Antitrust Law Daily Wrap Up, ADVERTISING—D. Utah: One of four Lanham Act claims preempted by Food, Drug and Cosmetic Act, (Jul 21, 2014)

By Bryant Storm, JD

One of four Lanham Act false advertising claims brought by a medical device manufacturer against a competitor was dismissed as preempted by federal law because the claim, relating to the Food and Drug Administration (FDA) approval process for the competitor’s product, would require a federal court to encroach on FDA expertise. The federal district court in Salt Lake City held that it was qualified to resolve factual disputes regarding three of the advertising claims and left the one issue of premarket approval for the FDA to resolve (Catheter Connections Inc., v Ivera Medical Corporation, July 17, 2014, Campbell, T.).

Regulation. The FDA regulates medical devices under the authority granted to it by the federal Food, Drug and Cosmetic Act (FDC Act). The FDA’s premarket approval process requires original medical devices to receive approval or clearance from the FDA prior to their introduction and sale in the market. Under the FDA’s 510(k) process, a manufacturer may obtain product approval by showing that the new product is “substantially equivalent” to a device that has already received FDA approval.

Advertising. False advertising claims brought under the Lanham Act against medical device manufacturers related to advertising of medical devices are complicated by the FDA’s regulatory authority. Although a private claim against a medical device manufacturer can succeed under the Lanham Act, it can do so only if it does not infringe on the FDA’s regulatory authority by attempting to privately enforce the FDC Act or by asking a court to decide an issue over which the FDA has exclusive discretion.

Catheters. Catheter Connections Inc. and Ivera Medical Corporation (Ivera) are manufacturers and competitors in the medical device market for infection control devices. The devices at issue were disinfectant caps that are incorporated into intravenous lines used to deliver fluids and drugs to patients. The products serve a dual function of preventing infection and preventing the disinfectant from entering the patient’s bloodstream. In November 2012, Ivera received 510(k) approval for a disinfecting cap device it called the X10. In December, Ivera began marketing and selling a newer design, the X13 model, under the FDA clearance letter from the X10. Ivera used language from the FDA approval of the X10 when marketing the X13 on both its website and the X13 packaging.

After Catheter Connections obtained an injunction in April 2014, preventing Ivera from selling the X13 because of a patent violation, Ivera developed a newer design of the X13 disinfecting cap called “the Rev. G.” Once again, Ivera did not obtain 510(k) approval and relied on statements from the X10 product’s approval when advertising the Rev. G. product. Catheter Connections filed a request for a preliminary injunction and temporary restraining order to stop Ivera’s advertising of the Rev. G, contending Ivera was engaging in false advertising under the Lanham Act.

Ad claims. Ivera made four advertising claims related to its Rev. G disinfecting cap that Catheter Connections challenged. The claims included assertions that: (1) the Rev. G did not need FDA approval apart from the November 2012 approval of the X10; (2) the Rev. G prevents the disinfectant from leaking into the infusion line and posing a safety risk to the patient; (3) Ivera tests revealed that the Rev. G was effective against six microorganisms; and (4) the FDA found the Rev. G was effective against six microorganisms.

Preemption. Ivera contended that each of the four claims was preempted by federal law because each claim was premised upon Ivera’s assertion that the Rev. G did not need additional market approval. In other words, Ivera argued that the court would have to interpret the FDC Act in order to resolve the claim. The court agreed with Ivera with respect to the first advertising claim. The question of whether Ivera had properly navigated the 510(k) process for the Rev. G was a question that only the FDA could answer. However, the court held that the three remaining advertising claims could survive because each rested on a factual question that the court was qualified to decide.

The court reasoned, for example, that the question of whether Ivera did or did not conduct a particular study was simply a factual one that required no special expertise or regulatory authority. The court did not rule on the question of whether an injunction or restraining order was appropriate for the surviving three claims, but required Ivera to file an opposition to Catheter Connection’s motion on that issue within 14 days.

The case number is 2:14-CV-70-TC.

Attorneys: Charity R. Williams (Law Office of Charity R. Williams) for Catheter Connections, Inc. Jonathan Hangartner (X-Patents APC) for Ivera Medical Corporation.

Companies: Catheter Connections, Inc.; Ivera Medical Corporation

Cases: Advertising UtahNews