By Rebecca Mayo, J.D.
A district court found that Rite Aid failed to show substantial ground for difference of opinion as to the question of law, sufficient to grant an order certifying the question of federal preemption.
A tentative final monograph issued by the FDA that does not mention the type of product at issue and FDA guidance that does not establish guidelines for a legally marketed product, are not requirements as defined in the Food Drug and Cosmetic Act (FDC Act). A district court found that because these guidance documents did not create a requirement under the National Uniformity for Nonprescription Drugs provision of the FDC Act, they could not preempt state law claims related to labeling of drug products (Bailey v. Rite Aid Corporation, October 25, 2019, Rogers, Y.).
Rapid release claim. In 2005, Tylenol Extra Strength Rapid Release Gels were released and in 2008 Tylenol PM Rapid Release Gels were released. These products were advertised as having specially designed holes in the gelcaps that allowed for the release of medicine faster than previous products. In response to these products, Rite Aid released its own version of the products and marketed them as comparable to the Tylenol counterparts. However, the Rite Aid products did not contain the unique laser drilled holes that were meant to allow for the rapid release, even though they were advertised and labeled as rapid release.
Class action. A consumer purchased a bottle of Rite Aid Acetaminophen Rapid Release Gelcaps, for a price more than the brand’s non-rapid release acetaminophen. The consumer claimed he relied on the marketing and labeling that misled him to believe that the Rite Aid Rapid Release product would provide faster relief than other Rite Aid products. In fact, rapid release does not actually work faster than non-rapid release products and a study showed that Rite Aid Rapid Release Gelcaps dissolve slower than the Rite Aid non-rapid release products. The consumer brought a putative class action against Rite Aid asserting eight causes of action arising out of the sale and marketing of the over-the-counter rapid release acetaminophen gelcaps. Rite Aid argued that the claims were preempted and moved to dismiss the claims. The court rejected the preemption argument and denied its motion on that basis (see State claims against ‘rapid release’ acetaminophen not preempted, Sept. 10, 2019). Rite Aid then moved for an order to certify the question of federal preemption to the Court of Appeals.
Difference of opinion. A district court may certify appeal of an interlocutory order if the order involves a controlling question of law, appealing the order may materially advance the ultimate termination of the litigation, and there is substantial ground for difference of opinion as to the question of law. The court here found the substantial ground for difference of opinion to be the only requirement at issue.
Rite Aid argued that the Court’s determination that the FDA Guidance it presented did not constitute a requirement under the FDC Act was counter to previous circuit court decision that held the FDA had promulgated specific requirements through a guidance. Here, the court noted that the FDA guidance at issue did not reflect a purpose of establishing guidelines for a legally marketed product. Therefore, Rite Aid failed to show substantial ground for difference of opinion as to whether the FDA guidance at issue here constituted a requirement under the FDC Act.
Rite Aid further argued that the court’s finding that the dissolution standards for immediate release acetaminophen did not encompass testing and dissolution procedures for rapid release acetaminophen because the two are not synonymous. The court here pointed to FDA publications, which included those provided by the consumer, which suggested that immediate and rapid were not synonymous and that drugs with rapid dissolution were, at most, a subset of those categorized as immediate release. The fact that FDA regulated the subject-matter of immediate release acetaminophen did not establish that a substantial ground for a difference of opinion exists where the consumer challenged the designation and marketing of a product as rapid release.
The case is No. 18-cv-06926-YGR.
Attorneys: Brittany A. Boswell (Simmons Hanly Conroy LLC) for Thomas Bailey. David Alexander Hickerson (Foley & Lardner LLP) for Rite Aid Corp.
Companies: Rite Aid Corp.
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