Case 4:22-cv-05191-DMR Document 1 Filed 09/12/22 Page 1 of 27
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`UMBERG ZIPSER LLP
`Mark A. Finkelstein (SBN 173851)
`Brent S. Colasurdo (SBN 281863)
`1920 Main Street, Suite 750
`Irvine, CA 92614
`Telephone: (949) 679-0052
`Email: mfinkelstein@umbergzipser.com
`Email: bcolasurdo@umbergzipser.com
`
`GLANCY PRONGAY & MURRAY LLP
`Peter A. Binkow (SBN 173848)
`Jonathan M. Rotter (SBN 234137)
`Natalie S. Pang (SBN 305886)
`1925 Century Park East, Suite 2100
`Los Angeles, California 90067
`Telephone: (310) 201-9150
`Email: pbinkow@glancylaw.com
`Email: jrotter@glancylaw.com
`Email: npang@glancylaw.com
`
`Counsel for Plaintiffs and the Putative Class
`
`THE UNITED STATES DISTRICT COURT 
`FOR THE NORTHERN DISTRICT OF CALIFORNIA 
`
`PRUSHTI DAVE, ARLENE BERGUM,
`EMILY DEPOL, KEYA JOHNIGAN,
`and BRIANNA MCKAY, on behalf of
`themselves and all others similarly
`situated,
`
`Plaintiffs,
`
`v.
`
`ABBOTT LABORATORIES,
`ALERE, PROCTER & GAMBLE
`MANUFACTURING COMPANY, SPD
`SWISS PRECISION DIAGNOSTICS
`GMBH, CHURCH & DWIGHT CO.,
`INC., TARGET CORPORATION, and
`WALGREEN CO.,
`Defendants.
`
`Case No. 
`
`3:22-cv-5191
`
`COMPLAINT FOR VIOLATIONS
`OF CALIFORNIA’S CONSUMERS
`LEGAL REMEDIES ACT, CAL.
`CIV. CODE §§ 1750-1785, UNFAIR
`COMPETITION LAW, CAL. BUS. &
`PROF. CODE §17200, AND FALSE
`ADVERTISING LAW, CAL. BUS. &
`PROF. CODE § 17500, ET SEQ.
`
`CLASS ACTION
`
`DEMAND FOR JURY TRIAL
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`{240909.5}
`
`CLASS ACTION COMPLAINT
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`Plaintiffs Prushti Dave, Arlene Bergum, Emily DePol, Keya Johnigan, and
`Brianna Mckay (collectively “Plaintiffs”), by and through their undersigned
`attorneys, bring this class action complaint on behalf of themselves and all others
`similarly situated as defined below (the “Class”), alleging facts related to their own
`purchases based on personal knowledge and all other facts based upon the
`investigation of counsel.
`PRELIMINARY STATEMENT
`Defendants Abbott Laboratories (“Abbott”), Alere (“Alere”), Procter
`1.
`& Gamble Manufacturing Company (“Procter & Gamble”), SPD Swiss Precision
`Diagnostics GmBH (“SPD”), Church & Dwight Co., Inc. (“Church & Dwight”),
`Target Corporation (“Target”), and Walgreen Co. (“Walgreens”) (collectively,
`“Defendants”) produce, market, label and sell various ovulation test kits (the
`“Ovulation Test Kits” or “Defendants’ Kits”) in the state of California and
`throughout the United States.
`2. Millions of people buy and rely upon the Ovulation Test Kits for
`family planning purposes. Defendants’ Kits are advertised as being able to tell
`women with 99% or greater accuracy when they will ovulate, and thus when they
`are the most fertile and most likely to be able to become pregnant.
`However, the Ovulation Test Kits do not predict ovulation with 99%
`3.
`or greater accuracy. The Kits merely test levels of Luteinizing Hormone (“LH”),
`which may or may not indicate ovulation will occur. LH is made by a person’s
`pituitary gland and is present in varying levels for people of all genders. LH levels
`generally rise quickly just before ovulation in women, but LH levels can spike at
`varying times in the menstrual cycle for a variety of other reasons unrelated to
`ovulation. Defendants’ Kits identify when a person has a spike in LH—not when
`ovulation will occur.
`Defendants intentionally mislabel their Kits as ovulation test kits.
`4.
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`{240909.5}
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`CLASS ACTION COMPLAINT
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`Defendants know that their Kits test LH and not ovulation, but marketing their
`products as “Luteinizing Hormone Test Kits,” which may or may not predict
`ovulation, would be far less attractive to women seeking to get pregnant. False
`promises such as these allow Defendants to capitalize on reproductive anxiety and
`reap massive profits, well in excess of $5,000,000 each year from unwitting
`consumers.
`This action arises out of deceptive and otherwise improper business
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`practices that Defendants engaged in with respect to the packaging of certain
`ovulation test kits, detailed below, which are packaged in boxes and regularly sold
`in major supermarkets, grocery stores, convenience stores, and pharmacies
`throughout the United States, as well as on Amazon and other online retailers.
`JURISDICTION AND VENUE
`Diversity subject matter jurisdiction exists over this class action
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`pursuant to the Class Action Fairness Act of 2005, conferring federal jurisdiction
`over class actions involving: (a) 100 or more members in the proposed class; (b)
`where at least some members of the proposed class have different citizenship from
`some defendants; and (c) where the claims of the proposed class members exceed
`the sum or value of five million dollars ($5,000,000) in the aggregate. 28 U.S.C.
`§ 1332(d)(2) and (6).
`Venue is proper in this district pursuant to 28 U.S.C. § 1391(a) because
`7.
`a substantial part of the events giving rise to Plaintiffs’ claims occurred in this
`district, and Defendants are subject to personal jurisdiction in this district.
`Defendants marketed and sold the products at issue in this action within this judicial
`district and do business within this judicial district.
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`{240909.5}
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`2
`CLASS ACTION COMPLAINT
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`PARTIES
`
`Plaintiffs
`A.
`Plaintiff Prushti Dave is a citizen of the state of California and at all
`8.
`relevant times has resided in Alameda County.
`Between December 2020 and January 2021, Plaintiff Dave purchased,
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`for her own use, Procter & Gamble’s, Abbott’s, Alere’s, and SPD’s (collectively,
`the “Clearblue Defendants”) ovulation test kits marketed and sold under their brand
`name Clearblue, in Alameda County, California. Plaintiff Dave reasonably
`expected that these products would test, with over 99% accuracy, whether she
`would ovulate in the next 24-36 hours, and not merely whether she was having an
`LH surge that may or may not be connected to ovulation. As a result of the
`Clearblue Defendants’ deceptive packaging, Plaintiff Dave was overcharged, did
`not receive the benefit of the bargain, and/or suffered out-of-pocket losses. Plaintiff
`Dave expects to continue to purchase ovulation test kits, including the Clearblue
`Defendants’ kits, in the future.
`10. Plaintiff Arlene Bergum is a citizen of the state of California and at all
`relevant times has resided in San Diego County.
`In or about April 2019, Plaintiff Bergum purchased, for her own use,
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`Church & Dwight’s ovulation test kits, marketed and sold under its brand name
`First Response, in San Diego County, California, from a Target retail store. Plaintiff
`Bergum reasonably expected that this product would test, with over 99% accuracy,
`whether she would ovulate in the next 24-36 hours, and not merely whether she was
`having an LH surge that may or may not be connected to ovulation. As a result of
`Church & Dwight’s deceptive packaging, Plaintiff Bergum was overcharged, did
`not receive the benefit of the bargain, and/or suffered out-of-pocket losses. Plaintiff
`Bergum expects to continue to purchase ovulation test kits, including Church &
`Dwight’s, in the future.
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`{240909.5}
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`3
`CLASS ACTION COMPLAINT
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`Plaintiff Emily DePol is a citizen of the state of California and at all
`12.
`relevant times has resided in Alameda County.
`13. Between September and December 2020, Plaintiff DePol purchased,
`for her own use, Target’s ovulation test kits, marketed and sold under its trademark
`up & up, in Sacramento County, California. Plaintiff DePol reasonably expected
`that these products would test, with an accuracy of 99%, whether she would ovulate
`in the next 24-36 hours, and not merely whether she was having an LH surge that
`may or may not be connected to ovulation. As a result of Target’s deceptive
`packaging, Plaintiff DePol was overcharged, did not receive the benefit of the
`bargain, and/or suffered out-of-pocket losses. Plaintiff DePol expects to continue
`to purchase ovulation test kits, including Target’s kits, in the future.
`14. Plaintiff Keya Johnigan is a citizen of the state of California and at all
`relevant times has resided in Los Angeles County.
`In or about March 2021, Plaintiff Johnigan purchased, for her own use,
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`Walgreens’s ovulation test kits in Los Angeles County, California. Plaintiff
`Johnigan reasonably expected that these products would test, with over 99%
`accuracy, whether she would ovulate in the next 24-48 hours, and not merely
`whether she was having an LH surge that may or may not be connected to ovulation.
`As a result of Walgreens’s deceptive packaging, Plaintiff Johnigan was
`overcharged, did not receive the benefit of the bargain, and/or suffered out-of-
`pocket losses. Plaintiff Johnigan expects to continue to purchase ovulation test kits,
`including Walgreens’ kits, in the future.
`Plaintiff Brianna McKay is a citizen of the state of California and at
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`all relevant times has resided in Los Angeles County.
`In or about September 2021, Plaintiff McKay purchased, for her own
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`use, Walgreens’s ovulation test kits from a Walgreens store in Los Angeles County,
`California. Plaintiff McKay reasonably expected that these products would test,
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`{240909.5}
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`CLASS ACTION COMPLAINT
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`with over 99% accuracy, whether she would ovulate in the next 24-48 hours, and
`not merely whether she was having an LH surge that may or may not be connected
`to ovulation. As a result of Walgreens’s deceptive packaging, Plaintiff McKay was
`overcharged, did not receive the benefit of the bargain, and/or suffered out-of-
`pocket losses. Plaintiff McKay expects to continue to purchase ovulation test kits,
`including Walgreens’s kits, in the future.
`In or about November 2020, Plaintiff McKay purchased, for her own
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`use, Church & Dwight’s ovulation test kits, marketed and sold under its brand name
`First Response, in Los Angeles County, California. Plaintiff McKay reasonably
`expected that these products would test, with over 99% accuracy, whether she
`would ovulate in the next 24-36 hours, and not merely whether she was having an
`LH surge that may or may not be connected to ovulation. As a result of Church &
`Dwight’s deceptive packaging, Plaintiff McKay was overcharged, did not receive
`the benefit of the bargain, and/or suffered out-of-pocket losses. Plaintiff McKay
`expects to continue to purchase ovulation test kits, including Church & Dwight’s
`kits, in the future.
`In or about 2019, Plaintiff McKay purchased, for her own use, the
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`Clearblue Defendants’ ovulation test kits marketed and sold under their brand name
`Clearblue Easy, from a Target location in Los Angeles County, California. Plaintiff
`McKay reasonably expected that these products would test, with over 99%
`accuracy, whether she would ovulate in the next 24-36 hours, and not merely
`whether she was having an LH surge that may or may not be connected to ovulation.
`As a result of the Clearblue Defendants’ deceptive packaging, Plaintiff McKay was
`overcharged, did not receive the benefit of the bargain, and/or suffered out-of-
`pocket losses. Plaintiff McKay expects to continue to purchase ovulation test kits,
`including the Clearblue Defendants’ kits, in the future.
`In or about 2020-2021, Plaintiff McKay purchased, for her own use,
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`{240909.5}
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`5
`CLASS ACTION COMPLAINT
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`Target’s up & up ovulation test kits from a Target location in Los Angeles County,
`California, and from Target’s online store. Plaintiff McKay reasonably expected
`that these products would test, with over 99% accuracy, whether she would ovulate
`in the next 24-36 hours, and not merely whether she was having an LH surge that
`may or may not be connected to ovulation. As a result of Target’s deceptive
`packaging, Plaintiff McKay was overcharged, did not receive the benefit of the
`bargain, and/or suffered out-of-pocket losses. Plaintiff McKay expects to continue
`to purchase ovulation test kits, including Target’s kits, in the future.
`B. Defendants
`21. Defendant Abbott Laboratories (“Abbott”) is an entity organized under
`the laws of Illinois and is headquartered at 100 Abbott Park Road, Abbott Park, IL
`60064. Defendant Abbott is the parent company and owner of defendant Alere.
`Alere and Procter & Gamble are co-owners of SPD Swiss Precision Diagnostics
`GmbH, which owns Clearblue. Abbott and Alere, through their subsidiaries and
`related entities, including Procter & Gamble, manufacture, package, advertise,
`market, distribute, and/or sell ovulation test kit products in the United States using
`the brand name Clearblue.
`22. Defendant Procter & Gamble Manufacturing Company (“Procter &
`Gamble”) is an entity organized under the laws of Ohio and is headquartered at One
`Procter & Gamble Plaza, Cincinnati, Ohio 45202. Defendants Procter & Gamble
`and Alere are co-owners of SPD Swiss Precision Diagnostics GmBH, which owns
`Clearblue. Procter & Gamble, through its subsidiaries and related entities,
`including Abbott and Alere, manufactures, packages, advertises, markets,
`distributes, and/or sells ovulation test kit products in the United States using the
`brand name Clearblue.
`23. Defendant SPD Swiss Precision Diagnostics GmBH (“SPD”) is an
`entity organized under the laws of Switzerland and is headquartered at 47 route de
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`{240909.5}
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`Saint Georges, 1213 Petit-Lancy, Geneva, Switzerland. SPD is co-owned by
`Procter & Gamble and Alere. SPD, through its subsidiaries and related entities,
`including Procter & Gamble, Alere, and Abbott, manufactures, packages,
`advertises, markets, distributes, and/or sells ovulation test kit products in the United
`States using the brand name Clearblue. Defendants Abbott, Alere, Procter &
`Gamble and SPD are collectively referred to as the “Clearblue Defendants.”
`24. Defendant Church & Dwight Co., Inc. (“Church & Dwight”) is an
`entity organized under the laws of Delaware and is headquartered at 500 Charles
`Ewing Blvd., Ewing NJ 08628. Church & Dwight, through its subsidiaries and
`related entities, manufactures, packages, advertises, markets, distributes, and/or
`sells ovulation test kit products in the United States using the brand name First
`Response.
`25. Defendant Target Corporation (“Target”) is an entity organized under
`the laws of Minnesota and is headquartered at 1000 Nicollet Mall, Minneapolis,
`MN 55403. Target, through its subsidiaries and related entities, manufactures,
`packages, advertises, markets, distributes, and/or sells ovulation test kit products in
`the United States using its trademark up & up.
`26. Defendant Walgreen Co. (“Walgreens”) is an entity organized under
`the laws of Delaware and is headquartered at 200 Wilmot Road, Deerfield, Illinois
`60015. Walgreens Boots Alliance, Inc. is the parent company and owner of
`Walgreens, and trades on the public stock market under the ticker “WBA.”
`Walgreens, through its subsidiaries and related entities, manufactures, packages,
`advertises, markets, distributes, and/or sells ovulation test kit products in the United
`States.
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`LEGAL BACKGROUND
`27. California’s Legal Remedies Act (“CLRA”), California Civil Code
`sections 1750-1785, et seq., declares it unlawful for any person to undertake unfair
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`{240909.5}
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`methods of competition and unfair or deceptive acts or practices in a transaction
`intended to result or which does result in the sale or lease of goods or services to
`any consumer.
`28. California’s Unfair Competition Law (“UCL”), California Business &
`Professions Code section 17200, et seq., prohibits businesses from engaging in “any
`unlawful, unfair or fraudulent business act or practice and unfair, deceptive, untrue
`or misleading advertising” in addition to any act in violation of California Business
`& Professions Code section 17500, et seq., as alleged below.
`29. The UCL allows for any person to pursue representative claims or
`relief on behalf of others if the claimant meets the standing requirements of
`California Business & Professions Code section 17204 and California Code of Civil
`Procedure section 382. Cal. Bus. & Prof. Code § 17203.
`30. Plaintiffs have standing under California Business & Professions Code
`section 17204, which provides that actions for relief pursuant to the UCL shall be
`prosecuted exclusively in a court of competent jurisdiction by, inter alia, any person
`who has suffered injury in fact and has lost money or property as a result of the
`unfair competition.
`31. California’s False Advertising Law (“FAL”), California Business &
`Professions Code section 17500, et seq., declares it unlawful for any person to
`disseminate before the public any statement concerning personal property that the
`person knows, or through the exercise of reasonable care should know, to be untrue
`or misleading, with intent to dispose of that property or to induce the public to enter
`into any obligation relating thereto; or to disseminate such untrue or misleading
`statements as part of a plan or scheme with the intent not to sell the property as
`advertised.
`32. Pursuant to California Business & Professions Code section 17535,
`any person, corporation, firm, partnership, or any other association or organization
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`{240909.5}
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`that violates the FAL may be enjoined by any court of competent jurisdiction.
`Actions for injunctive relief under the FAL may be prosecuted by any person who
`has suffered injury in fact and has lost money or property as a result of a violation
`of the FAL, and the court may make such orders or judgments which may be
`necessary to restore to any person in interest any money or property which may
`have been acquired by means declared to be unlawful by the FAL.
`FACTUAL ALLEGATIONS
`33. Defendants market and sell kits, which they misleadingly call
`“ovulation test kits,” in rectangular boxes. By indicating that their ovulation test
`kits have 99% or greater accuracy at testing for and predicting ovulation,
`Defendants deceive consumers.
`34. Since about 1989, Clearblue, which is owned by the Clearblue
`Defendants and their subsidiaries and related entities, has marketed and sold
`ovulation test kits (“Clearblue’s Kits”). Clearblue proclaims that it developed the
`world’s first one-step ovulation test kit. During the relevant timeframe, the
`Clearblue Defendants marketed and sold at least five different ovulation test kits: i)
`Easy Ovulation Kit, ii) Advanced Digital Ovulation Test, iii) Digital Ovulation
`Predictor Kit, iv) Trying for a Baby Advanced Ovulation Kit, and v) Easy
`Luteinizing Hormone (LH) Kit. Each of Clearblue’s Kits prominently bear the
`promise “99% Accurate” or “Over 99% Accurate” and are labeled as an “ovulation
`test” or “ovulation kit.” Clearblue’s Kits also include such representations as
`“Identify your 2 Most Fertile Days.” For example, below is a photo of one of
`Clearblue’s Kits1:
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`
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`1 This image is representative of Clearblue’s packaging at the time that Plaintiffs purchased
`their Clearblue Kits. Around January 2022, the Clearblue Defendants changed the packaging of
`their ovulation test kits.
`9
`CLASS ACTION COMPLAINT
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`{240909.5}
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`Clearblue’s website boasts that “over 20 million women choose to use
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`Clearblue products every year.” Accordingly, the Clearblue Defendants make well
`in excess of $5,000,00 every year on their fertility-related products, including their
`ovulation test kits.
`36. Clearblue’s Kits are regularly sold across the United States in various
`pharmacies and major retailers, such as CVS and Walgreens, and online through
`Amazon and other retailers.
`37. Since about 2011, Church & Dwight has marketed and sold ovulation
`test kits under the brand name First Response (“First Response’s Kits”). During the
`relevant timeframe, Church & Dwight marketed and sold at least three ovulation
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`CLASS ACTION COMPLAINT
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`{240909.5}
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`Case 4:22-cv-05191-DMR Document 1 Filed 09/12/22 Page 12 of 27
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`test kits under its brand name First Response: i) First Response Ovulation Plus
`Pregnancy Test, ii) First Response Advanced Digital Ovulation Test, and iii) First
`Response Easy Read Ovulation Test. Each of First Response’s Kits prominently
`bear the promise “OVER 99% ACCURATE” and are labeled as an “ovulation test.”
`First Response’s Kits also make such representations as “GET PREGNANT
`SOONER!” and “PREDICTS YOUR 2 MOST FERTILE DAYS.” For example,
`below is a photo of one of Church & Dwight’s Kits:
`
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`38. Church & Dwight claims that its home pregnancy and ovulation test
`kits, sold under its brand name First Response, are the number one selling brand in
`the United States.2 Church & Dwight’s consumer products marketing efforts are
`
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`2 Church & Dwight’s Form 10-K filed with the SEC for fiscal year ended December 31, 2020 at
`p. 6
`(https://www.sec.gov/ix?doc=/Archives/edgar/data/313927/000156459021006669/chd-
`10k_20201231.htm) (last visited on Mar. 30, 2022).
`11
`CLASS ACTION COMPLAINT
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`{240909.5}
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`focused principally on its 13 “power brands.” Its First Response home pregnancy
`and ovulation test kits are included in its “power brands.” Church & Dwight’s
`consumer products segment comprises the majority of its revenue; for instance, in
`2020, Church & Dwight’s consumer products segment comprised about 77% of its
`consolidated net sales. Each year Church & Dwight makes well in excess of
`$5,000,000 in profits from sales of First Response’s Kits.
`39. First Response’s Kits are regularly sold across the United States in
`various pharmacies and major retailers, such as CVS and Walgreens, and online
`through Amazon and other retailers.
` Since at least 2009, Defendant Target has marketed and sold ovulation
`40.
`test kits under its trademark up & up (“Target’s Kits”). During the relevant
`timeframe, Target marketed and sold at least two ovulation test kits under the up &
`up trademark, including the Ovulation + Pregnancy Test Combo Pack and Early
`Luteinizing Hormone (“LH”) Test. Each of Target’s Kits prominently bear the
`promise “99% accurate” and are labeled as an “ovulation test.” Target’s Kits also
`make representations such as “tells you the best 2 days to conceive.” For example,
`below is a photo of one of Target’s Kits:
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`{240909.5}
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`Case 4:22-cv-05191-DMR Document 1 Filed 09/12/22 Page 14 of 27
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`41. Target’s Kits are regularly sold at Target stores and through Target’s
`website, target.com. Target owns and operates approximately 2,000 stores in the
`United States, including 309 stores in California, the most of any state. Target
`makes well in excess of $5,000,000 in profits each year from sales of Target’s Kits.
`42. Since about 2004, Defendant Walgreens has marketed and sold
`ovulation test kits (“Walgreens’s Kits”). During the relevant timeframe, Walgreens
`marketed and sold at least four different ovulation test kits: Ovulation + Pregnancy
`Kit, Digital Ovulation Predictor, Daily Ovulation Predictor, and One Step Ovulation
`Predictor. Each of Walgreens’s Kits prominently bear the promise “OVER 99%
`ACCURATE” and are labeled as an “ovulation predictor” or “ovulation test.” For
`example, below is a photo of one of Walgreens’s Kits:
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`{240909.5}
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`Case 4:22-cv-05191-DMR Document 1 Filed 09/12/22 Page 15 of 27
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`43. Walgreens’s Kits are regularly sold at Walgreens stores and through
`Walgreens’s website, walgreens.com. Walgreens owns and operates over 9,000
`stores in the United States, including approximately 586 stores across the state of
`California.
`In the United States, there are approximately 64.5 million women in
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`the age range 15-44. Just over 21 million of those women are 35-44. According to
`the National Center for Health Statistics, the provisional number of births for the
`United States in 2020 was 3,605,201, down 4% from the number in 2019
`(3,747,540).3
`45. Over the past few decades, the proportion of women bearing children
`later in life has increased significantly. The birth rate for women in the age ranges
`30-34, 35-39, and 40-44 has grown steadily since 1990, and the age range with the
`most births in 2019 was 30-34:
`
`National Vital Statistics Reports, Vol 70, No.2, Births: Final Data for 2019, March
`23, 2021 (“2019 Birth Report”).
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`3 See NVSS, Vital Statistics Rapid Release, Division of Vital Statistics, National Center for
`Health Statistics, May 2021, p.2 (“2020 Provisional Birth Report”).
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`46. A woman’s fertility declines as she ages. Women above the age of 30
`are more likely to have trouble getting pregnant:
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`
`(https://www.cdc.gov/nchs/nsfg/key_statistics/i-keystat.htm#infertilityservices).
`47. As of 2015, an estimated 7.3 million women had received some form
`of infertility service:
`
`(https://www.cdc.gov/nchs/nsfg/key_statistics/i.htm#infertilityservices).
`48. Women over 30, who now make up the majority of childbearing
`women in the United States, are more likely to need fertility assistance, including
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`{240909.5}
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`Case 4:22-cv-05191-DMR Document 1 Filed 09/12/22 Page 17 of 27
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`ovulation testing:
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`(https://www.cdc.gov/nchs/nsfg/key_statistics/i-keystat.htm#infertilityservices).
`In order to become pregnant, a couple must have intercourse within the
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`window of time approximately between five days before and a few hours after
`ovulation. The highest probability of conception occurs when a couple has
`intercourse one or two days prior to ovulation. Therefore, especially for those
`couples who are having trouble getting pregnant, it is highly beneficial to be able to
`prospectively predict what day ovulation will occur each cycle.
`50. Defendants’ Kits detect a rise in urinary LH levels. Over-the-counter
`LH tests like Defendants’ Kits, designed for home use by the consumer, can be
`useful aids to help predict ovulation. When ovulation takes place, it is generally
`preceded by a surge in LH levels 24–36 hours beforehand. Other useful methods
`for timing intercourse include calendaring, measuring cervical mucus, and other
`hormone tests such as pregnanediol 3‐glucuronide. However, neither LH tests nor
`any of these methods are able to identify, with 99% accuracy, if a woman is, or soon
`will be, ovulating. Currently the only method to predict ovulation with a high
`degree of accuracy is a transvaginal ultrasound, an invasive procedure performed in
`a clinical setting, which allows the doctor to actually view the egg growing and
`preparing to detach. An LH test, even if it is 99% accurate in identifying LH, merely
`provides a “hint” at when ovulation will occur. Fever may be an indicator of viral
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`infection. But a thermometer, even if it was 99% accurate at indicating body
`temperature, could not be lawfully marketed as a “99% accurate viral infection
`test.”
` Defendants’ Kits are not 99% accurate at predicting ovulation because
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`the LH surge the tests detect is not always tied to the actual event of ovulation in a
`given menstrual cycle. LH surges may happen at other times in a woman’s cycle.
`Many variables—including BMI, age, time from contraceptive use, sports activity,
`and smoking—affect the natural logarithm of urinary LH levels from days 7 to 20
`of the cycle. If a test detects a different LH surge, not the surge that precedes actual
`ovulation, it will falsely predict the timing of ovulation for that cycle. The user of
`the test will then unknowingly miss the actual ovulation that takes place in that
`cycle, and the test will provide none of the fertility benefits for which it is marketed.
`52. Furthermore, many women do not have regular cycles. LH tests
`should be conducted at a specific time in the menstrual cycle, usually three to five
`days prior to expected ovulation. During irregular cycles, LH tests may be negative,
`falsely indicating that no ovulation occurred in that cycle. The common occurrence
`of irregular cycles thus further lower the chances that Defendants’ Kits will
`accurately predict ovulation.
`53. Many women trying to get pregnant also have variations in their
`reproductive systems that make an LH surge not predictive of ovulation. For
`example, more than 10% of menstrual cycles of fertile women exhibit a condition
`known as “Luteinized Unruptured Follicle Syndrome.” When this occurs, there is
`a normal LH surge and menstruation, but no egg is released. LH surge has also
`been detected in many women who are infertile.
`54. Therefore, a positive LH test does not predict, with 99% accuracy, that
`a woman will ovulate within the next 24–36 or 24–48 hours, as claimed in
`Defendants’ marketing. While some of Defendants’ Kits may have included an
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`Case 4:22-cv-05191-DMR Document 1 Filed 09/12/22 Page 19 of 27
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`asterisk next to “99% ACCURATE,” any attempt at a disclaimer was hidden in
`small text on a different part of the box or on a pamphlet inside the box. The
`additional information provided in the small text, such as “*at detecting LH levels,”
`would also not be understandable to a reasonable consumer, and certainly would
`not override the large, plain message on the front of the box that these were
`“OVULATION TESTS” with “99% ACCURACY.”
`55. As a result of Defendants’ misleading and deceptive marketing of
`“ovulation test kits,” Plaintiffs and the Class purchased Defendants’ Kits with the
`expectation that they were testing whether a woman is, or is about to be, ovulating,
`with an accuracy of 99%.
`56. Plaintiffs and the Class have been damaged by Defendants’ misleading
`and deceptive practices.
`CLASS ACTION ALLEGATIONS
`57. Pla