Consumers have a right to expect that medical device manufacturers not market their products in the United States for uses that have not been approved by the Food and Drug Administration (“FDA”). Accordingly, when an unscrupulous company misleads consumers by claiming that a product is fit for a purpose for which it has not been approved, consumers have a right to hold that company to account in a court of law.
Recently, the FDA issued a warning letter to SyncThink stating that it was engaging in precisely such behavior with its EYE-SYNC device, which was cleared as a prescription device only for the purpose of recording, viewing, and analyzing eye movements to help identify visual tracking impairment in human subjects. Indeed, the FDA found that “[SyncThink’s] promotion of the device provides evidence that the device is intended for cognitive assessment/testing of concussions and head trauma, including in injured athletes and soldiers, which would constitute a major change or modification to its intended use, for which your firm lacks clearance or approval.” Accordingly, the FDA recommended that SyncThink “immediately cease activities that result in the misbranding or adulteration of the EYE-SYNC device, such as the commercial distribution of the device for the uses discussed above.”
When consumers purchase a medical device reasonably believing, because of deceptive and misleading product claims, that it has been approved for use as a concussion detection tool, when it, in fact, has not, the company selling that device has been unjustly enriched at consumers’ expense. The attorneys at Finkelstein, Blankinship, Frei-Pearson & Garber, LLP have successfully brought lawsuits on behalf of consumers aggrieved by such deceptive product claims. If you have purchased SyncThink’s EYE-SYNC Device, please contact us today for a free consultation regarding your legal options.