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.”