Healthcare IT Today

APRIL 25, 2024

For a healthcare entity, the data and information are viewed as extremely valuable as it includes PII as well as other health information that can be used for insurance fraud and identity theft. Troy is a frequent speaker and highly published thought leader on IT compliance and cybersecurity topics.

Ransomware 117

Ransomware Compliance Fraud Governance 117

Drug & Device Law

SEPTEMBER 18, 2023

But what if the manufacturer allegedly failed to make its reports in compliance with the FDA’s restrictions on what types of adverse events were subject to ASR reporting? 341 (2001). So, if a plaintiff contends that a defendant abused the ASR program, that is a Buckman -preempted fraud on the FDA claim.

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FDA Fraud Governance Compliance 59

Drug & Device Law

FEBRUARY 15, 2024

2022) (recognizing the following product defect liability theories: “(1) negligent design of the product; (2) negligent manufacture of the product; (3) negligent failure to warn about some aspect of the product; (4) breach of express or implied warranty; or (5) misrepresentation or fraud”). Lynch & Co. Flex Techs., 2d 180, 182 (Mich.

FDA 52

FDA Fraud Compliance Hospitals 52

Drug & Device Law

JANUARY 30, 2023

341 (2001), with the rejection of the so-called “purposes and objectives” prong of implied preemption by the most conservative justices (at least in terms of federalism) on the Court. Plaintiffs Legal Committee , 531 U.S. Plaintiffs Legal Committee , 531 U.S. Mensing , 564 U.S. Mensing , 564 U.S. Lohr , 518 U.S.

FDA 72

FDA Fraud Governance Medicare 72

Drug & Device Law

MAY 5, 2022

But state-law claims that rest on alleged fraud on the FDA are contrary to Buckman Co. 341 (2001), which concluded that fraud-on-the-FDA claims are impliedly preempted because they “inevitably conflict” with the FDA’s regulatory discretion under. 2022 WL 1261318, at *1 (quoting N.J. Plaintiffs’ Legal Committee , 531 U.S.

Compliance 52

Compliance FDA Fraud 52

Drug & Device Law

JUNE 9, 2022

In our initial post, we focused on the exception to the presumption, which allows liability to be imposed if a plaintiff alleges and ultimately proves that the defendant manufacturer committed fraud on the FDA. Today’s post focuses not on the exception to the compliance presumption but on the antecedent issue of when the presumption applies.

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Compliance FDA Fraud 59