California-based Kurin has filed a lawsuit against its rival Magnolia Medical Technologies in the US alleging that the latter falsely implied that its Steripath device is approved/cleared by the US Food and Drug Administration (FDA).
Steripath has been developed by the Seattle-based Magnolia as a vein-to-bottle closed blood culture collection system. Magnolia claims that Steripath can virtually remove the preventable error of blood culture contamination and false-positive results for sepsis.
Kurin has sued Magnolia in the US District Court for the Southern District of California, accusing the latter of violating the Lanham Act based by giving false and misleading statements.
In its lawsuit, Kurin has also accused Magnolia of misrepresenting product performance data by picking only the most favorable results.
Kurin CEO Bob Rogers said: “Making claims about medical product performance is under the purview of the U.S. Food and Drug Administration. In this case, the FDA has not cleared Steripath for marketing, so making such claims is irresponsible.
“We have a responsibility to accurately portray the ability of medical devices to improve clinical outcomes. Magnolia has abused this principle, confusing healthcare providers.”
Kurin is the inventor and manufacturer of Kurin blood culture collection sets, which it said are 510(k)-cleared.
According to Kurin, its initial specimen diversion technology automatically and passively diverts potential contaminants at the time of blood culture collection.
When skin microbes enter into blood culture samples, false positive test results could misinform physicians. This could result in unnecessary medical treatment and increase risk for patients and costs for the hospital, said Kurin.
The company said that its automatic blood diversion product, which is protect by patent, is the only blood culture diversion product on the market that is FDA 510(k)-cleared as of now.
Rogers accused Magnolia of falsely claiming ‘virtual elimination of false positives’ based on studies that do not reflect the real conditions in the hospital. Adding further, Rogers said that in the actual world, there are widely used procedural exceptions that cannot be ignored when assessing true product efficacy and intentionally doing so is misleading.