Justia Medical Malpractice Opinion Summaries

Dr. Anita Jackson, an otolaryngologist, was convicted of various offenses related to her private medical practice in North Carolina. She was the leading Medicare biller for balloon sinuplasty surgery, a procedure treating chronic sinusitis. Jackson reused single-use medical devices, specifically the Entellus XprESS Multi-Sinus Dilation Tool, on multiple patients without proper sterilization, leading to potential contamination. She also incentivized employees to recruit Medicare patients for the procedure, often bypassing proper medical assessments. Additionally, Jackson falsified documents and patient signatures in response to Medicare audits.The United States District Court for the Eastern District of North Carolina convicted Jackson on all counts, including violating the Food, Drug, and Cosmetics Act (FDCA) by holding for resale adulterated medical devices, violating the federal anti-kickback statute, making materially false statements, committing aggravated identity theft, mail fraud, and conspiracy. Jackson was sentenced to twenty-five years in prison and ordered to pay over $5.7 million in restitution. She moved for a judgment of acquittal and a new trial, which the district court denied.The United States Court of Appeals for the Fourth Circuit reviewed the case. Jackson argued that the devices were not "held for sale" under the FDCA, that her actions were protected under 21 U.S.C. § 396, and that the Government relied on a defective theory of per se adulteration. She also challenged the exclusion of certain evidence and jury instructions. The Fourth Circuit found no reversible error in the district court's rulings, holding that the devices were indeed "held for sale," that § 396 did not protect her conduct, and that the Government's theory was valid. The court also upheld the exclusion of evidence and the jury instructions. Consequently, the Fourth Circuit affirmed all of Jackson's convictions. View "United States v. Jackson" on Justia Law