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2 October 2023

Third Circuit Ruling Highlights Burden With Statistical Sampling

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Riker Danzig LLP

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Riker Danzig LLP has served the business community for 140 years, with offices in Morristown and Trenton, New Jersey and in Midtown Manhattan. Riker Danzig is regional counsel, national defense counsel, and deal counsel to clients ranging from Fortune 500 corporations to middle-market businesses.
Legal proceedings questioning the medical judgment of a healthcare provider generally entail the production and review of voluminous amounts of data, such as medical and billing records.
United States Food, Drugs, Healthcare, Life Sciences
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Legal proceedings questioning the medical judgment of a healthcare provider generally entail the production and review of voluminous amounts of data, such as medical and billing records. Government agencies and/or prosecutors often extrapolate the total incidence of alleged misconduct based on a smaller data set.

For example, prosecutors often use statistical sampling and extrapolation in matters involving unlawful prescriptions. In these cases, the Third Circuit permits prosecutors to extrapolate for such purposes, but "the government must show, and the court must find, that there is an adequate basis in fact for the extrapolation and that the quantity was determined in a manner consistent with accepted standards of reliability." United States v. McCutchen, 992 F.2d 22, 25-26 (3d Cir. 1993).

A recent decision by the United States Court of Appeals for the Third Circuit demonstrates the high threshold prosecutors must satisfy to demonstrate that their expert's extrapolation was consistent with accepted standards of reliability. In United States v. Patrick Titus, the United States Department of Justice ("DOJ") sought to extrapolate the total converted drug weight ("TCDW") of illegal prescriptions issued by the physician-defendant, Patrick Titus ("Titus"). Titus had been convicted of thirteen counts of unlawfully dispensing and distributing controlled substances and one count of maintaining drug-involved premises. The calculation of the TCDW of Titus's illegal prescriptions was required at sentencing to determine the length of his incarceration. The United States District Court for the District of New Jersey accepted the DOJ's extrapolation of 30,000 kilos, sentencing Titus to 240 months of imprisonment. Titus filed an appeal, challenging the DOJ's extrapolation and his conviction.

The Third Circuit found that the DOJ's use of extrapolation had not been performed in a manner consistent with accepted standards of reliability. The Third Circuit held that it was an error for the District Court to rely on the DOJ's medical expert even though the District Court acknowledged that the medical expert's sample size was not "statistically valid." United States v. Titus, 2023 U.S. App. LEXIS 22009, *7. Moreover, the Third Circuit found that the District Court had based its decision on an extrapolation it deemed invalid "without much explanation and without giving Titus [a] chance to 'respond meaningfully, or for that matter, at all'." Id.

The Third Circuit further highlighted that the DOJ had (1) "never showed that [its] sample was large enough to be reliably representative of the remaining thousands of prescriptions"; (2) failed to document proper extrapolation methods; and (3) "never explained how extrapolating from [its] sample could prove the huge [TCDW] by a preponderance of the evidence." Id. At *7-8. The Third Circuit concluded that "[t]he government may not use a small sample size to justify a much larger criminal punishment without explaining how that evidence satisfies its burden of proof...[and] [a]t a minimum, any extrapolation must be shown to be reliable, and defendants must have a fair chance to challenge its reliability." Id. at *12.

As stated succinctly by the Third Circuit, "[t]hough the prosecution bears a heavy burden of proof, [the Court] will not let it cut corners." Titus, 2023 U.S. App. LEXIS 22009 at *1.

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

ARTICLE
2 October 2023

Third Circuit Ruling Highlights Burden With Statistical Sampling

United States Food, Drugs, Healthcare, Life Sciences

Contributor

Riker Danzig LLP has served the business community for 140 years, with offices in Morristown and Trenton, New Jersey and in Midtown Manhattan. Riker Danzig is regional counsel, national defense counsel, and deal counsel to clients ranging from Fortune 500 corporations to middle-market businesses.
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