Magnolia Medical Technologies said yesterday it filed a lawsuit against blood-culture-focused device developer Kurin claiming the company “mischaracterized its clinical data as well as the functionality and ease of use of its device.”
The suit comes in response to a similar suit filed by Kurin in the Southern District of California in May which claimed that Magnolia violated the Lanham Act based on false and misleading statements. Kurin claims that Magnolia falsely implied that “its Steripath device is FDA approved/cleared, and misrepresents product performance data by selecting only the most favorable results,” according to a press release.
“Making claims about medical product performance is under the purview of the US 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,” CEO Bob Rogers said in a prepared statement in May.
Magnolia, which makes the Steripath initial specimen diversion device, filed its countersuit in the same district court denying all allegations and making its own allegations against Kurin.
In the countersuit, Magnolia alleges that Kurin’s representations of its own devices was false and misleading on several occasions, including mischaracterizations about data used to support advertising statements and ease of use statements and claims that its device employs a “lock,” according to a press release.
“We believe that 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. 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. Our robust published clinical data sets 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. Kurin has no controlled clinical trials that have been published in peer-reviewed journals. From our perspective Kurin is selectively picking and manipulating data, misrepresenting the actual ‘real-world’ results attributable to its product,” Magnolia co-founder & CEO Greg Bullington said in a prepared statement.
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