Case: 1:21-cv-02351 Document #: 1 Filed: 05/01/21 Page 1 of 14 PageID #:1
`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE NORTHERN DISTRICT OF ILLINOIS
`
`Sherry Cruz, individually and on behalf of all
`others similarly situated,
`
`1:21-cv-02351
`
`Plaintiff,
`
`
`
`- against -
`
`Class Action Complaint
`
`Sanofi US Corporation,
`
`
`
`Defendant
`
`Jury Trial Demanded
`
`Plaintiff alleges upon information and belief, except for allegations pertaining to plaintiff,
`
`which are based on personal knowledge:
`
`1.
`
`Sanofi US Corporation (“defendant”) manufactures, markets and sells over-the-
`
`counter (“OTC”) external analgesic patches with an active ingredient of lidocaine (4%), under the
`
`Aspercreme brand (“Product”).
`
`I. Lidocaine in OTC Products
`
`2.
`
`Lidocaine is a topical anesthetic used to treat pain by depressing sensory receptors in
`
`the nerve endings in the skin, which prevents pain signals from reaching the brain.
`
`3.
`
`4.
`
`5.
`
`Lidocaine has been approved for use by the FDA since the early 1950s.
`
`FDA regulates products containing lidocaine through “OTC Monographs.”
`
`The 1983 Tentative Final Monography for External Analgesic Drug Products for
`
`Over-the-Counter Human Use, (“TFM”), provides guidelines for labeling OTC products
`
`containing between 0.5% to 4% lidocaine.1
`
`
`1 48 Fed. Reg. 5852-01 (Feb. 8, 1983).
`
`
`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE NORTHERN DISTRICT OF ILLINOIS
`
`Sherry Cruz, individually and on behalf of all
`others similarly situated,
`
`1:21-cv-02351
`
`Plaintiff,
`
`
`
`- against -
`
`Class Action Complaint
`
`Sanofi US Corporation,
`
`
`
`Defendant
`
`Jury Trial Demanded
`
`Plaintiff alleges upon information and belief, except for allegations pertaining to plaintiff,
`
`which are based on personal knowledge:
`
`1.
`
`Sanofi US Corporation (“defendant”) manufactures, markets and sells over-the-
`
`counter (“OTC”) external analgesic patches with an active ingredient of lidocaine (4%), under the
`
`Aspercreme brand (“Product”).
`
`I. Lidocaine in OTC Products
`
`2.
`
`Lidocaine is a topical anesthetic used to treat pain by depressing sensory receptors in
`
`the nerve endings in the skin, which prevents pain signals from reaching the brain.
`
`3.
`
`4.
`
`5.
`
`Lidocaine has been approved for use by the FDA since the early 1950s.
`
`FDA regulates products containing lidocaine through “OTC Monographs.”
`
`The 1983 Tentative Final Monography for External Analgesic Drug Products for
`
`Over-the-Counter Human Use, (“TFM”), provides guidelines for labeling OTC products
`
`containing between 0.5% to 4% lidocaine.1
`
`
`1 48 Fed. Reg. 5852-01 (Feb. 8, 1983).
`
`
`
`Case: 1:21-cv-02351 Document #: 1 Filed: 05/01/21 Page 2 of 14 PageID #:2
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`6.
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`Lidocaine is permitted for use as an active ingredient for only the temporary relief of
`
`pain and itching associated with minor burns, sunburn, minor cuts, scrapes, insect bites or minor
`
`skin irritations.2
`
`7. Around 2003, the FDA initiated rulemaking to classify products which delivered
`
`lidocaine in a patch form. 3
`
`8.
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`This was because there was no data on “[t]he safe and effective concentration” of
`
`lidocaine in this format, and uncertainties regarding the frequency of application that is considered
`
`safe and effective.
`
`9.
`
`The FDA proposed categorizing external analgesic patches as Category III products,
`
`that require agency review and approval of the product and its labeling through a New Drug
`
`Application (“NDA”) or Abbreviated New Drug Application (“ANDA”).4
`
`II. Defendant’s Misleading representations
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`10. Defendant’s Product contains 4% lidocaine and is marketed as compliant with FDA
`
`regulations for Category I products, based on the numerous claims with respect to the Product’s
`
`functions.
`
`11. However, the Product does not comply with the TFM requirements for Category I
`
`ingredients and has not undergone review for products with Category III ingredients.
`
`
`2 68 Fed. Reg. 42324-01, 42325-26 (July 17, 2003).
`3 See External Analgesic Drug Products for Over-the-Counter Human Use; Reopening of the Administrative Record
`and Amendment of Tentative Final Monograph, 68 Fed. Reg. 42324-01, 42326 (July 17, 2003).
`4 Category I products are considered “GRASE” and can be marketed without approvals required for Category III.
`
`2
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`
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`Case: 1:21-cv-02351 Document #: 1 Filed: 05/01/21 Page 3 of 14 PageID #:3
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`12. The Product’s front label focuses on its ability to “numb” and affect “nerves.”
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`
`
`
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`• MAX STRENGTH
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`• MAX STRENGTH LIDOCAINE
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`• NUMBS AWAY PAIN
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`• NUMBS AWAY PAIN
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`• FAST ACTING
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`• Desensitizes Aggravated Nerves
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`• TARGETS NERVES
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`• FAST ACTING
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`• Flexible Fabric
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`• Targets More Pain Receptors*
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`• Non Irritating
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`13. The lidocaine percentage is indicated in the fine print, next to “LIDOCAINE” or in
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`the lower right corner of the label.
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`3
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`Case: 1:21-cv-02351 Document #: 1 Filed: 05/01/21 Page 4 of 14 PageID #:4
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`14. The side panels indicate “Targeted Relief” for the main joint areas.
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`
`
`
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`• Targeted
`No Mess Relief
`
`• Easy to Apply
`& Remove
`
`• Flexible Fabric
`
`
`• TARGETED RELIEF
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`• BACK, NECK & SHOULDER
`
`• KNEE & ELBOW
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`• HAND & WRIST
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`• FOOT, ANKLE & LEG
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`A. Max Strength and Fast Acting Claims
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`15. The “Max Strength” claims are misleading because it implies the Product contains
`
`and delivers the maximum amount of lidocaine in patch form to the affected area.
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`16. However, this is false because other patch products deliver more lidocaine to affected
`
`areas, are more effective, are approved by the FDA for more purposes than defendant’s Product
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`and are supported by clinical studies.
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`17. The “fast acting” claim is misleading because it implies the Product provides
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`immediate pain relief when it does not.
`
`4
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`Case: 1:21-cv-02351 Document #: 1 Filed: 05/01/21 Page 5 of 14 PageID #:5
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`18. The Product uses a thicker patch than similar products, resulting in a less effective
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`and slower delivery of lidocaine to the affected area.
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`B. “12 hours” Claim
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`19. The Directions on the Drug Facts state to “use 1 patch for up to 12 hours.”
`
`
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`20. The other representations, such as “FLEXIBLE FABRIC,” “Easy to Apply &
`
`Remove,” and “Non Irritating,” further the impression that the Product will adhere to the body and
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`continuously relieve pain for the promised amount of time – 12 hours.
`
`21. However, numerous studies and reports revealed that users of the Product seldom
`
`experience anything close to 12 hours of relief, because the patch fails to adhere for even six hours.
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`22. According to the FDA, when a patch delivering lidocaine becomes “partially
`
`detached,” its efficacy of delivery and absorption of the active ingredient is greatly reduced.
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`C. “Numb” or “Completely Block Pain” Claims
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`23. The claim that the Product “NUMBS AWAY PAIN” falsely imply the Product
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`completely blocks pain receptors, eliminates responses to painful stimuli and provides a numbing
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`sensation.
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`24. These statements are misleading to consumers because whether a lidocaine patch like
`
`the Product is capable of these effects depends on the how it is used.5
`
`
`5 FDA concluded that “[c]laims regarding numbness or similar claims, such as completely blocking pain receptors or
`abolishing responses to painful stimuli, may be misleading to consumers because the manner in which external
`analgesic drug products are used determines whether they cause numbness or not.” Id.
`
`5
`
`
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`Case: 1:21-cv-02351 Document #: 1 Filed: 05/01/21 Page 6 of 14 PageID #:6
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`25. Additionally, the FDA determined that statements such as “numb[] away pain” on
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`external analgesic products like the Product are misleading to consumers because it is not capable
`
`to perform this function.
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`D. “Nerves” and “Pain Receptor” Claims are Misleading
`
`26. The
`
`label and marketing claim
`
`the Product “TARGETS NERVES,”
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`“DESENSITIZES AGGRAVATED NERVES,” “Targets More Pain Receptors,*” and that the
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`Product will “Relieve the nerves. Stop the pain.”
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`27. These representations imply that the Product provides pain relief by desensitizing
`
`
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`nerves and/or pain receptors.
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`28. The asterisked claim is qualified but in such small print it cannot overcome the
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`message consumers take away from this claim.
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`29. Consumers understand these representations to mean the Product contains
`
`ingredients that target nerves and pain receptors when this is not true.
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`30. Since consumers associate “nerves” and “pain receptors” with medical treatments
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`typically requiring a prescription (and FDA approval), seeing these claims tells them the Product
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`can achieve these results.
`
`6
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`Case: 1:21-cv-02351 Document #: 1 Filed: 05/01/21 Page 7 of 14 PageID #:7
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`31. However, the Product cannot achieve these results, which is why the FDA prohibits
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`external analgesic products containing lidocaine from making these types of claims.6
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`E. Misleading as to Product’s Indications
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`32. The side panels indicate the Product provides “Targeted Relief” for the main joint
`
`areas: (1) BACK, NECK & SHOULDER, (2) KNEE & ELBOW, (3) HAND & WRIST and (4)
`
`FOOT, ANKLE & LEG.
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`33. These representations give consumers the impression the Product can treat
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`neuropathic and musculoskeletal pain, including back and spinal pain.
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`34. However, the Product is only authorized for “temporary relief” of “pain,” “itching,”
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`or “pain and itching” “associated with” “minor burns,” “sunburn,” “minor cuts,” “scrapes,” “insect
`
`bites,” or “minor skin irritations.”7
`
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`6 48 Fed. Reg. 5852-01, 5860-61 (Feb. 8, 1983).
`7 48 Fed. Reg. 5852-01, 5868 (Feb. 8, 1983).
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`7
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`
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`Case: 1:21-cv-02351 Document #: 1 Filed: 05/01/21 Page 8 of 14 PageID #:8
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`35. The only place where the accurate indications are disclosed is buried within the fine
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`print and miniscule font of the Drug Facts: “Uses temporarily relieves minor pain.”
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`
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`III. Conclusion
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`36. Reasonable consumers must and do rely on defendant to honestly describe the
`
`components and features of the Product, relative to itself and other comparable products.
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`37. Plaintiff did not scrutinize the drug facts nor was she required to do so.
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`38. No independent, credible studies support the claims made in support of the Product.
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`39. Even if Plaintiff scrutinized the drug facts, it would not cure the misrepresentations.
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`40. Reasonable consumers must and do rely on defendant to honestly describe the
`
`components and features of the Product.
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`41. Defendant misrepresented the Product through affirmative statements, half-truths,
`
`and omissions.
`
`42. Defendant sold more of the Product and at a higher prices than it would have in
`
`absence of this misconduct, resulting in additional profits at the expense of consumers.
`
`8
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`Case: 1:21-cv-02351 Document #: 1 Filed: 05/01/21 Page 9 of 14 PageID #:9
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`43. Had Plaintiff and proposed class members known the truth, they would not have
`
`bought the Product or would have paid less for it.
`
`44. Plaintiff paid more for the Product based on the representations than she would have
`
`otherwise paid.
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`45. As a result of the false and misleading representations, the Product is sold at a
`
`premium price, approximately no less than no less than $8.52 for five patches, excluding tax,
`
`compared to other similar products represented in a non-misleading way, and higher than it would
`
`be sold for absent the misleading representations and omissions.
`
`Jurisdiction and Venue
`
`46.
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`Jurisdiction is proper pursuant to Class Action Fairness Act of 2005 (“CAFA”). 28
`
`U.S.C. § 1332(d)(2).
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`47. Plaintiff Sherry Cruz is a citizen of Illinois.
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`48. Defendant Sanofi US Corporation is a Delaware agricultural cooperative corporation
`
`with a principal place of business in Bridgewater, Somerset County, New Jersey.
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`49. Diversity exists because plaintiff Sherry Cruz and defendant are citizens of different
`
`states.
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`50. Upon information and belief, sales of the Product and any available statutory and
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`other monetary damages, exceed $5 million during the applicable statutes of limitations, exclusive
`
`of interest and costs.
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`51. Venue is proper because a substantial part of the events or omissions giving rise to
`
`the claim occurred here – the purchase of plaintiff and her experiences identified here.
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`52. Plaintiff Sherry Cruz is a citizen of Chicago, Cook County, Illinois.
`
`Parties
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`9
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`
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`Case: 1:21-cv-02351 Document #: 1 Filed: 05/01/21 Page 10 of 14 PageID #:10
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`53. Defendant Sanofi US Corporation is a Delaware corporation with a principal place
`
`of business in Bridgewater, New Jersey, Somerset County.
`
`54. Defendant is a French multinational pharmaceutical company which produces
`
`prescription medications, medical devices and OTC products.
`
`55. Plaintiff purchased one of the Lidocaine Products on at least one occasions within
`
`the statutes of limitations for each cause of action, between February and March 2021, at stores
`
`including CVS, 741 W 31st St, Chicago, IL 60616.
`
`56. Plaintiff bought the Product because she expected it would provide the type of pain
`
`relief it represented.
`
`57. The Product was worth less than what Plaintiff and consumers paid and she would
`
`not have paid as much absent Defendant's false and misleading statements and omissions.
`
`58. Plaintiff paid more for the Product than she would have paid otherwise.
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`59. Plaintiff intends to, seeks to, and will purchase the Product again when she can do so
`
`with the assurance that Product’s representations about its components and ingredients are
`
`consistent with its representations.
`
`Class Allegations
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`60. The class will consist of all purchasers of the Product who reside in Illinois during
`
`the applicable statutes of limitations.
`
`61. Plaintiff seeks class-wide injunctive relief based on Rule 23(b) in addition to a
`
`monetary relief class.
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`62. Common questions of law or fact predominate and include whether defendant’s
`
`representations were and are misleading and if plaintiff and class members are entitled to damages.
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`63. Plaintiff's claims and basis for relief are typical to other members because all were
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`10
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`Case: 1:21-cv-02351 Document #: 1 Filed: 05/01/21 Page 11 of 14 PageID #:11
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`subjected to the same unfair and deceptive representations and actions.
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`64. Plaintiff is an adequate representative because her interests do not conflict with other
`
`members.
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`65. No individual inquiry is necessary since the focus is only on defendant’s practices
`
`and the class is definable and ascertainable.
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`66.
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`Individual actions would risk inconsistent results, be repetitive and are impractical
`
`to justify, as the claims are modest relative to the scope of the harm.
`
`67. Plaintiff's counsel is competent and experienced in complex class action litigation
`
`and intends to protect class members’ interests adequately and fairly.
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`68. Plaintiff seeks class-wide injunctive relief because the practices continue.
`
`Illinois Consumer Fraud and Deceptive Business Practices Act
`(“ICFA”), 815 ILCS 505/1, et seq.
`
`(Consumer Protection Statute)
`
`69. Plaintiff incorporates by reference all preceding paragraphs.
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`70. Plaintiff and class members desired to purchase a product which would provide the
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`type of pain relief it represented.
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`71. Defendant’s false and deceptive representations and omissions are material in that
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`they are likely to influence consumer purchasing decisions.
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`72. Defendant misrepresented the Product through statements, omissions, ambiguities,
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`half-truths and/or actions.
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`73. Plaintiff relied on the representations.
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`74. Plaintiff and class members would not have purchased the Product or paid as much
`
`if the true facts had been known, suffering damages.
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`11
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`Case: 1:21-cv-02351 Document #: 1 Filed: 05/01/21 Page 12 of 14 PageID #:12
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`Breaches of Express Warranty,
`Implied Warranty of Merchantability and
`Magnuson Moss Warranty Act, 15 U.S.C. §§ 2301, et seq.
`
`75. The Product was manufactured, labeled and sold by defendant and expressly and
`
`impliedly warranted to plaintiff and class members that it possessed attributes and capabilities
`
`which it did not.
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`76. Defendant had a duty to disclose and/or provide non-deceptive descriptions and
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`marketing of the Product.
`
`77. This duty is based on Defendant’s outsized role in the market for this type of Product
`
`– a global international pharmaceutical company with hundreds of brands.
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`78. Plaintiff provided or will provide notice to defendant, its agents, representatives,
`
`retailers and their employees.
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`79. Defendant received notice and should have been aware of these issues due to
`
`complaints by regulators, competitors, and consumers, to its main offices over the past several
`
`years.
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`80. The Product did not conform to its affirmations of fact and promises due to
`
`defendant’s actions and were not merchantable because they were not fit to pass in the trade as
`
`advertised.
`
`81. Plaintiff and class members would not have purchased the Product or paid as much
`
`if the true facts had been known, suffering damages.
`
`Negligent Misrepresentation
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`82. Defendant had a duty to truthfully represent the Product, which it breached.
`
`83. This duty is based on defendant’s position, holding itself out as having special
`
`knowledge and experience in the sale of OTC pain relief products.
`
`84. The representations took advantage of consumers’ cognitive shortcuts made at the
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`12
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`Case: 1:21-cv-02351 Document #: 1 Filed: 05/01/21 Page 13 of 14 PageID #:13
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`point-of-sale and their trust in defendant.
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`85. Plaintiff reasonably and justifiably relied on these negligent misrepresentations and
`
`omissions, which served to induce and did induce, their purchases of the Product.
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`86. Plaintiff and class members would not have purchased the Product or paid as much
`
`if the true facts had been known, suffering damages.
`
`Fraud
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`87. Defendant misrepresented and/or omitted the attributes and qualities of the Product.
`
`88. Defendant’s fraudulent intent is evinced by its knowledge of the relevant regulations,
`
`as many of its misleading claims are carefully worded to avoid the obvious prohibited statements
`
`but still misleading.
`
`Unjust Enrichment
`
`89. Defendant obtained benefits and monies because the Product was not as represented
`
`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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`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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`13
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`Case: 1:21-cv-02351 Document #: 1 Filed: 05/01/21 Page 14 of 14 PageID #:14
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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 pursuant to any statutory claims and
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`interest pursuant to the common law and other statutory claims;
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`5. Awarding costs and expenses, including reasonable fees for plaintiff's attorneys and
`
`experts; and
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`6. Other and further relief as the Court deems just and proper.
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`Dated: May 1, 2021
`
`
`
`
`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
`
`14
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