NASHVILLE, Tenn. (Legal Newsline) -- Tennessee Attorney General Robert Cooper, Jr., announced a settlement Tuesday with a Tennessee firm that allegedly marketed a medical device without prior approval from the U.S. Food and Drug Administration.
Thomas Michael Haarlander, doing business as The Avalon Effect Inc., allegedly made misleading marketing claims about a medical device called the Quantum Series Wellness Pack.
Haarlander allegedly violated the Tennessee Consumer Protection Act by marketing the medical device with claims it could cure or treat symptoms of fungal meningitis, Lyme disease and methicillin-resistant Staphylococcus aureus without proper substantiation.
Haarlander's company allegedly made the marketing claims between Oct. 11 and Nov. 7, during the substantial media coverage of the nationwide fungal meningitis outbreak.
"It is imperative that a company can show that claims used to market a product are true," Cooper said in a statement. "This is especially true in this case because the claims were made during a time when Tennesseans were already frightened because of the fungal meningitis outbreak.
"It's always a good idea to do some research a product before buying a product or service touting instant or miracle cures or treatments."
Under the terms of the settlement, The Avalon Effect is permanently enjoined from offering any medical device for sale without prior FDA approval, permanently barred from offering for sale any good or service to improve, treat or cure any disease or illness without at least two valid medical studies to support the representations, and required to place $50,000 in an escrow fund to refund customers who bought the product.