Government Urges SCOTUS to Declare ALJ Process Unconstitutional
Client Alert | 1 min read | 12.08.17
On November 29, 2017, the United States filed a brief in support of certiorari in Raymond J. Lucia Cos., Inc. v. SEC, urging the U.S. Supreme Court to use the case to hold that the existing hiring process for federal administrative law judges (ALJs) is unconstitutional. To date, federal courts of appeals have split on the question: the D.C. Circuit ruled that ALJs are mere “employees” of the federal government and are properly hired through a competitive process overseen by the Office of Personnel Management (OPM); the Tenth and Fifth Circuits, on the other hand, ruled that ALJs are “inferior officers” of the United State and must therefore be appointed as dictated by the Appointments Clause of the U.S. Constitution, as previously discussed here and here. The answer to the question could have significant consequences for thousands of ALJs serving in dozens of federal agencies who are routinely charged with overseeing discovery in agency proceedings, issuing subpoenas, making findings of fact, and deciding cases. The Supreme Court should decide whether to accept the case for argument early next year.
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The life sciences sector is uniquely vulnerable to the inherent risks of AI-generated evidence in drug development and discovery. This client alert focuses on five core challenges: hallucinations, skewed predictions from unrepresentative training data, the opacity of AI reasoning, input sensitivity that undermines reproducibility, and adversarial manipulation of training data. To address these risks, companies should use experimental validation and human oversight as the common legal and regulatory safety net. This entails among other measures auditing AI outputs, characterizing training data, and structural oversight. Companies also should prepare for evolving frameworks and guidance from the U.S. Food and Drug Administration (FDA) and the European Union (EU) that address use of AI in drug discovery and development .
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