Posted: 14 Jul 2016 02:01 PM PDT
By David C. Gibbons & Jeffrey N. Wasserstein –
The United States Court of Appeals for the Seventh Circuit recently issued an unpublished Opinion in United States v. LeBeau, No. 16-1289, 2016 WL 3619838 (7th Cir. July 5, 2016), a case in which the pro se defendant-appellant raised a First Amendment defense after pleading guilty to a misdemeanor violation of the federal Food, Drug, and Cosmetic Act (“FD&C Act”) for introducing an unapproved new drug into interstate commerce.
In LeBeau, the defendant was charged with four misdemeanor counts of violating the FD&C Act for selling his product, “Perfect Colon Formula #1,” for use in the cure, treatment, prevention, or mitigation of a variety of conditions, which had not previously been generally recognized as safe and effective nor approved by FDA for such uses. Ultimately, LeBeau pled guilty to one of those counts, that is, for distributing his product for use in the treatment of food allergies. LeBeau at 2; Brief of Plaintiff-Appellee, United States v. LeBeau, No. 16-1289, at 3-4 (May 5, 2016). LeBeau’s plea agreement permitted him to preserve certain legal issues for appeal. Brief of Plaintiff-Appellee, at 4.
The appellant-defendant raised several issues on appeal, one of which was that the promotion of Perfect Colon Formula #1 for its intended uses was protected commercial speech under the First Amendment. LeBeau at 1. The government argued that LeBeau was not being prosecuted for his speech, but rather his speech was used as evidence of his intent to introduce an unapproved new drug into interstate commerce. The district court agreed with the government on this point and gave no relief to LeBeau. On appeal, the Seventh Circuit affirmed the lower court’s conclusion that “the government is not prosecuting LeBeau for having made claims about his products. Rather, it is prosecuting LeBeau for his acts—his attempts to profit from the sale of a product—which he represented to have palliative properties—without having received [FDA] approval to do so.” Id. at 3. Specifically regarding LeBeau’s First Amendment defense, the Seventh Circuit went on to say that, “[b]ecause LeBeau’s statements promoted the unlawful sale of an unapproved drug, they were not entitled to [First Amendment] protection.” Id.
Although this Seventh Circuit opinion arises from an unpublished Opinion, it is important to consider the proposition for which this case stands, which was not at issue in Caronia, and its progeny, nor the more recent settlements in Amarin and Pacira. That is, First Amendment protection does not extend to commercial speech regarding an unapproved product—that is, a product for which there are no “lawful” uses—even if that speech is truthful and not misleading. Seventh Circuit precedent in United States v. Caputo, 517 F.3d 935, 940-941 (7th Cir. 2008), cited by the court in LeBeau, elucidates this point. In Caputo, the Seventh Circuit stated that First Amendment protection for the promotion of off-label uses of a medical product rests on the “assumption” that a manufacturer can lawfully promote the product at all. Id. at 940. The Court stated, “[u]nless the [product] itself could be sold lawfully, there were no lawful off-label uses to promote.” Id. Thus, it appears that the Seventh Circuit would draw a distinction between commercial speech promoting unapproved uses of FDA-approved products and the promotion of unapproved products. First Amendment protection for truthful and non-misleading speech may apply to the former, but not the latter, according to the Seventh Circuit.
There are some important limitations of the LeBeau opinion to consider. First, as noted above, LeBeau is an unpublished opinion, thus, with limited precedential value. However, the principles articulated by the court in Caputo carry weight, at least in the Seventh Circuit, and were relied on, in part, by the court in LeBeau. Second, the pro se defendant-appellant’s arguments in his appellate brief were, at best, unartfully rendered and made without a sufficient understanding of the FD&C Act, the substantial jurisprudence concerning First Amendment protection for truthful and non-misleading commercial speech, and appellate practice. Finally, the promotional statements at issue in LeBeau were related to labeling statements associated with an unlawfully marketed drug. It is important to recall FDA regulations regarding preapproval promotion of unapproved, investigational drugs, which permit commercial speech in the context of scientific exchange and are intended only to restrict “promotional claims of safety or effectiveness of the drug for a use for which it is under investigation and to preclude commercialization of the drug before it is approved for commercial distribution.” 21 C.F.R. § 312.7(a).
The United States Court of Appeals for the Seventh Circuit recently issued an unpublished Opinion in United States v. LeBeau, No. 16-1289, 2016 WL 3619838 (7th Cir. July 5, 2016), a case in which the pro se defendant-appellant raised a First Amendment defense after pleading guilty to a misdemeanor violation of the federal Food, Drug, and Cosmetic Act (“FD&C Act”) for introducing an unapproved new drug into interstate commerce.
In LeBeau, the defendant was charged with four misdemeanor counts of violating the FD&C Act for selling his product, “Perfect Colon Formula #1,” for use in the cure, treatment, prevention, or mitigation of a variety of conditions, which had not previously been generally recognized as safe and effective nor approved by FDA for such uses. Ultimately, LeBeau pled guilty to one of those counts, that is, for distributing his product for use in the treatment of food allergies. LeBeau at 2; Brief of Plaintiff-Appellee, United States v. LeBeau, No. 16-1289, at 3-4 (May 5, 2016). LeBeau’s plea agreement permitted him to preserve certain legal issues for appeal. Brief of Plaintiff-Appellee, at 4.
The appellant-defendant raised several issues on appeal, one of which was that the promotion of Perfect Colon Formula #1 for its intended uses was protected commercial speech under the First Amendment. LeBeau at 1. The government argued that LeBeau was not being prosecuted for his speech, but rather his speech was used as evidence of his intent to introduce an unapproved new drug into interstate commerce. The district court agreed with the government on this point and gave no relief to LeBeau. On appeal, the Seventh Circuit affirmed the lower court’s conclusion that “the government is not prosecuting LeBeau for having made claims about his products. Rather, it is prosecuting LeBeau for his acts—his attempts to profit from the sale of a product—which he represented to have palliative properties—without having received [FDA] approval to do so.” Id. at 3. Specifically regarding LeBeau’s First Amendment defense, the Seventh Circuit went on to say that, “[b]ecause LeBeau’s statements promoted the unlawful sale of an unapproved drug, they were not entitled to [First Amendment] protection.” Id.
Although this Seventh Circuit opinion arises from an unpublished Opinion, it is important to consider the proposition for which this case stands, which was not at issue in Caronia, and its progeny, nor the more recent settlements in Amarin and Pacira. That is, First Amendment protection does not extend to commercial speech regarding an unapproved product—that is, a product for which there are no “lawful” uses—even if that speech is truthful and not misleading. Seventh Circuit precedent in United States v. Caputo, 517 F.3d 935, 940-941 (7th Cir. 2008), cited by the court in LeBeau, elucidates this point. In Caputo, the Seventh Circuit stated that First Amendment protection for the promotion of off-label uses of a medical product rests on the “assumption” that a manufacturer can lawfully promote the product at all. Id. at 940. The Court stated, “[u]nless the [product] itself could be sold lawfully, there were no lawful off-label uses to promote.” Id. Thus, it appears that the Seventh Circuit would draw a distinction between commercial speech promoting unapproved uses of FDA-approved products and the promotion of unapproved products. First Amendment protection for truthful and non-misleading speech may apply to the former, but not the latter, according to the Seventh Circuit.
There are some important limitations of the LeBeau opinion to consider. First, as noted above, LeBeau is an unpublished opinion, thus, with limited precedential value. However, the principles articulated by the court in Caputo carry weight, at least in the Seventh Circuit, and were relied on, in part, by the court in LeBeau. Second, the pro se defendant-appellant’s arguments in his appellate brief were, at best, unartfully rendered and made without a sufficient understanding of the FD&C Act, the substantial jurisprudence concerning First Amendment protection for truthful and non-misleading commercial speech, and appellate practice. Finally, the promotional statements at issue in LeBeau were related to labeling statements associated with an unlawfully marketed drug. It is important to recall FDA regulations regarding preapproval promotion of unapproved, investigational drugs, which permit commercial speech in the context of scientific exchange and are intended only to restrict “promotional claims of safety or effectiveness of the drug for a use for which it is under investigation and to preclude commercialization of the drug before it is approved for commercial distribution.” 21 C.F.R. § 312.7(a).
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