PA AG V Leda Health Corp Complaint
PA AG V Leda Health Corp Complaint
PA AG V Leda Health Corp Complaint
PENNSYLVANIA
NOTICE
You have been sued in court. If you wish to defend against the claims set forth in the
following pages, you must take action within twenty (20) days after this complaint and notice
are served, by entering a written appearance personally or by attorney and filing in writing with
the court your defenses or objections to the claims set forth against you. You are warned that if
you fail to do so the case may proceed without you, and a judgment may be entered against you
without further notice for any money claimed in the complaint or for any other claim or relief
requested by the plaintiff. You may lose money or property or other rights important to you.
BELOW. THIS OFFICE CAN PROVIDE YOU WITH INFORMATION ABOUT HIRING
A LAWYER.
FEE.
Ester Blair
Deputy Attorney General
PA Attorney I.D. No. 83151
Office of Attorney General
Public Protection Division
Health Care Section
14th Floor, Strawberry Square
Harrisburg, PA 17120
Telephone: (215) 965-1033
Email:[email protected]
2
THIS IS NOT AN ARBITRATION CASE
This case has been brought by the Commonwealth
under the Pennsylvania Unfair Trade Practices
and Consumer Protection Law, 73 P.S. §§ 201-1, et seq.
AN ASSESSMENT OF DAMAGES HEARING IS REQUIRED
______________________________________________________________________________
IN THE COURT OF COMMON PLEAS FOR ALLEGHENY COUNTY,
PENNSYLVANIA
COMPLAINT
AND NOW, comes the Commonwealth of Pennsylvania, acting through its Attorney
this action pursuant to the Unfair Trade Practices and Consumer Protection Law, 73 Pa. C.S.A. §
201-1, et seq. (hereinafter “Consumer Protection Law”), to restrain unfair or deceptive acts or
practices in the conduct of any trade or commerce declared unlawful by Section 201-3 of the
Consumer Protection Law, and to recover civil penalties and costs of this action.
The Consumer Protection Law authorizes the Attorney General to bring an action in the
1
unfair or deceptive acts or practices in the conduct of any trade or commerce declared unlawful
The Commonwealth has reason to believe that Defendant Leda Health Corporation and
Individual Defendant Madison Campbell are using, have used or are about to use, methods, acts
or practices declared unlawful by Section 201-3 of the Consumer Protection Law and that
citizens of the Commonwealth are suffering and will continue to suffer harm unless the acts and
practices complained of herein are enjoined. The Commonwealth believes that the public
interest is served by seeking before this Honorable Court a permanent injunction to restrain the
methods, acts and practices of the Defendants as herein set forth. Further, the Commonwealth
requests injunctive relief, civil penalties, costs and other appropriate equitable relief as redress
JURISDICTION
1. The Court has original jurisdiction over this action pursuant to Section 931(a) of the
VENUE
2. Venue lies with this court pursuant to Pa. R.C.P. 1006(a)(1). Venue is also proper
pursuant to Pa. R.C.P. 2179 because the registered office of Defendant Leda Health is
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THE PARTIES
Attorney General Michelle Henry, with offices located at Strawberry Square, 14th Floor,
4. Defendant Leda Health Corporation (“Leda Health”) was incorporated in the State of
Delaware on April 22, 2019 as a for-profit business corporation and has a registered
15201.
individual and the Chief Executive Officer (“CEO”) of Leda Health with a last known
residential address at 247 St. Clair Street, Bridgeville, Allegheny County, Pennsylvania,
15017.
6. Defendant Leda Health was formerly known as “Me Too Kits” and through its website,
organizations, legislators and universities for eventual use by individual members of the
organizations.
7. At all relevant times, Defendant Leda Health was engaged in trade and commerce in the
3
BACKGROUND
9. Defendants Leda Health, and its CEO, Individual Defendant Madison Campbell represent
that they provide services to survivors of sexual assault who are, “unable or unwilling” to
make it to a hospital to receive care and allow evidence to be collected to support the
10. Leda Health’s primary product is a DNA collection kit, the “Early Evidence Kit,” which
it markets as a self-administered test for sexual assault survivors. The Early Evidence Kit
administration, access to a mobile app and access to a remote care team. Leda Health
Corporation also advertises that it offers access to some Sexual Transmitted Infection
(“STI”) testing.
FACTS
11. Leda Health Corporation presents its products and services as an alternative to hospital-
collected sexual assault evidence and emergency services for survivors. However, Leda
Health’s products and services are not equivalent to the full range of services hospitals
must provide free of charge to survivors of sexual assault. Leda Health does not make
clear in its marketing and advertising that its products and services are not equivalent to
services standards.
1
https://www.leda.co/. Exhibit A. The Leda Health splash page has subpages at
https://www.leda.co/partner, https://www.leda.co/blog, https://www.leda.co/log-in, which are
included in Exhibit A. Additional subpages are explored in more depth later in the Complaint.
4
12. On the website, www.leda.co, Leda Health Corporation advertises that its mission is to
change “the landscape of sexual assault prevention, care and healing.” 2 It markets
products for, “self-administered DNA collection, and sexual health testing to meet the
collection is performed using Leda Health’s product, the “Early Evidence Kit” which is
featured in a video on its website, 4 (Exhibit B) and also advertised in a video on the Leda
13. Leda Health represents in its website video that the Early Evidence Kit is for survivors,
“who never make it to a hospital or care center,” and that it, “helps survivors identify
where DNA may be present and collect time sensitive samples for storage or testing.” 6
See, Exhibit B.
14. The Leda Health You Tube channel Early Evidence Kit video shows the contents of the
kit, which consists of a box containing an instruction manual, an intake form, a resource
card, tamper-evident tape, boxes of swabs for collecting DNA from the survivor, and
DNA relating to the assault, a garment bag, a storage bag and a bag with a pre-paid
shipping label. The video states that survivors can also connect to the Leda Health
mobile app, which allows the user to time stamp the collection process, capture photos
and videos, and chat live with care team members, who are trained in virtual forensics
collection, and available to testify in court on behalf of users. The video also states that
2
https://www.leda.co. Exhibit A.
3
Id.
4
https://www.leda.co, “Early Evidence Kit” video. Exhibit B.
5
Leda Health channel, You Tube, https://www.youtube.com/channel/UC-
BAgE38wU_ZfjHJlePRSnA. Exhibit C.
6
https://www.leda.co, “Early Evidence Kit” video. Exhibit B.
5
Leda Health provides access to emergency contraception and sexually transmitted
15. Leda Health’s website includes a disclaimer which states, “[t]he information and
materials on this website are intended to promote . . . general understanding and dialogue
on sexual health and sexual assault. This information is not a substitute for professional
medical or legal advice, diagnosis, treatment or counseling. Always seek the advice of
your physician or other qualified health provider with questions you may have regarding
a medical condition. If you have a medical emergency, contact your physician or call 911
immediately.” It further states that, “Leda is not a medical care provider and does not
report any assault to law enforcement and to visit their nearest hospitals for medical
16. The Leda Health website contains information about the laboratory used for testing its
Emergency Evidence Kits. This information represents that, “Leda Health’s Early
Evidence Kits are tested at our partner lab, which is ISO/IEC 17025 accredited.” 9 See,
website that the ISO/IEC accreditation is a basic standard required of all laboratories to
7
“Unboxing Leda’s Early Evidence Kit,” Leda Health Channel, You Tube,
https://www.youtube.com/channel/UC-BAgE38wU_ZfjHJlePRSnA. Exhibit C.
8
https://www.leda.co/. Exhibit A.
9
https://www.leda.co/lab. Exhibit D.
10
See, https://www.iso.org/ISO-IEC-17025-testing-and-calibration-laboratories.html.
Exhibit E.
6
17. Leda Health also states on its website, “Our partner lab has experience testing sexual
assault kits submitted by law enforcement, having results admitted in court, and testifying
in court.” The website also contains the information that, “[b]ecause Leda Health is a
private company, we do not have access to the federal Combined DNA Index System
(CODIS) database, which contains DNA profiles of convicted offenders and arrestees of
certain crimes and may be used by law enforcement authorities to help identify assailants
18. The Leda Health website contains a disclaimer that, “Leda cannot guarantee that
information collected using our kit will be admissible in a court of law and is not an
attorney able to provide survivors with legal advice.” 12 The website also contains the
disclaimer that, “Leda Health is not a medical service, and the information we provide is
not a substitute for medical advice, diagnosis, treatment or counseling.” 13 See, Exhibit G.
19. Leda Health further disclaims that it, “cannot guarantee that any information collected
through our Early Evidence Collection Kit will be offered, admitted, or relied upon in a
court of law. The ultimate admissibility and reliability of information that you collect
through Leda Health’s services will be dependent on the specific circumstances of your
11
https://www.leda.co/about, click on “learn more” link at the bottom of the webpage.
Exhibit F.
12
Id.
13
https://www.leda.co/agreements. Exhibit G.
14
Id.
7
20. Leda Health also represents on its website that, “to obtain the full benefits of our service,
you must carefully read and follow all related instructions. Do not tamper with or
improperly alter or use any of the materials included with our services.” 15 See, Exhibit G.
21. The Commonwealth seeks to promote the health and safety of victims of sexual assault
hospital-based services free of charge for the care and support of survivors while also
collecting evidence through a careful and rigorous process that will allow it to be used in
22. The Commonwealth has a strong interest in ensuring survivors of sexual assault receive
23. Sexual assaults often involve some form of intimidation, which can be physical as well as
treatment to the victim for all trauma incurred by the assault, both physical and
anxiety, and PTSD. A sexual assault can also result in sexual infection transmission or
15
Id.
16
35 P.S. § 10172.3.
17
Rape, Abuse and Incest National Network (“RAINN”), “Effects of Sexual Violence”
RAINN.org, https://www.rainn.org/effects-sexual-violence (last viewed June 13, 2024). Exhibit
H.
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24. In addition to ensuring that survivors of sexual violence receive care, another key
response is to prosecute the perpetrators in order to seek justice for the survivors and to
25. To provide the best possible opportunity for conviction, it is important to collect all
evidence of the assault, not only the possible DNA left behind by the assault, but also
evidence of the methods and means used to accomplish the assault. Therefore,
Pennsylvania’s Sexual Assault Testing and Collection Act provides sexual assault
survivors with the right to have comprehensive collection of crime evidence free of
charge. 19
26. The Sexual Assault Testing and Collection Act further requires that all commercially
available rape kits for use in this Commonwealth be tested and approved by the
27. As noted in the legislative history of Pennsylvania’s Sexual Assault Testing and Evidence
Collection Act, “A thorough and accurate forensic examination has proven to be the
28. None of the above key responses can be accomplished with Leda Health’s Early
18
35 P.S. § 10172.3.
19
35 P.S. § 10172.5.
20
35 P.S. §10172.3(a)(2).
21
Bridget Kosierowski, Representative, Pennsylvania House of Representatives,
Memorandum, “Ensuring Comprehensive, Compassionate Care for Sexual Assault Survivors,”
January 23, 2023.
https://www.legis.state.pa.us/cfdocs/Legis/CSM/showMemoPublic.cfm?chamber=H&SPick=202
30&cosponId=39439 (last viewed June 13, 2024). Exhibit I.
9
29. In Pennsylvania, in accordance with the Sexual Assault Emergency Services Act, a
survivor of a sexual assault who presents at any hospital providing emergency sexual
health, safety and welfare of the victim, or which may be used as evidence in a
Hospitals are required to utilize a rape kit that complies with the minimum
e. Oral and written instructions advising of the need for additional blood tests at
time periods after the sexual assault as medically indicated to determine the
and the telephone number of a local rape crisis center or sexual assault counselor.
10
The hospital shall promptly contact the local rape crisis center or sexual assault
g. The opportunity to consult with the rape crisis center or sexual assault counselor
h. Emergency contraception. 22
30. The Pennsylvania Sexual Assault Testing and Evidence Collection Act, 35 P. S. §§
10172.1-10172.6, provides that victims of sexual assault have the right to have crime
evidence collected at no cost. Under 28 P.S.§ 117.52(a)(1), hospitals and health care
facilities must utilize a sexual assault evidence collection or rape kit that complies with
31. The Pennsylvania Bulletin of October 28, 2023, 53 Pennsylvania Bulletin 6784, provides
that Sexual Assault Evidence Collection Kits contain the following required components:
Step 1: Consent for Collection and Release of Evidence and Information Form
Step 2: Clothing and Underpants Collection
Step 3: Oral Assault Collection Samples
Step 4: Miscellaneous Collection (Debris, Dried Secretions, Tampon/Sanitary Napkin)
Step 5: Fingernail Swabbings
Step 6: External Genitalia Collection Sample
Step 7: Vaginal Contact/Penetration Collection Samples
Step 8: Perianal/Anal Contact/Penetration Collection Samples
Step 9: Reference Sample Buccal Swab Collection (for DNA analysis)
Step 10: Transfer of Evidence/Chain of Custody Form 23 See, Exhibit J.
32. The Pennsylvania Department of Health has established detailed instructions for the
instructions contain a warning that, “Failure to thoroughly and accurately complete all
22
28 P.S. § 117.52.
23
53 PA Bulletin 6784 (October 28, 2023). (Exhibit J)
https://www.pacodeandbulletin.gov/Display/pabull?file=/secure/pabulletin/data/vol53/53-
43/1481.html
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information requested may jeopardize the successful investigation and prosecution of a
33. Local law enforcement agencies are required to take possession of sexual assault
evidence obtained by a health care facility within 72 hours of being notified of its
existence. When a victim has provided written notice of consent to the forensic testing,
the law enforcement agency must submit evidence awaiting testing to an approved
laboratory within 15 days. When a victim has not provided consent for testing, the
evidence must be preserved and stored for a period of no less than the duration of the
that period. This policy applies whether the victim is anonymous or identified and
34. Under the Pennsylvania’s Sexual Assault Testing and Evidence Collection Act, the
Pennsylvania Department of Health shall, “test and approve commercially available rape
kits for use in [the] Commonwealth.” 26 The Department of Health also approves, with
Pennsylvania State Police, “certain laboratories to receive sexual assault evidence for
testing and analysis.” The statute provides that, “[l]aboratories which have been
24
Pennsylvania Department of Health, “Commonwealth of Pennsylvania Sexual Assault
Evidence Collection Kit Instructions”
https://www.health.pa.gov/topics/Documents/Programs/Violence%20and%20Injury%20Preventi
on/Sexual%20Assault%20Evidence%20Collection%20Kit%20Instructions.pdf. (Exhibit K).
25
35 P.S. § 10172.3(c).
26
35 P.S. § 10172.3(a)(2)
12
federally administered national DNA database shall be automatically approved to receive
35. The Leda Health Early Evidence Kits do not meet the requirements of the Pennsylvania
Sexual Assault Testing and Evidence Collection Act. The Early Evidence Kits are not
approved by the Department of Health, they are not provided free of charge, they do not
contain all the steps required by 53 PA Bulletin 6784, resulting in a much more limited
collection of evidence of assault, and they do not ensure chain of custody. The laboratory
used by Leda Health is not approved to access CODIS, and therefore could not match any
DNA tested to the DNA evidence contained in CODIS to identify a perpetrator of the
assault.
36. Leda Health promotes its Early Evidence Kit and related services as an alternative to the
statutorily required hospital services for sexual assault survivors. However, its Early
Evidence Kits do not meet minimum standards required by the Pennsylvania’s Sexual
and have not been tested and approved by the Pennsylvania Department of Health. The
services marketed by Leda Health Corporation also do not meet minimum standards for
37. Moreover, the evidence collected via the Early Evidence Kit has never been admitted in
38. Because the collection of evidence by hospitals in compliance with the Pennsylvania
statutes described above must occur within a narrow window shortly after the
27
35 P.S. § 10172.3(a)(5).
13
marketing and disclaimers in the use of its products and services could lose the ability to
have their cases prosecuted with the kinds of evidence hospitals collect including DNA
evidence. Moreover, assault victims potentially lose the gateway to other important care
39. Leda Health, and its predecessor company Me Too Kits, have received warnings and
cease and desist letters from several states, 28 yet Leda Health continues to advertise,
market and offer its products for sale or use. See, Exhibit L. The use of Leda Health’s
self-administered sexual assault kits has been banned in the states of Maryland and
28
See, Cease-and-desist letter from Dana Nessel, Attorney General of Michigan to Me Too
Kits, August 29, 2019. https://www.michigan.gov/ag/-
/media/Project/Websites/AG/releases/2019/August/Notice_of_Intended_Action_to_MeToo_Kits
_Company_08-29-
19_664596_7.pdf?rev=467467d7282c44a68b5ba316172bec91&hash=67B8E5F1F6939D939350
CF213B6B3059; Announcement, Josh Stein, Attorney General of North Carolina, September 4,
2019. https://ncdoj.gov/attorney-general-josh-stein-me-too-at-home-sexual-assault-kits-are-
dangerous-and-misleading/ ; Warning, Mark Herring, Attorney General of Virginia, September
10, 2019, https://www.wavy.com/news/virginia/ag-herring-issues-warning-against-do-it-
yourself-sexual-assault-kits/. Cease-and-desist Letter, Letitia James, Attorney General of New
York to Me Too Kits, September 11, 2019. https://ag.ny.gov/sites/default/files/metoo_kits_-
_cease_and_desist_letter_2019_09_11.pdf; Statement, Kathy Jennings, Attorney General of
Delaware,; September 11, 2019. https://news.delaware.gov/2019/09/11/ag-jennings-warns-of-
misleading-at-home-sexual-assault-kits/; News Release, Clare Connors, Attorney General of
Hawaii, September 12, 2019. https://ag.hawaii.gov/wp-content/uploads/2019/09/News-Release-
2019-57.pdf; News Release, Ashley Moody, Attorney General of Florida, September 19, 2019.
https://www.myfloridalegal.com/newsrelease/ag-moody-fdle-and-victim-advocates-warn-home-
sexual-assault-kits; Letter to Me Too Kits, William Tong, Attorney General of Connecticut,
September 20, 2019. https://portal.ct.gov/-/media/ag/press_releases/2019/ltr-to-mcampbell---
metoo-kits-company.pdf. Exhibit L.
29
Shannon Lilly, “Maryland Bans Controversial At-home Rape Kits, Plans to Ramp up
Resources for Survivors,” Fox 45 News (May 8, 2024).
https://foxbaltimore.com/news/local/maryland-bans-controversial-at-home-rape-kits-ramps-up-
resources-for-survivors#; Eastside Legal Assistance Program, “Why Over-the-Counter Sexual
Assault Testing Kits are Now Banned” ELAP News (October 3, 2023). https://elap.org/why-
over-the-counter-sexual-assault-testing-kits-are-now-banned/. Exhibit M. See also, RCW
5.70.070; Md. Code, Crim. Pro. § 11-926(a)
14
40. On May 24, 2024, the Commonwealth issued a Cease and Desist letter to Leda Health,
requesting that Leda Health cease all advertising, marketing, and sales of its products in
the Commonwealth of Pennsylvania within seven (7) days. See, Exhibit N. Leda Health
confirmed its receipt of the Cease and Desist letter on June 4, 2024 and provided a
response on June 11, 2024. See, Exhibit O. In its response, Leda Health did not agree to
comply with Pennsylvania’s request and continues to promote its Early Evidence Kits
41. Leda Health does not make clear to consumers in its representations and disclaimers on
its website that the Early Evidence Kit does not meet Pennsylvania Sexual Assault
Evidence Kit requirements or that it has not been approved by the Pennsylvania
42. Leda Health markets, advertises and offers for sale or use, Early Evidence Kits which
43. Leda Health’s website disclaimer that it, “cannot guarantee that information collected
through [its] Early Evidence Collection Kit will be offered, admitted or relied upon in a
court of law,” 31 (Exhibit G) does not inform consumers that the Early Evidence Kits do
not meet the minimum standards for sexual assault evidence collection in Pennsylvania,
or that they have not been approved as rape kits by the Pennsylvania Department of
Health.
30
Paul Van Osdol, “At Home Rape Kits Sold by Pittsburgh Company Sparking
Controversy, wtae.com (February 12, 2024). https://krdo.com/news/2024/02/12/at-home-rape-
kits-sold-by-pittsburgh-company-sparking-controversy/. Exhibit P.
31
www.leda.co/agreements. Exhibit G.
15
44. The laboratory utilized by Leda Health does not have access to CODIS, and therefore is
not among the laboratories automatically approved to receive sexual assault evidence kits
in Pennsylvania.
45. Leda Health calls its product an “Evidence Kit.” The use of the term “evidence” suggests
defines evidence as, “[s]omething that furnishes truth. Specifically, something legally
46. Information collected using Leda Health’s Early Evidence Kit has not been admitted as
47. The disclaimer that Leda Health does not “guarantee” admissibility does not inform
consumers that the Early Evidence Kits have never been admitted by a court as evidence
48. Leda Health’s product also does not meet the minimum Pennsylvania standards for
49. Through its website Leda Health markets and sells DNA testing using its self-
administered Early Evidence Kits, access to Plan B emergency contraception, and STI
testing, along with a chat feature and local resource recommendations. 34 See, Exhibit A.
50. Leda Health’s website does not make clear how the company would ensure timely
32
Merriam Webster defines “evidence” as
33
“Evidence.”Merriam-Webster.com. 2024. https://www.merriam-
webster.com/dictionary/evidence (last viewed June 18, 2024).
34
www.ledahealth.co. Exhibit A.
16
however, it is recommended to take Plan B as soon as possible, as the efficacy of the
51. Leda Health’s marketing materials do not provide an explanation of how Plan B would be
delivered to consumers within the timeframe of providing effective treatment. This does
not meet the minimum Pennsylvania emergency treatment standard for survivors of
52. Leda Health advertises, markets and sells STI testing on its website, but it does not offer
treatment for STIs. It is not clear if this testing is included with the initial DNA swabbing
test in the Early Evidence Kit, or if it must be purchased separately. It also is not clear
which STIs Leda Health offers testing for, if those STIs include HIV, and how it would
provide treatment to survivors who do test positive or at risk for developing an STI.
53. Offering STI testing without access to treatment does not meet the standard of emergency
54. Failure to provide treatment in connection with testing also undermines an important
public health opportunity to prevent and/or treat STIs, including HIV, in sexual assault
victims.
55. Leda Health also does not offer any physical or mental health treatment for sexual assault
survivors. The company offers a, “team of trauma informed specialists,” to help with
questions about the kit or to connect survivors with local services. 38 This does not meet
the Pennsylvania minimum standard of providing sexual assault survivors with a medical
35
www.planbonestep.com. Exhibit Q.
36
28 P.S. § 117.52(a)(9).
37
28 P.S. § 117.52(a)(4)-(7).
38
www.ledahealth.co. Exhibit A.
17
examination and laboratory or diagnostic tests required to ensure the health, safety and
welfare of the victim. 39 It also does not provide survivors with the opportunity to consult
with the rape crisis center or sexual assault counselor in person and in private while at the
hospital. 40
56. Leda Health fails to disclose that the Early Evidence Kits and other Leda Health services
are not equivalent to the requirements under Pennsylvania’s standards for sexual assault
emergency services. Leda Health’s services do not include many of the services that
medical examinations and laboratory or diagnostic tests required to ensure the health,
safety and welfare of the victim; medication, as deemed appropriate by the attending
physician, including HIV and sexually transmitted disease prophylaxis; and the
opportunity for the victim to consult with the rape crisis center or sexual assault
57. Leda Health presents its Early Evidence Kit and services as sexual assault evidence
collection, testing, and treatment services for survivors who are unable or do not want to
go to a hospital, without disclosing that the Early Evidence Kits do not meet the
Pennsylvania sexual assault evidence collection standards and have not been found
admissible by a court, or that the services provided do not meet Pennsylvania sexual
58. Survivors relying on Leda Health’s Early Evidence Kit and services may be deprived of
mandated access to hospital treatment and services necessary for their mental and
39
28 P.S. § 117.52(a)(2).
40
28 P.S. § 117.52(a)(8).
41
28 P.S. §117.52(a)(1)-(9).
18
physical wellbeing, as well as the ability to collect evidence in accordance with
59. Pennsylvania Coalition to Advance Respect (“PCAR”) was established in 1975 and
works to end sexual violence and advocate for survivors, partnering with rape crisis
centers that serve all 67 counties in the Commonwealth. 42 See, Exhibit R. PCAR was
Pennsylvania Department of Health, and the Pennsylvania State Police, to establish and
maintain minimum standards for sexual assault evidence collection. 43 See, Exhibit S.
60. PCAR does not support the use of at-home rape kits, noting that it is important for
where they will have access to specially trained providers who will, “conduct a forensic
exam at no cost to the survivor, collect evidence, and screen for and treat sexually
transmitted infections and other possible injuries.” Survivors also are connected to rape
crisis counselors and can receive treatment for pregnancy prevention, as well as mental
and physical health issues related to the assault. PCAR states that it is highly unlikely that
an, “at-home kit collection would align with Pennsylvania’s legal requirements. This
would jeopardize the victim’s ability to see the evidence used in criminal proceedings to
42
https://pcar.org/about-us/about-pcar. Exhibit R.
43
See, 73 P.S. 101723(a)(1). See also, Pennsylvania Department of Health, “Sexual Assault
Evidence Collection,” https://www.health.pa.gov/topics/programs/violence-
prevention/Pages/Sexual-Assault-Evidence-Collection.aspx, included as Exhibit S.
44
Press Release, Pennsylvania Coalition to Advance Respect. “At-home Rape Kits Leave
Victims Without Services and Pathways to Justice.” https://pcar.org/news/home-rape-kits-leave-
victims-without-services-and-pathways-justice-0. Exhibit R.
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ACTIVITIES IN PENNSYLVANIA
61. Leda Health conducts advertising, marketing and sales activities via the Leda Health
website, which offers Leda Health products and services to partner organizations,
62. Leda Health has engaged in additional activities beyond the Leda Health website to
63. In October 2023, Leda Health entered into a partnership with Delta Gamma Fraternity,
which is a national Greek Life organization for women with 150 collegiate chapters,
Exhibit T. This partnership provides access for members of Delta Gamma to the Leda
Health portal, where they can connect with educational content and support for sexual
assault survivors, texting services and a care team. It also provides access to Bloom, an
64. The partnership with Leda Health provides members of Delta Gamma with access to
physical resources which include, “home toxicology testing kits, STI/STD/HIV testing
kits, Plan B One-Step and a 24/7 Clinical Care Team comprised of Licensed and
Certified Forensic Nurses and Clinicians with over 35 years of experience.” The physical
45
https://www.deltagamma.org/our-membership/.There are Delta Gamma chapters at
Pennsylvania State University, Gettysburg College, Bucknell University, Washington and
Jefferson College, Indiana University of Pennsylvania, Lafayette College, Villanova University
and Drexel University. https://www.deltagamma.org/library/handbookguidemanual/collegiate-
chapters-list/. Exhibit T.
46
Id.
20
resources require additional payment by users, and are not covered by the partnership
65. In 2023, Leda Health entered into a partnership with Syracuse University through the Air
Force Work Project (“AFWERX”), a Technology Directorate of the Air Force Research
Laboratory (“AFRL”), the Forensic and National Security Sciences to create self-
administered early evidence sexual assault kits for military service members in the
66. In January 2024, Leda Health reported on its Linked In website that it had partnered with
Curry College as part of its AFWERX award and was interested in partnering with the
911th Airlift Wing based in Pittsburgh, Pennsylvania for use of its kits. 49 See, Exhibit U.
LEGAL FRAMEWORK
67. The Consumer Protection Law prohibits any “person” from engaging in, “unfair or
68. The Attorney General is empowered under the Consumer Protection Law to bring an
practice, whenever there is, “reason to believe that any person is using or is about to use
47
https://www.deltagamma.org/wp-content/uploads/2023/10/Leda-Health-Partnership-
Services-10.2023.pdf. Exhibit T.
48
News, Forensic: On the Scene and in the Lab (August 9,
2023).https://www.forensicmag.com/599174-University-Partners-with-Leda-Health-to-Explore-
Feasibility-of-Early-Evidence-Sexual-Assault-Kits/. Exhibit P.
49
Leda Health, “Pittsburgh’s Leda Health Partners with AFWERX to Create a Holistic
Approach to Sexual Violence Prevention.” Linked In.
https://www.linkedin.com/posts/ledahealth_new-pittsburghs-leda-health-partners-with-activity-
7148707280614547456-s7nD. Exhibit U.
50
73 P.S. §201-3.
21
any method, act or practice” that violates the Consumer Protection Law and the
69. The Attorney General may bring an action to protect individuals or organizations from
70. Acts or practices are unfair or deceptive if they are capable of being interpreted in a
53
misleading way.
71. “Person” is defined twice in the Consumer Protection Law, both as, “natural persons,
other legal entities”, 54 and as, “an individual, corporation, trust, estate, partnership,
Law.
72. “Trade” and “commerce” are defined in the Consumer Protection Law as, “the
advertising, offering for sale, sale or distribution of any services and any property,
tangible or intangible, real, personal or mixed, and any other article, commodity, or thing
of value wherever situate, and includes any trade or commerce directly or indirectly
51
73 P.S. §201-4.
52
See, FTC v. American Future Systems, No. 2-20-cv-02266 JHS (E.D. Pa. April 30, 2021),
in ruling against the Defendant’s Motion to Dismiss, the Court stated that, “the General
Assembly intended to empower the Attorney General to bring a public action to protect both
individuals and businesses.”
53
Commonwealth v. Peoples Benefit Services, Inc., 923 A.2d 1230, 1236 (Pa. Commw.
2007) (citing Commonwealth v. Nickel, 26 Pa. D. & C.3d 115, 120 (1983).
54
73 P.S. § 201-2(2).
55
73 P.S. §201-2(11).
56
73 P.S. §201-2.
22
73. The Attorney General may bring an action to protect consumers under the Consumer
Protection Law even when a private citizen has not purchased a good or service. 57
74. The unfair or deceptive acts or practices prohibited by the Consumer Protection Law
COUNT I
57
Anadarko Petroleum Co. v. Commonwealth, 206 A.3d 51 (2019). Pennsylvania courts
also have noted that the Consumer Protection Law should be construed broadly to protect
consumers from unfair or deceptive business practices. See, e.g., Commonwealth v. Golden Gate
National Senior Care, LLC, 648 Pa. 604, 643, 194 A. 3d 1010, 1034 (2018).
58
73 P.S. § 201-2(4)(ii).
59
73 P.S. § 201-2(4)(iii).
60
73 P.S. § 201-2(4)(v).
61
73 P.S. § 201-2(4)(xxi).
23
75. The Commonwealth incorporates by reference the allegations contained in the preceding
76. Leda Health willfully made representations and omissions to Pennsylvanians regarding
the sufficiency and admissibility of its Early Evidence Kits as sexual assault evidence
collection and testing kits and the adequacy of its emergency services for sexual assault
survivors.
77. These representations and omissions failed to inform Pennsylvanians that its Early
Evidence Kits and services did not meet Pennsylvania standards for sexual assault
evidence collection and testing kits or Pennsylvania sexual assault emergency services.
78. These representations and omissions had the capacity to mislead or deceive
Pennsylvanians.
79. These deceptive, misleading, and unfair representations were made in Leda Health’s
marketing materials on its website, www.leda.co, and on its You Tube channel.
80. Leda Health misleads Pennsylvanians by marketing and offering for sale or use “Early
Evidence Kits” which do not meet the Pennsylvania Sexual Assault Evidence Kit
minimum requirements.
81. A survivor using an Early Evidence Kit sold by Leda Health would receive a less
82. The Leda Health Early Evidence Kits do not contain all elements of the kit mandated by
the Commonwealth, have not been tested and approved by the Pennsylvania Department
of Health, do not establish chain of custody and are not required to be taken into law
24
83. Leda Health does not make clear to consumers that the Early Evidence Kit does not meet
Pennsylvania Sexual Assault Evidence Kit requirements or that it has not been approved
84. These misleading, deceptive and unfair acts or omissions by Leda Health violate the
85. The above described conduct has been willful and is unlawful under Section 201-3 of the
86. The Commonwealth believes that the citizens of the Commonwealth will suffer harm
unless the acts and practices complained of herein are permanently enjoined.
87. WHEREFORE, the Commonwealth respectfully requests that this Honorable Court issue
an Order:
25
b. Directing Corporate Defendant and Individual Defendant Campbell to comply with
Section 201-8(b) of the Consumer Protection Law, to pay civil penalties in the
amount of one thousand dollars ($1,000.00) for each and every violation of the
Consumer Protection Law the number of violations to be proven at trial, and three
thousand dollars ($3,000.00) for each such violation involving a victim aged sixty
(60) or over;
from engaging in conduct that violates the Consumer Protection Law as detailed in
this Complaint;
e. Awarding the Commonwealth the cost of investigation, attorneys’ fee, filing fees
f. Granting such other relief as the Court deems necessary and appropriate.
COUNT II
88. The Commonwealth incorporates by reference the allegations contained in the preceding
89. Leda Health misleads Pennsylvanians by marketing and offering for sale, “Early
Evidence Kits” which have not been found admissible by Pennsylvania courts, and do not
meet Pennsylvania sexual assault evidence collection and testing kit requirements.
26
90. Leda Health’s disclaimer that it, “cannot guarantee that information collected through
[its] Early Evidence Collection Kit will be offered, admitted or relied upon in a court of
law,” 62 (Exhibit H) does not inform consumers that the Early Evidence Kits do not meet
the minimum standards for sexual assault evidence collection in Pennsylvania, or that
they have not been approved as sexual assault evidence kits by the Pennsylvania
Department of Health, and are unlikely to be found admissible by any court. The
laboratory utilized by Leda Health does not have access to CODIS, and therefore is not
among the laboratories automatically approved to receive sexual assault evidence kits in
Pennsylvania.
91. In using the term, “Evidence Kit” Leda Health is creating a likelihood of
misunderstanding that the DNA collection kit meets minimum standards and may be
admissible as evidence in a court. The disclaimer that Leda Health does not “guarantee”
admissibility does not sufficiently inform consumers that the Early Evidence Kits have
92. These misleading, deceptive and unfair acts or omissions by Leda Health violate the
62
www.leda.co/about (Exhibit H)
27
d. 73 P.S. § 201-2(4)(xxi), which prohibits engaging in any other fraudulent or
deceptive conduct which creates a likelihood of confusion or of
misunderstanding.
93. The above described conduct has been willful and is unlawful under Section 201-3 of the
94. The Commonwealth believes that the citizens of the Commonwealth will suffer harm
unless the acts and practices complained of herein are permanently enjoined.
95. WHEREFORE, the Commonwealth respectfully requests that this Honorable Court issue
an Order:
Section 201-8(b) of the Consumer Protection Law, to pay civil penalties in the
amount of one thousand dollars ($1,000.00) for each and every violation of the
Consumer Protection Law the number of violations to be proven at trial, and three
thousand dollars ($3,000.00) for each such violation involving a victim aged sixty
(60) or over.
from engaging in conduct that violates the Consumer Protection Law as detailed in
this Complaint.
e. Awarding the Commonwealth the cost of investigation, attorneys’ fee, filing fees
COUNT III
96. The Commonwealth incorporates by reference the allegations contained in the preceding
97. Leda Health misleads Pennsylvanians by failing to disclose that the Early Evidence Kits
and other Leda Health services do not meet standards under Pennsylvania’s standards for
98. Leda Health’s services do not include many of the services that must be provided to
and laboratory or diagnostic tests required to ensure the health, safety and welfare of the
victim; medication, as deemed appropriate by the attending physician, including HIV and
sexually transmitted disease prophylaxis; and the opportunity for the victim to consult
with the rape crisis center or sexual assault counselor in person and in private at the
hospital.
99. Leda Health’s services do not meet the requirements of the Pennsylvania sexual assault
emergency services statute as they are not offered free of charge and do not provide the
100. Leda Health does not make clear in its marketing materials that its services do not
meet Pennsylvania standards for sexual assault survivor emergency services. This
29
comprehensive services available at a hospital, believing that Leda Health is providing
equivalent services.
services for survivors who are unable or do not want to go to a hospital, without
disclosing that the services offered by Leda Health do not meet Pennsylvania sexual
assault emergency standards and that they have not been found admissible by any court.
102. These misleading, deceptive and unfair acts or omissions by Leda Health violate
103. The above described conduct has been willful and is unlawful under Section 201-
104. The Commonwealth believes that the citizens of the Commonwealth will suffer
harm unless the acts and practices complained of herein are permanently enjoined.
105. WHEREFORE, the Commonwealth respectfully requests that this Honorable Court
issue an Order:
30
a. Declaring the conduct of Corporate Defendant and Individual Defendant Campbell,
Section 201-8(b) of the Consumer Protection Law, to pay civil penalties in the
amount of one thousand dollars ($1,000.00) for each and every violation of the
Consumer Protection Law, the number of violations to be proven at trial, and three
thousand dollars ($3,000.00) for each such violation involving a victim aged sixty
(60) or over.
from engaging in conduct that violates the Consumer Protection Law as detailed in
this Complaint.
e. Awarding the Commonwealth the cost of investigation, attorneys’ fee, filing fees
f. Granting such other relief as the Court deems necessary and appropriate.
Respectfully Submitted,
COMMONWEALTH OF PENNSYLVANIA
Michelle Henry
Attorney General
31
(Phone: 717-705-2467)
Chief Deputy Attorney General
Health Care Section
Attorneys for Plaintiff
Commonwealth of Pennsylvania
Office of Attorney General
Public Protection Division
Health Care Section
14th Floor, Strawberry Square
Harrisburg, PA 17120
32
IN THE COURT OF COMMON PLEAS FOR ALLEGHENY COUNTY,
PENNSYLVANIA
CERTIFICATION
I certify that this filing complies with the provisions of the Public Access Policy of the United
Judicial System of Pennsylvania: Case Records of the Appellate and Trial Courts that require
filing confidential information and documents differently than non-confidential information and
documents.