Pom doesn't change preclusion analysis for medical devices

Catheter Connections, Inc. v. Ivera Medical Corp., 2014 WL 3536573, No. 2:14–CV–70 (D. Utah, July 17, 2014)

The parties compete in the medical device market for infection-control devices.  At issue here are disinfectant caps incorporated into intravenous (IV) lines that deliver fluids and drugs to patients. Ivera markets its product as Curos Tips (Rev. G model).  Before marketing the predecessor model X13 and the Rev. G, Ivera submitted a prototype (known as X10) to the FDA for 510(k) approval and received a clearance letter.  This letter contained an “Indications for Use Statement”:

The Curos Tips are intended for use as a disinfecting cleaner for male luer connectors. Curos Tips will disinfect the male luer (3) minutes after the application and will cover the luer until removed. The effectiveness of the Curos Tips was tested in vitro against Staphylococcus aureus, Staphylococcus epidermidis, Escherichia call, Pseudomonas aeruginosa, Candida glabrata, and Dandida albicans. The Curos Tips may be used in the home or healthcare facility.

When Ivera began marketing its new X13, it used this language on its website and product packaging.  After the X13 was enjoined in related patent litigation by Catheter Connections, Ivera marketed the Rev. G, and represented or implied to customers that no additional 510(k) clearance was necessary.

Catheter Connections claimed that Ivera engaged in false advertising by claiming (1) that Rev. G doesn’t need further FDA clearance; (2) that Rev. G keeps its disinfectant from leaking into the infusion line and posing a risk to the patient; (3) that Ivera tested Rev. G and found it to be effective against six specific microorganisms; and (4) that the FDA has found that Rev. G is effective against six specific microorganisms.

Ivera argued FDCA preclusion, contending that all these claims required interpreting FDA regulations, specifically that all the claims were based on Catheter Connections’ argument that a new 510(k) approval was required for the new model.  By regulation, new approval is required where a design modification “could significantly affect the safety or effectiveness of the device.”

The Tenth Circuit has a pre-Pom framework for FDCA/Lanham Act preclusion cases: affirmative misrepresentations are generally actionable even if the product is FDA-regulated.  But FDCA violations can’t be pursued using the Lanham Act, nor can claims that require “direct interpretation and application of the FDCA.”  Catheter Connections argued that Pom meant that the Lanham Act overlaps with the FDCA in “marketing and advertising” matters, thus allowing all its claims to go forward.  It pointed to the language in Pom indicating that the FDA “does not have the same perspective or expertise in assessing market dynamics that day-to-day competitors possess.”

However, the court found that the first claim—that it was a misrepresentation to claim that no new 510(k) clearance was required—was precluded.  Catheter Connections argued that the court had all the necessary facts to determine that new clearance was required as a matter of law, given that Ivera admitted that it had changed the design elements that it represented to the FDA gave it its “theory of operation.”  However, these facts didn’t answer the question whether the design change “could significantly affect the safety or effectiveness of the device.” That was a decision for the FDA.

By contrast, the remaining claims were within the scope of the Lanham Act, and resolving them wouldn’t require interpretation of the FDCA or FDA regulations. Those claims focused on the substance of Ivera’s representations “in the context of the medical device market and what drives buyers’ purchasing decisions.”  The issue of whether the Rev. G model kept the disinfectant on the exterior of the connector was “fundamental to the attractiveness” of the device, and resolving the claim would require determining facts about how the device worked, not interpretation or application of FDA policy or regulations.  Likewise, whether Ivera tested the Rev. G model for effectiveness on six specific microorganisms, and whether it got the touted results, was an issue going to marketability.  And the fourth claim, about a misleading representation of FDA approval, also went to marketability, since affirmative FDA approval of effectiveness would attract customers.  “The question is not whether the FDA should have granted approval, but whether FDA made a finding of fact about the product.”   (Note that allowing claims based on implicit misrepresentations of FDA approval can have potentially much broader effects.)
Ultimately, “[a]nalysis of the three claims will focus on the effect such representations have on Catheter Connections, as Ivera’s competitor, in the market. Accordingly, they are not precluded by the FDCA.” 

State law duties imposed on medical device makers can only be parallel to the requirements of the FDCA/FDA.  However, the state false advertising laws at issue here didn’t regulate medical devices, only the alleged misrepresentations to consumers.  Thus, the preclusion analysis applied with equal force to the state law claims: there was no preemption of the nonprecluded claims.