The landmark 2010 Supreme Court opinion in Citizens United cemented what had been a progressive transformation of the First Amendment into what one scholar has dubbed “the darling of economic libertarians and corporate lawyers who have recognized its power to immunize private enterprise from legal restraint.” Tim Wu, The Right to Evade Regulation: How corporations hijacked the First Amendment, New Republic, June 3, 2013. Four years later, the First Amendment is still being used as a shield for corporations, most recently by the Pharmaceutical Research and Manufacturers of America (“PhRMA”), which filed an amicus brief in a False Claims Act (“FCA”) suit that charged drug makers with issuing off-label claims. See United States ex rel. Solis v. Millennium Pharm. Inc., et al., No. 2:09-cv-3010. In the complaint, the Relator claimed that the manufacturer’s off-label promotion violated the FCA because the Food, Drug, and Cosmetics Act (“FDCA”) forbids the promotion of drugs for uses that were not approved by the FDA, thus supposedly rendering any claims influenced by the manufacturers’ off-label promotion (such as Medicare reimbursement claims) false because they allegedly ask the government to pay for illegal activity. PhRMA asked the court to dismiss the suit, arguing that the case infringes upon the companies’ free speech rights.
In its brief, PhRMA maintained that “[i]nterpreting the FDCA to punish manufacturers for truthfully speaking about unapproved uses impermissibly restricts speech based on its content and identity of the speaker.” PhRMA—no stranger to corporate First Amendment arguments having made the argument for examining FDA rules through a First Amendment lens as early as 2002—makes its point in the wake of a stream of opinions that together exhibit an increased willingness of courts to recognize pharmaceutical advertising as commercial speech deserving of constitutional protection.
Though an earlier case that opined on the First Amendment and pharmaceutical advertising was decided in 2002, see Thompson v. Western States Med. Ctr., 535 U.S. 357 (2002), perhaps the most well-known of the opinions—Sorrell v. IMS Health Inc., 131 S. Ct. 2653 (2011)—involved a Vermont statute that restricted the access of pharmaceutical companies to information about prescriptions that the companies would use in their marketing. In a 6-3 opinion, the Supreme Court held that the law was an unconstitutional restriction on speech. The Second Circuit famously relied on this opinion in its 2012 Caronia decision, which found that a pharmaceutical sales representative could not be charged with misbranding a drug by promoting off-label use because to do so would be a violation of the First Amendment.
The use of the First Amendment to protect commercial speech has not been limited to pharmaceutical advertising. Indeed, various food trade groups invoked the First Amendment this summer in their challenge to Vermont’s genetically modified food labeling law and, as we have previously written (see here), federal courts have issued conflicting rulings with respect to whether requiring tobacco companies to place certain warning images on cigarette packages infringes upon the tobacco companies’ free speech. In any event, we can expect the commercial speech argument to continue as a new brand of defense against regulation.