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Who Spilled The (Kidney) Beans? 11th Circuit Unseals Private Emails in Organ Transplant Dispute

Client Alert | 2 min read | 12.01.21

The 11th Circuit upheld a decision to unseal “embarrassing internal communications” between members of the United Network for Organ Sharing (“UNOS”) relating to its new policy directing liver transplants to go to the sickest patients within a certain radius of the donor.

The Court opened its opinion with a powerful question: “Organ donation saves lives—but whose?” Decades ago, Congress enacted the National Organ Transplant Act which authorized UNOS to create policies to facilitate the equitable distribution of organs among potential recipients. UNOS recently approved the Acuity Circles Policy, claiming its intent is to provide more liver transplants to patients in the greatest need, even if they are farther away from donors. Several hospitals and transplant centers who oppose the policy (and filed this lawsuit to prevent implementation of the policy), argue that it will make it more difficult for those outside of urban areas – and in particular those in socioeconomically disadvantaged areas – to access organs.

During discovery, the hospitals argued that certain of UNOS’s emails exposed “bad faith and improper behavior” in its policymaking process and should be unsealed and considered as proof that the policy change was arbitrary, capricious, and the result of a denial of due process. The Georgia District Court agreed, and UNOS appealed.

In determining whether to keep certain records sealed, Courts must evaluate whether good cause exists to prevent access, balancing “the asserted right of access against the other party’s interest in keeping the information confidential.”  Concerns about trade secrets or other proprietary information are particularly relevant and are not taken lightly; such concerns can overcome the public interest in access to judicial documents.

Here, the 11th Circuit ultimately found that the emails involve policymaking on a topic of genuine public concern, and do not contain proprietary information or trade secrets that require protection. The Court further explained that UNOS offered “no particularly compelling reasons” to keep the documents sealed in the first place. Specifically, while UNOS’s “eagerness to keep the documents secret is understandable” the Court noted that a desire to keep indiscreet communications out of the public eye “is not enough to satisfy our standard for good cause.” Even lack of relevancy is not a sufficient ground to seal documents in the 11th Circuit, absent a specific showing that the materials were offered for an abusive or improper purpose.

This case demonstrates the high burden litigants may face to overcome the presumption of public access to judicial records, particularly where records do not contain obvious trade secrets or proprietary information.

Insights

Client Alert | 7 min read | 09.14.26

AI in Life Sciences: Ten Legal Considerations and Risks of AI Use in Drug Discovery and Development

Over the past several years, the biopharmaceutical industry has embraced artificial intelligence and machine learning (AI/ML) in near lockstep with the pace of AI/ML innovations. Today, industry leaders are using AI/ML to, among other things: discover and assess biological pathways, target chemical structures and sequences; design proteins; model pre-clinical and clinical trials; recruit and screen potential patient populations; evaluate clinical trial results and biomarker data; prepare regulatory filings; and manage supply chains. Deployment of new AI/ML models promises extraordinary advances in pharmaceutical development. However, as with any technological and scientific advances, the use of AI/ML also poses substantial legal risks that life sciences companies need to consider and proactively manage. ...