NEW YORK (360Dx) – Medical device firm Kurin this week sued Magnolia Medical Technologies for allegedly making false claims about its Steripath blood culture collection system, which competes with Kurin's similar technology.
Magnolia's Steripath is designed to divert a small volume of an initial blood sample from the main collection container to prevent contamination and false positives. Kurin, meanwhile, markets a similar product called the Kurin Lock. Unlike Steripath, Kurin Lock has received 510(k) clearance from the US Food and Drug Administration.
In its suit — which was filed in the US District Court for the Southern District of California — Kurin alleges that Magnolia has made inaccurate claims about the efficacy of Steripath, as well as the system's status with US regulators.
Specifically, Kurin said that Magnolia represents Steripath as "registered and listed" with the FDA as a Class I device while providing "false and misleading" claims about its efficacy, which together imply FDA approval to consumers.
Among Magnolia's alleged false claims is that the use of Steripath results in a false positive rate of .2 percent and a 92 percent decrease in contamination rates, Kurin told the court. However, "reported clinical studies of Steripath show contamination rates as much as 8.5 times higher than the claimed contamination rate … and decreases in contamination rates as much as 20 percent lower than the claimed … decrease," Kurin charged.
The Steripath claims are, in fact, based on "the single best result for each measurement among multiple studies, none of which reflects real-world conditions and where other studies showed materially worse performance," Kurin said in the suit.
"Making claims about medical product performance is under the purview of the US Food and Drug Administration," Kurin CEO Bob Rogers said in a statement. "In this case, the FDA has not cleared Steripath for marketing, so making such claims is irresponsible."
Rogers added that "Magnolia claims 'virtual elimination of false positives' based on studies that do not reflect actual conditions in the hospital, including non-compliance due to deficiencies in their product design. In the real world, there are commonly used procedural exceptions that cannot be ignored when evaluating true product efficacy. To knowingly do so is misleading."
In the suit, Kurin states that Magnolia's activities constitute unfair competition and false advertising. It is seeking an injunction forcing Magnolia to halt all sales resulting from its allegedly false and misleading statements, correct its advertising, and withdraw from any contracts awarded based on its claims.
Earlier this year, Magnolia announced a contract to supply Steripath to US Department of Veterans Affairs hospitals and treatment facilities.
Kurin is also asking the court for damages, among other restitution, and a jury trial.
Representatives from Magnolia were unavailable for comment as of press time.