Popular Ovulation Test Kits Are Misleadingly Advertised, Class Action Alleges

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A collection of ovulation test makers faces a proposed class action that alleges the companies have misleadingly advertised the “99% or greater” accuracy of the products to capitalize on buyers’ “reproductive anxiety.”

The 25-page lawsuit says that although ovulation test kits sold under the Clearblue, First Response and certain private label brands are touted as able to accurately tell women when they will ovulate—and thus are most fertile and able to become pregnant—the products, in reality, do not actually test whether a woman is ovulating, but rather for luteinizing hormone levels.

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The complaint, filed in New York on September 12, says that luteinizing hormones (LH) are made by a person’s pituitary gland and present in “varying levels for people of all genders.” Put simply, the defendants’ ovulation test kits do not test for exactly when ovulation will occur, but instead identify when a person has a spike in luteinizing hormones, the suit contends. 

“[Luteinizing hormone] 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,” the filing states. “Defendants’ Kits identify when a person has a spike in LH – not when ovulation will occur.” 

According to the filing, the defendants’ test kits are not 99 percent accurate given that the LH surge detected by the tests may not be tied to the actual event of ovulation in a given menstrual cycle. Luteinizing hormone surges can be affected by variables such as body mass index, age, time of contraceptive use, sports activity and smoking, all of which “affect the natural logarithm of urinary LH levels from days 7 to 20 of the cycle,” the case says. 

“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 suit states. “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.”

According to the lawsuit, defendants Abbott Labs, Alere, Procter & Gamble, SPD Swiss Precision Diagnostics GmBH, Church & Dwight Co., Inc., Target Corporation, Walgreen Co., and CVS Pharmacy have intentionally mislabeled the products at issue as “ovulation test kits.” The filing charges that the companies know that their test kits actually test LH levels and not ovulation, but misleadingly market the products in a way that makes them more attractive to women looking to become pregnant. 

“False promises such as these allow Defendants to capitalize on reproductive anxiety and reap massive profits … from unwitting consumers,” the lawsuit alleges. 

Central to the case are the ovulation tests made by Clearblue, which is owned by Abbott Labs, Alere, Procter & Gamble, and SPD. Per the suit, Clearblue’s ovulation tests—including the Easy Ovulation Kit, Advanced Digital Ovulation Test, Digital Ovulation Predictor Kit, Trying for a Baby Advanced Ovulation Kit and Easy Luteinizing Hormone (LH) Kit—bear labels that prominently promise that the products, identified as “ovulation tests” or “ovulation kits,” are “99% Accurate” or “Over 99% Accurate.” 

Similarly, Church & Dwight’s First Response Ovulation Plus Pregnancy Test, First Response Advanced Digital Ovulation Test and First Response Easy Read Ovulation Test are each touted as “Over 99% Accurate,” and bear labels that make representations such as “Get Pregnant Sooner” and “Predicts Your 2 Most Fertile Days,” the case says. 

Private label ovulation test kits sold by Target, Walgreens and CVS bear similar label representations, according to the complaint. 

The suit states that when ovulation takes place, it is generally preceded by a surge in LH levels 24 to 36 hours prior. The case charges that neither LH tests nor any other method for timing intercourse for pregnancy is able to pinpoint, with 99 percent accuracy, whether a woman is, or soon will be, ovulating. 

“An LH test, even if it is 99% accurate in identifying LH, merely provides a ‘hint’ at when ovulation will occur,” the lawsuit argues. 

The case analogizes that monitoring basal body temperature is another method that may indicate when ovulation will occur, but that doesn’t mean a thermometer can be marketed as “99% accurate” for the purposes of detecting ovulation. 

The lawsuit also adds that many women do not have regular menstruation cycles, and during irregular cycles LH tests may be negative and falsely indicate that no ovulation has occurred. 

“The common occurrence of irregular cycles thus further lower the chances that Defendants’ Kits will accurately predict ovulation,” the case contends. 

Although some of the defendants’ ovulation test kits may include an asterisk next to their “99% Accurate” claim, the related disclaimer is “hidden in small text on a different part of the box or on a pamphlet inside the box,” the filing says. Moreover, this additional disclaimer information, such as “*at detecting LH levels,” is “not understandable to a reasonable consumer,” and certainly does not override the “large, plain message on the front of the box” touting the products’ accuracy, the lawsuit relays. 

The case looks to cover all consumers who purchased ovulation test kits made by Abbott Labs, Alere, Procter & Gamble, SPD Swiss Precision Diagnostics GmBH, Church & Dwight Co., Inc., Target Corporation, Walgreen Co., or CVS Pharmacy in New York for purposes other than resale. 

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