A San Diego County woman brought a class-action lawsuit against a medical product manufacturer and four individuals in the Superior Court of California, County of San Diego, on Feb. 6, alleging unfair trade practices.
Stacy Lucas filed charges against BREG Inc., et al, on charges of fraud, omission or concealment of safety information, unfair competition practices including false advertising.
Lucas alleges she and others acquired the BREG “Polar Care 500” cold therapy device by prescription from 1992 to the present. According to court papers, BREG allegedly received over 18 accident reports dating back to 1998 regarding tissue damage from this product categorized as “cold injury” similar to frostbite.
According to the complaint, BREG did not properly report these incidents to the FDA. The suit cites issues with the language contained in the instructions, which condone “continuous use” for certain periods of time; and alleges continued marketing despite consumer concerns.
Defendants are: Orthofix International, NV of the Netherlands Antilles; Brad Mason, President and CEO of BREG; Greg Nelson, vice president and director; Gary Losse, officer and director of Oasis Sports Medical Group, Inc., who prescribed the product to the plaintiff; and Mark Howard, a former Oasis employee and a current BREG program director. All four individuals are San Diego County residents.
The plaintiff seeks injunctive relief and reimbursement for the product cost and punitive damages, along with attorneys’ fees. She is represented by Marc Stern of the Law Office of Marc O. Stern, La Jolla, California. Judge Joan M. Lewis is presiding over the suit.