Healthcare Law Blog

FEBRUARY 13, 2023

This topic always involves a legal angle, such as Stark Law or Anti-Kickback compliance, or state fraud and abuse law considerations. C-02-1786 JSW (EMC), 245, 248, 2004 U.S. 23, 2004). [4] For example, consider physician compensation. However, it almost always involves a business angle too. Are bonuses involved? 3d 413 (2d Cir.

Compliance 52

Compliance Fraud Governance 52

Hall Render

FEBRUARY 2, 2024

continues crackdown on nursing homes, 2 more cited for poor care and ‘massive fraud’ Wow! Mary’s welcome new board members Northeast Georgia Health System named one of nation’s top workplaces for diversity HAWAII How Adventist Health Castle achieved becoming a verified Level III Trauma Center Queen’s debuts $4.5M

Nursing Homes 40

Nursing Homes US Department of Health and Human Services Nurses Hospitals 40

Drug & Device Law

DECEMBER 4, 2023

Basically, CPAP II purported to do precisely what Buckman itself prohibited: using express preemption to limit the “ordinary working” of implied preemption of fraud on the FDA claims. We saw more of the same with the discussion of consumer fraud claims in CPAP II. 2023 WL 7019287, at *7 (twice), *8 (four times), *9 (twice).

Fraud 52

Fraud FDA Hospitals Doctors 52

Drug & Device Law

MAY 4, 2023

The intersection between these statutes, or the more complete “FDA defense” provisions in Michigan and Texas, and Buckman ’s prohibition on fraud-on-the-FDA claims has been the subject of variable treatment from courts. Warner-Lambert & Co. , 3d 85, 98 (2d Cir. 2006), aff’d by equally divided court , 552 U.S. Wyeth-Ayerst Labs. ,

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FDA Fraud Compliance 64

Drug & Device Law

FEBRUARY 2, 2023

2004); and Hackett v. Atkinson pointed out that the main exception – fraud on the FDA − to this otherwise not easily rebutted presumption of warning adequacy is preempted. March 4, 2005), rev’d on other grounds , 462 F.3d 3d 364 (5th Cir. 2006) (reversal concerned warning issues); Blackmon v. American Home Products Corp. , & Rem.

FDA 59

FDA Licensing Fraud 59

Drug & Device Law

DECEMBER 9, 2022

Accordingly,” the court concluded “the opinion of Dr. Rosenzweig does not demonstrate a genuine issue of material fact that Defendants acted with ‘malice, oppression or fraud’ under California Civil Code § 3294.” Id. Pfizer, Inc ,196 F. 2d 984 (C.D. 2001), aff’d sub nom. Pfizer Inc. Roerig Div.) 3d 659 (9th Cir. at *17 (citation omitted).

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Doctors Fraud Informed Consent 64

Drug & Device Law

MAY 5, 2022

Stated differently, the rebuttal provision makes allegations and evidence of fraud on the FDA a prerequisite to state-law liability. But state-law claims that rest on alleged fraud on the FDA are contrary to Buckman Co. Plaintiffs’ Legal Committee , 531 U.S. 21 U.S.C. § McNeil Consumer & Specialty Pharms., 3d 372 (5th Cir.

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Compliance FDA Fraud 52