HIPAA Journal

OCTOBER 21, 2022

A pharmaceutical sales rep has pleaded guilty to conspiring to commit healthcare fraud and wrongfully disclosing and obtaining patients’ protected health information in an elaborate healthcare fraud scheme involving criminal HIPAA violations. Alario pleaded guilty to his role in the healthcare fraud scheme earlier this month.

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Healthcare Law Today

JANUARY 11, 2023

The government alleged that, between April 2014 and April 2019, Jet Medical introduced devices into interstate commerce that were misbranded under the Federal Food, Drug and Cosmetic Act (FDCA) because Jet Medical did not obtain approval or clearance from the U.S. Food and Drug Administration (FDA) prior to distribution.

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Hall Render

JANUARY 3, 2024

He represents clients in actions and investigations initiated under the False Claims Act and has experience working closely with state and federal authorities to resolve fraud and abuse-related matters. from the University of Dayton School of Law in 2014. Matt graduated with his J.D. Jennifer received her J.D. McKinney School of Law.

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Drug & Device Law

MARCH 19, 2024

Plaintiff had surgery in 2014 in which the clips were used. Plaintiff’s primary allegation is that the clips have a migration rate higher than what was reported to the FDA. Plaintiff was missing any “indicia of fraud, wrongdoing, domination, misuse, or subversion of corporate formalities.

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Drug & Device Law

FEBRUARY 15, 2024

As the DDL blog has previously reported , Michigan’s longstanding presumption of non-defectiveness applicable to FDA-approved drugs was recently repealed by the Michigan legislature in S.B. As this provision is newly applicable to FDA-approved products, it has not been tested by the courts on this issue. 410 repeal in Law360 (i.e.,

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Drug & Device Law

DECEMBER 4, 2023

CPAP II shrugs off plaintiffs’ repeated allegations that defendants “failed to apprise the FDA” of this or that, with the excuse that plaintiffs don’t really “rely” on them. We saw more of the same with the discussion of consumer fraud claims in CPAP II. Plaintiffs Legal Committee , 531 U.S. 341 (2001). 2023 WL 7019287, at *7.

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Drug & Device Law

NOVEMBER 10, 2023

Indeed, the FDA stated, in connection with the same drug recalls that the Valsartan plaintiffs use to define their classes, 2023 WL 1818922, at *20-21: [These] medicines. . . FDA, “ Statement on the agency’s ongoing efforts to resolve safety issue with ARB medications ” (Aug. 18, 2019) (emphasis added). 2023 WL 1818922, at *36.

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