United States v. Vascular Solutions, Inc., No. SA-14-CR-926, --- F.Supp.3d ----, 2016 WL 5475999 (W.D. Tex. Jan. 27, 2016)
Defendants sell a medical device which permanently closes varicose veins using a laser, allowing healthier veins to move blood. The device is approved for treatment of superficial veins only, not perferator veins. The government indicted defendants for misbranding: they failed to provide the FDA with required notification of a new intended use, and the devices’ labeling lacked adequate directions for that new intended use.
Defendants argued that the government’s case threatened the First Amendment. The court (Royce Lamberth, which means that the government was treading lightly indeed!) disagreed, in part because the government limited its claims. Under Wisconsin v. Mitchell, “[t]he First Amendment ... does not prohibit the evidentiary use of speech to establish the elements of a crime or to prove motive or intent.”
Misbranding requires that the device have an “intended use” other than that approved by the FDA. The regulations say that “intended use” means
the objective intent of the persons legally responsible for the labeling of devices. The intent is determined by such persons’ expressions or may be shown by the circumstances surrounding the distribution of the article. … [I[f a manufacturer knows, or has knowledge of facts that would give him notice that a device introduced into interstate commerce by him is to be used for conditions, purposes, or uses other than the ones for which he offers it, he is required to provide adequate labeling for such a device which accords with such other uses to which the article is to be put.
The government represented that it didn’t plan “to use promotional speech to doctors to prove the intended use of the devices for perforator vein ablation,” and will instead rely on conduct alone. “Should the government change its plan and decide to use promotional speech to prove intended use, or should the Court become concerned that the government is indeed pursuing a theory that the FDCA prohibits even truthful non-misleading off-label promotion, the Court will address this issue at that time.”
The government did plan to rely on statements to doctors to prove the conspiracy charge because a lawful act may serve as the “overt act” in furtherance of a conspiracy. The speech might be truthful, but it could still serve as an act taken to effect the object of the conspiracy without violating the First Amendment. Moreover, a jury instruction could make clear that speech about off-label use is not misleading merely because the FDA has not approved that off-label use or reviewed or approved the speech.
Defendants also wanted the court to hold that “to prove that a communication was actually misleading, the government must prove that the communication misled a substantial subset of its intended audience.” This is the Lanham Act standard, not the FDCA standard, and there’s no indication in the case law that this is the First Amendment floor for misleadingness.
Defendants also moved to exclude any evidence of their subjective intent. However, the governing law requires manufacturers to provide appropriate labeling “if the manufacturer has reason to believe that its medical device might be used for purposes different from the purposes for which the device is approved.” That makes their knowledge and subjective intent relevant. Moreover, statements need not be published to the marketplace to show objective intent, as long as they manifest “oral or written statements.” A hypothetical manufacturer “who learns over the phone from a customer-physician that the physician is ordering a device approved for use A but intends to use it for use B, and must now consider whether he can legally fill the order … would face no peril from such a rule because he made no oral or written statement from which objective intent could be proven.”