Chelsea Polis was at her home in New York City when she discovered she was being sued for defamation. It was May 2020, mid-lockdown, and the security person at the front desk of her apartment block refused to allow the courier upstairs to serve the papers. “It was a very strange situation,” she said.
When she did see the papers, Polis found out she was the subject of a lawsuit by Valley Electronics, the maker of a £299 smart thermometer called Daysy. It tracks a woman’s basal body temperature – her temperature when she is at rest – which fluctuates slightly throughout her menstrual cycle, and which, combined with other data about her cycle, can help to identify when she has ovulated. The thermometer, its makers had insisted, was highly effective at preventing pregnancy; over the previous three years, Polis, an epidemiologist who focuses on contraception, HIV, abortion and fertility, had been engaged in an increasingly bitter battle over that claim.
The dispute had begun after Polis saw the company stating on social media that its device was “similar in effectiveness” to the copper intrauterine contraceptive device (IUD, or coil). One tweet in particular had troubled her: “Did you know the FDA blocks us from calling Daysy birth control or contraception? But she’s 99.3% effective. #ThxBirthControl”.
Polis reached out to the company to voice her concerns. “They kind of patted me on the head and said, oh, we’ll raise this to our board,” she said. In its responses to her, a representative for the company also dismissed the need for higher quality prospective effectiveness studies instead of the less rigorous retrospective questionnaire approach it had used, citing the cost. “He said, ‘the costs and benefits are all out of proportion’.”
“If you’re marketing a product as a contraceptive method without appropriate regulatory approval and you’re claiming that it’s as effective as an IUD based on flawed data, the cost, I would argue, is that people are going to be put at greater-than-expected risk of unintended pregnancy,” she said. “The phrasing of that just blew my mind.”
The company persisted. In March 2018, it published a paper in the Reproductive Health journal indicating that its device was 99.4 per cent effective. Polis was “horrified” by the methodology. She filed an allegation of regulatory misconduct to the US Food and Drug Administration (FDA), and did what any scientist would do: submitted a peer-reviewed paper describing the study’s “egregious methodological flaws” to Reproductive Health, and called for the study’s retraction.
In May 2019, the journal published a retraction: Polis used it as an opportunity to speak to the media, pointing out the problem with firms marketing their products as contraceptives without regulatory approval and when the science behind them was flawed, and calling Valley Electronics “unethical” and its study “junk science”. That was where it took exception.
Now, after two years, a New York court of appeals has sided with her, finding Valley’s lawsuit to be “without merit” and throwing it out. For Polis, the decision came as a huge relief. “A lot of these kinds of lawsuits aren’t filed with even necessarily a hope of winning. They’re filed with the hope of intimidating, and they’re filed in the knowledge that the defendant most likely will have to bear the legal costs,” she said. “I was terrified, not only for myself – but what does this mean for scientists who are speaking out truthfully, in evidence-based ways? It could have a chilling effect.”
Polis’ experience comes at a time when hormonal contraception methods are subject to suspicion – specifically the pill, which has been the subject of criticism in recent years. So-called “femtech” solutions such as Daysy, which are based on the “fertility awareness” method, are an attractive prospect to women who are tired of taking hormones: according to research by McKinsey, femtech startups received $2.5bn of funding last year, while the sector could be worth as much as $1bn. Some 3 per cent of all digital health funding is invested in femtech firms.
In the UK, the government has shown enthusiasm for medtech companies, including telemedicine apps such as Babylon Health, notably during the tenure of the former health secretary, Matt Hancock. For politicians, such technology offers to take some pressure off NHS budgets, but researchers are concerned that it is not being properly verified. The Family Planning Association has called for more research into devices and apps after Natural Cycles, an app that claims to show users when their fertile days are, was approved as a Class 2B medical device. “There are currently hundreds of fertility apps and period trackers and no independent system to evaluate these technologies,” said Dr Cecilia Pyper, of the University of Oxford. “The research we do have suggests that many are ineffective.”
Polis agreed that femtech firms need more oversight. “I do think it’s a bit of a Wild West,” she said. “Bodies like the FDA and those in other countries that are similar [should] have strong regulatory oversight of these kinds of devices, exactly to avoid these kinds of situations like that with Daysy – I don’t think that most consumers are aware that these devices are sometimes inappropriately marketed as contraceptive methods without necessarily going through some sort of oversight.”
Polis pointed out that some women may turn to these devices because they feel let down by the medical establishment. “Sometimes their concerns or their desires are maybe a little bit brushed off,” she said. “I would like to see the reproductive health field step up more and do a better job of providing accurate information, so that people who are interested in using these methods have better resources to turn to when they’re trying to make these decisions.”
Valley Electronics did not respond to requests for comment.
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