Hall Render

MAY 31, 2024

Vincent Named President of the Association of Black Cardiologists Arkansas Children’s Hires Morse as Chief Administrator for ACNW Children’s Miracle Network Hospitals partners raise $5.4 area philanthropist opens women’s wellness center in Bethesda D.C. public relations firm strikes second acquisition after landing PE investment D.C.’s

Nursing Homes 40

Nursing Homes Nurses Hospitals Medicaid 40

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reported , Michigan’s longstanding presumption of non-defectiveness applicable to FDA-approved drugs was recently repealed by the Michigan legislature in S.B. As this provision is newly applicable to FDA-approved products, it has not been tested by the courts on this issue. Auto Owners Ins.

FDA 52

FDA Fraud Compliance Hospitals 52

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. 2006), aff’d , 526 F.3d We saw more of the same with the discussion of consumer fraud claims in CPAP II. Plaintiffs Legal Committee , 531 U.S. 341 (2001).

Fraud 52

Fraud FDA Hospitals Doctors 52

Drug & Device Law

MAY 4, 2023

2015), finally gave appellate recognition to the preemption of design defect claims for FDA-approved branded prescription drugs. FDA approved the drug with its particular formulation and the manufacturer could not have changed the formulation on its own. 2006), aff’d by equally divided court , 552 U.S. 3d 281 (6th Cir.

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FDA Fraud Compliance 64

Drug & Device Law

FEBRUARY 2, 2023

2006) (reversal concerned warning issues); Blackmon v. Texas, unlike most states, enforces a strong statutory presumption that prescription medical product warnings complying with FDA requirements imposed by “pre-market approval or licensing of the product” are adequate as a matter of law. Hoffman-La Roche, Inc. 15, 2007); McNeil v.

FDA 59

FDA Licensing Fraud 59

Drug & Device Law

DECEMBER 30, 2022

When you hear Class III medical device product liability case, you should look for all claims to be dismissed unless there is something as unusual as a basis to claiming the plaintiff’s particular device deviated from its FDA-approved specifications. An unfortunate fiction developed post- Buckman —particularly after Riegel v. Stryker Corp. ,

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FDA Fraud 59

Drug & Device Law

DECEMBER 12, 2022

Nothing in DeCostanzo suggests that the defendant’s vaccine lacked whatever warnings the FDA had approved, and the likelihood that the FDA would give these antivaxxers the time of day on any violation claim is minimal. 2006 WL 2038436, at *8 (N.D.N.Y. Olin Corp. , 3d 148, 154 (2d Cir. 1997) (“a manufacturing defect. . .

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FDA Public Health Fraud Hospitals 115