The FDA announced on November 5, 2012 that it had issued a formal “Warning Letter” to the Tennessee-based company The Avalon Effect Inc. regarding its marketing of a light therapy product that it claims to be a cure or treat symptoms of fungal meningitis as well as methicillin-resistant Staphylococcus aureus (“MRSA”), concussions, Lyme disease, and other diseases. The Warning Letter was issued because the company’s Quantum Series Personal Wellness Pack (“Wellness Pack”) is considered to be a “medical device” under the Federal Food, Drug, and Cosmetic Act (“Act”) because it is intended to prevent, diagnose, treat, or cure a disease, or to affect the body. The FDA warned that the Wellness Pack violated the Act because the company does not have an approved application to market the device or an exemption to investigate the device for purposes of safety and effectiveness.
Furthermore, the FDA warned the company that its device was “misbranded” because the company failed to submit a “510(k)” (before marketing a medical device, a company must submit what is referred to as a 510(k), which is a premarket submission made to the FDA to demonstrate that the medical device to be marketed is at least as safe and effective and substantially equivalent to a legally marketed device that is not subject to Premarket Approval (“PMA”) by the FDA. Submitters must compare their device to one or more similar legally marketed devices and make and support their substantial equivalency claims. Submitters must receive an order, in the form of a letter, from the FDA which finds the device to be substantially equivalent (“SE”) and states that the device can be marketed in the U.S. This order “clears” the device for commercial distribution). Source
In announcing the issuance of the warning letter to the company, a FDA representative stated, ““Consumers should be aware that, especially during disease outbreaks or other public health crises, they may see opportunistic advertisements for products touted as cures or treatments. Bogus medical claims can actually harm consumers by causing them to delay seeking treatments that have been proven to be safe and effective. Consumers should carefully evaluate and discuss the claims with their health care providers.”
The FDA’s Warning Letter that was issued to the company on November 5, 2012 requires the company to take prompt action to correct the violations. If the company fails to do so, the FDA may take regulatory action against the company.
To view the company’s website, click here.
As of November 9, 2012, the CDC reported that Tennessee had 81 cases of fungal meningitis linked to steroid injections, with 13 of those involving death. Nationwide, there have been 438 cases of fungal meningitis in 19 states that are associated with steroid injections, with 32 reported deaths. The U.S. state with the most total cases of fungal meningitis related to steriod injections is Michigan (128), with the most deaths reported in Tennessee (13).
Fungal meningitis is a very serious medical condition that must be promptly diagnosed and properly treated with the best effective medical treatment in order for the suffers to have the best chance of survival and recovery. The last thing anyone who has been diagnosed with fungal meningitis needs is false claims of treatment options and treatment efficacy.
If you or a family member may be effected by fungal meningitis due to a steroid injection, it is important to promptly consult with a medical malpractice attorney to learn about your rights and responsibilities with regard to a potential medical malpractice or product liability claim.
Click here to visit our website to be connected with medical malpractice lawyers or product liability lawyers in your state who may be able to assist you with your possible claim, or call us toll-free at 800-295-3959.
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