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Exhibit B
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4SUPREME COURT OF THE STATE OF NEW YORK
COUNTY OF KINGS
CHELSEA B. POLIS, Index No. 528434/2022
Plaintiff, NOTICE OF MOTION
v.
VALLEY ELECTRONICS AG,
VALLEY ELECTRONICS GmbH, and
VALLEY ELECTRONICS, LLC,
Defendants.
PLEASE TAKE NOTICE, that upon the accompanying Memorandum of Law,
Affirmation of David E. Potter and the exhibits annexed thereto, Defendants Valley Electronics
AG, Valley Electronics GmbH, and Valley Electronics, LLC, by their undersigned attorneys, will
move this Court, located at 360 Adams Street, Brooklyn, New York 11201, on June 1, 2023 at
9:30 a.m. or as soon thereafter as counsel may be heard, for an Order dismissing Plaintiff’s
Amended Complaint in its entirety, with prejudice, pursuant to CPLR §§ 3211 (a)(1) and (a)(7).
PLEASE TAKE FURTHER NOTICE, that pursuant to CPLR § 2214(b), answering
papers, if any, are required to be served on the undersigned at least seven (7) days prior to the
return date of this motion.
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Dated: New York, New York
April 25, 2023
LAZARE POTTER GIACOVAS & MOYLE LLP
By: s/ David E. Potter
David E. Potter
747 Third Avenue, 16th Floor
New York, New York 10017
(212) 758-9300
dpotter@lpgmlaw.com
Attorneys for Defendants Valley Electronics
AG, Valley Electronics GmbH, and Valley
Electronics, LLC
TO: ARNOLD & PORTER KAY SCHOLER LLP
Dori Ann Hanswirth
Paul Q. Andrews
Rachel A. Carpman
250 West 55th Street
New York, NY 10019
(212) 836-8000
dori.hanswirth@arnoldporter.com
Attorneys for Plaintiff
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SUPREME COURT OF THE STATE OF NEW YORK
COUNTY OF KINGS
CHELSEA B. POLIS, Index No. 528434/2022
Plaintiff, AFFIRMATION OF
DAVID E. POTTER
v. IN SUPPORT OF
DEFENDANTS’ MOTION TO
VALLEY ELECTRONICS AG, DISMISS PLAINTIFF’S AMENDED
VALLEY ELECTRONICS GmbH, and COMPLAINT WITH PREJUDICE
VALLEY ELECTRONICS, LLC, PURSUANT TO CPLR §§ 3211(a)(1)
AND (a)(7)
Defendants.
DAVID E. POTTER, an attorney duly admitted to practice law before the courts of this
State, hereby affirms, subject to the penalty of perjury pursuant to C.P.L.R. 2106, as follows:
1. I am a partner at Lazare Potter Giacovas & Moyle LLP, attorneys for
Defendants Valley Electronics AG, Valley Electronics GmbH, and Valley Electronics, LLC in the
above captioned matter.
2. I submit this affirmation in support of Defendants’ Motion to Dismiss the
Complaint with Prejudice Pursuant to CPLR § 3211(a)(1) and (a)(7).
3. Annexed hereto as Exhibit A are true and correct copies of Plaintiff’s
Amended Complaint and the Exhibits thereto, which are also available at NYSCEF Dkt. #s 14-21.
4. Annexed hereto as Exhibit B is a true and correct copy of a defamation
complaint Defendants filed against Polis in the Eastern District of New York on May 11, 2020,
which is also available at NYSCEF Dkt.# 4.
5. Annexed hereto as Exhibit C is a true and correct copy of Plaintiff’s initial
complaint (without exhibits), which is also available at NYSCEF Dkt. # 2.
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Dated: New York, New York
April 25, 2023
s/ David E. Potter
DAVID E. POTTER
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Exhibit A
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SUPREME COURT OF THE STATE OF NEW YORK
COUNTY OF KINGS
----------------------------------x
:
CHELSEA B. POLIS, : Index No. 528434/2022
:
Plaintiff, : Hon. Francois A. Rivera
: (IAS Part 52)
--against- :
: AMENDED COMPLAINT
VALLEY ELECTRONICS AG, :
VALLEY ELECTRONICS GmbH, and :
VALLEY ELECTRONICS, LLC, :
:
Defendants. :
:
----------------------------------x
Plaintiff, Dr. Chelsea B. Polis, brings this amended complaint against Valley Electronics
AG, Valley Electronics GmbH, and Valley Electronics, LLC (collectively, “Valley”), and alleges
as follows:
NATURE OF ACTION
1. This case is about a medical device company’s unsuccessful efforts to silence
legitimate scientific and regulatory criticisms leveled against it by a leading reproductive health
epidemiologist. Those efforts failed spectacularly in court, and now the critic is asserting her
right to sue the company for attorneys’ fees and damages under New York’s anti-SLAPP law.
2. Valley manufactures and markets a basal body thermometer, the Daysy, which it
claimed can be used to both attempt and to prevent pregnancy. The latter claim violates U.S.
Food and Drug Administration (“FDA”) regulations, as Daysy has never been FDA-cleared or
approved for contraceptive use.
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3. Valley had published a flawed study claiming 99.4% contraceptive effectiveness;
that study has since been retracted due to the efforts of plaintiff, Dr. Chelsea Polis —a decorated
Johns Hopkins-trained reproductive health epidemiologist who has devoted her career to
improving global sexual and reproductive health. After Dr. Polis’s research, commentary, and
activism before the U.S. Food and Drug Administration (“FDA”) resulted in the retraction of
Valley’s published study and an FDA investigation into Valley’s deceptive marketing practices,
Valley reacted not by correcting its bad conduct, but by suing Dr. Polis for defamation in the
United States District Court for the Eastern District of New York.
4. Valley’s baseless claims against Dr. Polis were dismissed on their face, in a
decision that was affirmed on appeal, see Valley Electronics AG et al. v. Polis, No. 20-cv-2133,
2021 WL 3919244 (E.D.N.Y. Aug. 6, 2021), aff’d, No. 21-2108-CV, 2022 WL 893674 (2d Cir.
Mar. 28, 2022), but the damage caused by Valley’s transparent retaliation had already been done.
Dr. Polis has experienced significant personal and professional distress as a result of being
placed in Valley’s legal crosshairs, and her ability to contribute to the public discourse was
curtailed and chilled by her reasonable fear of being unfairly subjected to expense and
uncertainty of the legal system, merely for doing her best to inform and protect the public within
the areas of her considerable expertise. Fortunately, when, as here, corporations attempt to use
the legal system as a cudgel to silence individuals speaking against them to government agencies
and the public at large, New York law provides a remedy.
5. Dr. Polis now brings this action under New York Civil Rights Law § 70-a, both as
it was originally enacted in 1992 and as it is now amended, to recover the substantial costs,
2
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attorney’s fees, and compensatory and punitive damages caused by Valley’s baseless and
retaliatory defamation suit targeting her protected speech on significant issues of public interest.
PARTIES
6. Dr. Polis is a reproductive health epidemiologist living in Brooklyn, New York.
7. Defendant Valley Electronics AG is a Swiss corporation headquartered in
Switzerland.
8. Defendant Valley Electronics GmbH is a German corporation headquartered in
Germany.
9. Defendant Valley Electronics, LLC is a Pennsylvania limited liability company
headquartered in Pennsylvania.
JURISDICTION AND VENUE
10. This Court has personal jurisdiction pursuant to New York Civil Practice Law and
Rules (“CPLR”) §§ 301 and 302 because Valley commenced and continued a strategic litigation
against public participation (“SLAPP suit”) against Dr. Polis in New York, which forms the basis
of this claim.
11. Venue is proper in Kings County pursuant to CPLR § 503(a) because Dr. Polis is
a resident of Kings County and because Valley commenced and continued its SLAPP suit against
Dr. Polis in Kings County.1
FACTS
Dr. Polis
1
A SLAPP suit is a civil action brought by an individual or an organization for the purpose of dissuading critics
from speaking out about the plaintiff’s actions. They are particularly insidious as they can chill a defendant’s First
Amendment protected speech simply through fear of litigation, even though that litigation turns out to be baseless.
3
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12. Dr. Polis’s twenty year career in reproductive health has focused on issues
including contraception and fertility. Her work on contraception has helped form the guidance of
major national and international public health organizations, including the Centers for Disease
Control and Prevention and the World Health Organization. At the time of the events at issue,
Dr. Polis served as a Principal Research Scientist at the Guttmacher Institute, a research and
policy organization devoted to sexual and reproductive health and rights. Dr. Polis currently
serves as Senior Scientist, Epidemiology at the Center for Biomedical Research, a non-profit
product development entity that investigates, inter alia, new approaches to preventing
unintended pregnancy. She holds an Associate appointment in the Department of Epidemiology
at the Johns Hopkins Bloomberg School of Public Health.
Valley and the Daysy
13. Valley manufactures, markets, and sells basal body temperature2 thermometers.
Its current offering is called the Daysy, which can be used in conjunction with a mobile app
called DaysyView (together, the “Daysy”).
14. The FDA permits Valley to refer to the Daysy as a proceptive device, that is, a
device that may assist its user in trying to become pregnant by tracking daily basal body
temperature and dates of menstruation. The Daysy mobile app then purports to use these inputs
to calculate the fertile days of a user’s cycle via an algorithm.3 If the algorithm suggests that the
user is in a more fertile phase, the Daysy shows a red indicator. If the algorithm deems the user
to be an infertile phase, the Daysy shows a green indicator.
2
“Basal body temperature” refers to a person’s body temperature measured when fully at rest.
3
Because ovulation may cause a slight increase in basal body temperature, observing and tracking basal body
temperature can provide information that may indicate when a person has already ovulated.
4
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The FDA Regulates The Daysy
15. Pursuant to its authority under section 201(h)(1) of the Food, Drug and Cosmetic
Act (“FDCA”), the FDA monitors medical devices that come to market in the United States. 21
U.S.C. § 360. Medical devices are categorized into three classes according to the risk they pose
to the user, with Class I devices posing the lowest risk and Class III devices posing the highest
risk. Devices for which no classification regulation has been promulgated are referred to as
“unclassified.”
16. Contraceptive medical devices, which help users prevent pregnancy, are Class II
or III medical devices. 21 C.F.R. § 884. Contraceptive devices must be cleared or approved by
the FDA and the manufacturers of such devices must comply with the FDA’s 510(k) Premarket
Notification process (Class II devices) or complete a Premarket Approval application (Class III
devices), both of which require manufacturers to demonstrate, among other things, that the
medical device is safe and effective for the purpose of contraception.
17. The Daysy has never been approved by the FDA as a Class II or Class III
contraceptive device. To the contrary, Valley has listed the Daysy with the FDA as a proceptive
device only, that is, one that may assist a user in trying to become pregnant. Currently, the FDA
considers proceptive fertility diagnostic devices such as the Daysy (FDA product code LHD)4 as
unclassified medical devices. In the past, manufacturers of proceptive devices were required to
complete the 510(k) Premarket Notification process before bringing their products to market.
18. All manufacturers of medical devices (whether Classes I, II, III or unclassified)
are subject to general controls delineated in the FDCA, which include requirements for annual
4
The FDA defines product code LHD as “Device, Fertility Diagnostic, Proceptive.”
5
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registration, listing of devices, good manufacturing practices, labeling, and prohibitions against
misbranding and adulteration. 21 U.S.C.A. § 360c(a)(1)(A).
19. Valley must register as a manufacturer of medical devices with the FDA every
year.
20. Valley must also list the Daysy with the FDA. The Daysy is listed with the FDA
as a proceptive device with product code LHD.
21. In 2005, consistent with then-prevailing FDA requirements, Valley submitted a
510(k) Premarket Notification application to the FDA for a prior version of its basal body
temperature thermometer, called the “Lady-Comp.” Under “Intended Use,” Valley wrote, “Lady-
Comp USA is intended for measuring and recording basal body temperature (BBT) as an aid in
ovulation prediction to facilitate conception (not to be used for contraception).” (Emphasis
added.) In other words, Valley has never sought FDA approval to market the Lady-Comp or the
Daysy as a contraceptive device.
Valley’s Noncompliance with FDA Regulations
22. On information and belief, Valley has never filed anything with the FDA for
clearance or approval to market and sell any contraceptive device. Without doing so, it is illegal
to market any device as a contraceptive within the United States.
23. Despite lacking FDA approval to market any of its products as contraceptive
devices, Valley had wrongfully marketed both the Daysy and its predecessor product, the Lady-
Comp, as effective for preventing pregnancy in the United States for over 20 years. Indeed,
6
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Lady-Comp’s first website, created in 2002, touted the device as being “as safe as the pill if used
properly,” and “for contraception and conception, birth control and family planning.”5
24. The FDA has repeatedly warned Valley that marketing its devices as
contraceptives is in violation of the FDCA.
25. In December 2010, the FDA issued warning letters to Valley based on statements
on Valley’s website representing that the Lady-Comp was intended for contraceptive use. The
FDA demanded Valley immediately cease making such claims and take prompt action to correct
the violations.
26. The FDA issued another warning letter to Valley in 2013 listing violations of
branding and manufacturing practices discovered during an FDA inspection of Valley’s German
operations center.
27. Despite these repeated warnings from the FDA, Valley’s marketing continued to
tout the purported contraceptive effectiveness of its products. In making these claims, Valley
relied heavily on a 1998 study by G. Freundl called “Retrospective clinical trial of contraceptive
effectiveness of the electronic fertility indicator Ladycomp/Babycomp,” published in the (now-
defunct) journal Advances in Contraception (the “Freundl Study”). This study purportedly found
that Lady-Comp was 99.3% effective at preventing pregnancies, but as detailed below, this study
was fatally flawed. In 2016, Valley published an advertisement on social media purposely trying
to sidestep the FDA’s prohibition on labeling the Daysy as a method of contraception, saying
5
https://web.archive.org/web/20021128102646/http://www.ladycomp.com/.
7
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“Did you know the FDA blocks us from calling Daysy birth control or contraception? But she’s
99.3% effective. #ThxBirthControl.”6
28. In another 2016 social media advertisement, Valley compared the Daysy’s
effectiveness to that of an intrauterine device (“IUD”). IUDs are among the most effective
methods of contraception on the market. Based solely on the flawed Freundl Study, Valley
claimed that the Daysy was “99.3% effective” as compared to the IUD’s 99.4%.7
29. In March 2018, Dr. Martin C. Koch and coauthors who included Valley’s
Director of Medical Affairs Niels van de Roemer, published a Valley-funded study in the journal
Reproductive Health entitled, “Improving usability and pregnancy rates of a fertility monitor by
an additional mobile application: results of a retrospective efficacy study of Daysy and
DaysyView app” (the “Koch Study”). The Koch Study purported to find that the Daysy was
99.4% effective at preventing pregnancy.
30. Valley immediately announced this new statistic. On March 15, 2018, Valley
posted to Facebook, “We are proud to be able to prove that the Daysy fertility tracker and
DaysyView app, when used together, provides a highly trustworthy and reliable method for
avoiding pregnancy.” Beneath this, Valley posted an ad that said “Daysy is not 99.3% effective.
Daysy is now 99.4% effective.”8
Dr. Polis’s Speech
6
Chelsea B. Polis, “Pushing Daysy’s: how people could be misled into buying an unproven device for
contraception” (June 27, 2018) http://chelseapolis.com/blog/pushing-daysys-how-people-could-be-misled-into-
buying-an-unproven-device-for-contraception.
7
Chelsea B. Polis, “Published analysis of contraceptive effectiveness of Daysy and DaysyView app is fatally
flawed,” Reproductive Health 15.113 (2018), https://reproductive-health-
journal.biomedcentral.com/articles/10.1186/s12978-018-0560-1.
8
Id.
8
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31. Among other things, as part of her work as a leader in reproductive health science
and education, Dr. Polis studies and comments on how women may try to become pregnant and
may try to prevent pregnancy. She has published numerous peer-reviewed studies and book
chapters focused on calculation of contraceptive effectiveness. She frequently addresses the
contraceptive efficacy of fertility awareness based methods (“FABMs”).9
32. For several years, Dr. Polis has studied claims made by the developers of several
FABM technologies, and has, when deemed necessary, commented on their advertising language
(directly to those companies as well as in public fora), in an effort to prevent companies from
misleading and potentially endangering their users.
33. As a scientist, Dr. Polis is interested in any studies that FABM developers point to
regarding the contraceptive efficacy of their products. One such study is the Freundl Study. Upon
reading the Freundl Study after encountering it in ads for the Daysy, Dr. Polis discovered
Valley’s use of the data from this study was particularly problematic.
34. Dr. Polis’s first concern was that even though the Freundl Study was being used
to support marketing for the Daysy, the Freundl Study assessed the company’s predecessor
devices (the Lady-Comp and its sister device, the Baby-Comp), and not the Daysy. The Daysy
differs from these predecessor devices in shape, size, weight, available settings, memory size,
how temperature information is displayed, how data are transferred, how the device is powered,
whether the device can be used with an app, software, and possibly other factors. Indeed, the
9
Fertility awareness-based methods (“FABMs”) are methods used to track and predict the fertile window each
month. FABMs are based on the idea that unprotected sexual intercourse can only lead to pregnancy during
approximately 6-9 days of the menstrual cycle (the “fertile window”), the timing of which can vary each month.
FABM users track changes in their bodies using one or more biomarker of fertility. Biomarkers may include
menstrual cycle start dates, basal body temperature, cervical mucus, and urinary hormone metabolites. The Daysy is
a FABM that tracks basal body temperature and menstrual cycle start dates.
9
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Freundl Study could not have tested the Daysy’s effectiveness since the Daysy (released in 2014)
had not been available in 1998, when the study was published. In other words, Valley was using
a study that had never tested the Daysy to claim to potential customers the Daysy was an
effective contraceptive. Second, Dr. Polis was concerned about several methodological features
of the Freundl Study, including that it used incorrect denominators in calculating contraceptive
effectiveness.10 Moreover, the Freundl Study was a retrospective, mailed survey: the researchers
mailed letters to people who had purchased the device in the prior three years and asked them to
report and mail back information on whether they had become unintentionally pregnant while
using the device. Well-designed clinical trials assessing contraceptive effectiveness perform
recurrent pregnancy tests on study participants over time to prospectively identify contraceptive
failures, rather than using self-reported pregnancy information. There are many reasons people
may not report experiencing an unintended pregnancy in a retrospective study. For example, a
person reflecting back on a pregnancy is more likely to say that the pregnancy was intended, or
not to report a pregnancy that was terminated. In all, retrospective mailed surveys are not a
reliable way to determine a device’s contraceptive efficacy.
35. In September 2017, Dr. Polis privately reached out to Valley to raise the above
concerns regarding the methodology of the retrospective Freundl Study, with the hope that she
could convince Valley to change its misleading marketing without involving the FDA. Valley’s
Director of Medical Affairs, Niels van de Roemer, brushed her concerns aside saying that, while
10
Chelsea B. Polis, “Published analysis of contraceptive effectiveness of Daysy and DaysyView app is fatally
flawed.” Reproductive Health 15, 113 (2018) https://doi.org/10.1186/s12978-018-0560-1
10
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Valley would be interested in a prospective multi-center study, the “costs and benefits [were] out
of all proportion.”11 Exhibit 1. Valley did not change its marketing.
36. In March 2018, Dr. Polis read the Koch Study. Dr. Polis determined that the Koch
Study also contained numerous methodological flaws, leading to a very unreliable conclusion
about the Daysy’s effectiveness at preventing unintended pregnancy. These included again using
a retrospective, rather than a prospective, mailed survey with a low response rate, in addition to
major errors in their mathematical calculations (such as inappropriately excluding data from
women at greatest risk of unintended pregnancy in their effectiveness calculations, without
justification), as well as an array of other methodological concerns pertaining to data collection
and analysis. These errors, in Dr. Polis’s view, led to the Koch Study presenting an overinflated
estimate of the Daysy’s effectiveness at preventing pregnancy.
37. Dr. Polis was concerned that, rather than correcting its past misleading advertising
and reliance on flawed studies, Valley was doubling down, using the new, but equally flawed
Koch Study in marketing materials to promote the Daysy as a purportedly even more effective
contraceptive.
38. On June 25, 2018, Dr. Polis published a commentary critiquing the Koch Study in
the same journal that originally published it—Reproductive Health (the “Commentary”). Exhibit
2. The Commentary identified the study’s numerous methodological flaws that resulted in severe
underestimation of the rate at which Daysy users became pregnant unintentionally. Dr. Polis
concluded that “[t]hose estimates are being used in marketing materials which may
11
Chelsea B. Polis, “How an unethical company (Daysy) responded to the retraction of their study.” (June 9, 2019)
https://chelseapolis.com/blog/how-an-unethical-company-daysy-responded-to-retraction-of-their-study.
11
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inappropriately inflate consumer confidence and leave consumers more vulnerable than expected
to the risk of unintended pregnancy.” Dr. Polis called for retraction of the Koch Study and for
appropriate regulatory oversight of marketing materials on contraceptive effectiveness.
39. On the same day that her Commentary was published, June 25, 2018, Dr. Polis
submitted an “Allegation of Regulatory Misconduct” (“ARM”) to the FDA, in which she
reported that the Daysy was “being marketed as a contraceptive device—without having been
cleared or approved by the FDA for this contraceptive purpose.” Exhibit 3. Dr. Polis included a
copy of the Commentary in her ARM.
40. Two days later, on June 27, 2018, Dr. Polis published a post on her personal blog
(the “June 2018 Blog Post”) explaining the Commentary, discussing Valley’s deceptive
marketing, and calling for an investigation by regulatory authorities. She also provided a link to a
webpage where readers could report allegations of regulatory misconduct to the FDA. Exhibit 4.
41. On January 20, 2019, Dr. Polis submitted a Freedom of Information Act
(“FOIA”) request to the FDA, asking for documents relating to the Daysy and her ARM.
The FDA Investigation
42. In response to Dr. Polis’s ARM, and unbeknownst to Dr. Polis at the time, the
FDA launched an investigation. On February 14, 2019, an FDA analyst delivered a memo to his
superior assessing “whether the technology and/or claims found on the company website triggers
the need for a 510(k).” Exhibit 5. The analyst found that although some of the Daysy’s labeling
stated the device was not a contraceptive, “statements on the Daysy website make numerous
claims regarding how the patient-specific output of the algorithm can be used…to prevent a
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pregnancy.” Id. In fact, the majority of the statements on the website claimed the Daysy was so
effective, additional contraceptive methods were only needed on “fertile” days.
43. The analyst concluded: “Based on the claims provided…the device is not a
conception-use device….For this reason, a 510(k) would be needed to support these claims.” Id.
44. Accordingly, on March 12, 2019, the FDA sent a letter to Valley CEO, Natalie
Rechberg, stating the FDA’s concern that Valley appeared to be marketing the Daysy in a
manner that violated the FDCA. Specifically, the FDA informed Rechberg that “your website
includes multiple statements regarding use of patient-specific output from the Daysy fertility
tracker to provide information to users trying to avoid a pregnancy.” Exhibit 6.
45. On May 14, 2019, while the FDA’s investigation was still pending, Reproductive
Health publicly retracted the Koch Study (the “Retraction”). The Retraction cited Dr. Polis’s
Commentary and explained that independent peer review had confirmed that Valley’s study had
“fundamental flaws” that produced “unreliable” conclusions.
Dr. Polis’s Subsequent Publications
46. On June 9, 2019, Dr. Polis published a post on her personal blog describing her
experiences and commenting on Valley’s behavior and marketing leading up to and following
the Retraction (the “June 2019 Blog Post”). She wrote that “Valley Electronics…has a long
history of ignoring FDA rules. They received two FDA warning letters in 2010…for marketing
their products as contraception without approval. They received another FDA warning letter in
2013 for the multiple concerns.” Dr. Polis provided hyperlinks to the FDA warning letters in the
text of the June 2019 Blog Post. Dr. Polis expressed being “glad to have helped to remove junk
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