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The Supreme Court Clarifies the Government’s FCA Dismissal Power and Invites Constitutional Challenge to the FCA’s Qui Tam Provision

Health Law RX

Earlier, in the SuperValu decision (discussed in a recent Health Law Rx Blog ), the Court clarified that subjective intent is relevant in determining whether an objectively reasonable (but incorrect) interpretation of a rule or regulation could negate the FCA’s scienter element ( U.S. 3d 250, 252 (D.C. Bayer Healthcare Pharms.,

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Navigating Dual Purpose Communications After SCOTUS (Almost) Weighs in on Attorney-Client Privilege: 5 Practical Tips for Healthcare Attorneys

Healthcare Law Blog

This topic always involves a legal angle, such as Stark Law or Anti-Kickback compliance, or state fraud and abuse law considerations. 2003); Visa U.S.A., For many healthcare attorneys, these types of dual-purpose communications are more common than communications involving only purely “legal” advice. Are bonuses involved? 23, 2004). [4]

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April-July 2022 State Regulatory Developments

New Jersey Healthcare Blog

These include the purpose and scope, definitions, standard of care, licensee-patient relationship, provision of health care services through telemedicine or telehealth, records, prevention of fraud and abuse, and privacy and notice to patients. On June 20, 2022, at 54 N.J.R. 191 (N.J.S.A. –5.6), and Stephen Komninos’ Law, P.L.

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Terrible Decision Contravenes the Vaccine Act’s Purpose and Would Gut Its Protections

Drug & Device Law

Some of us on the Blog are veterans of the original vaccine wars – those that preceded the enactment of the Vaccine Act, 42 U.S.C. 2003), and Doe v. 300aa-10, et seq. Because [her] claims arise out of a vaccine-related injury, it appears her claims are subject to the [Act’s] exhaustion requirement.” Aventis Pasteur, Inc. , 559 (2d Cir.

FDA 115
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Logical Contradiction Doctrine:  Buckman for Textualists

Drug & Device Law

For those of you accessing the Blog on mobile devices, this post may be hard to read. 470 (1996), was decided – removing express preemption as a defense for manufacturers of §510(k) products So defendants moved on fraud on the FDA under an implied preemption theory and won. Plaintiffs Legal Committee , 531 U.S. Mensing , 564 U.S.

FDA 72