Friday, May 10, 2024

reasonable consumers of ovulation test kits understand details of hormone signalling

La Rosa v. Abbott Laboratories, No. 22-CV-5435 (RER) (JRC), 2024 WL 2022297 (E.D.N.Y. May 7, 2024)

Plaintiffs alleged that defendants’ at-home ovulation test kits were deceptive because they advertised “ovulation test kits” alongside the front-of-package statement “99% ACCURATE,” which conveyed that that the tests are 99% accurate at testing for ovulation, when in fact, the products detect a surge in luteinizing hormone (LH), and not actual ovulation. “All the kits state in small writing on the side or back of the packaging that they are 99% accurate at detecting LH levels.” Some kits include an asterisk next to the claim “99% ACCURATE”;  others include statements on the front of the packaging that they detect “LH Surge” or “No LH Surge.”

As alleged, the kits detect a rise in urinary LH levels, which typically precedes ovulation by twenty-four to thirty-six hours. But LH surges may occur at other times in a person’s menstrual cycle; body mass index, age, contraceptive use, sports activity, and smoking may affect urinary LH levels; when a person has an irregular cycle, the test could inaccurately indicate that no ovulation occurred; and more than ten percent of menstrual cycles are subject to a condition known as “Luteinized Unruptured Follicle Syndrome,” during which there is a normal LH surge and menstruation, but no egg releases. LH surges may also be detected in women who are infertile. The only current method for predicting ovulation with “a high degree of accuracy” is an invasive transvaginal ultrasound.

The court found that plaintiffs failed to state a claim under NY and California consumer protection law. Courts sometimes demand a lot of “reasonable” consumers—here, the court reasoned that reasonable consumers know the scientific details of fertility and should know the difference between LH surges and ovulation, especially given the package disclosures:

First, a key contextual inference arises from the products themselves: it is impossible to test for actual ovulation. A reasonable consumer does not expect to purchase a product that is impossible to find in the marketplace. … The FDA explains that at-home ovulation urine tests measure LH to detect ovulation and are successful at doing so “reliably about 9 times out of 10[.]” This explains that tests that reveal actual ovulation do not exist. Although a reasonable consumer is not expected to have medical expertise, in the context of a niche, specialty product, purchasers exhibit a higher degree of care. And indeed, Defendants’ products are a specialty item targeted to a class of informed consumers to aid in their attempts to become pregnant. Many buyers of ovulation test kits have had trouble getting pregnant in the past, and as such, seek help from various sources. According to Plaintiffs, “[a]s of 2015, an estimated 7.3 million women had received some sort of infertility service[.]” In turn, many ovulation test kit consumers would be expected to have at least some information leading up to their purchase, and therefore know what to expect to find in the marketplace—they do not expect to find at-home test kits that indicate actual ovulation.

This does not seem to me—as someone who has indeed been in the general market for this type of product—to be a description of reasonable consumers of specialized medical services, who tend to outsource a lot of the details to presumed experts.

In addition, the court reasoned,

a reasonable purchaser of Defendants’ products necessarily looks to the side and back of the box to understand how to use the products. Alongside these directions, the boxes for all the products in question clarify that the products test for LH, not for ovulation itself, and that an LH surge typically precedes ovulation. By contrast, a consumer of something such as a basic food item is not expected to flip over the packaging to look for clarification or disclaimers.

Read together, “Ovulation Test Kit” and “99% Accurate” could imply 99% accuracy at testing for ovulation, but the two phrases could also be read separately. And, true, some products include phrases on the front like, “Predicts Your 2 Most Fertile Days” and “Early ovulation test ... tells you the best 2 days to conceive.” Nonetheless, “regardless of where the front package falls on the spectrum, the product requires a standard of care that necessitates looking at the complete package.” And it wasn’t alleged that the tests didn’t reliably predict ovulation, even if not at the 99% accuracy level. Thus, “the clarifying language on the side or back of the packaging dispels any confusion.”

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