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Danielle Vrabie

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Danielle Vrabie is a partner in the Business Trial Practice Group in the firm’s New York office and a member of the firm’s healthcare practice team.

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Nearly three months after hearing oral arguments, a divided Fifth Circuit panel issued its decision in Alliance for Hippocratic Medicine v. FDA, upholding the U.S. Food and Drug Administration’s (“FDA”) underlying approval of Mifepristone in 2000, but reinstating the limitations and restrictions under the pre-2016 protocol. Despite rejecting Judge Matthew Kacsmaryk’s blanket suspension of the drug’s approval, the federal appeals court found that the FDA overstepped its authority in expanding access and loosening restrictions on the drug in 2016 and 2021. Specifically, the Fifth Circuit agreed with the lower court’s ruling to invalidate the FDA’s modifications that increased the gestational age and relaxed dispensing requirements such as allowing the drug to be dispensed through the mail and ordered by a non-physician. The 96-page ruling issued by the conservative three-judge panel will likely not have any immediate legal effect, and Mifepristone will remain broadly available due to the Supreme Court’s stay implemented earlier this year.…

Continue Reading Fifth Circuit Rules to Reinstate Abortion Pill Restrictions

For a brief moment in time last April, the U.S. Food and Drug Administration’s (“FDA”) approval of the commonly-used abortion medication, Mifepristone, was curtailed. Just days after a Texas federal judge’s ruling suspended the FDA’s approval of the drug, the U.S. Department of Justice (the “DOJ”) asked the Fifth Circuit to grant an emergency or administrative stay of that decision. On review, the Fifth Circuit held that Mifepristone could only be prescribed in the first seven weeks of pregnancy, under a physician’s supervision, and the drug cannot be sent by mail, temporarily suspending more recent modifications to the FDA’s approval. …

Continue Reading Access to Abortion Pill on the Precipice: A Deep Dive into the Federal Court Rulings that will Decide the Fate of Mifepristone 

The U.S. Food and Drug Administration’s (“FDA”) approval of the commonly-used abortion medication, Mifepristone, has been curtailed following dueling federal court decisions in Texas and Washington. Just days after a Texas federal judge’s ruling suspended the FDA’s approval of the drug, the U.S. Department of Justice (the “DOJ”) asked the Fifth Circuit to grant an emergency or administrative stay of that decision. Although the Fifth Circuit did grant temporary, albeit limited, relief, the court maintained that Mifepristone could only be prescribed in the first seven weeks of pregnancy, under a physician’s supervision, and the drug cannot be sent by mail. …

Continue Reading Access to Abortion Pill in Limbo: Navigating the Intricacies of Conflicting Federal Court Rulings in Texas and Washington State

Following remarks made on March 2 and March 3, 2023 at the American Bar Association’s 38th Annual National Institute on White Collar Crime, the U.S. Department of Justice (“DOJ”) issued revisions to its Evaluation of Corporate Compliance Programs (“ECCP”). The newly revised ECCP guidance contains two important changes: (1) the DOJ has directed prosecutors to “consider more closely compensation structures and consequence management when evaluating compliance programs”, and (2) the DOJ will consider corporate practices surrounding the use of personal devices, communications platforms, and messaging applications, including ephemeral messaging applications, and the company’s ability to access and produce underlying data.

Continue Reading DOJ Revises Guidance on Evaluation of Corporate Compliance Programs Concerning Compensation and Employee Use of Personal Devices and Personal Messaging Applications

The COVID-19 Public Health Emergency (“PHE”) led to a rapid expansion in the utilization of telehealth. Now, almost three years later, governmental entities have focused their attention on telehealth services and the potential for fraud and abuse. In July 2022, the Department of Health and Human Services Office of Inspector General (“OIG”) issue a Special Fraud Alert alerting practitioners to exercise caution when entering into arrangements with telemedicine companies. The issuance of this report is a significant step and reinforces the government’s interest in scrutinizing telehealth arrangements. The Department of Justice (“DOJ”) and the Drug Enforcement Agency (“DEA”) have also launched several high-profile investigations that the industry is monitoring closely. Telehealth providers should carefully review and update their practices given the heightened enforcement climate.…

Continue Reading Recent Developments in Telehealth Enforcement

A major California-based health care system, Sutter Health, and several of its medical practice foundation affiliates have agreed to pay a total of $90 million to settle allegations that they violated the False Claims Act (“FCA”) by knowingly submitting inaccurate information about the health status of beneficiaries enrolled in Sutter Health’s contracted Medicare Advantage (“MA”) Plans.[1]  The Sutter Health settlement is the largest FCA settlement ever paid by a health care provider for alleged MA fraud.
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Continue Reading Sutter Health Settles Medicare Fraud Case For $90 Million: The Largest Settlement For Medicare Advantage Fraud

U.S. Attorney’s Offices (“USAOs”) across the country are issuing warning letters to physicians and other prescribers (collectively, “Prescribers”) cautioning them about their opioid prescribing practices (the “Warning Letters”). In just the last week, the USAO for the Eastern District of Wisconsin sent warning letters to over 180 prescribers identified by Drug Enforcement Administration (“DEA”) data as prescribing opioids at relatively high levels. The Food and Drug Administration and the Federal Trade Commission have also been issuing their own warning letters to opioid marketers and distributors over the past several months, evidencing a concerted effort to combat the opioid epidemic on a number of fronts through various federal enforcement and regulatory efforts.
Continue Reading Compliance Risk Alert: Opioid Warning Letters issued by the U.S. Department of Justice Target Prescribers