New Jersey Healthcare Blog

JULY 22, 2022

Below are the most recent health care related regulatory developments as published in the New Jersey Register in April-July 2022: April 2022. On April 4, 2022, at 54 N.J.R. On April 4, 2022, at 54 N.J.R. 290 (2022). On April 4, 2022, at 54 N.J.R. 292 (2022). On April 4, 2022, at 54 N.J.R.

COVID-19 Vaccine 40

COVID-19 Vaccine Licensing COVID-19 Public Health 40

Health Law RX

JUNE 27, 2023

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. SuperValu Inc., 1391, 1401 (U.S. Last week, in U.S.

Governance 52

Governance Fraud Compliance 52

Drug & Device Law

JULY 31, 2023

We have blogged several times about the somewhat esoteric issue of whether intangible items – chiefly computer software, website algorithms, and other electronic information – is treated as a “product” for purposes of imposing strict liability on their creators. 171, 212 (Fall 2022). at 1291-93 (construing 19 U.S.C. at 1291-92.

Governance 52

Governance Payment Systems Hospitals Licensing 52

Drug & Device Law

DECEMBER 12, 2022

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. GlaxoSmithKline PLC , 2022 WL 17338047 (E.D.N.Y. 29, 2022), which (if allowed to stand) imperils everything that Congress and the Supreme Court accomplished through the Vaccine Act. Merck & Co.

FDA 115

FDA Public Health Fraud Hospitals 115

Drug & Device Law

APRIL 10, 2023

That’s why this defense oriented blog has inveighed against claims solely for “ medical monitoring ” ever since it was founded. 135, 156-57 (2003); Metro-North Commuter Railroad Co. Plaquemines Parish Government , 982 So.2d 2022 WL 2274876, at *10-11 (D. June 23, 2022). 2022 WL 909406, at *3 (E.D.N.C.

Malpractice 59

Malpractice Governance Hospitals 59

Drug & Device Law

FEBRUARY 20, 2023

Yet another vaccine case addressed at length the reasons why viable design alternatives for products governed by the FDCA must be limited to those that the FDA has allowed onto the market. 2003), aff’d , 810 N.Y.S.2d 3d , 2022 WL 6225596 (S.D. 2022 WL 6225661, at *5 (S.D. 4:20-CV-02256, 2022 WL 6225573, at *3 (S.D.

FDA 59

FDA Licensing Hospitals Governance 59