Magnolia Medical Technologies, Inc. has announced that the US District Court for the Southern District of California ruled on summary judgment motions in the Lanham Act false advertising case filed between Magnolia and Kurin, Inc.
The Court granted Magnolia’s motion for summary judgment on all of Kurin’s claims—determining, based on the undisputed facts and the law, that it would be impossible for Kurin to prevail on its claims. The effect of the order is that Kurin may no longer pursue its false advertising claims against Magnolia, and they will be dismissed.
In the same ruling, the Court also denied Kurin’s attempt to obtain summary judgment of Magnolia’s counterclaims against Kurin, allowing Magnolia to proceed with its false advertising claims against Kurin.
The Court found that Magnolia’s use of controlled clinical study results in its advertising is appropriate and that the controlled clinical studies cited in Magnolia’s advertising accurately reflect the effectiveness of the Steripath® device. In contrast, the Court stated that the “blended rate” results used in Kurin’s advertising are “the opposite of controlled study results, because the study does not control for the use of the relevant device.”
Additionally, the Court found that Magnolia accurately cited to clinical studies in support of its claims that the Steripath device has demonstrated a 92% and 93% reduction in contamination rate and that Magnolia’s advertising appropriately stated that Steripath “virtually eliminates” blood culture contamination because clinical study results demonstrate that Steripath eliminates “all but less than 1% of false positives.”
Finally, the Court found that Magnolia’s product superiority claims were not false or misleading and Magnolia did not misrepresent the Kurin Lock’s effectiveness in Magnolia’s comparative advertising.
“We are pleased with and gratified by the Court’s ruling. As we have clearly stated from the beginning in response to this meritless lawsuit, Magnolia was founded as an evidence-based company. We rely on clinical data, scientific evidence and documented conclusions from third party institutions and experts to support statements regarding the performance profile of the Steripath device,” said Greg Bullington, CEO of Magnolia Medical.
“We find it unfortunate that Kurin filed this baseless lawsuit in an attempt to gain commercial advantage over Magnolia and create significant confusion in the marketplace. As a result, we were forced to defend against this unfounded lawsuit for over two years at very significant expense. However, as we believe the market recognizes, the real fight between Magnolia and Kurin is in federal court in Delaware, where Magnolia has unilaterally asserted patent infringement of 3 separate Magnolia patents against Kurin,” said Bullington.
The patented Steripath® Gen2 ISDD® product portfolio, including both direct-to-media and syringe configurations, are the only FDA 510(k)-cleared devices indicated to reduce blood culture contamination.1 This exclusive indication was cleared by the FDA based on peer-reviewed published controlled clinical studies demonstrating Steripath’s ability to reduce blood culture contamination by 83%2 and 88%3.
The Steripath Gen2 platform integrates user-controlled negative pressure to divert and sequester the initial 1.5 to 2.0 mL of blood collected for culture, the portion known to most likely contain contaminants.4 The device has been demonstrated effective for use with blood cultures drawn via both venipuncture and peripheral IV starts.2,3
Steripath is a clinically proven solution to address a significant hidden problem in healthcare, misdiagnosis of sepsis.2,3 Improving the accuracy of diagnostic test results for sepsis reduces unnecessary antibiotic treatment. This helps to address the growing threat of antibiotic-resistance, decreases hospital length of stay and associated healthcare-acquired infections while significantly reducing avoidable hospital costs.5,6
Magnolia Medical Technologies develops, manufactures and markets innovative blood and bodily fluid collection devices to facilitate significant improvements in the accuracy, consistency and predictability of critical laboratory tests. Magnolia Medical invented and patented the Initial Specimen Diversion Technique (ISDT™) and Device (ISDD®) for blood culture collection and contamination prevention. The company has amassed an intellectual property portfolio including more than 70 issued method, apparatus and design patents with more than 50 additional patent applications pending.
- Indicated to reduce blood culture contamination when contaminants are present, compared to standard method controls without diversion.
- M. Bell, et al. Journal of Emergency Nursing (2018)
- M. Rupp, et al. Clinical Infectious Diseases (2017)
- Patton, R., et al. Journal of Clinical Microbiology (2010)
- E. Skoglund, et al. Journal of Clinical Microbiology (2019)
- B. Geisler, et al. Journal of Hospital Infection (2019)