Magnolia Medical Countersues Kurin for False & Misleading Advertising, Unfair Competition.
Magnolia is the pioneer in Initial Specimen Diversion, both the technique and technology, for blood culture collection and contamination prevention, and inventor of the Steripath Initial Specimen Diversion Device franchise. In Magnolia's countersuit, filed in federal court in the Southern District of California, the company emphatically denies all allegations contained in an initial complaint filed by Kurin and alleges specific claims against Kurin.
"We believe Kurin's lawsuit is meritless and nothing more than a tactic by Kurin to distract customers and to attempt to hinder Magnolia's growth and success in the marketplace," said Greg Bullington, Magnolia co-founder and CEO. "Magnolia takes great pride in being an evidence-based company and remains focused on providing a clinically proven technology solution that removes human factors to virtually eliminate blood culture contamination and false positive diagnostic results for sepsis, improving patient safety and driving antimicrobial stewardship."
Magnolia's proprietary and patented technology is supported by two controlled clinical studies published in leading peer-reviewed medical journals and seven clinical abstracts accepted and presented at major medical conferences. "Our published clinical datasets are technology-specific, using a clinically proven diversion volume and proprietary product design attributes. Every statement we make is supported by verifiable data that has not been manipulated to report better results," Bullington said.
Steripath has become the standard of care for blood cultures drawn in a rapidly growing number of hospitals across the United States. The only technology of its kind, Steripath mechanically diverts, sequesters, and isolates the initial 1.5-2.0 mL of blood, the portion known to contain contaminants. The device then opens an independent, second sterile blood flow path for specimen collection into the blood culture bottles.
In contrast, "Kurin has no controlled clinical trials that have been published in peer-reviewed journals," Bullington added. In March 2018, Kurin's first non-controlled clinical data set from a five-month evaluation was presented at a conference. However, two months, or 40 percent, of the data was not reported after "traveling nurses" did not properly use the device, resulting in a"big bump"in contamination rates, according to a presentation of the results. Further, while the published results suggest eight contaminations during the study period, the presentation of the results at the conference indicated there were 15 contaminated blood cultures.
"From our perspective, Kurin is selectively picking and manipulating data, misrepresenting the actual'real-world'results attributable to its product," Bullington said.
Accordingly, Magnolia's counterclaims allege several instances where Kurin's representations about its own device are false and misleading, including its mischaracterizations about data used to support its advertising statements, as well as statements about the product's ease of use, the claim its device employs a "lock,"and Kurin was first to market when it was not.
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|Title Annotation:||TOP OF THE NEWS|
|Publication:||Medical Product Outsourcing|
|Date:||Sep 1, 2018|
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