Case 1:20-cv-10272-JPC Document 1 Filed 12/06/20 Page 1 of 18
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`
`
`Sheehan & Associates, P.C.
`Spencer Sheehan
`60 Cuttermill Rd Ste 409
`Great Neck, NY 11021-3104
`Telephone: (516) 268-7080
`spencer@spencersheehan.com
`
`United States District Court
`Southern District of New York
`
`Luz Sanchez, individually and on behalf of
`all others similarly situated,
`
`Plaintiff,
`
`1:20-cv-10272
`
`- against -
`
`Class Action Complaint
`
`Avadim Health, Inc.,
`
`
`
`Defendant
`
`
`
`Plaintiff by attorneys alleges upon information and belief, except for allegations pertaining
`
`to plaintiff, which are based on personal knowledge:
`
`1. Avadim Health, Inc. (“defendant”) manufactures, distributes, markets, labels and
`
`sells Theraworx Muscle Cramp & Spasm Relief Foam (“Theraworx MCS” or “Product”), sold
`
`with a compression knee garment, with the active ingredient magnesium sulfate.
`
`2.
`
`The Product is sold to consumers from retail and online stores, and directly by
`
`Defendant, in containers of various sizes.
`
`3.
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`The Product and its advertising contain numerous false, deceptive and misleading
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`claims about its ability to provide pain relief.
`
`4.
`
`These claims were recently the subject of a decision by the National Advertising
`
`Division (NAD) which concluded the claims and marketing were not accurate and misleading.
`
`5.
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`The Product is similar to external analgesic products which contain the active
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`ingredients capsaicin, trolamine salicylate, and/or lidocaine.
`
`
`
`
`
`Sheehan & Associates, P.C.
`Spencer Sheehan
`60 Cuttermill Rd Ste 409
`Great Neck, NY 11021-3104
`Telephone: (516) 268-7080
`spencer@spencersheehan.com
`
`United States District Court
`Southern District of New York
`
`Luz Sanchez, individually and on behalf of
`all others similarly situated,
`
`Plaintiff,
`
`1:20-cv-10272
`
`- against -
`
`Class Action Complaint
`
`Avadim Health, Inc.,
`
`
`
`Defendant
`
`
`
`Plaintiff by attorneys alleges upon information and belief, except for allegations pertaining
`
`to plaintiff, which are based on personal knowledge:
`
`1. Avadim Health, Inc. (“defendant”) manufactures, distributes, markets, labels and
`
`sells Theraworx Muscle Cramp & Spasm Relief Foam (“Theraworx MCS” or “Product”), sold
`
`with a compression knee garment, with the active ingredient magnesium sulfate.
`
`2.
`
`The Product is sold to consumers from retail and online stores, and directly by
`
`Defendant, in containers of various sizes.
`
`3.
`
`The Product and its advertising contain numerous false, deceptive and misleading
`
`claims about its ability to provide pain relief.
`
`4.
`
`These claims were recently the subject of a decision by the National Advertising
`
`Division (NAD) which concluded the claims and marketing were not accurate and misleading.
`
`5.
`
`The Product is similar to external analgesic products which contain the active
`
`ingredients capsaicin, trolamine salicylate, and/or lidocaine.
`
`
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`Case 1:20-cv-10272-JPC Document 1 Filed 12/06/20 Page 2 of 18
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`6.
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`The relevant FDA Monograph for these products limit the indications for use: “For
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`the temporary relief of minor aches and pains of muscles and joints" [which may be followed by:
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`"associated with" (select one or more of the following: ‘simple backache,’ ‘arthritis,’ ‘strains,’
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`‘bruises,’ and ‘sprains.’).”
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`7.
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`The Monograph states, “the indications for OTC external analgesic drug products
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`should emphasize that these products relieve only minor pain and have an action that is only
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`temporary.”
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`8. Defendant’s Product emphasizes its ability to provide pain relief of a more significant
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`and enduring type than those covered by the Monograph, even though its active ingredient,
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`magnesium sulfate, has not been reviewed or found to be generally recognized as safe or effective
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`by the FDA to diagnose, treat, cure, prevent or mitigate any diseases or conditions.
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`9.
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`The front label representations include “Muscle Cramp and Spasm Relief,” “Prevents
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`Cramps & Spasms,” “Releases Muscle Tightness,” “Reduces Muscle Soreness” and “Foam with
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`Magnesium Sulfate.”
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`2
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`Case 1:20-cv-10272-JPC Document 1 Filed 12/06/20 Page 3 of 18
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`10. Defendant’s online marketing proclaims: “Apply as Needed for Fast Relief – As soon
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`
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`as you feel a muscle cramp or spasm coming on, use Theraworx Relief to quickly release muscle
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`tightness and reduce the soreness afterwards. There’s no limit to how many times you can apply it
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`per day!”
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`3
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`Case 1:20-cv-10272-JPC Document 1 Filed 12/06/20 Page 4 of 18
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`11. Other online marketing describes the Product as “Fast-Acting Muscle Cramp Relief.”
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`
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`12. The Product claims it “Prevents cramps and spams, Releases muscle tightness, [and]
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`
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`Relieves muscle soreness.”
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`4
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`Case 1:20-cv-10272-JPC Document 1 Filed 12/06/20 Page 5 of 18
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`13. The representations on the packaging and website include:
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`• “REDUCES the severity of symptoms associated with RLS [restless leg
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`syndrome].”
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`• “PREVENTS cramps and spasms when used daily.”
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`• “[Q]uickly relieves muscle cramps and even prevents them when used daily.”
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`• “Use Theraworx Relief twice daily (in the morning and before bedtime) to
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`prevent nighttime muscle cramps and spasms, or three times daily if you also
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`experience cramps or spasms during the day.”
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`• “Theraworx Relief for Muscle Cramps and Spasms can be used as a companion
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`product to manage the leg cramps associated with many important, commonly
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`prescribed medications.”
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`5
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`Case 1:20-cv-10272-JPC Document 1 Filed 12/06/20 Page 6 of 18
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`14. The Product’s marketing – on the packaging and in various media – touts its unique
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`ability to deal with leg pain:
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`• “Theraworx Relief is better than any product out there for leg cramps or spasms
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`or even muscle soreness.”
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`• “Nothing Else Like It on the Shelves.”
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`• “Theraworx Relief is unique because it can be used prophylactically to prevent
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`muscle spasms as well as to treat muscle spasms and cramps.”
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`• “Before Theraworx Relief there wasn’t really a lot of options on the
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`market…nothing really to get to the root of the problem.”
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`• “And it works really quickly, like no other product I’ve ever seen on the market.
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`And I love that there’s no side effects associated with it.”
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`• “Non-opioid, non-centrally acting Theraworx Relief products offer real relief
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`for those suffering from nocturnal cramps, symptoms associated with restless
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`legs syndrome, and inflammation associated with arthritis or other joint
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`conditions.”
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`• “HEALTHCARE
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`PROFESIONALS RECOMMEND THERAWORK
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`RELIEF.”
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`15. The side of the Product’s packaging states it is “Clinically proven to prevent and
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`relieve muscle cramps and spasms, and symptoms associated with Restless Legs Syndrome.”
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`6
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`Case 1:20-cv-10272-JPC Document 1 Filed 12/06/20 Page 7 of 18
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`16. The Product’s website contains numerous representations that it is “clinically
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`
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`proven” for the purpose which it is marketed:
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`• “Clinically proven to prevent foot and leg cramps when used daily.”
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`• “In multiple clinical studies, Theraworx Relief has been proven to: Provide fast
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`acting relief of muscle cramps and spasms, as well as post-cramp soreness --
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`most people get relief within minutes . . . [and] Reduce symptoms associated
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`with restless leg syndrome (RLS).”
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`• “In a research study including patients diagnosed with RLS, Theraworx Relief
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`was shown to reduce symptoms commonly associated with and accompanying
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`RLS, including muscle cramps and spasms.”
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`7
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`Case 1:20-cv-10272-JPC Document 1 Filed 12/06/20 Page 8 of 18
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`• “In a clinical study, participants noticed a significant reduction in the frequency
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`of their leg & foot cramps within the first 2 weeks of daily use.”
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`• “All Theraworx Relief products are clinically proven safe and effective.”
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`• “Clinically proven.”
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`17. Defendant’s “clinically proven” claims mean it is promising that scientific evidence
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`proves or “establishes” the truth of its claims.
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`18. These types of claims are required to be proven with double-blind, randomized
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`studies.
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`19. Even the claims relating to efficacy that do not claim clinical proof are required by
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`the FDA to be based on double-blind randomized evidence because the claims involve pain relief.
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`20. A competent and reliable study must include blinding, randomization, and be
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`appropriately-controlled, demonstrating that the treatment group experienced statistically
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`significant difference to the 95% confidence level as compared to the control group, to mitigate
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`bias and avoid placebo effects.
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`21. Defendant has offered five studies in support of its claims, which fail to establish the
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`Product is effective in support of its muscle cramp and spasm relief claims.1
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`22. The studies focus on treating leg cramps/spasms and symptoms associated with RLS
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`and nocturnal leg cramps.
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`23. However, Defendant’s advertising is focused on relieving muscle cramps and spams
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`more generally (i.e., everyday muscle cramps and spams).
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`1 “The effect of Theraworx® Relief [MCS] on night-time cramps and associated symptoms.” “The Effect of a Topical
`Homeopathic Solution on Nocturnal Leg Cramps and Associated Symptoms,” “Nocturnal Cramps and Introduction
`of a Novel Topical Therapy,” “Effect of a Topical, Non-Systemic, Non-Centrally Acting Anti-Spasmodic on Division-
`One Athletes in Competition After Crossing Individual Muscle Spasm Threshold and Experiencing Exercise-
`Associated Muscle Cramps (EAMC)” and “Restless Leg Syndrome: The Efficacy of a Non-Systemic, Non-Centrally
`Acting Topical Treatment
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`8
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`Case 1:20-cv-10272-JPC Document 1 Filed 12/06/20 Page 9 of 18
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`24. None of the studies evaluated the Product’s efficacy on “muscle soreness,” “post-
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`cramp soreness,” “foot cramps,” “muscle tightness” or “leg cramps associated with many
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`important, commonly prescribed medications.”
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`25. None of the studies were designed to assess whether the Product prevents muscle
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`cramps.
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`26. None of the studies support the Product’s claims of “fast-acting muscle cramp and
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`spasm relief” or “quick[] release [o]f muscle tightness,” since the time to relief was not measured.
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`27.
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`In fact, the time period of the studies were several weeks long, which is inconsistent
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`with the “fast-acting” claims.
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`28. The studies were not consistent with typical consumer usage based on the Product’s
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`instructions, i.e., whether the product was used with the accompanying compression garment.
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`29. The subject populations in many of the submitted studies were not relevant to the
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`target audience of the challenged advertising – i.e., Division I college athletes.
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`30. The studies failed to account for potential confounding factors.
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`31. More than half of the studies were not blinded, which calls into question whether
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`results were biased by either the technician or study participants.
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`32. No evidence was presented about adequate controls or safeguards in the studies to
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`prevent bias.
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`33. Where one study had an adequate sample size, it otherwise failed to support the
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`claims due to other reasons, such as not being randomized or blinded.
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`34. There is no genuine scientific research and no scientifically reliable studies that
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`support the extraordinary claims that the Product can provide the effects indicated.
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`35. Defendant makes Product claims based on the recommendations of medical
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`Case 1:20-cv-10272-JPC Document 1 Filed 12/06/20 Page 10 of 18
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`professionals: “HEALTHCARE PROFESSIONALS RECOMMEND THERAWORX RELIEF.”
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`36. Such claims are significant to consumers, yet they are not supported by reliable
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`evidence such as statistically significant surveys showing that a substantial portion of them
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`recommend the product.
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`37. The message to consumers is that the consensus among healthcare professionals is a
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`recommendation of the Product.
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`38. Defendant’s website makes misleading use of testimonials by pharmacists, in
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`violation of the FTC’s Guides Concerning Use of Endorsements and Testimonials in Advertising
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`(“FTC Endorsement Guides”).
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`39. These endorsements include statements such as:
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`• “Theraworx Relief is better than any product out there for leg cramps or spasms
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`or even muscle soreness”
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`• “Theraworx Relief is unique because it can be used prophylactically to prevent
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`muscle spasms as well as to treat muscle spasms and cramps.”
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`• “[b]efore Theraworx Relief there really weren’t a lot of options on the market...
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`it was just some supplements that you could try or other over-the-counter
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`medications that would be able to distract the nerve endings…nothing really to
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`get to the root of the problem”
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`• “it works really quickly, like no other product I’ve ever seen on the market.”
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`• “I’ve never seen a product that works as well [as Theraworx Relief] for muscle
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`cramps and muscle spasms.”
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`• “Theraworx works so fast, usually within thirty seconds to a minute,”
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`• “it can help prevent the actual muscle cramp by being applied before activity or
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`10
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`Case 1:20-cv-10272-JPC Document 1 Filed 12/06/20 Page 11 of 18
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`before you have night cramps, before you go to bed at night.”
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`40. Even if endorsements are the accurate sentiments of an endorser, §255.1(a) of the
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`FTC Endorsement Guides states that “an endorsement may not convey any express or implied
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`representation that would be deceptive if made directly by the advertiser.”
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`41. Where the honest opinion of an endorser “would not be enough to substantiate a
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`claim…the endorsement should also be supported by competent and reliable scientific evidence.”
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`42. The endorsements are so broad that they reasonably can be understood to compare
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`the Product to FDA-approved prescription medications.
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`43. However, there is no reliable data showing that the Product exceeds all other
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`competitors with respect to the attributes for which superiority is claimed
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`44. Defendant’s claims are harmful and misleading because they cause consumers
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`relying on their claims about the therapeutic benefit of the Product to forgo proven treatments.
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`45. This results in painful and potentially serious underlying muscle or joint affliction
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`and moderate to severe joint inflammation from arthritis or other causes going untreated or
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`inadequately treated.
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`46. Even if the Product has no harmful side effects, consumers are still harmed due to
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`the failure to seek proven treatments and the economic deception through purchasing the Product
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`based on false and misleading claims.
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`47. Defendant’s branding, marketing and packaging of the Product is designed to – and
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`does – deceive, mislead, and defraud plaintiff and consumers.
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`48. Defendant sold more of the Product and at higher prices than it would have in the
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`absence of this misconduct, resulting in additional profits at the expense of consumers.
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`49. The value of the Product that plaintiff purchased and consumed was materially less
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`Case 1:20-cv-10272-JPC Document 1 Filed 12/06/20 Page 12 of 18
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`than its value as represented by defendant.
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`50. Had plaintiff and class members known the truth, they would not have bought the
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`Product or would have paid less for it.
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`51. As a result of the false and misleading labeling, the Product is an sold at a premium
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`price, approximately no less than $18.99 per 7.1 OZ compared to other similar products
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`represented in a non-misleading way, and higher than the price of the Product if it were represented
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`in a non-misleading way.
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`Jurisdiction and Venue
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`52.
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`Jurisdiction is proper pursuant to Class Action Fairness Act of 2005 (“CAFA”). 28
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`U.S.C. § 1332(d)(2)
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`53. Under CAFA, district courts have “original federal jurisdiction over class actions
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`involving (1) an aggregate amount in controversy of at least $5,000,000; and (2) minimal
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`diversity[.]” Gold v. New York Life Ins. Co., 730 F.3d 137, 141 (2d Cir. 2013).
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`54. Plaintiff Luz Sanchez is a citizen of New York.
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`55. Defendant Avadim Health, Inc. is a Delaware corporation with a principal place of
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`business in Asheville, Buncombe County, North Carolina and is a citizen of North Carolina.
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`56. “Minimal diversity” exists because plaintiff Luz Sanchez and defendant are citizens
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`of different states.
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`57. Upon information and belief, sales of the Product exceed $5 million during the
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`applicable statutes of limitations, exclusive of interest and costs.
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`58. Venue is proper a substantial part of the events or omissions giving rise to the claim
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`occurred in this District.
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`59. Plaintiff Tracey Jones purchased the Product on numerous occasions including but
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`Case 1:20-cv-10272-JPC Document 1 Filed 12/06/20 Page 13 of 18
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`not limited to between August and November 2020, at stores including Rite Aid, 282 8th Ave New
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`York, NY 10001.
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`60. Plaintiff bought the Product at or exceeding the above-referenced price because she
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`liked the product for its intended use and relied upon its “clinically proven” claims and other health
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`claims, as described herein.
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`61. Plaintiff was deceived by and relied upon the Product's deceptive labeling and
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`marketing.
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`62. Plaintiff would not have purchased the Product in the absence of Defendant’s
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`misrepresentations and omissions or would have paid less for it.
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`63. Plaintiff intends to, seeks to, and will purchase the Product again when she can do so
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`with the assurance that Product's labels are consistent with the Product’s components.
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`Class Allegations
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`64. The class will consist of all purchasers of the Product who reside in New York during
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`the applicable statutes of limitations.
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`65. Plaintiff seeks class-wide injunctive relief based on Rule 23(b) in addition to a
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`monetary relief class.
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`66. Common questions of law or fact predominate and include whether defendant’s
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`representations were and are misleading and if plaintiff and class members are entitled to damages.
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`67. Plaintiff's claims and basis for relief are typical to other members because all were
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`subjected to the same unfair and deceptive representations and actions.
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`68. Plaintiff is an adequate representative because her interests do not conflict with other
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`members.
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`69. No individual inquiry is necessary since the focus is only on defendant’s practices
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`Case 1:20-cv-10272-JPC Document 1 Filed 12/06/20 Page 14 of 18
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`and the class is definable and ascertainable.
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`70.
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`Individual actions would risk inconsistent results, be repetitive and are impractical
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`to justify, as the claims are modest relative to the scope of the harm.
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`71. Plaintiff's counsel is competent and experienced in complex class action litigation
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`and intends to protect class members’ interests adequately and fairly.
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`72. Plaintiff seeks class-wide injunctive relief because the practices continue.
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`New York General Business Law (“GBL”) §§ 349 & 350
`(Consumer Protection Statutes)
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`73. Plaintiff incorporates by reference all preceding paragraphs.
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`74. Plaintiff and class members desired to purchase and consume products which were
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`as described and marketed by defendant and expected by reasonable consumers, given the product
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`type.
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`75. Defendant’s acts and omissions are not unique to the parties and have a broader
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`impact on the public.
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`76. Defendant misrepresented the substantive, quantitative, qualitative, compositional
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`and/or restorative attributes of the Product.
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`77. The Product’s claims have a material bearing on price and consumer acceptance of
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`the Product.
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`78. Plaintiff relied on the statements, omissions and representations of defendant, and
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`defendant knew or should have known the falsity of same.
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`79. Plaintiff and class members would not have purchased the Product or paid as much
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`if the true facts had been known, suffering damages.
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`Negligent Misrepresentation
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`80. Plaintiff incorporates by reference all preceding paragraphs.
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`Case 1:20-cv-10272-JPC Document 1 Filed 12/06/20 Page 15 of 18
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`81. Defendant had a duty to disclose the absence of support for its claims and statements.
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`82. This duty is based on defendant’s position as an entity which has held itself out as
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`having special knowledge and experience in the production, service and/or sale of the product type.
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`83. The representations took advantage of consumers’ cognitive shortcuts made at the
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`point-of-sale and their trust in defendant, a well-known and respected brand or entity in this sector.
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`84. Plaintiff and class members reasonably and justifiably relied on these negligent
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`misrepresentations and omissions, which served to induce and did induce, the purchase of the
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`Product.
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`85. Plaintiff and class members would not have purchased the Product or paid as much
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`if the true facts had been known, suffering damages.
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`Breaches of Express Warranty, Implied Warranty of Merchantability and
`Magnuson Moss Warranty Act, 15 U.S.C. §§ 2301, et seq.
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`86. Plaintiff incorporates by reference all preceding paragraphs.
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`87. The Product was manufactured, labeled and sold by defendant or at its express
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`directions and instructions, and warranted to plaintiff and class members that it possessed
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`substantive, quality, restorative, and/or compositional attributes it did not.
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`88. Defendant had a duty to disclose and/or provide non-deceptive descriptions and
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`marketing of the Product.
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`89. This duty is based, in part, on defendant’s position as one of the most recognized
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`companies in the nation in this sector.
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`90. Plaintiff provided or will provide notice to defendant, its agents, representatives, and
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`their employees.
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`91. Defendant received notice and should have been aware of these misrepresentations
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`due to numerous complaints by consumers to its main office over the past several years regarding
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`Case 1:20-cv-10272-JPC Document 1 Filed 12/06/20 Page 16 of 18
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`the Product, of the type described here.
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`92. The Product did not conform to its affirmations of fact and promises due to
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`defendant’s actions and were not merchantable because plaintiffs expected a product that was
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`capable and proven to have the effects promised.
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`93. Plaintiff and class members would not have purchased the Product or paid as much
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`if the true facts had been known, suffering damages.
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`Fraud
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`94. Plaintiff incorporates by reference all preceding paragraphs.
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`95. Defendant’s fraudulent intent is evinced by its failure to accurately market the
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`Product on the packaging and in other media, when it knew its statements were neither true nor
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`accurate and misled consumers.
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`96. Plaintiff and class members would not have purchased the Product or paid as much
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`if the true facts had been known, suffering damages.
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`Unjust Enrichment
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`97. Plaintiff incorporates by reference all preceding paragraphs.
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`98. Defendant obtained benefits and monies because the Product was not as represented
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`and expected, to the detriment and impoverishment of plaintiff and class members, who seek
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`restitution and disgorgement of inequitably obtained profits.
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`Jury Demand and Prayer for Relief
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`Plaintiff demands a jury trial on all issues.
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` WHEREFORE, Plaintiff prays for judgment:
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`1. Declaring this a proper class action, certifying plaintiff as representative and the
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`undersigned as counsel for the class;
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`Case 1:20-cv-10272-JPC Document 1 Filed 12/06/20 Page 17 of 18
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`2. Entering preliminary and permanent injunctive relief by directing defendant to correct the
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`challenged practices to comply with the law;
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`3. Injunctive relief to remove, correct and/or refrain from the challenged practices and
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`representations, and restitution and disgorgement for members of the class pursuant to the
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`applicable laws;
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`4. Awarding monetary damages, statutory damages under the GBL and interest pursuant to
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`the common law and other statutory claims;
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`5. Awarding costs and expenses, including reasonable fees for plaintiff's attorneys and
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`experts; and
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`6. Other and further relief as the Court deems just and proper.
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`Dated: December 6, 2020
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`Respectfully submitted,
`
`Sheehan & Associates, P.C.
`/s/Spencer Sheehan
`Spencer Sheehan
`60 Cuttermill Rd Ste 409
`Great Neck NY 11021-3104
`Tel: (516) 268-7080
`Fax: (516) 234-7800
`spencer@spencersheehan.com
`E.D.N.Y. # SS-8533
`S.D.N.Y. # SS-2056
`
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`Case 1:20-cv-10272-JPC Document 1 Filed 12/06/20 Page 18 of 18
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`1:20-cv-10272
`United States District Court
`Southern District of New York
`
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`Luz Sanchez, individually and on behalf of all others similarly situated,
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`
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` - against -
`
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`Avadim Health, Inc.,
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`Plaintiff,
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` Defendant
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`Class Action Complaint
`
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`Sheehan & Associates, P.C.
`60 Cuttermill Rd Ste 409
`Great Neck NY 11021-3104
`Tel: (516) 268-7080
`Fax: (516) 234-7800
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`Pursuant to 22 NYCRR 130-1.1, the undersigned, an attorney admitted to practice in the courts of
`New York State, certifies that, upon information, and belief, formed after an inquiry reasonable
`under the circumstances, the contentions contained in the annexed documents are not frivolous.
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`Dated: December 6, 2020
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` /s/ Spencer Sheehan
` Spencer Sheehan
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