kim kardashian lawsuit

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Radiancy Inc.’s Answer and Affirmative Defenses to Tria Beauty, Inc.’s Amended Complaint; Radiancy, Inc.’s First Amended Counterclaims - Case No. CV10-5030-RS

Brendan J. O’Rourke* [email protected] Kristin H. Neuman* [email protected] Victoria L. Loughery* [email protected] PROSKAUER ROSE LLP Eleven Times Square New York, NY 10036 Phone: (212) 969-3000 Facsimile: (212) 969-2900 * Admitted Pro Hac Vice

Robert H. Horn (SBN #134710) [email protected] PROSKAUER ROSE LLP 2049 Century Park East, 32nd Floor Los Angeles, CA 90067-3206 Phone: (310) 557-2900 Facsimile: (310) 557-2193

Attorneys for Defendant-Counterclaim Plaintiff Radiancy, Inc.

UNITED STATES DISTRICT COURT

NORTHERN DISTRICT OF CALIFORNIA

SAN FRANCISCO DIVISION

TRIA BEAUTY, INC.,

Plaintiff,

vs.

RADIANCY, INC.,

Defendant.

RADIANCY, INC., Counterclaim Plaintiff,

vs.

TRIA BEAUTY, INC. Counterclaim Defendant, and KIMBERLY KARDASHIAN, Counterclaim Defendant.

Case No. CV-10-5030 RS RADIANCY, INC.’S ANSWER AND AFFIRMATIVE DEFENSES TO TRIA BEAUTY, INC.’S AMENDED COMPLAINT; RADIANCY, INC.’S FIRST AMENDED COUNTERCLAIMS AGAINST TRIA BEAUTY, INC. AND KIMBERLY KARDASHIAN JURY TRIAL DEMANDED Honorable Richard Seeborg Action Filed: November 5, 2010

Case3:10-cv-05030-RS Document52-1 Filed08/03/11 Page2 of 48Case3:10-cv-05030-RS Document71 Filed09/07/11 Page1 of 47

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Defendant-counterclaim plaintiff Radiancy, Inc. (“Radiancy”), by and

through its attorneys, Proskauer Rose LLP, hereby answers the First Amended

Complaint of TRIA Beauty, Inc. (“TRIA” or “plaintiff”):

1. Radiancy admits that TRIA has filed an Amended Complaint (the

“Amended Complaint”) which purportedly asserts claims against Radiancy, arising

from allegedly false or misleading advertising for Radiancy’s hair removal product

(“no!no! Hair”) and acne product (“no!no! Acne”), but otherwise denies the

allegations in paragraph 1 of the Amended Complaint.

PARTIES

2. Radiancy is without knowledge or information sufficient to form a

belief as to the truth of the allegations in paragraph 2 of the Amended Complaint

and therefore denies them.

3. Radiancy admits the allegation of paragraph 3 of the Amended

Complaint.

JURISDICTION

4. Radiancy admits that, in commencing this action, TRIA has made

allegations that invoke the jurisdiction of this court, but otherwise lacks sufficient

knowledge or information at this time to form a belief as to the truth of the

remaining allegations in paragraph 4 of the Amended Complaint and therefore

denies them.

5. Radiancy admits for purposes of this action only that this Court may

exercise personal jurisdiction over Radiancy, but otherwise denies the allegations in

paragraph 5 of the Amended Complaint.

VENUE

6. Radiancy admits that this action may be brought in the Northern

District of California, but otherwise denies the allegations in paragraph 6 of the

Amended Complaint.


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FACTUAL BACKGROUND

The TRIA LHRS

7. Radiancy admits that TRIA markets and sells a hair removal product

under the brand name TRIA Laser Hair Removal System (“TRIA Hair”), and that

the TRIA Hair is a hand-held device that consists of, among other things, a laser

light source. Radiancy lacks knowledge or information sufficient to form a belief as

to the truth of the remaining allegations in paragraph 7, and therefore denies them.

8. Radiancy lacks knowledge or information sufficient to form a belief as

to the truth of the allegations in paragraph 8, and therefore denies them.

9. In response to paragraph 9 of the Amended Complaint, Radiancy

admits that the United States Food and Drug Administration (“FDA”) is charged

with the regulation of medical devices, and that a definition of “device” is provided

in section 201(h) of the Federal Food, Drug, and Cosmetic Act (“FDCA”), 21

U.S.C. § 301, et. seq, and otherwise refers the Court to the contents of the FDCA,

and the relevant FDA regulations promulgated thereunder, for the conditions upon

which a medical device (as defined by the Act) may be approved or cleared to be

legally marketed and sold in the United States. Radiancy lacks knowledge or

information sufficient to form a belief as to the truth of the remaining allegations in

paragraph 9 of the Amended Complaint, and therefore denies them.


to the truth of the allegations in paragraph 10 of the Amended Complaint, and

therefore denies them.

The “no!no!” Hair

11. In response to paragraph 11, Radiancy admits that it markets and sells

an over-the-counter (“OTC”) consumer hair-removal product under the brand name

“no!no!” (“no!no! Hair”), and denies the remaining allegations in paragraph 11 of

the Amended Complaint.


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12. Radiancy admits that no!no! Hair consists of, among other things, a

rectangular metal casing and a replaceable thermal filament, and that, when used as

directed, the no!no! Hair removes hair. Radiancy also admits that the no!no! Hair

product includes a buffer pad, which may be used to clear the remnants of hairs that

have crystallized during the removal process. Radiancy denies the remaining


13. Radiancy admits the allegations of paragraph 13 of the Amended

Complaint.

14. Radiancy admits that the third-party re-sellers listed in the first

sentence of paragraph 14 of the Amended Complaint have sold or are currently

selling no!no! Hair. Radiancy lacks knowledge or information sufficient to form a

belief as to the truth of the allegations in the second sentence of paragraph 14 of the

Amended Complaint, and therefore denies them.

Radiancy’s Allegedly False and Misleading Advertising Claims About The

no!no! Hair

15. Radiancy admits that it has marketed various models of the no!no! Hair

to the general public through television and internet advertising since approximately

2007. Radiancy denies the remaining allegations in paragraph 15 of the Amended

Complaint.

16. Radiancy denies the allegations in paragraph 16 of the Amended

Complaint.

17. Radiancy admits that the phrase “Up to 94% Reduction in Hair Re-

Growth” has appeared on https://www.trynono.com/PS3/index.aspx?mid=807732,

that the phrase “Up to 94% less hair regrowth” has appeared on https://www.my-no-

no.com/, and that the phrase “with repeated use, hair density can be reduced by up to

94%” has appeared in the infomercial, but denies plaintiff’s characterization of the

quoted phrases. Radiancy denies the remaining allegations of paragraph 17 of the


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Amended Complaint.

18. Radiancy admits that the phrase “Now you finally have a solution that

lets you achieve long-term, professional quality hair removal results – in the comfort

of your own home!” and the phrase “Guaranteed long-term results” have appeared

on the https://trynono.com website, and that the phrase “Get rid of unwanted hair

and keep it gone” has appeared on the https://www.my-no-no.com website, but

denies plaintiff’s characterization of the quoted phrases. Radiancy admits that the

quoted phrases in the bullet points of paragraph 18 of the Amended Complaint have

been used on the referenced webpages, but denies plaintiff’s characterization of the

quoted phrases. Radiancy denies the remaining allegations of paragraph 18 of the

Amended Complaint.

19. Radiancy admits that the quoted words and phrases in paragraph 19 of

the Amended Complaint have been used on the referenced webpages, but denies

plaintiff’s characterization of the quoted words and phrases, and denies the

remaining allegations in paragraph 19 of the Amended Complaint.


Complaint.

21. Radiancy admits that the quoted phrases in the bullet points of

paragraph 21 of the Amended Complaint have been used on the referenced

webpages and the infomercial, but denies plaintiff’s characterization of the quoted

phrases, and denies the remaining allegations in paragraph 21 of the Amended

Complaint.

22. Radiancy admits that the https://www.my-no-no.com website has

contained links to three clinical studies relating to no!no! Hair, and otherwise denies

the allegations in paragraph 22 of the Amended Complaint.


to the truth of any allegation as to what TRIA “believes,” and therefore denies them.


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Radiancy denies any and all of the remaining allegations in paragraph 23 of the

Amended Complaint.

24. Radiancy admits that the website https://trynono.com/PS3/faq.aspx has

contained a link to a list of “Frequently Asked Questions”, and admits that the list

has contained the question “How long do results last?” with the answer “After 3-5

months of no treatments, hair might return to pretreatment values. You can easily

maintain results with continued use of no!no!” Radiancy denies all of the remaining



Complaint.


Complaint.

27. Radiancy admits that the https://trynono.com website contains a chart

comparing various attributes of no!no! Hair to other common methods of hair

removal, and otherwise denies the allegations in paragraph 27 of the Amended

Complaint.


Complaint.


Complaint.

30. Regarding paragraph 30 of the Amended Complaint, Radiancy states

that the allegations contained therein are matters of opinion and/or conclusions of

law (as opposed to allegations of fact), such that no response is required of

Radiancy. To the extent that paragraph 30 purports to state allegations of fact,

Radiancy is without knowledge or information sufficient to form a belief as to the

truth of those allegations, and therefore denies them.

31. Regarding paragraph 31 of the Amended Complaint, Radiancy states


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that the allegations contained therein are matters of opinion and/or conclusions of

law (as opposed to allegations of fact), such that no response is required of

Radiancy. To the extent that paragraph 31 purports to state allegations of fact,

Radiancy is without knowledge or information sufficient to form a belief as to the

truth of those allegations, and therefore denies them.


Complaint.


Complaint.

34. Radiancy admits that it markets a product called “no!no! Smooth,”

which is formulated with an ingredient called Capislow. Radiancy lacks sufficient

knowledge or information to form a belief as to the truth of the remaining

allegations in paragraph 34 of the Amended Complaint, and therefore denies them.

35. Radiancy admits that the quoted phrases in the first, fourth, fifth and

sixth bullet points of paragraph 35 of the Amended Complaint have been used on

the referenced webpages, but denies plaintiff’s characterization of the quoted

phrases, and denies the remaining allegations in paragraph 35 of the Amended

Complaint.


Complaint.

37. Radiancy denies that the phrases “no pain”, “totally pain-free” and

“there’s no pain involved,” referenced in paragraph 37 appear at the referenced

weblinks. Radiancy admits that the remaining quoted words and phrases in

paragraph 37 have appeared at the referenced webpages, but denies TRIA’s

characterization of the aforementioned phrases. Radiancy denies the remaining

allegations of paragraph 37.

38. Radiancy admits that the quoted phrases in the bullet points of


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paragraph 38 of the Amended Complaint have been used on the referenced

webpages and infomercial, but denies plaintiff’s characterization of the quoted

phrases. Radiancy admits that the quoted phrases from the no!no! User’s Manual,

https://www.my-no-no.com/nono-how-to-use.asp and https://www.my-no-

no.com/nono8800about.asp have been used on the referenced sources, but denies

plaintiff’s characterization of the quoted phrases. Radiancy denies the remaining


The TRIA SCS

39. Radiancy admits that TRIA markets and sells an OTC acne treatment

device under the brand name TRIA Skin Clarifying System (“TRIA Acne”), and

that one of the components of the TRIA Acne is a handheld blue-light device sold

under the name TRIA Clarifying Blue Light (“TRIA Blue Light”). Radiancy lacks

knowledge or information sufficient to form a belief as to the truth of the remaining

allegations in paragraph 39, and therefore denies them.

40. Radiancy lacks sufficient knowledge or information to form a belief as

to the truth of the allegations in paragraph 40, and therefore denies them.

41. Radiancy admits that TRIA Acne includes a foam cleanser sold under

the name “Clarifying Foam Cleanser” and another component called the

“Rebuilding Complex.” Radiancy lacks sufficient knowledge or information to

form a belief as to the truth of the remaining allegations in paragraph 41, and

therefore denies them.

The no!no! Skin

42. Radiancy admits that it sells an FDA-cleared OTC device for the

treatment of acne called no!no! Skin, refers to the FDA’s publicly available 510(k)

clearance decision for its contents, and denies the remaining allegations of

paragraph 42.

43. Radiancy admits the allegations in the first and second sentence of


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paragraph 43 of the Amended Complaint. Radiancy lacks knowledge or information

sufficient to form a belief as to the truth of the allegations in the third sentence of

paragraph 43 of the Amended Complaint, and therefore denies them.

Radiancy’s Allegedly False And Misleading Advertising Claims About the

no!no! Skin


Complaint.

45. Radiancy admits that the words and phrases listed in the bullet points of

paragraph 45 have been used at the referenced webpages, denies TRIA’s

characterization of the aforementioned phrases, and denies the remaining allegations

of paragraph 45.

46. Radiancy denies that the phrase “I’m not having breakouts anymore”

appears on www.nonoskin.com. Radiancy admits that the remaining words and

phrases listed in the bullet points of paragraph 46 have been used at the referenced

webpages, but denies TRIA’s characterization of the aforementioned phrases, and

denies the remaining allegations of paragraph 46.


paragraph 47 have been used at the referenced webpages, but denies TRIA’s


of paragraph 47.




of paragraph 48.





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of paragraph 49.

FIRST CLAIM FOR RELIEF

FEDERAL UNFAIR COMPETITION

[Lanham Act § 43(a), 15 U.S.C. § 1125(a)]

50. In response to paragraph 50, Radiancy incorporates by reference and

re-alleges its responses to the allegations contained in paragraphs 1 through 49 of



Complaint.


Complaint.


Complaint.


Complaint.


Complaint.

SECOND CLAIM FOR RELIEF

CALIFORNIA FALSE ADVERTISING

[Cal. Bus. & Prof. Code § 17500]





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Complaint.


Complaint.

THIRD CLAIM FOR RELIEF

UNFAIR COMPETITION

[Cal. Bus. & Prof. Code § 17200]





Complaint.


Complaint.


Complaint.


Complaint.

FOURTH CLAIM FOR RELIEF

INFRINGEMENT OF FEDERALLY REGISTERED TRADEMARKS

[Lanham Act § 32, 15 U.S.C. § 1114]





Complaint.



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Complaint.

FIRST AFFIRMATIVE DEFENSE

The allegations and claims in the Amended Complaint, in whole or in part,

fail to state a claim upon which relief may be granted.

SECOND AFFIRMATIVE DEFENSE

The allegations and claims in the Amended Complaint are barred, in whole or

in part, by TRIA’s unclean hands.

THIRD AFFIRMATIVE DEFENSE


in part, by the doctrines of laches, waiver, and/or estoppel.

FOURTH AFFIRMATIVE DEFENSE


in part, by the applicable statutes of limitations.

FIFTH AFFIRMATIVE DEFENSE


in part, because TRIA’s claims have been filed for an improper purpose and lack a

reasonable good faith basis in fact.

SIXTH AFFIRMATIVE DEFENSE


in part, because they are preempted by federal law.

SEVENTH AFFIRMATIVE DEFENSE


in part, because they fall within the primary jurisdiction of the FDA.

EIGHTH AFFIRMATIVE DEFENSE

The claims for damages in the Amended Complaint are barred, in whole or in

part, because they are too remote and/or speculative.


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NINTH AFFIRMATIVE DEFENSE

Radiancy reserves the right to rely on all matters constituting an avoidance or

defense pursuant to Rule 8(c) of the Federal Rules of Civil Procedure or otherwise

to the extent that such defenses are supported by information developed through

discovery.

WHEREFORE, Radiancy demands judgment against TRIA: (a) dismissing

the Amended Complaint, with prejudice; (b) denying the relief requested by TRIA;

(c) awarding Radiancy its costs, expenses, attorneys’ fees and disbursements in

connection with the defense of this action; and (d) granting Radiancy such other and

further relief as this Court deems just and proper.

RADIANCY AMENDED COUNTERCLAIMS AGAINST TRIA

AND KIMBERLY KARDASHIAN

Radiancy, by and through its attorneys, for its Amended Counterclaims

against TRIA and Kimberly Kardashian, hereby states as follows:

1. This is an action for false advertising and unfair competition under

Section 43(a) of the Lanham Act, 15 U.S.C. § 1125(a), and trademark infringement

under Section 32 of the Lanham Act, 15 U.S.C. § 1114 against TRIA Beauty, Inc.

(“TRIA”), and for related violations of California’s Unfair Competition Law, Cal.

Bus. & Prof. Code § 17200, et seq, and False Advertising Law, Cal. Bus. & Prof.

Code § 17500, et seq. against TRIA, and its celebrity endorser/spokesperson, Kim

Kardashian. The parties sell competing over-the-counter (“OTC”) consumer hair

removal and acne treatment products in the United States. This action arises out of

the advertising campaign for the TRIA OTC laser hair removal device, in which

TRIA and its endorser/spokesperson, Kim Kardashian (“Ms. Kardashian”), make


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materially false and misleading claims about the efficacy of the TRIA hair removal

product, and out of the advertising campaign for TRIA’s OTC acne treatment blue

light system, in which TRIA makes materially false and misleading claims about the

efficacy of its acne product.

2. TRIA’s false and misleading advertisements, and wrongful use of

Radiancy’s trademarks, have deceived and confused, and will continue to deceive

and confuse, consumers into purchasing TRIA’s hair removal and acne treatment

products, and is thereby causing Radiancy substantial injury in the relevant product

markets in violation of Section 43(a) of the Lanham Act, 15 U.S.C. § 1125(a). In

addition, TRIA’s wrongful actions, as well as the actions of Ms. Kardashian, have

deceived consumers and caused Radiancy to suffer a loss of money and property, in

violation of California’s Unfair Competition Law, Cal. Bus. & Prof. Code § 17200,

et seq, and False Advertising Law, Cal. Bus. & Prof. Code § 17500, et seq.

The Parties

3. Radiancy is a Delaware corporation with its principal place of business

in Orangeburg, New York.

4. Upon information and belief, TRIA is a Delaware corporation, with its

principal place of business in Dublin, California.

5. Upon information and belief, Ms. Kardashian is a citizen of the state of

California, and resides in or near the city of Los Angeles.

Jurisdiction

6. This Court has jurisdiction over the claims against TRIA under 15

U.S.C. § 1121, and 28 U.S.C. §§ 1331, 1332 and 1338, and under the principles of

supplemental jurisdiction pursuant to 28 U.S.C. § 1367.

7. This Court has personal jurisdiction over TRIA because TRIA’s

principal place of business is in California, and, upon information and belief, TRIA

sells its products and offers its products for sale (including through the


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advertisements that are the subject of this action) in California.

8. This Court has jurisdiction over the claims against Ms. Kardashian

under the principles of supplemental jurisdiction pursuant to 28 U.S.C. § 1332,

because there is diversity of citizenship between Radiancy and Ms. Kardashian, and

the amount in controversy exceeds $75,000, exclusive of interest and costs.

9. This Court has personal jurisdiction over Ms. Kardashian because,

upon information and belief, she is a citizen of California, has contracted to do

business with a TRIA, a corporation with its principal place of business in

California, and has advertised, solicited or encouraged the sale of the TRIA Hair in

California.

Venue

10. As to the claims against TRIA, venue is proper pursuant to 28 U.S.C. §

1391(b).

11. As to the claims against Ms. Kardashian, venue is proper pursuant to 21

U.S.C. § 1391 (a).

Intradistrict Assignment

12. Intradistrict assignment to the San Francisco Division is proper

pursuant to Civil L.R. § 3-2(c) because a substantial part of the events or omissions

that give rise to this action occurred in this judicial district.

Facts Common To All Claims For Relief

The Parties and Their Products

13. Radiancy and TRIA are competitors in the home hair removal and

home dermatology markets in the United States.

14. Radiancy markets and sells its products under the no!no! brand

(“no!no!”) as the no!no! Hair (for hair removal) and no!no! Skin (for dermatological

treatment).

15. TRIA markets and sells its products under the TRIA brand; its hair


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removal product is called the TRIA Laser Hair Removal System (“TRIA Hair”) and

its skin product is called the TRIA Skin Clarifying System (“TRIA Acne”).

16. The TRIA Hair product consists of, among other things, a laser light

source contained within a plastic housing.

17. TRIA Acne is a three-step treatment regime which consists of: 1) the

Clarifying Foam Cleanser (“Cleanser”) containing, among other things, salicylic

acid; 2) the Clarifying Blue Light device (the “Blue Light”); and 3) the Skin

Clarifying Rebuilding Complex (the “Complex”), which also contains salicylic acid.

The Blue Light is a handheld device consisting of, among other things, light

emitting diodes (“LEDs”) contained within a plastic housing.

18. Both TRIA Hair and TRIA Blue Light are regulated by the FDA as

Class II laser medical devices under the FDCA, as amended by the Medical Device

Amendments of 1976 (“MDA”), 21 U.S.C. §§360c-360dd, and the federal

regulations and guidelines promulgated thereunder.

19. TRIA distributes TRIA Hair nationally through its websites at

http://www.triabeauty.com and http://www.trytrialaser.com, and its toll-free

telephone numbers at 1-800-398-9530 and 1-800-398-1697. TRIA also distributes

TRIA Hair through third-party online and in-store re-sellers, including but not

limited to Nordstrom, Neiman Marcus, Bloomingdales, Amazon.com, QVC, Bliss

Spas, and various other spas and dermatologist offices.

20. TRIA distributes TRIA Acne nationally through its websites at

http://www.triabeauty.com and http://www.trytriablue.com, and its toll free number

at 1-800-398-1903, as well as through third-party online and in-store re-sellers,

including but not limited to Nordstrom, Neiman Marcus, Bloomingdales,

Amazon.com, and QVC.

21. In connection with the sale of TRIA Hair and TRIA Acne, TRIA has

conducted a national advertising campaign, through internet advertising,


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infomercials, and, upon information and belief, appearances by paid spokespersons

on various television talk shows and news shows.

TRIA’s False And Misleading Advertisements For TRIA Hair

Claims That Using TRIA Hair Results In Permanent Hair Removal

22. In its labeling and advertising for TRIA Hair, TRIA falsely and

misleadingly claims that TRIA Hair provides users with permanent hair removal.

23. For instance, at http://www.trytrialaser.com (last visited on

11/30/2010), TRIA claims in a large bold font “permanent hair removal is our

promise;” beneath this claim, in slightly smaller typeface, it claims “The TRIA

Laser is the only way to get permanent hair removal at home – guaranteed.” On the

frequently asked questions (“FAQ”) page of the same website,

http://www.trytrialaser.com/faqs.aspx (last visited 11/30/2010), in response to the

question “Are the results permanent?” TRIA claims “In as little as 90 days, you’ll

see permanent results—and in 6 months, you’re done!”

24. Similarly, at http://www.triabeauty.com (last visited on 11/30/2010)

TRIA claims that users of its device may “take a permanent holiday from unwanted

hair,” and at http://www.triabeauty.com/info/hair-removal-faqs.htm (last visited on

11/30/2010), in response to the question on its FAQ page “Are the results

permanent?” TRIA makes the claim: “In as few as eight treatments you’ll never

have to shave or wax again. End of story.” Likewise, on another page of the

triabeauty.com website, http://www.triabeauty.com/tria-laser-hair-removal-system

(last visited on 11/30/2010), TRIA claims “Get permanent hair-free results at home

– guaranteed!”

25. The TRIA packaging and labeling makes the claims “No more endless

shaving * No more endless waxing,” and “Stop shaving. Stop waxing.”

26. TRIA also runs an Infomercial for TRIA Hair (“Hair Removal

Infomercial”) which is replete with claims that TRIA Hair provides permanent hair


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removal. For instance, the Hair Removal Infomercial states that “Now you can get

rid of hair forever, with the Tria Laser,” and that consumers can “get permanent

results and be free from unwanted hair, for good.”

27. The Hair Removal Infomercial makes similar claims, such as, “Now

you can get permanent hair removal at home with the Tria Laser…”; “Permanent

hair removal, that’s right, I said it – permanent…it’s the first and only real laser hair

removal treatment to achieve permanent hair removal, at home” ; and “what can you

do with the TRIA? Permanent hair removal.”

28. In addition, the Hair Removal Infomercial falsely claims that TRIA

Hair “is the first technology to really deliver permanent hair free results,” and that

women are “experiencing the freedom of being hair free and care free for life.”

(emphasis added)

29. Both of TRIA’s websites contain similar false and misleading claims of

permanent hair removal. At http://www.triabeauty.com/info/hair-removal-

permanent-results.htm (last visited 12/2/10), TRIA claims “Experience the

permanent results that only genuine laser hair removal can provide,” and “The TRIA

Laser Hair Removal System is the first and only FDA-cleared laser hair removal

system available that uses the same trusted laser technology as the professionals and

provides the same results—at home.” At

http://www.trytrialaser.com/howitworks.aspx (last visited 12/2/10), TRIA claims “In

as little as six months, you’ll be done. The hair will be gone forever - like the hair

was never there!” At http://www.triabeauty.com/tria-laser-hair-removal-system.htm

(last visited 7/19/10) TRIA advertises that consumers should “[i]magine a place

where showing a little skin doesn’t require any grooming maintenance whatsoever”

and that its product is “the only hair removal laser that delivers professional,

permanent results in the comfort of your home.” At http://www.triabeauty.com/

(last visited 7/19/10) TRIA advertises that consumers can “[f]ree yourself from a


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lifetime of shaving and waxing without one trip to the doctor’s office or spa with

our professional-grade, at-home Hair Removal Laser.”

30. Similar claims also appear on TRIA’s Facebook page: “Discover more

about the TRIA Laser – the first and only FDA-cleared at-home laser hair removal

device that delivers permanent results” and “The TRIA Laser Hair Removal System

is designed to gently disable hair growth so that your skin remains smooth and hair-

free – permanently.” (found at: http://www.facebook.com/triabeauty?v=feed&

story_fbid=174763155983#!/triabeauty?v=info (last visited 12/9/2010)) (emphasis

added).

31. TRIA has also made these false and misleading permanent hair removal

claims through its Twitter account. For example, on August 15, 2010, TRIA

‘tweeted’, “TRIA Laser Hair Removal System will have you living happily ever

after with beautifully hair free skin!” (found at: http://twitter.com/TRIABeauty (last

visited 12/9/10)).

32. TRIA’s claims of permanent hair removal are contradicted by the

Instructions for Use for TRIA Hair, which indicate (on page 8) that “occasional

touch-ups” may be necessary, even after the recommended eight months of

treatment, and by the publicly available FDA clearance letter for TRIA Hair, which

states that the device was indicated for the “permanent reduction in hair

regrowth…” (emphasis added), not “permanent hair removal.”

33. Published articles regarding the efficacy of TRIA Hair further

demonstrate the falsity of TRIA’s permanent hair removal claims. For instance, a

clinical assistant professor at the Yale School of Medicine explained, in a December

2008 issue of Allure magazine, that “…the Tria isn’t as powerful as a doctor’s

machine and will likely result in the thinning and lightening of dark hair, rather than

the permanent removal of it.” Also, in a June 2010 issue of Oprah magazine, the

reviewer stated that even after the recommended eight months of treatment “I shave


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any remaining fuzz about every two weeks (and do a touch-up laser treatment about

every four).” An article on TRIA Hair in a July 2008 issue of Lucky states that

“Most people do need a once yearly touch up after six months of treatments,

though.”

34. One clinical study on the safety and efficacy of TRIA Hair by Ronald

G. Wheeland, MD, FACP, which was published in a 2007 issue of Lasers in Surgery

and Medicine showed that, study subjects who completed the recommended regime

of three treatments at three-week intervals reported various percentages of hair

regrowth at the one-month, three-month and twelve-month marks following the

third treatment.

35. TRIA’s repeated claims of “permanent results” are also false and

misleading because TRIA does not adequately disclose to consumers that

“permanent” is defined in the industry only as a long-term (four to twelve month)

stable reduction in hair regrowth, following a treatment regime, and does not mean

that users will experience a permanent reduction in the total number of body hairs or

permanent reduction in the removal of all body hair.

36. TRIA’s advertising also conveys the false and misleading message that

TRIA Hair was cleared or approved by the FDA for permanent hair removal.

37. For instance, in an on-air QVC presentation for TRIA Hair (available

at: http://www.qvc.com/qic/qvcapp.aspx/view.2/app.detail/params.item.A97878.

desc.Tria-Beauty-At-Home-Laser-Hair-Removal-System-with-Body-Wash (last

visited 12/9/10)), the QVC host claims that, “Again, this is FDA cleared for

permanent hair removal.” (Emphasis added.) Upon information and belief, the

QVC Commercial first aired in or around October 2009; as of December 9, 2010, it

is still available on QVC.com.

38. Similarly, the Hair Removal Infomercial claims that “Now you can get

rid of hair forever, with the Tria Laser, the first and only FDA cleared hair removal


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laser for use at home, get permanent results and be free from unwanted hair, for

good.” (Emphasis added.) While this claim is spoken, a picture of the TRIA device

is shown, along with the claim “real laser. permanent results.” at the bottom of the

screen, and, in the upper right hand corner of the screen, a gold badge with the

words “PROVEN * FDA cleared * SAFE & EFFECTIVE” written inside it. The

Hair Removal Infomercial also claims that, “Now you can get permanent hair

removal at home with the Tria Laser, the first and only FDA cleared hair removal

laser available for home use.” (Emphasis added.)

39. Eric F. Bernstein, MD, who is credited in the Hair Removal

Infomercial as a board certified dermatologist, laser surgeon and an equity holder in

TRIA Beauty, makes the claim, “TRIA is the only FDA-cleared laser for home laser

hair removal and, what can you do with the TRIA? Permanent hair removal.”

(emphasis added)

40. Currently, the FDA does not permit manufacturers of laser hair removal

devices to advertise their products as providing permanent hair removal. Instead,

provided the FDA finds there is sufficient data to support the claim, the FDA may

clear a laser hair removal device to be marketed for the intended use in hair removal

sustained by periodic treatments and for permanent reduction in hair regrowth,

defined as a stable, long-term, or permanent reduction in the number of hairs re-

growing following a treatment regime, where the reduction is stable over a time

greater than the duration of the complete growth cycle of the hair follicles, which

may vary from four to twelve months, depending on where the hair is located on the

body.

41. Upon information and belief, in December of 2009, TRIA Hair was

cleared by the FDA to be marketed as an OTC device intended for “adjunctive use

with shaving for hair removal sustained with periodic treatments” and for the

“permanent reduction in hair regrowth defined as a long-term stable reduction in


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hair counts following a treatment regime,” but was not cleared to be marketed for

permanent hair removal.

42. False and misleading statements regarding the FDA approval or

clearance of an OTC device for permanent hair removal are material, and likely to

influence the purchasing decisions of a substantial number of consumers. TRIA’s

Hair Removal Infomercial reinforces the importance of an “FDA cleared” claim by

showing Rebekah George, a fashion and beauty editor, states that “Knowing that the

Tria Laser is FDA cleared is so important to me as a beauty influencer, because you

know that it’s that stamp of approval that is safe and effective…”

Claims That TRIA Hair Is “Safe and Effective”

43. TRIA makes numerous unqualified claims on its websites that TRIA

Hair is safe and effective (see, e.g., “FDA-cleared safe, effective, permanent results”

(at http://www.trytrialaser.com/ (last visited 12/1/10)) and “FDA-cleared safe and

effective” (at http://www.triabeauty.com/tria-laser-hair-removal-system (last visited

12/1/10)) and in its Hair Removal Infomercial (e.g., “Knowing that the Tria Laser is

FDA cleared is so important to me as a beauty influencer, because you know that

it’s that stamp of approval that is safe and effective…”).

44. TRIA’s unqualified claims of safety and efficacy are false and

misleading, because TRIA’s device is not “safe” for certain skin tones or on certain

areas of the body, and is not “effective” on certain shades of hair.

45. For instance, the TRIA Hair packaging cautions that the device should

not be used “if you have dark skin tones,” (described as medium brown, dark brown

and black skin), and that if used on dark skin the device can “burn, discolor, or scar”

the skin.

46. Similarly, the TRIA packaging warns that the device is not safe to use

“on or around the eyes, eyebrows, or eyelashes,” because doing so “can cause

serious and permanent eye injury,” and further warns the device is not safe for use


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on the “face, head, ears, neck, nipples, or genitals, or around the anus,” because

“using the TRIA System there may injure the skin.”

47. Likewise, the TRIA packaging and the Instructions for Use for TRIA

Hair caution that the device only “works on naturally brown or black hair. It does

NOT work on white, gray, blond, or red hair, even if the hair is dyed a darker color.”

(emphasis in original)

48. Similar warnings appear in published articles reviewing the device.

49. However, neither the unqualified “safe and effective” claims in the Hair

Removal Infomercial nor those on the website adequately disclose to consumers that

the device is only “safe and effective” for a limited segment of the relevant

consumer population, and, even then, it is only safe to be used on some, but not all,

parts of the body.

50. TRIA’s unqualified statements of safety and effectiveness as alleged

herein are likely to mislead a significant number of consumers for whom TRIA Hair

is not safe or effective into purchasing the product.

Claims that TRIA Hair Is Equivalent To Professional Laser Hair Removal

51. Both of TRIA Hair’s websites falsely claim that TRIA Hair is the

equivalent, in technology and results, to professional laser hair removal performed

by doctors. For instance, at http://www.trytrialaser.com/, TRIA claims “get the

same results as professional laser hair removal, for thousands of dollars less.”

Similarly, at http://www.triabeauty.com/info/hair-removal-permanent-results.htm,

TRIA claims, “The TRIA Laser Hair Removal System is the first and only FDA-

cleared laser hair removal system available that uses the same trusted laser

technology as the professionals and provides the same results—at home,” and at

http://www.triabeauty.com/info/hair-removal-save-money.htm, TRIA claims that

“[t]he TRIA Laser delivers the same permanent results at a fraction of the cost of

professional treatments.”


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52. Likewise, the Hair Removal Infomercial for TRIA Hair repeatedly

equates the device to professional laser hair removal treatments, making claims such

as, “only Tria uses the same laser technology as dermatologists, with the same

permanent results,” and “the Tria Laser is the same laser dermatologists use and

gives you the same permanent results, for your entire body, without the

appointments and for a lot less money.”

53. In one scene from the Hair Removal Infomercial, one of TRIA’s

founders, Dr. Robert Grove, points to a large, professional-looking laser device, and

says, “here is the Light Sheer, as you can see, it is a huge machine. We figured out

a way to harness the same technology...into a device small enough and light enough

and safe enough and powerful enough to get those same professional permanent

results but now in the privacy and convenience of your own home.”

54. In the same scene of the Hair Removal Infomercial, the host, Ereka

Vetrini, says, “It really is amazing, I mean the Tria Laser is the same laser hair

removal technology with the same permanent results that you get in a dermatologist

office. So this [holds up TRIA device] does exactly what that [gesturing to

professional device] does.”

55. The above claims are false and misleading because the TRIA device is

not based on the same technology as professional devices and cannot provide users

with the same results as laser hair removal treatments performed in doctors’ offices.

56. For instance, professional devices such as the one depicted in TRIA’s

Hair Removal Infomercial, are more powerful, because they use a columnated beam

of light, instead of the diffused beam used by TRIA Hair.

57. Furthermore, upon information and belief, professional laser hair

removal can be performed on the face, and on dark skin tones, whereas the TRIA

device is not safe or effective for those uses.


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Claims That TRIA Hair Is Painless

58. TRIA’s advertising also falsely claims that users of TRIA Hair will not

experience any pain.

59. For instance, at http://www.trytrialaser.com/testimonials.aspx, TRIA

posts a quote from a purported TRIA Hair user, Christina S., who states “I was

really happy that it wasn’t painful.” This user also appears in the TRIA Hair

Removal Infomercial, making the same claim.

60. TRIA posts another claim from a purported “TRIA Beauty Customer”,

Darlene S., who claims that TRIA Hair is “virtually painless.”

61. In the Hair Removal Infomercial, host Ereka Vetrini claims that “even

on the highest level I just feel a little pinch.” Later in the Infomercial, another host,

Kylie Jay, asks purported first time TRIA users, “It’s not uncomfortable at all?”

One user replies, “not at all,” and another states that it’s “maybe like a little snap.”

62. However, a simulated consumer use study on the device sponsored by

TRIA (then-known as SpectraGenics) demonstrated that a significant number of test

subjects reported feeling pain, ranging on scale from ‘slight’ to ‘severe’. One test

subject even reported feeling that “the pain level was severe enough to request being

dropped from the study.”

63. Even articles reviewing the product have cautioned that users will

experience pain. For instance, in the June 2010 issue of Oprah magazine, the

review of the TRIA Hair device states, “Aaak! Eeep! Owww! That’s the audio

version of my at-home laser hair removal project…Why the sound effects? Because

the process hurts.”

Claims That TRIA Hair Is The “First” and “Only” At-Home Laser

Hair Removal Device

64. The TRIA Hair Removal Infomercial contains numerous false and

misleading claims that TRIA Hair is the “first” and/or “only” laser hair removal


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device that is cleared for at-home use, such as:

“the TRIA is the only FDA cleared laser for home hair removal,”

“Tria Laser, the first and only FDA cleared hair removal laser for

use at home”

“Now you can get permanent hair removal at home with the Tria

Laser, the first and only FDA cleared hair removal laser available

for home use.”

65. Similar claims appear on TRIA’s websites, and on their Facebook page:

“The TRIA Laser is the first and only FDA-cleared laser hair

removal system available for use at home.” (found at:

http://www.trytrialaser.com/faqs.aspx (last visited 12/9/2010)).

“The TRIA Laser Hair Removal System is the first and only FDA-

cleared laser hair removal system available that uses the same

trusted laser technology as the professionals and provides the same

results—at home.” (found at: http://www.triabeauty.com/info/hair-

removal-permanent-results.htm (last visited 12/9/2010)).

“Discover more about the TRIA Laser – the first and only FDA-

cleared at-home laser hair removal device that delivers permanent

results.” (found at:

http://www.facebook.com/triabeauty?v=feed&story_fbid=17476315

5983#!/triabeauty?v=info (last visited 12/9/2010)).

66. These claims are also repeated in the QVC Commercial. In the

Commercial, the QVC host claims, “and it is the only one that is FDA cleared for at

home use,” and the TRIA spokesperson, Dr. Eric Bernstein, agrees, claiming, “it is

the only laser you can buy at home that is FDA cleared.”

67. However, TRIA Hair is not the only laser hair removal device cleared

by the FDA for at home use. The Flash N’ Go device by Home Skinovations, Ltd.


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was cleared by the FDA for OTC use as a hair removal device in October of 2008,

and is also cleared by the FDA to be marketed for use in the permanent reduction of

hair re-growth.

68. Nor, upon information and belief, was TRIA the “first” laser hair

removal device to be cleared by the FDA for at-home hair removal. Upon

information and belief, the ABC Hair Removal System by Palomar Technologies

was cleared for OTC use in 2006, whereas TRIA Hair did not receive OTC

clearance from the FDA until some time in 2008.

False And Misleading Claims Made By TRIA Spokesperson Kim Kardashian

69. In or around December 2010, TRIA began using Kim Kardashian as a

paid celebrity spokesperson for TRIA Hair.

70. Shortly thereafter, Kim Kardashian, in her capacity as a paid

spokesperson, began promoting and advertising the TRIA Hair product on talk

shows, in interviews, and in her Twitter feed, where she repeated many of the same

false statements about the TRIA Hair that had appeared in TRIA’s other advertising.

71. For instance, during Kim Kardashian’s appearance on CBS Network’s

“The Early Show”, on or about December 10, 2010, she repeated the false claim that

TRIA Hair is the “only” FDA-cleared at home laser hair removal treatment available

to consumers. See http://www.facebook.com/video/video.php?v=1617432169852

(last visited 6/1/11).

72. She repeated this false and misleading claim during her appearance on

the Rachel Ray Show, on or about December 16, 2010, stating that TRIA Hair is

“the first FDA product that is cleared, and you can use it at home.” See

http://www.youtube.com/watch?v=eZzP70Ndz-8 (last visited 6/1/11).

73. Ms. Kardashian’s Rachel Ray appearance was deceptive in yet another

respect. Ms. Kardashian offered the TRIA Hair as the purported “solution” to the

problem of a viewer who complained about having unwanted hair “all over [her]


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body”, and who was shown in a video plucking her eyebrows and bleaching the

hairs on her upper lip. Although Ms. Kardashian gave the viewer a free TRIA Hair

device, Ms. Kardashian failed to disclose to the viewer, or the viewing audience,

that TRIA Hair cannot be used on the face.

74. On or about May 2, 2011, Ms. Kardashian appeared on the Wendy

Williams Show, where she made a number of false and misleading statements about

TRIA Hair. For instance, she again stated that TRIA Hair is the “first FDA-cleared

at home” laser hair removal product. See http://www.youtube.com/watch?v=R7ks-

oTS6y8 (last visited 6/1/11).

75. Also during her Wendy Williams appearance, Ms. Kardashian falsely

claimed that TRIA Hair provided permanent hair removal, stating that TRIA Hair

users will “never have to buy a razor or shaving cream” again.

76. Ms. Kardashian failed to disclose during this appearance that TRIA

Hair could not be used on all hair or skin types, or that it could not be used on all

parts of the body – in fact, to the contrary, Ms. Kardashian falsely claimed that she

uses it “on [her] entire body.”

77. Shortly thereafter, on or about May 4, 2011, Ms. Kardashian appeared

on Fox News to advertise and promote the TRIA Hair. During this appearance she

again falsely claimed that TRIA Hair is the “first FDA-cleared product in laser hair

removal.” This false claim was accompanied by on-screen text which made the

even more egregiously false claim that TRIA Hair was “FDA Approved.” TRIA

Hair was cleared for sale by the FDA through the 510(k) application process, not the

more rigorous pre-market approval process, and therefore cannot claim to be an

“FDA Approved” device. See http://ht.ly/4O3F6 (last visited 6/2/11).

78. Additionally, on December 22, 2010, Ms. Kardashian “tweeted”

through her Twitter account that “I’ve been using the @TRIABeauty Laser since

they first sent it to me to try & Im [sic] loving the results so far!” This statement


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was “re-tweeted” by TRIA through TRIA’s Twitter account. See

http://twitter.com/#!/TRIABeauty (last visited 6/2/11).

79. Upon information and belief, Ms. Kardashian is not a bona fide user of

the TRIA Hair product and thus the above “tweet” – as well as her other public

statements with regard to the TRIA product – are false and or misleading, and in

violation of the FTC Guidelines Concerning the Use of Endorsements and

Testimonials in Advertising.

80. Many of Ms. Kardashian’s own statements reveal that she is not a bona

fide user of the product.

81. For instance, Ms. Kardashian’s statement on the Wendy Williams

Show that she doesn’t have any hair “because [she] uses it on [her] entire body,”

indicates that she is not familiar with the device or how it is used.

82. Likewise, her statement on that same show that a person using TRIA

never has to buy a razor or shaving cream again also shows that she has not used the

device. The instructions for use states that the system is “intended for adjunctive

use with shaving” and it tells users to “cleanse, shave, and dry [the] skin” first

before treating the skin with the laser, that between treatments the user can shave,

and that “occasional touch-ups” may be necessary for users even after the

recommended eight-month treatment period.

83. Moreover, upon information and belief, Ms. Kardashian only became a

spokesperson for TRIA in early December, just a few short weeks before she began

advertising the TRIA Hair. Thus contrary to her “tweet” on December 22, 2010,

that she was “loving the results so far,” she could not possibly have been seeing any

“results” from any use of TRIA Hair at that time. According to TRIA’s own

website, a user will not “begin to see results” for at least 90 days, and would not see

any “permanent” results for at least 6 months. See

http://www.trytrialaser.com/faqs.htm (last visited 6/2/11).


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84. Similarly, upon information and belief, her appearances on the Early

Show and the Rachel Ray show were also made before Ms. Kardashian could

possibly have had time to experience any noticeable hair removal results from using

TRIA.

85. Furthermore, even if Ms. Kardashian had been using the TRIA Hair for

the at least the 6 months it would take (according to TRIA’s website) to experience

any “permanent” reduction in hair, Ms. Kardashian’s statements are still false and

misleading in yet another respect: since Ms. Kardashian has admitted on numerous

occasions (including during the Early Show, Rachel Ray and Wendy Williams

appearances described above) that she has been receiving “professional” laser hair

removal treatments for almost a decade, any “results” she may experience, or have

experienced, as a result of her alleged use of the TRIA Hair, would not be typical of

what the majority of consumers would experience.

86. However, at no time during her promotional appearances for TRIA

does she disclose the fact that her results are atypical consumers.

87. Nor has TRIA made any attempt to qualify any of Ms. Kardashian’s

public statements. To the contrary, TRIA compounds the falsity of these statements

by using Ms. Kardashian’s results to convey the false message to consumers that

they can have the same results as Ms. Kardashian. For instance, on May 4, 2011,

TRIA posted a link to Ms. Kardashian’s Wendy Williams Show appearance on the

TRIA Beauty Facebook page, stating “Kim’s right: hairless is best!” See

http://www.facebook.com/triabeauty?sk=wall&filter=2 (last visited 6/10/11).

88. In addition, in an April 18, 2011 post to its Facebook page, TRIA tells

consumers: “Get hair-free forever – just like Kim Kardashian.” See Id.

89. Ms. Kardashian’s false and misleading statements regarding the TRIA

Hair are material, and, due to her celebrity status, her statements are likely to

influence the purchasing decisions of a substantial number of consumers.


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TRIA’s False And Misleading Advertisements Regarding TRIA Acne

TRIA Acne’s Superiority Claims

90. TRIA’s advertising for TRIA Acne repeatedly claims to be superior to

any and all existing acne treatments.

91. For instance, in an April 5, 2010 press release on the triabeauty.com

website (at: http://www.triabeauty.com/medias/sys_master/8799244451870.pdf (last

visited 12/9/2010)), TRIA claims that its system is “clinically-proven to clear acne

breakouts three times faster than any other leading acne treatment* (* Based upon

comparisons to published clearance rates and physician assessment of prevention).”

Nowhere in the press release does TRIA disclose the “leading acne treatments” to

which TRIA compares itself.

92. In the same press release, Mike O’Neil, Ph.D, TRIA’s Director of

technology development is quoted as saying, “Research shows that our system is

superior to any other acne treatment available, without the harsh drying, irritation

and premature aging side effects typical of most acne treatments.”

93. TRIA also claims, “TRIA Beauty’s scientists created the most

advanced blue light treatment available today, and made it safe and simple for you

to use at home. See clear skin faster and better than any other acne treatment you’ve

ever used before, or your money back!” (found at:

http://www.triabeauty.com/info/what-is-tria-blue-light-therapy.htm (last visited

12/9/10) (emphasis in original). Similarly, at http://www.trytriablue.com/faqs.aspx

(last visited 12/9/2010), TRIA claims that its “Clarifying Blue Light is the most

advanced blue light therapy available today made safe and simple for you to use at

home.” (Emphasis added.)

94. Furthermore, in the Infomercial for TRIA Acne (“Acne Infomercial”),

TRIA claims that TRIA Acne “bathes your skin in natural, healthy blue light to clear

breakouts three times faster and prevent breakouts better than any other leading acne


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treatment available on tv, in stores, online, or even from a doctor.” While this claim

is made in the Infomercial, a chart is shown onscreen, purportedly comparing TRIA

to “other treatments.” The chart depicts TRIA as ranging from around 5%

‘effective’ at week 1, to being up to 70% effective at an unmarked time point, while

a number of unspecified “other treatments” are shown as ranging from less than 5%

at week 1 to less than 30% at the latest unmarked time point. At the bottom of the

screen, beneath the chart is a nearly illegible qualifier stating “Based on

comparisons to published clearance rates and physician assessment of prevention.”

Nowhere in the Acne Infomercial does TRIA disclose the “other treatments” to

which TRIA compares itself.

95. The TRIA Acne brochure also claims that it “clears acne breakouts

faster than any other leading acne treatment.”

96. Upon information and belief, TRIA’s superiority claims, such as those

alleged herein, are false because other acne treatments are just as effective, if not

more effective, in treating acne than TRIA Acne.

97. For instance, both a March 2009 article in The Journal of Clinical and

Aesthetic Dermatology and an August 2010 article in The Journal of the American

Academy of Dermatology article state that the current most effective treatment

available for acne vulgaris is oral isotretinoin, a prescription medication available

from doctors.

98. One study comparing the efficacy of blue light therapy to that of

benzoyl peroxide (an active ingredient found in many OTC acne products) on test

subjects with acne grades II and III, found that the improvement achieved by

benzoyl peroxide was the same as that achieved by the blue light therapy.

99. There are also other published articles and studies which indicate that

treatment of acne with a combination of blue and red light therapy may be more

effective than treatment with blue light alone.


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Claims That TRIA Blue Light Is Equivalent To Professional Blue Light Therapy

100. TRIA’s advertising falsely and misleadingly claims that the Blue Light

included with its acne product provides the same blue light therapy that a consumer

would obtain from a dermatologist.

101. For instance, TRIA makes the following claims on its websites:

“…TRIA is the first and only acne system to provide the same blue

light therapy and guarantee the same great results that

dermatologists have offered exclusively in their offices since 2002.”

(found at: http://www.triabeauty.com/medias/sys_master/

8799244517406.pdf (last visited 12/9/2010).

“Until now, therapeutic doses of blue light were only available by

appointment in a doctor’s office…” (Found at:

http://www.triabeauty.com/medias/sys_master/8799244484638.pdf

(last visited 12/9/2010).

“TRIA Beauty developed a technology that delivers up to 10 times

more blue light than other OTC blue light devices – and the same

levels of blue light as professional systems used in dermatologists’

offices.” (Found at: http://www.triabeauty.com/medias/sys_master

/8799244451870.pdf (last visited 12/9/10)).

“Dermatologists have used blue light therapy in their offices since

2002 – now, get the same professional results at home, for a lot

less.” (Found at: http://www.trytriablue.com/ (last visited

12/9/2010).

“The TRIA Skin Clarifying System offers up to 10x more blue light

than other at-home devices. It’s the only way to achieve the same

skin-clearing and brightening results as professional treatments in


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just minutes per day.” (Found at: http://www.trytriablue.com/

faqs.aspx (last visited 12/10/10)).

102. In addition to the claims on TRIA’s websites, the Acne Infomercial

shows a large professional blue light device, which is referred to as “the

ClearLight”, after which the infomercial host, Ereka Vetrini, holds up the TRIA

Blue Light and says “I want to make sure everybody understands this does exactly

what [gesturing to the “ClearLight” machine] this does.”

103. The Acne Infomercial also falsely claims that “only the TRIA

clarifying blue light has the same professional strength that dermatologists use,” and

that consumers will receive these professional results by using the device just 2 ½

minutes, twice a day.

104. For example, Dr. Zakia Rahman, who is credited in the Acne

Infomercial as being a board-certified dermatologist and ‘international light therapy

expert,’ comparing the TRIA Blue Light to professional blue light therapy, claims,

“each professional treatment takes about 20 minutes or more, two to three times a

week, for weeks at a time. And, in contrast, the TRIA blue light takes only about 2

½ minutes, twice a day.”

105. A voiceover in the Acne Infomercial further claims that “it only takes 2

½ minutes, twice a day to treat your entire face.” (emphasis added).

106. A recently aired QVC commercial for TRIA Acne repeats these false

claims. In the QVC commercial, the host, speaking with Dr. Eric Bernstein, says

“This is the real deal, and this is the same technology you use in your practice.” Dr.

Bernstein agrees, “Absolutely.” See http://www.qvc.com/qic/qvcapp.aspx/view.2/

app.detail/params.item.A215151.desc.TRIA-Skin-Clarifying-System-BeClear-Kit-

wBonusCartridge (last visited 12/13/10).

107. However, according to TRIA Acne’s Instructions for Use, in order to

get the advertised results and the alleged “professional strength” blue light


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treatment, the user is required to spend that 2 ½ minutes, twice a day, treating one

approximately 3.3cm x 3.3cm patch of skin. If additional 3.3cm x 3.3cm areas are

to be treated, it will require an additional 5 minutes a day to treat each additional

area.

108. In contrast, professional blue lights like the one featured in the Acne

Infomercial are capable of treating a large area, such as the entire face, all at once.

109. The Acne Infomercial also shows various TRIA Blue Light users

running the device over their face, covering the entire area in just a few seconds.

This demonstration conveys the message to consumers that they can obtain the

advertised results of the bluelight treatment by just waving the light over their entire

face. This message is false, and is contradicted by the product’s own instructions

for use.

110. The demonstration is also false and misleading because, if the device is

used that way the user will not be receiving the same “professional strength” of blue

light that TRIA’s advertising repeatedly touts.

111. For example, the ClearLight™ Therapy System (CureLight Ltd.) is a

professional light source intended for treating dermatological disorders such as acne

by emitting “visible light in the violet-blue range with irradiance ranging between

50-200 mW/cm2.” See http://curelight.com/_Articles/Article.asp?ArticleID=

63&CategoryID=83 (last visited 12/14/10). At the recommended treatment time of

15 minutes (900 seconds), the ClearLight Therapy System delivers to the entire face

a dose of 45 Joules at the minimum 50 mW/cm2 setting and a dose of 180 Joules at

the maximum 200 mW/cm2 setting. Based on measurements made by Radiancy, the

TRIA Acne BlueLight has an irradiance (power density) of approximately 221

mW/cm2. At the recommended treatment time of 5 minutes (300 seconds), the

TRIA Acne BlueLight delivers 66.3 Joules, which is at the low end of the

professional dose range and is achievable only if the user confines the light to the


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recommended 3.3 X 3.3 cm treatment area for the entire 5-minute treatment time. If

the user applies the TRIA BlueLight in a “painting” fashion over the whole face (as

demonstrated in the Infomercial), the device will not deliver anything close to a

professional dose.

Claims that TRIA Blue Light Has 8 to 10 Times More Blue Light

Than Other At-Home Devices

112. TRIA has made various claims on its website that its Blue Light has 8

to 10 times more blue light than competing blue light devices, such as:

“8-10 times more blue light than other at-home blue light devices”

(found at: http://www.triabeauty.com/info/what-is-tria-blue-light-

therapy.htm (last visited 12/9/2010)).

“…TRIA Beauty developed a technology that is 10 times more

powerful than other OTC blue light devices…” (found at:

http://www.triabeauty.com/medias/sys_master/8799244320798.pdf

(last visited 12/9/2010)).

“…TRIA Beauty developed a technology that delivers up to 10

times more blue light than other OTC blue light devices…” (found

at: http://www.triabeauty.com/medias/sys_master/8799244451870.

pdf (last visited 12/9/10)).

“The TRIA Skin Clarifying System offers up to 10x more blue light

than other at-home devices.” (found at: http://www.trytriablue.com/

faqs.aspx (last visited 12/10/10)).

113. In the recently aired QVC commercial for TRIA Acne discussed above,

Dr. Eric Bernstein makes similar quantified blue light claims, saying, “This is eight

to ten times stronger than any other home light on the market,” and “It’s a real [sic]

eight to ten times more powerful than any blue light out there.”

114. However, upon information and belief, TRIA’s quantified blue light


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claims are false and/or misleading.

115. Radiancy purchased the TRIA Acne product (which purchase

benefitted TRIA), and performed testing on the product in order to investigate the

allegations made in TRIA’s advertising. Radiancy’s testing showed that (as stated

above), the power density of the TRIA Acne Blue Light as approximately 221

mW/cm2. However, the Omnilux clear-UTM (from Photo Therapeutics Inc,

Carlsbad, CA), which, like the TRIA Blue Light, is also available for at home use in

the treatment of acne, reportedly emits 415 nm blue light at a power density of 40

mW/cm2 and 633 nm red light at 70 mW/cm2. See http://findarticles.com/

p/articles/mi_m0PDG/is_4_7/ai_n25436953/?tag=content;col1 (last visited

12/13/10).

116. At 221 mW/cm2, the power density of the TRIA Bluelight is not 8-10

times the power density of the Omnilux blue light (40 mW/cm2). Furthermore, as

stated above, at the recommended treatment time of 5 minutes per day, the TRIA

BlueLight delivers a dose of 66.3 Joules. The Omnilux blue light treatment is

recommended for 20 minutes (1200 seconds) a day, which provides a dose of 48

Joules. At 66.3 Joules, the TRIA BlueLight does not deliver 8-10 times more light

than the Omnilux (at 48 Joules).

Claims That TRIA Acne Provides A Permanent Cure To Acne

117. The advertising for TRIA Acne also conveys the false and misleading

message that use of the product can essentially cure acne. For instance, on TRIA’s

websites, it claims:

“The TRIA Skin Clarifying System makes it simple to break the

cycle of breakouts – for good.” (Found at: http://www.trytriablue.

com/howitworks.aspx (last visited 12/10/10)).


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“The Clarifying Blue Light stopped acne in its tracks—and reversed

it…” – Jackie G. (found at: http://www.trytriablue.com/

testimonials.aspx (last visited 12/10/10)).

“You deserve clear, beautiful skin and now you can break the

endless cycle of breakouts.” (found at: http://www.triabeauty.com/

info/what-is-tria-blue-light-therapy.htm (last visited 12/10/10)).

“With continued use of the Skin Clarifying System, existing

breakouts may be eliminated and you’ll experience less future

breakouts.” (found at: http://www.triabeauty.com/info/tria-blue-

light-how-it-works.htm (last visited 12/10/10)).

118. TRIA also conveys the false and misleading message that TRIA Acne

provides a long-term or permanent cure for acne through its Acne Infomercial. For

instance, early in the Infomercial, Dr. Eric Bernstein, one of TRIA’s equity holders

says of the TRIA Blue Light, “There is now a device that you can use at home to

battle acne long term and hopefully push it into remission so it doesn’t come back.”

119. The Acne Infomercial also claims, “Imagine – no more breakouts, no

more red bumps at the wrong time, just clear, calm, healthy skin every day.”

Infomercial host, Ereka Vetrini, further conveys the message that the product can

cure acne, claiming that “today we’re going to shine a light on a way to treat acne

that breaks the breakout cycle.”

120. Similarly, in the recently aired QVC commercial for TRIA Acne, Dr.

Eric Bernstein proclaims that the blue light is “not like devices where you’re

treating the pimple when it comes, this prevents it from coming. This clears your

skin.”

121. However, any such claims that TRIA Acne can cure acne or “break the

breakout cycle” are false and misleading because, among other reasons (and as

TRIA Acne’s own Instructions For Use admit), the TRIA Blue Light is not effective


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on comedonal, nodular or cystic acne – a fact which neither the Acne Infomercial

nor TRIA’s websites adequately disclose.

122. Moreover, TRIA’s advertising claims that its ability to “break the

breakout cycle” is tied to the fact that TRIA Blue Light purportedly kills p. acnes

bacteria. However, studies have shown that p. acnes is not the only cause of acne

breakouts.

123. Even if an individual was suffering from acne solely caused by p. acnes

bacteria, TRIA’s claims that it can cure, or “break the breakout cycle” are still false

and misleading, because blue light has not been proven to be 100% effective at

killing all p. acnes bacteria.

Claims That TRIA Acne Is “FDA-Cleared”

124. TRIA’s advertising also falsely communicates the message that TRIA

Acne has been cleared by the FDA as a combined treatment for acne.

125. For instance, the TRIA Acne infomercial states, “Introducing the Tria

Skin Clarifying System, the only FDA cleared at home acne treatment,” while text

appears on-screen stating “FDA cleared SAFE & EFFECTIVE.”

126. Such a statement is false because, upon information and belief, TRIA

has only received FDA clearance for the TRIA Blue Light, and has not received

FDA clearance for the TRIA Acne system, as a combination treatment for acne.

TRIA’s Use of Radiancy’s “no!no!” Marks

127. In an effort to divert customers looking to purchase Radiancy’s no!no!

Hair and/or no!no! Skin products, TRIA has purchased, and uses, the terms “no!no!

hair removal”, “nono hair removal,” and other phrases incorporating Radiancy’s

no!no! mark, or confusingly similar marks, as keywords on internet search engines,

including but not limited to, Yahoo!, Google, and Bing.

128. TRIA’s intentional use of Radiancy’s marks as keywords on search

engines have caused and will continue to cause consumers searching for Radiancy’s


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products to be confused and misled into clicking on a link to TRIA’s website, where

it sells competing products.

Count I [Against TRIA]

False Advertising Under Lanham Act § 43(a)

[15 U.S.C. § 1125(a)]

129. Radiancy incorporates by reference and re-alleges the allegations of

paragraphs 1 through 128.

130. TRIA’s false and misleading advertisements violate Section § 43(a) of

the Lanham Act, 15 U.S.C. § 1125(a).

131. TRIA has published its false and misleading statements of fact

regarding TRIA Hair and TRIA Acne on its product labeling, on the internet,

through social media, and in nationally aired Infomercials and television shows, and

thus caused them to enter interstate commerce.

132. TRIA’s false and misleading statements are material for at least the

reason that they have influenced, and are likely to continue to influence, consumers’

purchasing decisions.

133. TRIA’s advertising claims have actually deceived or have a tendency to

deceive a substantial number of consumers in the relevant home beauty product

markets, and to influence those consumers’ purchasing decisions.

134. TRIA’s false and misleading advertising has caused and/or is likely to

cause injury to the general public, and to injure and cause Radiancy damages in an

amount to be proven at trial. Such damages include, among other things, lost sales,

harm to Radiancy’s business reputation and goodwill, lost profits and harm to the

value and goodwill associated with Radiancy’s products in general, and its no!no!

Hair and no!no! Skin products in particular.

135. Upon information and belief, TRIA’s wrongful actions will continue if

not enjoined, and will cause irreparable harm to the general public, and irreparable


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injury to Radiancy’s business, goodwill, and reputation, for which Radiancy has no

adequate remedy at law.

136. TRIA knew, or by exercise of reasonable care should have known, that

the above-described advertising claims were false and/or misleading, and likely to

deceive the public. Accordingly, the actions of TRIA were willful, and this is an

exceptional case within the meaning of 15 U.S.C. § 1117.

Count II [Against TRIA and Ms. Kardashian]

False Advertising Under California Law

[Cal. Bus. & Prof. Code § 17500, et seq.]



138. TRIA’s and Ms. Kardashian’s false and misleading advertising, as

alleged herein, are in violation of Section § 17500, et seq. of the California Business

& Professions Code, because it is, by its nature, unfair, deceptive, untrue, or

misleading advertising within the meaning of the statute.

139. TRIA and Ms. Kardashian knew, or by exercise of reasonable care

should have known, that the above-described advertising claims are false and/or

misleading, and likely to deceive the public, and that they have caused, and will

continue to cause significant injury to Radiancy’s business.

140. As a result of TRIA’s and Ms. Kardashian’s wrongful actions, and

consumers’ reliance thereon, Radiancy has suffered an injury in fact and lost money

or property, including but not limited to injury to Radiancy’s goodwill and

reputation, increased marketing expenses, money spent on investigating TRIA’s and

Ms. Kardashian’s allegedly false advertising statements, lost sales, and lost profits

from sales wrongfully diverted to TRIA.

141. Upon information and belief, TRIA’s and Ms. Kardashian’s wrongful

actions will continue if not enjoined, and will cause irreparable harm to the general


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public, and irreparable injury to Radiancy’s business, goodwill, and reputation, for

which Radiancy has no adequate remedy at law.

Count III [Against TRIA and Ms. Kardashian]

Unfair Competition Under California Law

[Cal. Bus. & Prof. Code § 17200, et seq.]



143. TRIA’s and Ms. Kardashian’s acts and practices, as alleged herein,

violate the California Business & Professions Code § 17200, et. seq. (“UCL”). By

engaging in the above-described acts and practices, including the actions and

omissions herein alleged, TRIA has committed one or more acts of unfair

competition within the meaning of Section § 17200, et seq. of the California

Business & Professions Code.

144. TRIA’s and Ms. Kardashian’s acts and practices constitute unlawful,

fraudulent and/or unfair business acts and practices within the meaning of the UCL.

145. TRIA’s and Ms. Kardashian’s acts and practices are “unlawful,” within

the meaning of the UCL because they, inter alia, violate Business & Professions

Code § 17500 as set forth above in Radiancy’s Second Cause of Action. TRIA’s

acts and practices additionally violate Sections 32 and 43(a) of the Lanham Act, as

set forth in Radiancy’s First and Fourth Causes of Action.

146. These acts and practices are also unlawful because TRIA’s statements

and the statements of TRIA’s paid spokesperson, Ms. Kardashian, violate the FTC

Act and/or the related FTC Guidelines Concerning the Use of Endorsements and

Testimonials in Advertising.

147. These aforementioned acts are “fraudulent” within the meaning of the

UCL because they are likely to deceive members of the public.

148. These acts and practices are “unfair,” within the meaning of the UCL,


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because they are immoral, unethical, oppressive, unscrupulous, and significantly

threaten or harm competition. The harm to competition and to consumers from

TRIA’s acts and practices outweigh any utility of the acts and practices.

149. TRIA and Ms. Kardashian knew, or by exercise of reasonable care

should have known, that the above-described advertising claims are false and/or

misleading, and likely to deceive the public, and that they have caused, and will

continue to cause significant injury to Radiancy’s business.

150. As a result of TRIA’s and Ms. Kardashian’s wrongful actions, and

consumers’ reliance thereon, Radiancy has suffered an injury in fact and lost money

or property, including but not limited to injury to Radiancy’s goodwill and

reputation, increased marketing expenses, money spent on investigating TRIA’s and

Ms. Kardashian’s allegedly false advertising, lost sales, and lost profits from sales

wrongfully diverted to TRIA.

151. Upon information and belief, TRIA’s and Ms. Kardashian’s wrongful

actions will continue if not enjoined, and will cause irreparable harm to the general

public, and irreparable injury to Radiancy’s business, goodwill, and reputation, for

which Radiancy has no adequate remedy at law.

Count IV [Against TRIA]

Trademark Infringement Under Lanham Act § 32

[15 U.S.C. § 1114]



153. TRIA’s use of Radiancy’s marks is in violation of Section 32 of the

Lanham Act, 15 U.S.C. § 1114.

154. Radiancy’s no!no! mark is a valuable registered trademark, and is in

active use in commerce in the United States (and elsewhere) in connection with,

among other things OTC consumer products for personal use in hair removal, and in


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the treatment of acne and other dermatological conditions.

155. TRIA has used the registered no!no! mark in commerce in connection

with the sale, offering for sale, advertising, marketing or distribution of competitive

goods in such a manner as is likely to cause consumer confusion, mistake or

deception in the relevant marketplaces.

156. TRIA used the no!no! mark without Radiancy’s consent.

157. As a result of TRIA’s infringing use of Radiancy’s mark, TRIA has

caused damage to Radiancy in an amount to be determined at trial. Upon

information and belief, TRIA’s wrongful actions will continue if not enjoined.

Count V [Against TRIA]

Common Law Unfair Competition



159. TRIA’s use of Radiancy’s no!no! marks as alleged herein constitutes

unfair competition under California common law.

160. Radiancy has invested substantial time, money and skill in developing

the no!no! marks, and TRIA has used and, upon information and belief, is still using

said marks without Radiancy’s consent, and without compensating Radiancy for

their use.

161. As a result of TRIA’s wrongful use of Radiancy’s marks, Radiancy has

suffered injury in an amount to be determined at trial.

Prayer For Relief

WHEREFORE, Radiancy prays for judgment:

A. Preliminarily and/or permanently enjoining TRIA, its officers, agents,

servants and employees, and Ms. Kardashian, and all persons in active concert

and/or participation with them, from further dissemination of the following:

1. Any express or implied statements that use of TRIA Hair results


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in “permanent hair removal,” as well as all substantively similar statements;

2. Any express or implied claims that consumers who use TRIA

Hair will never need to shave, wax or use any other form of hair removal again;

3. Any express or implied statements that the FDA has cleared or

approved TRIA Hair for permanent hair removal;

4. Any express or implied statement that TRIA Hair is “safe and

effective” for all consumers and for all body parts;

5. Any express or implied statement that TRIA Hair is painless or

pain-free

6. Any express or implied statement that TRIA Hair is equivalent to

professional hair removal treatment;

7. Any express or implied statement that TRIA Hair is the “only” or

“first and only” OTC laser hair removal product;

8. Any express or implied statement that TRIA Acne is superior to

all other available acne treatments;

9. Any express or implied statement that TRIA Acne is equivalent

to professional acne treatments and/or that TRIA Blue Light provides professional

strength levels of blue light;

10. Any express or implied statement that TRIA Acne provides eight

to ten times more blue light than other at-home blue light products;

11. Any express or implied statement that TRIA Acne provides a

long-term or permanent cure for acne;

12. Any other express or implied statements concerning the nature,

characteristics and qualities of the TRIA Hair that constitute materially false and

misleading advertising or unfair competition;


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B. Requiring TRIA to prominently disclose, in conjunction with any claim

that TRIA Hair provides a permanent reduction in hair regrowth, that “permanent”

is defined only as a reduction in the number of hairs re-growing following a

treatment regime that is stable over a time greater than the duration of the complete

growth cycle of the hair follicles, which may vary from four to twelve months,

depending on where the treated hair is located on the body.

C. Requiring TRIA to prominently disclose, in conjunction with any claim

that TRIA Hair is “safe and effective” that TRIA Hair is not safe for use on medium

or dark skin tones, not safe or recommended for use on all body parts, and not

effective on red, grey, or blond hair.

D. Requiring TRIA to disseminate among consumers corrective

advertising to dispel the impact of the false and misleading claims, and similar

claims, complained of herein;

E. Requiring TRIA to recall and destroy all tangible copies of the

advertisements that make the false and misleading claims, and similar claims,

complained of herein;

F. Preliminarily and/or permanently enjoining Ms. Kardashian from

advertising the TRIA Hair.

G. Preliminarily and/or permanently enjoining TRIA, its officers, agents,

servants and employees, and all persons in active concert and/or participation with

them, from using any registered or unregistered Radiancy trademark in commerce in

connection with the sale, offering for sale, distribution, or advertising of TRIA’s

goods in connection with which such use is likely to cause confusion, mistake, or

consumer deception, including without limitation, the use of such marks as an

internet keyword search, metatag, or domain name;

H. Directing that TRIA and Ms. Kardashian account to Radiancy for all

gains, profits, and advantages derived from the wrongful acts herein;


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I. Directing that TRIA pay Radiancy such damages as Radiancy has

sustained as a consequence of TRIA’s wrongful acts complained of in the First,

Fourth and Fifth Causes of Action, the precise amount of which is to be determined

at trial, and that the actual amount of damages under the First and Fourth causes of

action be trebled, pursuant to 15 U.S.C. § 1117;

J. Directing that all damages awarded be otherwise multiplied or

enhanced as authorized by law;

K. Directing that TRIA pay Radiancy the costs of this action and its

reasonable attorneys’ fees herein; and

L. Granting Radiancy such other and further relief as the Court may deem

just and proper.

Jury Demand

Radiancy demands a jury in this action for all issues so triable.

DATED: August 3, 2011

Brendan J. O’Rourke Kristin H. Neuman Victoria L. Loughery Robert H. Horn

PROSKAUER ROSE LLP

By: /s/ Robert H. Horn

Robert H. Horn Attorneys for Defendant, Counterclaim-

Plaintiff Radiancy, Inc.


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