The November 2013 issue of the Yale Law Journal features a very interesting comment on an important issue at the intersection of health law and policy. A First Amendment Approach to Generic Drug Manufacturing, by Connor Sullivan, argues that the First Amendment principles underlying the Supreme Court’s opinion in Sorrell v. IMS Health Inc. provide a viable legal avenue for challenging the FDA regulations that prevent generic drug manufacturers from sending letters warning physicians of the risks of their drugs.
These FDA regulations became a source of legal controversy when the Supreme Court heard PLIVA, Inc. v. Mensing, 131 S. Ct. 2567 (2011), a case concerning whether the FDA’s requirement that generic drug manufacturers use the same labels as brand name manufacturers preempts state tort laws that allow injured parties to challenge the sufficiency of a generic manufacturer’s warnings. The Court held that the FDA requirements did pre-empt state tort law on the theory that a generic drug manufacturer could not comply with both the FDA labeling requirements and state tort law at the same time because state tort law might require different, greater warnings than the brand name manufacturer of that same drug used. The Court noted the unfortunate inconsistency that had befallen the plaintiffs in the case; had they taken the brand name drug, they could challenge the labeling requirements of the brand name manufacturer, which has the flexibility under federal law to change their labeling scheme. But because the plaintiffs took the generic version of the same drug, their suit was foreclosed.
We might intuitively assume that these plaintiffs could simply sue the brand name manufacturer; after all, it is their poor labeling scheme that the plaintiffs were challenging by noting the deficiencies in the generic manufacturer’s similar label. But the law is not so wise. After many attempts and subsequent failures to convince a court of such an argument, the law has virtually foreclosed any mechanism for an injured party to recover from a brand name manufacturer for the labeling deficiencies that are passed onto a generic manufacturer. Indeed, Sullivan cites to Gardley-Starks v. Pfizer, Inc., 917 F. Supp. 2d 597, 604 n.4 (N.D. Miss. 2013), which noted that “sixty-six decisions applying the law of twenty-three different jurisdictions [have held] that brand name manufacturers of a drug may not be held liable under any theory for injuries caused by the use of a generic manufacturer’s product.”
In sum, the combination of FDA rules and a Supreme Court pre-emption decision has created a real inconsistency in how people experience the tort laws as applied to their drug manufacturers. After the jump, I’ll explain Sullivan’s idea for solving this problem.
As part of the Mensing litigation, the plaintiffs argued that generic manufacturers could have sent “Dear Doctor letters” to provide additional warnings about their drugs to prescribing physicians. The thrust of the argument was that these letters are not part of a generic drug’s label, and therefore a generic manufacturer could send them without violating the FDA regulations at issue. However, the FDA interpreted its labeling regulations as encompassing “Dear Doctor letters,” meaning that generic manufacturers could not independently send such letters without running afoul of the sameness requirement. While Sullivan explains that the plaintiffs did not mount much of an argument against this interpretation, he contends that not all hope is lost. He suggests a novel argument that would upend the FDA’s authority to prevent generic manufacturers from sending these letters.
As Sullivan explains, the Supreme Court in Sorrell v. IMS Health, Inc., 131 S. Ct. 2653 (2011), invalidated a Vermont statute that “prohibited brand name manufacturers from accessing or using ‘prescriber-identifying information’ to tailor marketing to individual physicians” on First Amendment grounds. I’ll save you from some of the convoluted First Amendment doctrine involved here, and simply quote Sullivan explaining the importance of the case for present purposes: “The case says at a minimum that pharmaceutical manufacturer speech has First Amendment value; open communication between manufacturers and physicians is an important aspect of the free flow of ideas in society.” Sullivan further explains that the Second Circuit has applied this principle from Sorrell to the context of off-label marketing regulations, which prevent manufacturers from advertising drugs for unapproved uses. Applying these cases to the “Dear Doctor letters” partially at issue in Mensing, Sullivan concludes that the FDA interpretation regulating these letters “actively discriminates against speakers: brand-name manufacturers may independently send Dear Doctor letters, but generic manufacturers may not. The interpretation also burdens specific content: generic manufacturers may send approved advertising material to physicians, but they may not communicate unapproved information, even when truthful.”
Sullivan’s analysis goes much deeper than this blog post will permit, and it is well worth the read. But the punch-line here is that, if the FDA could not constitutionally regulate “Dear Doctor letters,” the pre-emption issue that was presented in Mensing would disappear. Once generic manufacturers are permitted to send warnings to physicians, injured parties can legitimately claim that, under state tort law, their warnings (or lack thereof) were insufficient. Of course, none of this is to say that the First Amendment doctrine on which Sullivan’s comment relies has been a positive development in the law. In all honesty, I personally found Justice Breyer’s dissent in Sorrell to be extremely persuasive. But Sullivan seems to have exposed an interesting and logical application of Sorrell to a real problem in health law and health policy.