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Date: 10-21-2024
Case Style:
Leda Health Corporation v. Jay Robert Inslee
Case Number: 2:24-cv-871
Judge: David G. Estudillo
Court: United States District Court for the Western District of Washington (King County)
Plaintiff's Attorney:
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Defendant's Attorney: Tera M. Heintz
Description:
Seattle, Washington civil litigation lawyer sought a preliminary injunction against the Defendant.
Leda Health is a company known for developing Early Evidence Kits (“EEKs”)- products that allegedly enable sexual assault survivors to “self-collect and store evidence such as DNA” if they are unable or unwilling to seek a traditional forensic medical examination. (Dkt. No. 11 at 4.) Each EEK is branded with a unique barcode and contains an instruction manual on DNA self-collection, diagnostic swabs, sterile water for swabbing dry areas, a prepaid FedEx bag for shipping to an accredited partner lab, tamper-evident tape, plastic bags for storing clothing or other relevant items, and an intake form for documenting the assault and chain of custody. (Id. at 6.) Leda sells its EEKs to companies or other entities with which it partners-including sorority chapters on college campuses. (Id. at 5.) In 2022, Leda attempted to partner with the University of Washington's Kappa Delta sorority. (Id. at 4.)
On October 31, 2022, the Washington State Attorney General's Office (AGO) issued Leda a cease-and-desist notification. The letter directed Leda to “immediately cease and desist from advertising, marketing, and sales to Washington consumers related to its ‘Early Evidence Kits' on the basis that Leda's business practices related to these kits violated the Washington Consumer Protection Act.” (Dkt. No 19-1 at 29.) The letter stated that “Leda's claims regarding the admissibility of its at-home kits have the capacity to deceive a Washington consumer into believing that its Early Evidence Kits have equivalent evidentiary value to a sexual assault evidence kit (“SAEK”) administered by a medical professional.” (Id. at 30). The notice went on to assert that the self-administered nature of Leda's EEKs would predictably result in “numerous barriers to admission as evidence, including on the basis of potential cross-contamination, spoilation, and validity.” (Id.) It emphasized that, in Washington, exams by a trained Sexual Assault Nurse Examiner (SANE) are “both free and routinely admissible.” (Id. at 31.) Thus, the letter concluded that “Leda charging consumers for Early Evidence Kits despite the fact they are unlikely to be admissible in a criminal court is an unfair and deceptive business practice” in violation of the Washington Consumer Protection Act. (Id.)
Washington was not the first state to raise concerns about the emergence of at-home sexual assault evidence collection kits. In 2019, Attorneys General from New York, Oklahoma, Connecticut, Michigan, North Carolina, Hawaii, and Florida sent cease and desist notifications to Leda's precursor company, MeToo Kits. (See Dkt. No. 19-1 at 35-67.) In 2020, New Hampshire's legislature passed a bill establishing that “[n]o person shall sell or offer for sale in the state of New Hampshire an over-the-counter rape test kit.” N.H. Rev. Stat. § 359-R:1. Washington and Maryland[1] followed New Hampshire's lead.
On January 24, 2023, Washington's legislature first considered House Bill 1564: “An Act Relating to prohibiting the sale of over-the-counter sexual assault kits.” (Dkt. No. 19-1 at 3.) After multiple hearings, the bill was passed and went into effect on July 23, 2023. (Dkt. No. 30 at 13.) Several representatives from Leda Health testified at the hearings, asserting that Leda's kits are not misleading but rather intended to be an additive option for the approximately 70% of sexual assault victims who do not go to the hospital, or for those who go but are not able to see a SANE nurse. (Dkt. No. 13 at 181.) Leda further stated that while the company did not guarantee evidence admissibility, it had procedures in place to establish chain of custody and believed that evidence from its kits should be admissible in court. (Id.) Nevertheless, the legislature found that “[a]t-home sexual assault test kits create false expectations and harm the potential for successful investigations and prosecutions.” 2023 Wash. Sess. Laws, ch. 296, § 1. Thus, it concluded “[t]he sale of over-the-counter sexual assault kits may prevent survivors from receiving accurate information about their options and reporting processes; from obtaining access to appropriate and timely medical treatment and follow up; and from connecting to their community and other vital resources.” Id. Entitled “[o]ver-the-counter sexual assault kits” and codified at Washington Revised Code § 5.70.070, the act establishes that:
(2) A person may not sell, offer for sale, or otherwise make available a sexual assault kit: a) That is marketed or otherwise presented as over-the-counter, at-home, or self-collected or in any manner that indicates that the sexual assault kit may be used for the collection of evidence of sexual assault other than by law enforcement or a health care provider; or b) If the person intends, knows, or reasonably should know that the sexual assault kit will be used for the collection of evidence of sexual assault other than by law enforcement or a health care provider.
Wash. Rev. Code § 5.70.070(2). The statute defines “sexual assault kit” as “a product with which evidence of sexual assault is collected.” Wash. Rev. Code § 5.70.070(1). It further stipulates that a violation of the section constitutes “an unfair or deceptive act in trade or commerce and an unfair method of competition for the purpose of applying [Washington's] consumer protection act.” Wash. Rev. Code § 5.70.070(3).
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Leda Health Corp. v. Inslee, 2:24-cv-00871-DGE (W.D. Wash. Oct 21, 2024)
Leda Health is a company known for developing Early Evidence Kits (“EEKs”)- products that allegedly enable sexual assault survivors to “self-collect and store evidence such as DNA” if they are unable or unwilling to seek a traditional forensic medical examination. (Dkt. No. 11 at 4.) Each EEK is branded with a unique barcode and contains an instruction manual on DNA self-collection, diagnostic swabs, sterile water for swabbing dry areas, a prepaid FedEx bag for shipping to an accredited partner lab, tamper-evident tape, plastic bags for storing clothing or other relevant items, and an intake form for documenting the assault and chain of custody. (Id. at 6.) Leda sells its EEKs to companies or other entities with which it partners-including sorority chapters on college campuses. (Id. at 5.) In 2022, Leda attempted to partner with the University of Washington's Kappa Delta sorority. (Id. at 4.)
On October 31, 2022, the Washington State Attorney General's Office (AGO) issued Leda a cease-and-desist notification. The letter directed Leda to “immediately cease and desist from advertising, marketing, and sales to Washington consumers related to its ‘Early Evidence Kits' on the basis that Leda's business practices related to these kits violated the Washington Consumer Protection Act.” (Dkt. No 19-1 at 29.) The letter stated that “Leda's claims regarding the admissibility of its at-home kits have the capacity to deceive a Washington consumer into believing that its Early Evidence Kits have equivalent evidentiary value to a sexual assault evidence kit (“SAEK”) administered by a medical professional.” (Id. at 30). The notice went on to assert that the self-administered nature of Leda's EEKs would predictably result in “numerous barriers to admission as evidence, including on the basis of potential cross-contamination, spoilation, and validity.” (Id.) It emphasized that, in Washington, exams by a trained Sexual Assault Nurse Examiner (SANE) are “both free and routinely admissible.” (Id. at 31.) Thus, the letter concluded that “Leda charging consumers for Early Evidence Kits despite the fact they are unlikely to be admissible in a criminal court is an unfair and deceptive business practice” in violation of the Washington Consumer Protection Act. (Id.)
Washington was not the first state to raise concerns about the emergence of at-home sexual assault evidence collection kits. In 2019, Attorneys General from New York, Oklahoma, Connecticut, Michigan, North Carolina, Hawaii, and Florida sent cease and desist notifications to Leda's precursor company, MeToo Kits. (See Dkt. No. 19-1 at 35-67.) In 2020, New Hampshire's legislature passed a bill establishing that “[n]o person shall sell or offer for sale in the state of New Hampshire an over-the-counter rape test kit.” N.H. Rev. Stat. § 359-R:1. Washington and Maryland[1] followed New Hampshire's lead.
On January 24, 2023, Washington's legislature first considered House Bill 1564: “An Act Relating to prohibiting the sale of over-the-counter sexual assault kits.” (Dkt. No. 19-1 at 3.) After multiple hearings, the bill was passed and went into effect on July 23, 2023. (Dkt. No. 30 at 13.) Several representatives from Leda Health testified at the hearings, asserting that Leda's kits are not misleading but rather intended to be an additive option for the approximately 70% of sexual assault victims who do not go to the hospital, or for those who go but are not able to see a SANE nurse. (Dkt. No. 13 at 181.) Leda further stated that while the company did not guarantee evidence admissibility, it had procedures in place to establish chain of custody and believed that evidence from its kits should be admissible in court. (Id.) Nevertheless, the legislature found that “[a]t-home sexual assault test kits create false expectations and harm the potential for successful investigations and prosecutions.” 2023 Wash. Sess. Laws, ch. 296, § 1. Thus, it concluded “[t]he sale of over-the-counter sexual assault kits may prevent survivors from receiving accurate information about their options and reporting processes; from obtaining access to appropriate and timely medical treatment and follow up; and from connecting to their community and other vital resources.” Id. Entitled “[o]ver-the-counter sexual assault kits” and codified at Washington Revised Code § 5.70.070, the act establishes that:
(2) A person may not sell, offer for sale, or otherwise make available a sexual assault kit: a) That is marketed or otherwise presented as over-the-counter, at-home, or self-collected or in any manner that indicates that the sexual assault kit may be used for the collection of evidence of sexual assault other than by law enforcement or a health care provider; or b) If the person intends, knows, or reasonably should know that the sexual assault kit will be used for the collection of evidence of sexual assault other than by law enforcement or a health care provider.
Wash. Rev. Code § 5.70.070(2). The statute defines “sexual assault kit” as “a product with which evidence of sexual assault is collected.” Wash. Rev. Code § 5.70.070(1). It further stipulates that a violation of the section constitutes “an unfair or deceptive act in trade or commerce and an unfair method of competition for the purpose of applying [Washington's] consumer protection act.” Wash. Rev. Code § 5.70.070(3).
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Leda Health Corp. v. Inslee, 2:24-cv-00871-DGE (W.D. Wash. Oct 21, 2024)
Outcome: Denied.
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