rule 29 motion was pending for four years, which the court noted stemmed from the “challenging” issues raised at trial and in the pleadings. Despite denying the motion, the court’s recognition of the complex intersection between truthful, non-misleading speech and the criminalization of off-label promotion through the adulteration and misbranding statutes is an important point in the long and winding off-label-enforcement road.

Implications

The court’s opinion is not binding (and was not favorable to the two Acclarent executives), but it does indicate an uneasiness among the federal judiciary toward strict liability off-label promotion prosecutions. In 2012, the Second Circuit in Caronia broke circuit-court ranks and held that a prosecution that, at its core, targeted off-label promotional speech violated the First Amendment. Though predictions that off-label prosecutions following Caronia would sputter have not yet come true, Facteau suggests the issue is ripe for review.