Glucosamine Case Can Inform Drug, Device Cases: Attorney

A recent New York federal court dismissal of a dietary supplement preemption case can be instructive for drug and medical device manufacturers. Attorney Stephen McConnell (Reed Smith) writes in an online Drug and Device Law post that the case was one of several around the U.S. that involved plaintiffs suing manufacturers and sellers of glucosamine supplements, complaining that the product contained a glucosamine blend instead of single crystal glucosamine.

The court dismissed the case on the grounds that the Federal Food, Drug, and Cosmetic Act preempted the claims and that the state consumer protection law claims failed on the merits.

McConnell says the plaintiff argued that the product was mislabeled because it called itself glucosamine sulfate, suggesting single crystal glucosamine, when in reality it contained a glucosamine blend.

The court held that FDA had accepted the nomenclature because it was included in the U.S. Pharmacopeia. According to the decision, once FDA had chosen to rely on a compendium the plaintiff could not disregard the compendium and it was not the court’s role to second-guess the scientific and technical judgment of FDA.

In the drug/device area, McConnell writes, the government (Medicare and other programs) likewise relies on official compendia of valid off-label uses to determine the reimbursability of the cost of drugs/devices that are used off-label.

The glucosamine defendant also argued that the plaintiff’s claims were preempted to the extent they were premised on testing at odds with FDA regulations. “We similarly see instances of plaintiffs making claims against drugs (not devices, as far as we know) based on their own questionable testing,” McConnell writes…. “To the extent that FDA has made regulatory decisions based on different types of testing, preemption could also be a defense.”