Class Action Complaint Filed Against Avadim Health Alleging Deceptive Product Label

In the Southern District of New York, Luz Sanchez and other class members alleged false, deceptive and misleading advertising against Avadium Health concerning a muscle cram relief foam. The class-action complaint was filed Sunday.

Avadim Health is a Delaware company doing its principal business in North Carolina, according to the complaint, and manufactures and sells Theraworx Muscle Cramp & Spasm Relief Foam. The foam allegedly contains magnesium sulfate, which the company claims “Prevents Cramps & Spasms,” “Releases Muscle Tightness” and “Reduces Muscle Soreness,” according to the product label, and that its results are “fast-acting” and “clinically proven,” according to the product’s website.

In order for a product to be consiered clinically proven, the complaint explained, it must be tested for the claims it makes through randomized double-blind studies; in this product’s case, some of its efficacy claims do not tout clinical proof, but since they involve pain relief, the complaint said, the FDA requires those claims also to be proved by randomized double-blind studies. 

According to the complaint, the defendant has five studies meant to provide clinical proof, but they “fail to establish the Product is effective in support of its muscle cramp and spasm relief claims” and instead they focus on treatment of leg cramps and spasms related to restless leg syndrome (RLS) and nighttime leg cramps, when the product is advertised to treat “more generally” everyday cramps and spasms. The complaint purported other issues with the defendant’s studies, including no test of whether the product could prevent cramps, no measurement of time elapsed to prove whether the product is fast-acting and that more than half of the studies were not blind.

The misrepresentation is “harmful” to consumers of the product because it “cause(s) consumers relying on their claims about the therapeutic benefit of the Product to forgo proven treatments” and possibly exacerbate muscle or joint conditions that may not be getting the best treatment, the complaint argued.

The named plaintiff and class members, as they were all purchasers of the product, were “deceived and relied upon the Product’s deceptive label and marketing” and otherwise “would not have purchased the Product in the absence of Defendant’s misrepresentations and omissions or would have paid less for it,” the complaint said.

Alleged against the defendant are violations of New York General Business Law, negligent misrepresentation, breach of express warranty, implied warranty of merchantability, violation of the Magnuson Moss Warranty Act, fraud, and unjust enrichment. The plaintiff requested correction of the alleged deception by the defendant, monetary and statutory damages, reasonable fees, and other relief deemed proper by the court.

The plaintiffs are represented by Sheehan & Associates PC.