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Kate Ledden

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Kate focused heavily on healthcare law and policy, public health, and related antitrust regulations during her legal studies. She also earned a master’s of public health degree to give her a fuller understanding of the needs of healthcare clients.

After law school, Kate began her legal career with nearly 10 years in federal district courts, where she worked directly with judges on all aspects of trial preparation. She came to know federal procedure backwards and forwards—and she also knows where cases can go wrong. With an inside perspective on how best to succeed in court and at trial, Kate aims to set clients up for the best result from the very beginning of their cases.

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Provider Relief Fund Update

Corporate defendants are frequently faced with a quandary—is the company’s highly sophisticated professional employee simply a fact witness or does their anticipated testimony propel them into the world of expert discovery? The individual knows the business inside and out, and typically has a comprehensive understanding of the entire industry, but the legal parameters of whether they qualify as a lay witness or expert witness in this context is not always clear. And either designation presents potentially significant risks. Companies must proceed with caution and consider the following before proceeding.

On June 27, 2022, the United States Supreme Court, by a vote of 9-0, overturned the lower circuit courts’ rulings affirming the convictions of two physicians of the unlawful distribution of controlled substances. In Ruan v. United States (Case No. 20-1410), consolidated with Kahn v. United States (Case No. 21-5261), the Supreme Court was asked to determine whether a physician may be convicted of unlawful distribution of controlled substances under 21 U.S.C. § 841(a)(1) without regard to whether, in good faith, the physician “reasonably believed” or “subjectively intended” that his or her prescriptions fall within that course of professional practice. The Controlled Substances Act makes it unlawful for “any person knowingly or intentionally … to manufacture, distribute, or dispense” a controlled substance, “except as authorized.” A prescription is authorized when it is “issued for a legitimate medical purpose by an individual practitioner acting in the usual course of his professional practice.” 21 C.F.R. § 1306.04(a). The “vague and highly general regulatory language” left open the question of what conduct would fall under the statute’s exception and thus be considered legal.