Consumers have a right to expect that products that claim to diagnose, cure, mitigate, treat, or prevent serious medical conditions, such as sleep apnea, have been reviewed by the Food and Drug Administration (“FDA”) and approved for such marketing. Accordingly, when unscrupulous companies mislead consumers by marketing such products without having been approved the FDA, consumers have a right to hold that company to account in a court of law.
Recently, the FDA issued a warning letter to CPAPNEA Medical Supply, who manufactures the Optipillows EPAP mask. Based on the “firm’s website (www.optipillows.com), printed instructions for use, and packaging,” the FDA determined that the Optipillows EPAP mask is adulterated and misbranded because the CPAPNEA Medical Supply failed to secure approval to market the mask for treatment of obstructive sleep apnea and claims that the mask could be used as a substitute for CPAP devices. Specifically, the FDA found:
The Optipillows EPAP Mask is . . . misbranded . . . because statements found in the device labeling are false or misleading because they claim the Optipillows EPAP Mask is as effective as CPAP devices at treating obstructive sleep apnea, suggest that the Optipillows EPAP Mask can be substituted for CPAP devices, and claim that FDA has clear[ed] EPAP technology for treating obstructive sleep apnea.
The FDA further noted that “[m]arketing [the Optipillows EPAP mask] to treat obstructive sleep apnea and suggesting it is as effective as CPAP masks in treating sleep apnea raises serious public health and safety concerns.” As the FDA explained in its warning letter:
CPAP devices are class II devices that are prescribed after a patient is evaluated by a licensed dentist or other health professional and is determined to be an appropriate candidate for the device. To date, your firm has not provided any evidence that supports use of your device to treat obstructive sleep apnea and FDA is unaware of any evidence supporting use of EPAP masks to treat obstructive sleep apnea or that EPAP devices are as effective and safe as CPAP devices for treating obstructive sleep apnea of any severity level.
When consumers purchase a product reasonably believing, because of deceptive and misleading product claims, that the product is safe and approved to use, when it is not, the company selling that product 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 or someone you know has purchased the Optipillows EPAP mask based on the claims made by CPAPNEA Medical Supply on its websites or product labelling, please contact us today for a free consultation regarding your legal options.