Biolase Technology has filed a counterclaim lawsuit against Indianapolis-based National Laser Technology (NLT), alleging violations of FDA regulations, federal trademark infringement, false designation of origin, unfair competition, and false advertising in a suit involving a range of alleged business practices and market access for dental lasers.
NLT, which claims to be the largest reseller of Biolase products in the world, filed a lawsuit against Biolase on August 20, alleging unfair competition and coercion. Biolase has formally denied these allegations and is now asserting its own counterclaims against NLT for unlawful conduct.
"Biolase is a respected company in the dentistry industry, and we will vigorously defend our reputation against what we believe is unfair business practices by competitors," said CEO Jake St. Philip in a company press release. "This suit is about patient safety, fairness, and truthful product promotion."
Biolase's counterclaims allege that NLT has violated the Federal Food, Drug, and Cosmetic Act by modifying and reselling Biolase's products without complying with federal medical device regulations. By providing modifications that have not been cleared by the FDA, Biolase alleges that these changes could potentially place dentists and Biolase at risk of liability if patients are injured by a laser adulterated by NLT.
Biolase's counterclaims further allege that NLT intentionally infringed upon Biolase's federally registered trademarks by, among other things, unlawfully using the names "AMD Waterlase" and "AMDLase." Biolase seeks a permanent injunction enjoining NLT from continuing to engage in any unlawful conduct. Biolase also seeks damages and costs. The lawsuit is pending in the U.S. District Court for the Southern District of Indiana.
"We believe that National Laser Technology has deliberately misled the public by suggesting an affiliation with Biolase that simply does not exist," St. Philip said. "Despite what NLT may be suggesting, there is no connection or association between NLT and Biolase. To be clear, NLT is not now and has never been an authorized dealer of Biolase products."