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Dr Chelsea Polis: ‘The scientific world recognises when you stick your neck out and do the right thing’


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Chelsea Polis, a reproductive health scientist located in New York City, faced a lawsuit from a medical device company for $1 million after speaking out against their deceptive advertising regarding their digital fertility tracker as a form of birth control. However, after a lengthy two-year legal battle, the case was ultimately dismissed. Recently, she was awarded the prestigious 2023 John Maddox prize, which recognizes early career individuals who defend evidence-based science against opposition. She currently holds a senior position as an epidemiologist at the Population Council’s Center for Biomedical Research.

In May of 2020, you were the subject of a lawsuit by Valley Electronics of Zurich, Switzerland, seeking $1 million in damages for defamation. This company is the maker of the Daysy fertility tracker and DaysyView app, and they took legal action against you for expressing your concerns about their device being advertised as a contraceptive. How did it personally affect you to be sued for such a large amount?

Surprising. Frightening. Utterly confusing because the reason for my lawsuit was based on something that had been proven valid by both a scientific publication and a US government agency – the US Food and Drug Administration [FDA]. The FDA had taken my concerns seriously and initiated an investigation, leading to a change in the company’s marketing statements.

What did the company assert and what were your apprehensions?

Daysy is a type of thermometer used for fertility tracking. It records the start date of your menstrual cycle and measures your basal body temperature every day. Its purpose is to predict the most fertile days of your cycle. In 2017, I noticed that the company was promoting it as a form of birth control, claiming it was just as effective as an IUD (intrauterine device), which is known to be one of the most reliable methods. They advertised it as 99% effective for contraception, but this claim was based on a flawed study and went against regulations set by the Food and Drug Administration for contraceptive marketing.

What were the reasons provided by the company for promoting Daysy as a form of birth control and how did you react to them?

There have been two main studies referenced over time. One was conducted in 1998 on a previous device called Lady-Comp. This was the study that initially caught my attention when I reached out to the company to express my concerns. I noticed that it had miscalculated the contraceptive effectiveness. When I asked if they had ever conducted a study with prospective pregnancy measurement, which is necessary for accurately assessing the device’s effectiveness, they replied that they would love to but the costs outweighed the benefits. This was alarming to me because it showed a lack of understanding of the potential costs of an unintended pregnancy for someone who relies on the device’s supposed 99% effectiveness rate.

A new research report was released few months after. My primary concern with the study was the flawed data collection and analysis methods used. I wrote a commentary in June 2018 for the same journal, Reproductive Health, highlighting all the shortcomings and urging for the paper’s retraction. A year later, I was informed that the journal had sought an independent expert’s opinion and validated my concerns. The journal retracted the paper and allowed the authors to submit a response letter.

You also reached out to the regulatory agency, the FDA, in order to request an investigation…

On the same day that my peer-reviewed commentary was released, I contacted the FDA to report potential regulatory misconduct. This complaint addresses concerns regarding possible violations in marketing. Many of these claims were being shared on social media, where younger individuals make up a larger portion of the audience and are at a higher risk of unintended pregnancy. It is important for everyone to have access to accurate information about contraception, but it is especially concerning to see what I believe to be false information spreading rapidly, particularly among young people.

What was the reason for the company’s lawsuit against you?

Retracting a scientific paper can be challenging, as it often attracts attention from the media. I was happy to see this, as it meant that those who are interested in or currently using Daysy would be aware of the situation. I participated in several media interviews, during which I may have used language that the company deemed defamatory. As a result, they have filed a lawsuit against me for $1 million.

How did you end up receiving pro bono assistance from Dori Hanswirth and her team at Arnold & Porter law firm?
I was incredibly fortunate. I explained the situation to them, and they were horrified. They generously dedicated the next two years and a significant amount of resources to my case. As a privileged Caucasian woman residing in New York City with lawyers in my family, this was my first encounter with the legal system. Thanks to my connections, which not everyone has, I was connected with a family friend who is knowledgeable about various law firms and their pro bono work. She provided me with a list of potential contacts and advised me to compile a document outlining the specifics of my case.

I want to acknowledge my perspective in this matter because it has shown me that my privilege played a role in my ability to be connected to helpful individuals, have the time and resources to create a document while juggling other responsibilities. If someone earlier in their career, or in a less financially stable situation, or without a supportive family, or lacking social connections, or facing other challenges…if they did not have the same comforts and privileges as I did, they would have had a much lower chance of receiving the assistance they needed to defend the truth.

What was the resolution of the case?

We successfully obtained a dismissal within a little over a year. We were pleased with the outcome, but shortly after, we learned that Valley Electronics had filed an appeal with the second circuit court of appeals. It seemed like we were in for another round. However, the appeal was once again dismissed in a shorter amount of time.

Can you provide more information about your support for promoting federal anti-SLAPP legislation in the United States?

Slapp is a term used for strategic lawsuits aimed at silencing individuals speaking out about matters of public interest. These types of lawsuits are commonly brought by influential parties. While they occur in various locations, their impact differs depending on jurisdiction. In the United States, the level of protection against Slapp suits may vary depending on geographical location. In some states, even if the individual is proven innocent and their statements are deemed truthful, they may still be responsible for covering the costs of their defense, which can be a significant financial burden.

After learning that Representative Jamie Raskin, a member of Congress from Maryland, had proposed a federal anti-Slapp law, I reached out to his office when we won our case. I was connected with a coalition, including Protect the Protest, Union of Concerned Scientists, Public Citizen, and Amnesty International, that is dedicated to advancing anti-Slapp legislation. This group aims to bring attention to the harmful effects of Slapp suits on individuals and conducts interviews with environmental activists, scientists, and others who may be affected. We will support the reintroduction of this federal legislation.

How did you feel when you were awarded the John Maddox Prize for early career researchers?

Rephrased: Receiving this award is the highlight of my career. I have been following it for many years, as it was one of the first sites I visited when searching for stories after being sued. It has been a significant part of my life for six or seven years, and it required persistence to continue pursuing it. Despite receiving advice from colleagues to let it go, this recognition serves as validation that my efforts were worthwhile and noticed by the scientific community. It feels wonderful to know that someone appreciates my willingness to take risks and do what is right.

Source: theguardian.com