C&M Health Law

JANUARY 25, 2023

trillion spending package, which consists of all 12 fiscal year (FY) 2023 appropriations bills and funds the federal government through September 30, 2023, provides additional assistance to Ukraine, and makes numerous health care policy changes. 117-164 ) (the “Act”)—an approximately $1.7

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Medicaid Medicaid Medicare Medicare 104

HIPAA Journal

APRIL 8, 2025

The Food and Drug Administration (FDA) was given greater authority over medical device cybersecurity and is now assessing the cybersecurity of medical devices when reviewing premarket submissions. The patient monitor was cleared by the FDA in 2011, and the backdoor had been present for more than 13 years before it was detected.

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FDA HIPAA Governance Hospitals 52

Drug & Device Law

FEBRUARY 22, 2024

The history of litigation over a June 2009 to March 2012 shortage of a drug called Fabrazyme, which was at the time the only FDA-approved drug to treat a nasty thing called Fabry’s disease, helps to explain our view. We do not even need to call out the emphasis that plaintiff lawyers place on FDA approval when it suits them.

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FDA Governance 52

Drug & Device Law

JANUARY 15, 2024

That is significant because, unlike (now) every other state in the country, since 1987 Pennsylvania precedent prohibited defendants from introducing evidence of their compliance with government and/or industry standards (“standards compliance” or “compliance” evidence, for short) in strict liability design defect cases – generally.

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Compliance FDA Governance State Policy 52

Drug & Device Law

DECEMBER 29, 2023

2023) (federal government may unilaterally obtain dismissal of FCA claims, and calling the constitutionality of the FCA’s private enforcement mechanism into question) ( here ); Quishenberry v. Further, the plaintiffs’ arguments were based on scientific standards “not utilized by the FDA,” and thus preempted. Polansky v. 3d 239 (Cal.

FDA 105

FDA US Department of Health and Human Services COVID-19 COVID-19 Vaccine 105

Drug & Device Law

NOVEMBER 10, 2023

These class certifications combined 428 different pharmaceutical products, produced and marketed by 28 separate defendants, with claims governed by the laws of 52 separate jurisdictions. FDA, “ Statement on the agency’s ongoing efforts to resolve safety issue with ARB medications ” (Aug. Valsartan , 2023 WL 1818922, at *24.

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Drug & Device Law

OCTOBER 23, 2023

312 (2008), that essentially all product liability claims against manufacturers of FDA pre-market approved (“PMA”) medical devices were preempted. 604, 624-25 (2011) (FDCA preemption case). Back in 2008, the United States Supreme Court held, in Riegel v. Medtronic, Inc. , E.g. , Kindred Nursing Centers Ltd. Partnership v. at 1206.

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Drug & Device Law

MAY 26, 2023

We are not looking do either of those, but we will weigh in on what NPP means for non-product liability cases involving FDA-regulated medical products. Both talk a fair amount about “commerce” and the respective roles of the states and federal government. 2011), aff’d , 741 F.3d Pfizer, Inc. , 2d 654, 659 (D. 3d 470 (4th Cir.

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FDA Licensing Doctors Governance 59

Drug & Device Law

MAY 19, 2023

The core premise of Bexis’ article is very simple: Once the FDA has said “yes” and approved a particular drug for a particular indication (“intended use”) for sale in the United States, federal preemption precludes any state from saying say “no” and trying to ban that same FDA-approved drug. T]he growing market for mifepristone. . .

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Drug & Device Law

MARCH 30, 2023

About two months ago, we marveled at the notion that challenges to facially neutral state and local government vaccine requirements were still percolating through the legal system. The side it picked was against public health and the authority of FDA, which is charged by Congress with protecting public health. IMS Health, Inc. ,

COVID-19 75

COVID-19 Public Health FDA Governance 75

Drug & Device Law

MARCH 13, 2023

Unlike almost every state in the country, since 1987, Pennsylvania law has prohibited defendants from introducing evidence of their compliance with government and/or industry standards in strict liability design defect cases – generally. Coloplast Corp. , 3d 448 (W.D. E.g. , Lewis v. Coffing Hoist Division , 528 A.2d 2d 590, 593-94 (Pa.

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FDA Compliance Governance Doctors 59

Drug & Device Law

FEBRUARY 20, 2023

But in prescription medical product liability litigation, products must receive FDA approval, clearance or other authorization (hereafter, collectively referred to as “approval” for short) before they can be marketed. Are manufacturers liable only for failing to employ an alternative design that the FDA has approved for distribution. . .

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FDA Licensing Hospitals Governance 59

Drug & Device Law

JANUARY 30, 2023

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. Bartlett , 570 U.S. 472 (2013), implied preemption decisions, cited only by the dissent in Wyeth v. Levine , 555 U.S.

FDA 72

FDA Fraud Governance Medicare 72

Drug & Device Law

DECEMBER 12, 2022

223, 231-33 (2011), holding that the Vaccine Act preempted all design defect claims asserted by claimants who rejected Vaccine Act awards and sought to litigate their claims instead. The Supreme Court did its part in Bruesewitz v. Wyeth LLC , 562 U.S. Now comes DeCostanzo v. that they would not have received otherwise.” 300aa-11(a)(2)(a).

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FDA Public Health Fraud Hospitals 115

Drug & Device Law

OCTOBER 7, 2022

One particular “permanent” implantable contraceptive device has been the subject of litigation for years, even though it was approved by FDA as a class III device. (Our Plaintiff had the device implanted in 2011 and explanted more than seven years later, apparently not because of any symptoms or known injury. 2022 WL 4536240, *1.

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FDA Fraud Doctors Public Health 59

Drug & Device Law

MAY 10, 2022

Nor can they include the logo of a federal or state government agency, so as not to suggest affiliation with any such agency. Finally, they cannot use the word “recall” except “when referring to a product that has been recalled by a government agency or through an agreement between a manufacturer and government agency.”

Governance 52

Governance FDA Doctors Public Health 52

Drug & Device Law

APRIL 25, 2022

Back in 2010, we examined one restrictive judicial gloss on Rule 407 – a “policy” based exception that the rule somehow doesn’t apply to government-mandated measures. Fortunately, that 2010 decision has been a pro-plaintiff anomaly, and FDA required label changes, recalls, etc. Before 2011, Rule 407 used to at least mention causation

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FDA Governance 52

Drug & Device Law

MARCH 25, 2022

Even before the anti-osteoporosis drug Fosamax was FDA approved, its manufacturer was aware of a biologically plausible mechanism for that class of drug (“bisphosphonates”) to cause low-energy – later renamed “atypical” ? The manufacturer informed the FDA, but no evidence then established that risk as anything more than hypothetical.

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