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1:21-cv-01360-JES-JEH # 1 Page 1 of 12
`E-FILED
` Sunday, 12 December, 2021 12:51:19 AM
` Clerk, U.S. District Court, ILCD
`
`UNITED STATES DISTRICT COURT
`CENTRAL DISTRICT OF ILLINOIS
`
`PEORIA DIVISION
`
`Julie Foster, individually and on behalf of all
`others similarly situated,
`
`1:21-cv-01360
`
`Plaintiff,
`
`
`
`- against -
`
`Class Action Complaint
`
`Nestle Health Science US Holdings, Inc.,
`
`Defendant
`
`
`
`Jury Trial Demanded
`
`Plaintiff alleges upon information and belief, except for allegations pertaining to plaintiff,
`
`which are based on personal knowledge:
`
`1. Nestle Health Science US Holdings, Inc. (“Defendant”) manufactures, labels,
`
`markets, and sells peppermint oil capsules promoted as a treatment for irritable bowel syndrome
`
`(“IBS”) under the IBgard brand (“Product”).
`
`
`
`
`
`

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`1:21-cv-01360-JES-JEH # 1 Page 2 of 12
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`2.
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`The relevant front label representations include “Clinically Proven to Help Relieve
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`Irritable Bowel Syndrome (IBS) Symptoms” (left), “A Medical Food for the Dietary Management
`
`of Irritable Bowel Syndrome” (right), and a gold seal relating to the Product’s approval by doctors.
`
`3.
`
`4.
`
`The representations are misleading.
`
`The FDA has established guidance to assist the pharmaceutical industry and
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`investigators who are developing drugs for the treatment of IBS.
`
`5.
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`IBS diagnosis and assessment of clinical status depend mainly on an evaluation of
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`signs and symptoms that are known to the patient.
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`6.
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`The studies upon which Defendant’s claims that the Product is “Clinically Proven”
`
`fail to meet the FDA’s criteria.
`
`7.
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`This is based on factors which may include the length of the studies, conflicts of
`
`interest, sample size, outcome measures, and subsets of IBS considered.
`
`8. No competent or reliable scientific evidence supports the claims that the Product is
`
`clinically proven to have the effects promised.
`
`9.
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`Studies have shown that peppermint oil and a placebo both showed clinically
`
`meaningful improvement in IBS symptoms, with no significant differences between them.
`
`10. The Product is misleadingly identified as a medical food but does not meet the
`
`definition of a medical food. 21 U.S.C. § 360ee(b)(3); 21 C.F.R. § 101.9(j)(8).
`
`11. A “medical food” is “a food which is formulated to be consumed or administered
`
`enterally under the supervision of a physician and which is intended for the specific dietary
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`management of a disease or condition for which distinctive nutritional requirements, based on
`
`recognized scientific principles, are established by medical evaluation.”
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`12. 21 CFR 101.9(j)(8) provides that a food is considered a medical food only if
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`2
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`

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`1:21-cv-01360-JES-JEH # 1 Page 3 of 12
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`i.
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`It is a specially formulated and processed product (as opposed to a naturally
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`occurring foodstuff used in its natural state) for the partial or exclusive feeding of
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`a patient by means of oral intake or enteral feeding tube;
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`ii. It is intended for the dietary management of a patient who, because of therapeutic
`
`or chronic medical needs, has limited or impaired capacity to ingest, digest, absorb,
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`or metabolize ordinary foodstuffs or certain nutrients, or who has other special
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`medically determined nutrient requirements, the dietary management of which
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`cannot be achieved by the modification of the normal diet alone;
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`iii. It provides nutritional support specifically modified for the management of the
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`unique nutrient needs that result from the specific disease or condition, as
`
`determined by medical evaluation;
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`iv. It is intended to be used under medical supervision; and
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`v. It is intended only for a patient receiving active and ongoing medical supervision
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`wherein the patient requires medical care on a recurring basis for, among other
`
`things, instructions on the use of the medical food.
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`13. Medical foods are distinguished from the broader category of foods for special
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`dietary use by the requirement that medical foods be intended to meet distinctive nutritional
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`requirements of a disease or condition and must be intended to be used under medical supervision.
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`14. Medical foods are not those simply recommended by a physician as part of an overall
`
`diet to manage the symptoms or reduce the risk of a disease or condition.
`
`15.
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`Instead, medical foods are foods that are specially formulated and processed (as
`
`opposed to a naturally occurring foodstuff used in a natural state) for a patient who is seriously ill
`
`or who requires use of the product as a major component of a disease or condition’s specific dietary
`
`3
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`

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`1:21-cv-01360-JES-JEH # 1 Page 4 of 12
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`management.
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`16. Pursuant to 21 CFR 101.9(j)(8)(ii), a medical food must be intended for a patient
`
`who has a limited or impaired capacity to ingest, digest, absorb, or metabolize ordinary foodstuffs
`
`or certain nutrients, or who has other special medically determined nutrient requirements, the
`
`dietary management of which cannot be achieved by the modification of the normal diet alone.
`
`17. The Product is promoted as a medical food for use by persons with irritable bowel
`
`syndrome.
`
`18. However, the FDA has stated it is not aware of any distinctive nutritional
`
`requirements for individuals with irritable bowel syndrome.
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`19. Therefore, the Product does not meet the definition of a medical food or the
`
`regulatory criteria for a medical food.
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`20. The Product includes claims that it is intended for use in the cure, mitigation,
`
`treatment, or prevention of disease, which are drug claims, and because the products are not
`
`generally recognized as safe and effective for treating these conditions, they are considered
`
`unapproved new drugs under the FDCA.
`
`21. The Product’s gold seal and doctor recommended statements are misleading because
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`these types of representations have been shown to elicit an additional level of trust in the product.
`
`22. However, without uniform standards established by FDA or by industry groups,
`
`manufacturers cannot compare the quality of their products or hold each other accountable
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`23. The Product contains other representations which are misleading.
`
`24. Reasonable consumers must and do rely on a company to honestly identify and
`
`describe the components, attributes, and features of a product, relative to itself and other
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`comparable products or alternatives.
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`4
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`1:21-cv-01360-JES-JEH # 1 Page 5 of 12
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`25. The value of the Product that plaintiff purchased was materially less than its value as
`
`represented by defendant.
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`26. Defendant sold more of the Product and at higher prices than it would have in the
`
`absence of this misconduct, resulting in additional profits at the expense of consumers.
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`27. Had Plaintiff and proposed class members known the truth, they would not have
`
`bought the Product or would have paid less for it.
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`28. The Product is sold for a price premium compared to other similar products, no less
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`than approximately $7.50 for 12 capsules, a higher price than it would otherwise be sold for, absent
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`the misleading representations and omissions.
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`Jurisdiction and Venue
`
`29.
`
`Jurisdiction is proper pursuant to Class Action Fairness Act of 2005 (“CAFA”). 28
`
`U.S.C. § 1332(d)(2).
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`30. The aggregate amount in controversy exceeds $5 million, including any statutory
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`damages, exclusive of interest and costs.
`
`31. Plaintiff Julie Foster is a citizen of Illinois.
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`32. Defendant Nestle Health Science US Holdings, Inc., is a Delaware corporation with
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`a principal place of business in Arlington, Arlington County, Virginia
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`33. Defendant transacts business within this District through sale of the Product at
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`dozens of stores within this State and District, and online, sold directly to residents of this District.
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`34. Venue is in this District because plaintiff resides in this district and the actions giving
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`rise to the claims occurred within this district.
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`35. Venue is in the Peoria Division in this District because a substantial part of the events
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`or omissions giving rise to the claim occurred in McLean County, i.e., Plaintiff’s purchase of the
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`5
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`1:21-cv-01360-JES-JEH # 1 Page 6 of 12
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`Product and her awareness of the issues described here.
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`Parties
`
`36. Plaintiff Julie Foster is a citizen of Bloomington, McLean County, Illinois.
`
`37. Defendant Nestle Health Science US Holdings, Inc., is a Delaware corporation with
`
`a principal place of business in Arlington, Virginia, Arlington County.
`
`38. Defendant is one of the largest and most trusted food and nutrition companies in the
`
`world, which consumers rely upon to supply foods and medical foods to improve their lives.
`
`39. Plaintiff purchased the Product on one or more occasions within the statutes of
`
`limitations for each cause of action alleged, at stores within this District between August and
`
`September 2021, among other times.
`
`40. Plaintiff bought the Product because she expected it was clinically proven to treat the
`
`conditions indicated and was a medical food because that is what the representations said and
`
`implied.
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`41. Plaintiff relied on the words and images on the Product, on the labeling and/or claims
`
`made by Defendant in digital and/or social media.
`
`42. Plaintiff bought the Product at or exceeding the above-referenced price.
`
`43. Plaintiff would not have purchased the Product if she knew the representations and
`
`omissions were false and misleading or would have paid less for it.
`
`44. Plaintiff chose between Defendant’s Product and products represented similarly, but
`
`which did not misrepresent their attributes.
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`45. The Product was worth less than what Plaintiff paid and she would not have paid as
`
`much absent Defendant's false and misleading statements and omissions.
`
`46. Plaintiff intends to, seeks to, and will purchase the Product again when she can do so
`
`6
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`1:21-cv-01360-JES-JEH # 1 Page 7 of 12
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`with the assurance that Product's representations are consistent with its abilities and/or
`
`composition.
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`47. Plaintiff is unable to rely on the labeling of not only this Product, but other similar
`
`products, because she is unsure of whether their representations are truthful.
`
`Class Allegations
`
`48. Plaintiff seeks certification under Fed. R. Civ. P. 23(b)(2) and (b)(3) of the following
`
`classes:
`
`Illinois Class: All persons in the State of Illinois who
`purchased the Product during the statutes of limitations for
`each cause of action alleged.
`
`Consumer Fraud Multi-State Class: All persons in the
`States of Minnesota, Arizona, New Jersey, Rhode Island,
`Maine, Oregon, Washington, North Dakota, Texas, Iowa,
`Kansas, Georgia, Ohio, West Virginia, Virginia, North
`Carolina, Delaware, Montana, Kentucky, Tennessee, New
`Hampshire, Alaska, South Dakota, Oklahoma, Utah,
`Nebraska, Maine, and Wyoming, who purchased the Product
`during the statutes of limitations for each cause of action
`alleged
`
`49. 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.
`
`50. Plaintiff's claims and basis for relief are typical to other members because all were
`
`subjected to the same unfair and deceptive representations and actions.
`
`51. Plaintiff is an adequate representative because her interests do not conflict with other
`
`members.
`
`52. No individual inquiry is necessary since the focus is only on defendant’s practices
`
`and the class is definable and ascertainable.
`
`53.
`
`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.
`
`7
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`1:21-cv-01360-JES-JEH # 1 Page 8 of 12
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`54. 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.
`
`55. 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)
`
`56. Plaintiff incorporates by reference all preceding paragraphs.
`
`57. Plaintiff and class members desired to purchase a product that was clinically proven
`
`to treat the conditions indicated and was a medical food.
`
`58. Defendant’s false and deceptive representations and omissions are material in that
`
`they are likely to influence consumer purchasing decisions.
`
`59. Defendant misrepresented the Product through statements, omissions, ambiguities,
`
`half-truths and/or actions.
`
`60. Plaintiff and class members would not have purchased the Product or paid as much
`
`if the true facts had been known, suffering damages.
`
`61. Defendant misrepresented the Product through statements, omissions, ambiguities,
`
`half-truths and/or actions.
`
`62. Plaintiff relied on the representations that the Product was clinically proven to treat
`
`the conditions indicated and was a medical food
`
`63.
`
` Plaintiff and class members would not have purchased the Product or paid as much
`
`if the true facts had been known, suffering damages.
`
`8
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`

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`1:21-cv-01360-JES-JEH # 1 Page 9 of 12
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`Violation of State Consumer Fraud Acts
`
`(On Behalf of the Consumer Fraud Multi-State Class)
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`64. The Consumer Fraud Acts of the States in the Consumer Fraud Multi-State Class
`
`prohibit the use of unfair or deceptive business practices in the conduct of trade or commerce.
`
`65. Defendant intended that plaintiff and each of the other members of the Consumer
`
`Fraud Multi-State Class would rely upon its deceptive conduct, and a reasonable person would in
`
`fact be misled by this deceptive conduct.
`
`66. As a result of defendant’s use or employment of artifice, unfair or deceptive acts or
`
`business practices, plaintiff, and each of the other members of the Consumer Fraud Multi-State
`
`Class, have sustained damages in an amount to be proven at trial.
`
`67.
`
`In addition, defendant’s conduct showed motive, and the reckless disregard of the
`
`truth such that an award of punitive damages is appropriate.
`
`Breaches of Express Warranty,
`Implied Warranty of Merchantability and
`Magnuson Moss Warranty Act, 15 U.S.C. §§ 2301, et seq.
`
`68. The Product was manufactured, identified, and sold by defendant and expressly and
`
`impliedly warranted to plaintiff and class members that it was clinically proven to treat the
`
`conditions indicated and was a medical food.
`
`69. Defendant had a duty to disclose and/or provide non-deceptive descriptions and
`
`marketing of the Product.
`
`70. This duty is based on Defendant’s outsized role in the market for this type of Product,
`
`a trusted company known for its high quality products.
`
`71. Plaintiff provided or will provide notice to defendant, its agents, representatives,
`
`retailers, and their employees.
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`1:21-cv-01360-JES-JEH # 1 Page 10 of 12
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`72. Defendant received notice and should have been aware of these issues due to
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`complaints by regulators, competitors, and consumers, to its main offices, and by consumers
`
`through online forums.
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`73. The Product did not conform to its affirmations of fact and promises due to
`
`defendant’s actions and were not merchantable because it was not fit to pass in the trade as
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`advertised.
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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.
`
`Negligent Misrepresentation
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`75. Defendant had a duty to truthfully represent the Product, which it breached.
`
`76. This duty is based on defendant’s position, holding itself out as having special
`
`knowledge and experience in this area, a trusted company known for its high quality products.
`
`77. The representations took advantage of consumers’ cognitive shortcuts made at the
`
`point-of-sale and their trust in defendant.
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`78. 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, their purchase of the
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`Product.
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`79. 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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`Fraud
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`80. Defendant misrepresented and/or omitted the attributes and qualities of the Product,
`
`that it was clinically proven to treat the conditions indicated and was a medical food.
`
`81. Moreover, the records Defendant is required to maintain, and/or the information
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`1:21-cv-01360-JES-JEH # 1 Page 11 of 12
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`inconspicuously disclosed to consumers, provided it with actual and/or constructive knowledge of
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`the falsity of the representations.
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`82. Defendant’s fraudulent intent is evinced by its knowledge that the Product was not
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`consistent with its representations.
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`Unjust Enrichment
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`83. 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.
`
` 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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`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 and/or punitive damages pursuant to any statutory
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`claims and 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
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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 12, 2021
`
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`11
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`1:21-cv-01360-JES-JEH # 1 Page 12 of 12
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`Respectfully submitted,
`
`Sheehan & Associates, P.C.
`/s/Spencer Sheehan
`60 Cuttermill Rd Ste 409
`Great Neck NY 11021
`Tel: (516) 268-7080
`spencer@spencersheehan.com
`
`
`
`
`
`
`
`12
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`

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