Two Nexus Suits Invoke Buckman Implied Preemption

Two suits filed by Nexus Pharmaceuticals against two drug compounding firms were dismissed by a California federal court under implied preemption as stated in Buckman v. Plaintinffs Legal Committee. Attorney James Beck (Reed Smith) says in an online post that the court said the suits were preempted because Nexus challenged FDA’s determination that the compounding firms’ products were not “essentially a copy” of Nexus approved drugs.

The court held that FDA approval is within the scope of the Federal Food, Drug, and Cosmetic Act’s (FFDCA) comprehensive regulatory authority and said Nexus was asking the court to displace the law.

It said the FFDCA is to be enforced exclusively through FDA’s comprehensive regulatory authority. Granting the requested preliminary injunction, the court said, would ignore Congress’ determination that the public interest is best served when the FFDCA is enforced by FDA.