Leda Health Corporation v. Inslee

District Court, W.D. Washington·Decided October 21, 2024·No. 2:24-cv-00871·Unknown

Opinion

UNITED STATES DISTRICT COURT WESTERN DISTRICT OF WASHINGTON AT TACOMA LEDA HEALTH CORPORATION, CASE NO. 2:24-cv-00871-DGE Plaintiff, ORDER ON MOTION FOR v. PRELIMINARY INJUNCTION (DKT. NO. 10), MOTION TO JAY ROBERT INSLEE et al., DISMISS (DKT. NO. 30), AND MOTION FOR EVIDENTIARY Defendant. HEARING (DKT. NO. 34)

This matter comes before the Court on Plaintiff’s motion for a preliminary injunction (Dkt. No. 10) and Defendants’ motion to dismiss for failure to state a claim (Dkt. No. 30). Defendants filed a response to Plaintiff’s motion for injunctive relief (Dkt. No. 18), to which Plaintiff replied (Dkt. No. 29). Plaintiff subsequently filed a motion for an evidentiary hearing (Dkt. No. 34), to which Defendants responded (Dkt. No. 36), Plaintiff replied (Dkt. No. 39), and Defendant surreplied (Dkt. No. 40). Plaintiff then filed a response to Defendants’ motion to dismiss (Dkt. No. 37), to which Defendant replied (Dkt. No. 41). Upon careful consideration of the briefing filed by both parties, the Court concludes this matter is suitable for disposition without oral argument. See LCR 7(b)(4); United States v. State of Or., 913 F.2d 576, 582 (9th Cir. 1990) (“[W]e have rejected any presumption in favor of evidentiary hearings[.]”). The Court DENIES Plaintiff’s motion for a preliminary injunction and GRANTS Defendants’ motion to dismiss for the reasons set forth below. Accordingly, Plaintiff’s motion

for an evidentiary hearing is DENIED as moot, and Defendants’ surreply is also moot. A. Factual Background 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 Maryland1 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

1 See Md. Code Ann. Com. Law § 14-4602 - Sale, offer for sale, or distribution of a self- administered sexual assault kit prohibited. 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:

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