While the focus of this blog is on product liability cases, we have had occasion to touch upon Lanham Act cases involving litigation between commercial competitors. One reason is because Lanham Act cases provided significant early precedent for the principle that FDA exclusive enforcement powers prohibit plaintiffs from bringing what amount to private FDCA violation claims in the guise of private civil litigation. You’ll find no shortage of posts here expounding that 21 U.S.C. §337(a) represents express congressional policy that nobody but the FDA can seek to enforce the FDCA in a court of law. The concept took a hit with the Supreme Court’s decision in POM Wonderful v. Coca-Cola Co., 134 S.Ct. 2228 (2014), discussed here, but that decision involved food, not drugs or devices, which is an important distinction because the FDA does not pre-approve food labels. And indeed, drug and device cases post POM Wonderful have done a good job of holding to that distinction finding that POM Wonderful didn’t open the door to Lanham Act claims that are based on proving FDCA violations. A couple of 2019 cases discussed here and here.
Which brings us to today’s case – Belcher Pharmaceuticals, LLC v. Hospira, Inc., slip op. (M.D. FL Jan. 7, 2020). The facts here are interesting. The drug at issue was epinephrine. Defendant had been manufacturing the drug since before the 1938 enactment of the FDCA. Therefore it was grandfathered – did not need FDA approval. However, the drug was in short supply. So, the FDA asked the defendant to increase production, which defendant did. A few years later, plaintiff had a competing product approved. By 2017, the shortage was over and the FDA ask defendant to stop manufacturing its grandfathered product. Defendant complied. Not surprisingly, once defendant discontinued its product, plaintiff saw an increase in the sales of its product. Slip op. at 1. Plaintiff brought suit under the Lanham Act alleging that defendant falsely advertised its product as FDA-approved when it was not and sought recovery of any profits defendant made “for doing what the FDA requested.” Slip op. at 2. Talk about no good deed goes unpunished.
First, it was undisputed that defendant “never explicitly marketed its products as FDA-approved.” Slip op. at 6. Rather, plaintiff argued that defendant misled consumers into believing the product was FDA-approved merely based on the fact that defendant was selling its product. Plaintiff pointed to the fact that defendant’s labeling and packaging included indications for use and shelf-life representations. Id. So, the pre-1938 product had labeling that looked like labeling that would routinely accompany FDA approved products. OK? And? There has to be more right. Yep.
[T]he very act of placing a drug on the market, with standard package inserts often used for FDA-approved drugs fails to state a claim under the Lanham Act because it would usurp the FDA’s authority to enforce the Food, Drug, and Cosmetics Act.
Id. at 7-8 (citations omitted). The court doesn’t elaborate, but it doesn’t need to. Where a case involves the intersection of the Lanham Act and the FDCA and would require the court to interpret and/or apply the FDCA, such claims are not permitted. It’s not a products case, but any decision that trumpets FDA authority deserves a shout out on this blog.