Health Law Advisor

AUGUST 10, 2023

But the question is, to what extent do health care providers need to worry about FDA requirements as they use AI? FDA has been regulating machine learning algorithms used in a clinical context for decades. It’s important to understand that FDA regulation isn’t punitive in the sense that it’s only intended to apply to bad people.

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FDA Licensing Hospitals Medicaid 98

C&M Health Law

JANUARY 25, 2023

The Act also did not provide the Department of Labor enforcement authority (which was requested in its 2022 Report to Congress) to issue civil monetary penalties against health plans that it finds are noncompliant with the Mental Health Parity and Addiction Equity Act (MHPAEA).

Medicaid 104

Medicaid Medicaid Medicare Medicare 104

Hall Render

MARCH 16, 2022

On Tuesday, March 15, 2022, President Biden signed into law the Consolidated Appropriations Act of 2022 ( H.R. 2471 ) that funds the federal government for the remainder of FY 2022. An overview of the FY 2022 funding bill and a summary of its health care-related provisions can be found below.

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COVID-19 Medicare Medicare FDA 40

Drug & Device Law

DECEMBER 21, 2023

FDA , 78 F.4th 2023), was the Fifth Circuit’s blatantly politicized attack on the FDA’s regulation of abortion-related drugs. The questionable allegations of that single complaint thus effectively trumped many years of the FDA’s science-based decision-making. The FDA, for one, advised patients to keep using these drugs.

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Drug & Device Law

JULY 24, 2023

Nonetheless, the Ninth Circuit’s PATDC82 I allowed a RICO claim alleging that, between 1999 and 2011, defendants concealed that risk from the FDA and that, as a result, every TPP in the country paid for Actos prescriptions that it otherwise would not have reimbursed. But the FDA has concluded just the opposite. 3d 1243 (9th Cir.

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Drug & Device Law

NOVEMBER 10, 2023

2022), a decision that sliced diced, and pureed almost identical nitrosamine/cancer causation allegations raised about a different class of prescription drug. Indeed, the FDA stated, in connection with the same drug recalls that the Valsartan plaintiffs use to define their classes, 2023 WL 1818922, at *20-21: [These] medicines. . .

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Drug & Device Law

SEPTEMBER 19, 2022

604 (2011) , failure-to-warn claims targeting a pharmaceutical are preempted unless the manufacturer could have provisionally changed its warning label without prior FDA approval under the “changes being effected” (“CBE”) provision codified at 21 C.F.R. 2022 WL 3927868 (E.D. 2021), aff’d , 2022 WL 898595 (9th Cir.

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FDA 10

Drug & Device Law

FEBRUARY 25, 2022

We return to a theme we’ve repeated twice before, in 2011 and in 2014 – that in addition to industry-specific groups, manufacturers of prescription medical products should definitely consider joining the Product Liability Advisory Council (“PLAC”). allegations of failure to report adverse events to the FDA. 21, 2022).

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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. GlaxoSmithKline PLC , 2022 WL 17338047 (E.D.N.Y. 2022 WL 17338047, at *1. DeConstanzo , 2022 WL 17338047, at *4 (citing Laughter v.

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Drug & Device Law

MARCH 25, 2022

3d , 2022 WL 855853 (D.N.J. March 23, 2022), is further confirmation that our initial analysis of Albrecht was spot on. The manufacturer informed the FDA, but no evidence then established that risk as anything more than hypothetical. 2022 WL 855853, at *4-7. Fosamax , 2022 WL 855853, at *10. femur fractures.

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Drug & Device Law

DECEMBER 29, 2023

Since the FDA requires pre-approval of any warnings about off-label uses, preemption at some point should have been pre-ordained under the Mensing ( 2011+1 ) independence principle, but off-label use did not really figure in Zofran ’s analysis. The FDA’s five reviews of teratogenic risk all came to the same conclusion.

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

Drug & Device Law

MAY 10, 2022

4th –, 2022 WL 1233240 (4 th Cir. 27, 2022), two plaintiff attorneys and one client challenged the constitutionality of West Virginia’s Prevention of Deceptive Lawsuit Advertising and Solicitation Practices Regarding the Use of Medications Act. In Recht v. Morrissey , — F.4th Public Service Comm’n , 447 U.S. Recht at *3.

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Governance FDA Doctors Public Health 52

Drug & Device Law

JUNE 6, 2022

The prescriber] provided explicit, uncontroverted testimony that, even when provided with the most current research and FDA mandated warnings, as well as the information found in [defendant’s] updated. . . 2011) (no causation where “at the time of her deposition ? May 23, 2011) (no causation where prescriber “testified. . .

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FDA Doctors Malpractice Medical Personnel 59

Drug & Device Law

JANUARY 8, 2024

The Acetaminophen MDL was a classic example, where the FDA had independently looked at the science no fewer than six times (in 2014, 2015, 2016, 2017, and 2022, and 2023) and each time concluded that the science did not justify any warning. Ohio 2011), aff’d , 567 F. Doyle , 2015 WL 4528759, at *21 (Mag. 2d 712, 743 (N.D.

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FDA 52

Drug & Device Law

AUGUST 2, 2022

223 (2011), product liability litigation over childhood vaccines is rare but not extinct. The Act expressly preempts design defect claims where the vaccine is accompanied by a proper warning (which is presumed if it complies with FDA requirements). Since the Supreme Court decided Bruesewitz v. Wyeth LLC , 562 U.S. Sanofi Pasteur Inc.

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FDA 59

Drug & Device Law

MARCH 7, 2022

2022 WL 610276 (C.D. 31, 2022), fell into our laps. 2011 WL 2149095, at *5 (N.D. May 31, 2011). “[I]n These allegations lack any contention or inference that [defendant] withheld or misrepresented information to the FDA. . ., 2011), and Fowler v. But even before that was done, Poozhikala v. Medtronic Inc.

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Drug & Device Law

AUGUST 22, 2022

2022), is a very peculiar case and will probably leave some plaintiffs wondering if, maybe, they would be better off without their lawyers. The plaintiff in Jacob sued the manufacturer of a Class III, FDA premarket-approved medical device. She also tried to sue three new defendants – a doctor, a medical society and the FDA itself.

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Informed Consent FDA Doctors 59

Drug & Device Law

OCTOBER 27, 2022

2022 WL 4329094 (N.D. 2022), is neither a medical-device nor a pharmaceutical case. 2022 WL 4329094, at *4 (quoting Benson v. 2022 WL 715494 (5th Cir. 2022); Caplinger v. Drake Oak Brook Resort LLC , 2022 WL 2715854, at *4 (N.D. 2022) (quotation marks omitted). The case we discuss today, Vaughan v.

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FDA Licensing Compliance 59

Drug & Device Law

DECEMBER 19, 2022

2022 WL 16729466 (11th Cir. 7, 2022) (thankfully unpublished), is such a decision. 2022 WL 16729466, at *3. 604, 620 (2011) (“The question for ‘impossibility’ is whether the private party could independently do under federal law what state law requires of it.”). 2022 WL 16729466, at *3. Blackburn v. b)(2)(v)(A).

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FDA 59

Drug & Device Law

FEBRUARY 2, 2022

2022 WL 204360 (N.D. 24, 2022), does not involve any physical injuries. A 2020 statutory change (the CARES Act) deemed these tentative monographs to be final FDA action, thus creating an avenue for express OTC preemption in non-personal injury cases such as this. Front and center on the second shelf was our product. Walgreen Co.

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Drug & Device Law

MARCH 30, 2023

The side it picked was against public health and the authority of FDA, which is charged by Congress with protecting public health. Throwing that aside for non-funny political theater, Missouri enacted a law in 2022 that limited the ability of pharmacists to react to prescriptions for human use of either of these drugs.

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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 1:21-cv-00666 MIS/JFR, 2022 WL 4536240 (D.N.M. 2022 WL 4536240, *1. Contraceptive devices without a pharmacologic action have not avoided litigation.

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Drug & Device Law

SEPTEMBER 12, 2022

9, 2022), and the decision has a number of useful – for our side – rulings concerning branded drug preemption post- Merck Sharp & Dohme Corp. Preemption turns on the availability of the FDA’s changes being accepted (“CBE”) regulation, 21 C.F.R. This internal FDA decision was one of the reasons that preemption prevailed in Pfaff.

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Drug & Device Law

APRIL 11, 2022

312 (2008), and here’s what the Court said about why the “reasonable assurance of safety and effectiveness” standard is preemptive of personal injury claims: [The FDA] may thus approve devices that present great risks if they nonetheless offer great benefits in light of available alternatives. 3d , 2022 WL 827235 (D. 3d 1306, 1353 n.48

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Drug & Device Law

JANUARY 13, 2022

. § 360k(a) because those claims were based on an alleged failure to report adverse events to the FDA and the plaintiff had not shown that Massachusetts recognizes a duty to submit such reports. Earlier this week, the First Circuit side-stepped the question of whether Massachusetts recognizes a duty to submit adverse-event reports to the FDA.

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Drug & Device Law

MARCH 13, 2023

2022 WL 2703611, at *3-4 (E.D. July 12, 2022); Bostic v. 2022 WL 952129, at *8-9 (E.D. March 29, 2022); Brown v. 2022 WL 420914, at *4 & n.7 11, 2022); McDonnell v. 2022 WL 221612, at *5 (E.D. 25, 2022); Ramos-Soto v. 2022 WL 1056581 at *1 n.i (E.D. 2022 WL 1056581 at *1 n.i (E.D.

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FDA Compliance Governance Doctors 59

Drug & Device Law

JUNE 28, 2022

2022 WL 2276808 (U.S. June 24, 2022), we fully expect attempts by such states to ban FDA-approved prescription drugs that can be used to bring about abortions by chemical means. But when the FDA has approved a product, states no longer have the power to prohibit their sale or use for FDA-approved indications.

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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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