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Pennsylvania-based Leda Health, a company that sells at-home rape kits, has reached a settlement with the state Attorney General’s Office following allegations of deceptive marketing practices, officials announced Thursday.

Under the settlement terms, Leda Health must now provide explicit written warnings that its products do not meet the same standards as hospital-based evidence collection services. The company must also implement a comprehensive data security program to protect sensitive information collected from sexual assault survivors and clearly disclose how this data is shared.

The legal dispute began in June 2024 when Pennsylvania Attorney General Dave Sunday’s office filed a lawsuit against the company in Allegheny County Common Pleas Court. The suit alleged that Leda Health and its CEO, Bridgeville native Madison Campbell, violated the state’s Unfair Trade Practices and Consumer Protection Law by misleadingly marketing their “Early Evidence Kit” as a viable substitute for professional medical care and evidence collection.

“We must strongly support and advocate for sexual abuse survivors, and part of that support involves providing them with accurate information as they navigate the difficult road following a traumatic incident,” Sunday said in a statement. “As a career prosecutor, I am keenly aware of the sensitive time period following an assault, and maintain that the best options for a survivor is to seek treatment and help at a hospital or rape crisis center.”

The settlement comes after a complex legal battle that included Leda Health filing its own federal lawsuit against the attorney general’s office just one day before the state’s action. In that countersuit, the company claimed coercion and retaliation, arguing that the attorney general interfered with its constitutional right to aid sexual assault survivors.

The federal case was dismissed in January by U.S. District Judge Cathy Bissoon, and the 3rd U.S. Circuit Court of Appeals denied Leda’s subsequent appeal on Wednesday. Court documents reveal that in February, Leda disclosed it was facing severe financial difficulties, claiming it might be forced to dissolve due to the burden of legal costs.

“Leda Health is a small company that will be forced to dissolve by the burdens and cost of defending against defendant Sunday’s unconstitutional state action. Ms. Campbell is a young, private citizen who will face correspondingly high legal fees, which will either force her into bankruptcy or deplete her young life savings,” the company’s attorneys wrote in a court filing.

Leda’s legal team alleged that the attorney general “filed their state lawsuit not to protect consumers, but to make this federal case go away,” adding, “They succeeded.”

While denying all allegations of wrongdoing in the settlement, Leda Health agreed to pay the commonwealth’s litigation costs, totaling $4,800.83, within seven days.

The company, which originally formed in New York under the name “Me Too Kits,” relocated to Pittsburgh’s Lawrenceville neighborhood in 2023. It marketed its products to sexual assault survivors as a means of collecting and preserving evidence themselves when unable to obtain a traditional forensic examination.

The case highlights the growing tension between innovative health tech companies and regulatory agencies concerned with consumer protection, particularly in sensitive areas like sexual assault response. While companies like Leda argue they’re filling a gap in care for survivors who cannot or choose not to seek immediate medical attention, authorities maintain that such alternatives could potentially mislead survivors about their options during a critical time.

Leda Health representatives did not respond to requests for comment on Thursday, and an attorney for the company declined to comment on the settlement.

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18 Comments

  1. This settlement raises important questions about the regulation and oversight of medical devices, especially those related to sensitive health issues like sexual assault. Clear standards and transparency are essential.

    • I hope this case leads to broader reforms to ensure vulnerable consumers are protected from deceptive marketing claims, particularly around products intended for use in legal proceedings.

  2. The lawsuit highlights the need for strong consumer protection laws and enforcement when it comes to sensitive medical products. Misleading marketing around sexual assault evidence kits is simply unacceptable.

    • Kudos to the Pennsylvania Attorney General’s office for taking action to hold Leda Health accountable and uphold the rights of survivors.

  3. This settlement is a positive outcome, but it also raises broader questions about the state of the medical device industry and the need for tighter oversight to protect vulnerable consumers.

    • Patricia Thompson on

      Kudos to the Pennsylvania AG’s office for taking decisive action. Deceptive marketing practices around sexual assault evidence collection kits are simply unacceptable.

  4. The Leda Health case underscores the importance of accurate information and professional standards when it comes to sensitive medical products. Misleading claims can have serious consequences for survivors seeking justice.

    • Robert Rodriguez on

      I’m glad to see the company must now implement robust data security measures to protect sensitive survivor information. Transparency around data sharing is critical in this context.

  5. The details of the Leda Health settlement underscore the complexities involved in developing and marketing products for sensitive medical contexts. Navigating these issues requires nuance and a commitment to ethical practices.

    • Patricia Johnson on

      Hopefully this case will serve as a cautionary tale for other companies seeking to capitalize on vulnerable populations. Rigorous oversight is clearly needed in this space.

  6. This settlement is a win for sexual assault survivors and the integrity of the legal system. At-home kits should not be marketed as a substitute for professional medical care and evidence collection.

    • Patricia S. Garcia on

      The data security requirements are also an important safeguard to protect sensitive survivor information. Transparency around data sharing is critical.

  7. The Leda Health case underscores the need for stronger regulations and enforcement around medical devices, especially those related to sensitive health issues. Misleading marketing has no place in this domain.

    • I hope this settlement sets a precedent for how companies must be held accountable for deceptive claims, particularly when it comes to products intended for use in legal proceedings.

  8. Amelia Hernandez on

    This settlement highlights the complex challenges in balancing innovation, consumer needs, and ethical practices in the medical device industry. Stronger regulation and oversight are clearly needed to protect vulnerable populations.

    • Kudos to the Pennsylvania Attorney General’s office for taking decisive action to hold Leda Health accountable. Deceptive marketing around sexual assault evidence kits is simply unacceptable.

  9. This settlement with Leda Health is an important step in ensuring accurate information and proper standards for sexual assault evidence collection. Deceptive marketing of at-home kits could mislead vulnerable survivors and compromise legal cases.

    • Elizabeth Rodriguez on

      Protecting data privacy and security is also critical. Glad to see the company must implement robust security measures as part of the settlement.

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