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FDA Consumer magazine
July-August 2000
By Tamar Nordenberg
A lucrative enterprise selling gas grill igniters as pain-relief devices went up in smoke recently when an appeals court ruled that two companies broke the law by marketing the devices without Food and Drug Administration approval.
In September 1999, the appellate court upheld a lower court's ruling that prohibited the two Akron, Ohio, companies, Universal Management Services Inc. and Natural Choice Inc., and their managers, Paul M. Monea and his son Paul A. Monea, from making or selling the "Stimulator" devices. The court also ordered the Moneas to offer full refunds to customers.
The companies made the Stimulators by simply outfitting gas grill igniters with finger grips. Users were instructed to apply the tip of the Stimulator to so-called accupressure points on the body and press on a plunger to send an electric current into the body. The companies also sold an accessory called the "Xtender" to help consumers reach otherwise hard-to-reach areas of the body, such as the spine.
Advertisements for the Stimulator claimed that the device could relieve many kinds of pain, including migraine headaches, painful swollen joints, allergies, sciatica, and carpal tunnel syndrome. Starting in 1994, promotions for the product appeared in USA Today, The New Yorker, and other magazines and newspapers, as well as in national TV "infomercials" that featured celebrities such as daredevil Evel Knievel and actress Lee Merriweather.
According to court documents, between 1994 and 1997 the companies sold a total of 800,000 of the gas grill igniters--which cost them one dollar each--for about $88 apiece. All told, the profits from the Stimulator sales exceeded $65 million, according to FDA estimates.
FDA's interest in the devices was sparked when complaints began coming in to the agency in 1994 from disappointed purchasers of the device. There were no reports of injuries more serious than simple stinging, says Lawrence E. Boyd, a compliance officer with FDA's Cincinnati district. But, Boyd says, "Some people did say the devices caused more pain than they solved. And, you could say the Stimulators were a pain to people's wallets. They were sold mostly to older people with aches and pains, those who could least afford to be targeted."
In May 1995, U.S. Marshals seized about 16,000 Stimulators, worth more than $1.2 million, from the companies' Akron offices. Even after the seizure, the Moneas continued to flout the law by selling the Stimulator and Xtender, Boyd says, which is why FDA went to court seeking an injunction against them and their companies.
The issue for FDA was not whether the devices worked, Boyd says, but more basically that the Stimulator hadn't been demonstrated to work, or even to be safe, and the companies didn't have the FDA approval needed to market it as a medical device.
In December 1997, the U.S. District Court for the Northern District of Ohio ordered a permanent halt to the sale of the unapproved Stimulators and Xtenders, and told the companies to refund the purchase price to those who had bought the devices after the date of the May 1995 seizure.
The court rejected the sellers' claim that the Stimulator fell outside the definition of a medical device. Specifically, the court found that the device did not work primarily through chemical action, as the company argued, and that it was intended to affect the structure or function of the body, as evidenced by the pain-relief claim.
On Sept. 13 of last year, the Sixth Circuit U.S. Court of Appeals agreed with the lower court that the Stimulator and Xtender were medical devices being sold illegally and ruled that the companies could not resume making and selling the unapproved products. Also, the appellate court held, despite the companies' claim otherwise, that it was within the lower court's authority to order a refund of purchasers' money "to make the consumer whole."
In rejecting the companies' buyer-beware, "they-got-what-they-bargained-for" philosophy, the court said, "The approval process exists to protect consumers' health and their pocketbooks ... To circumvent the law by marketing illegally without approval is to deceive the public both as purchasers and users of the device."
To FDA's knowledge, the Stimulator and Xtender are no longer on the market. The Moneas have asked the U.S. Supreme Court to revisit the issue of refunding customers' money and are awaiting the Court's decision on whether it will hear the case.
Tamar Nordenberg is a staff writer for FDA Consumer.
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