Unapproved 'Brain Wave' Devices
Condemned after Seizure Reports
Under an FDA-requested court order, 78 seized cartons of unapproved medical devices valued at $200,000 were destroyed in Little Rock, Ark., in June 1993 after at least 12 complaints attributed epileptic seizures to their use. The manufacturer destroyed another $200,000 worth of the devices rather than have them seized.
The devices were various models of a product called the InnerQuest Brain Wave Synchronizer--headgear (an audio cassette and eyeglasses) that emitted sounds and flashing lights. Sold without prescription and promoted to relieve conditions such as stress, InnerQuest had never been proven safe and effective.
On April 22, 1993, Judge Stephen M. Reasoner, of the U.S. District Court for the Eastern District of Arkansas, ordered the devices condemned and destroyed. The court ruled that the products were:
- class III medical devices, requiring FDA pre-market approval
- adulterated because they weren't approved, or exempted from approval, by the agency
- misbranded because they weren't labeled with adequate directions for use and the firm wasn't registered with FDA.
The device manufacturer, I.Q. International, Inc., of Little Rock, was previously known as Psych-Research, Inc.
In September 1989, FDA's San Francisco district office detained a shipment of InnerQuest glasses because they were accompanied by medical claims. Inspecting Psych-Research in October, Robert Wilson Jr. and Newton Brown, of FDA's Dallas district office, found the firm was making medical devices, including InnerQuest, but hadn't met FDA's registration and listing requirements.
On Nov. 9, 1989, through the firm's attorney, Jay Geller, Psych-Research applied to FDA to market InnerQuest under Section 510(k) of the Federal Food, Drug, and Cosmetic Act. This section allows marketing if a device is "substantially equivalent" to a marketed product that doesn't require pre-market approval.
Over the next few months, FDA staff and Geller discussed the application, which did not properly document that the "predicate" device (a brain wave synchronizer to which InnerQuest was compared) had been marketed before the 1976 amendments to the FD&C Act that brought medical devices under FDA's authority. The agency explained what was needed, such as invoices proving interstate shipment. FDA physiologist Stephen Hinckley told Geller that flashing lights could cause epileptic seizures and that concentrating light to the eye, as InnerQuest did, might increase the possibility of seizures.
In March 1990, FDA formally notified Psych-Research by letter that InnerQuest was a medical device and that the law requires device firms to register and list their products with FDA and submit a proper application before marketing.
Wilson and Brown reinspected Psych-Research in August. They found the firm had contracted with a local firm, Lucas Industries, Inc., to make the devices, basic operating unit and was stockpiling inventory in anticipation of increased sales through a national distributor headquartered in San Francisco. But Psych-Research president, W. A. Robinson, made them stop taking photographs required for the inspection and refused to let them review or have a list of his inventory, asserting that his firm was not distributing medical devices.
Discussions continued as Geller submitted more documents, and Hinckley and others at FDA reiterated the requirements for a 510(k) application.
In a letter dated March 29, 1991, FDA informed Geller that InnerQuest was not "substantially equivalent" because the firm failed to establish that the product they claimed equivalence to was legally marketed in the United States. The letter stated that InnerQuest was a class III device, requiring FDA approval, and that marketing it without approval was illegal.
Geller submitted a new 510(k) application on May 14, 1991, again trying to prove that the product they claimed equivalence to was legally marketed in the United States.
In August 1991, FDA investigators Randy Baxter and Frederic French inspected Psych-Research. They found it had added two new InnerQuest models and audio cassette tapes promoting uses such as diet control, pain relief, and increased mental capacity. Again, the firm refused to allow photographs. The investigators learned that Psych-Research had bought Lucas Industries, renamed it PR Technologies, Inc., and moved it to a new location in Little Rock.
Shortly afterwards, FDA notified Geller that the second marketing application did not prove that InnerQuest was substantially equivalent, and reiterated that pre-market approval was required.
FDA reinspected Psych-Research from July 14 to 16, 1992. The agency wanted updated information on the marketing of InnerQuest, labeling claims, and an inventory of the products—for regulatory action. The inspection confirmed continued misbranding and distribution of the unapproved device. Also, the firm had changed its name to I.Q. International (IQI).
During a July 27 visit to the national distributor by FDA's San Francisco district office, investigators learned of 12 reports of epileptic seizures the firm had received from its retail stores across the nation. The firm agreed to return the brain wave synchronizers to its distribution center in Little Rock for return to IQI.
At FDA's request, Arkansas state officials embargoed the devices at the Little Rock distribution center, and on Nov. 4, 1992, FDA compliance officer James Lahar accompanied a deputy U.S. marshal in seizing the devices.
Also at FDA's request, on Feb. 1, 1993, more devices, which had been returned from a foreign consignee, were seized in Little Rock.
A hearing was held Feb. 26 on an IQI temporary restraining order-injunction filed against FDA in bankruptcy court for release of the devices. The claim gave numerous reasons for alleging the products weren't medical devices—for instance, that Robinson no longer intended the products to alter brain wave function.
The court held, however, that Robinson's reasoning was illogical, stating: "Why would a person want to buy Mr. Robinson's 'brain wave synchronizers' if they did not believe it altered brain waves? Mr. Robinson's self-serving statement that the intended uses of his products have suddenly changed is simply not credible."
The court found none of the reasons valid and dismissed IQI's injunction request on March 4.
IQI withdrew its claim on March 23.
On April 5, IQI destroyed its inventory of devices and major components to avoid their seizure. On May 13, the court released to FDA 35 devices the agency had requested for educational programs. On June 9, FDA investigator Paula Edge and two deputy U.S. marshals witnessed a bulldozer crush the remaining seized devices at a landfill.
This article was originally published in the March 1994 issue of FDA Consumer. Ms. Farley was a staff writer.
This article was posted on February 13, 2005.