SQA

AUGUST 1, 2024

The most recent version of the IMDRF guidance IMDRF/AE WG/N43 Terminologies for Categorized Adverse Event Reporting (AER): terms, terminology and codes was published in 2020, but the document originated in 2006 as a Global Harmonization Task Force guidance document. Kappin Ltd. was also ordered to pay prosecution costs of 82,262.20.

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FDA Licensing Compliance World Health 40

SQA

AUGUST 2, 2021

ISO 10651-5:2006, Lung ventilators for medical use – Particular requirements for basic safety and essential performance – Part 5: Gas-powered emergency resuscitators. Led by the FDA and ASPR, the White House report and its recommendations ( report PDF ) have been accepted by President Biden. United States FDA – Guidances for Devices.

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FDA COVID-19 Pharmaceutical Industry Hospitals 83

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 operating income, 4.1% operating income, 4.1%

Nursing Homes 40

Nursing Homes Nurses Hospitals Medicaid 40

Health Populi

SEPTEMBER 19, 2018

Over the ten years 2006 to 2016, deductibles increased an average of 176% and coinsurance, 67%. They’ll begin to apply to the FDA in early 2019 to make and sell the generic drugs. Specifically, specialty drug trend is expected to be 14.3% in 2019, compared with 17.7% Thus far, about 500 U.S.

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Pharmaceutical Industry Hospitals Governance FDA 54

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reported , Michigan’s longstanding presumption of non-defectiveness applicable to FDA-approved drugs was recently repealed by the Michigan legislature in S.B. As this provision is newly applicable to FDA-approved products, it has not been tested by the courts on this issue.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

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FDA Fraud Compliance Hospitals 52

Drug & Device Law

JANUARY 15, 2024

We have discussed how exclusion of FDA compliance in pelvic mesh cases, based on a false equivalence between preemption and evidentiary admissibility, has hampered the defense in that litigation. Medtronic, Inc. , In state court, Creazzo remains binding precedent. 3d 1245 (N.J.

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Compliance FDA Governance State Policy 52

Drug & Device Law

DECEMBER 7, 2023

In particular, we’re not surprised to learn that AI is being used in the context of FDA-required adverse event reporting, purported problems with which have become one of the other side’s go-to preemption dodges. But that doesn’t mean that AI won’t impact prescription medical product liability litigation. stored in any medium.”

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FDA 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 2006), holds that “same rational applicable to prescription drugs” applies to medical devices. Plaintiffs Legal Committee , 531 U.S.

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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. 2006); Doe 1 v. Back in 2008, the United States Supreme Court held, in Riegel v. Medtronic, Inc. , at 514 (citations omitted). See also Varela v. Elizabeth’s Hospital of Chicago, Inc. ,

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FDA Governance Nurses Hospitals 59

Drug & Device Law

SEPTEMBER 22, 2023

It is fair to say that Bexis co-founded this blog (in 2006!) As Carter recounts, starting in 1976, FDA developed the OTC Cough and Cold Monograph, 21 C.F.R. in part to aid the cause of medical device and pharmaceutical manufacturers , targets in our lawsuit-obsessed country. at 1276. 379r(e) product liability savings clause Id.

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FDA Public Health 105

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 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

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.

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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. 300aa-22(b)(1). 300aa-22(c). Eli Lilly & Co.

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FDA Public Health Fraud Hospitals 115

Drug & Device Law

JUNE 6, 2022

2006), affirmed summary judgment because even if the omitted risk “had been added to the ‘Warnings’ section of the label,” the prescribing physician testified he “would still have prescribed the drug for [plaintiff].” Feb. Sigueiros , 2006 WL 1510408, at *3 (Cal. Lineberger v. Wyeth , 894 A.2d 2d 141 (Pa. 3d 1223, 1233 (11th Cir.

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FDA Doctors Malpractice Informed Consent 59

Drug & Device Law

JUNE 2, 2022

2012), addressed a challenge to the application of Idaho’s Pain-Capable Unborn Child Protection Act to criminalize the use of an FDA-approved abortifacient medication obtained through an internet prescription and mailed to the plaintiff from out of state. As we discussed here , McCormack v. Hiedeman, 694 F.3d 3d 1004 (9th Cir.

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FDA Licensing 127

Drug & Device Law

MAY 26, 2022

They also had to have been made between the May 2006 PMA approval and the June 2007 implant, and been relied upon by the implanting surgeon or the plaintiff. Plaintiff claimed the implanter was misled during a November 2006 BHR training course he attended in England. “But at *7 (citing the case discussed here ).

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Drug & Device Law

MAY 5, 2022

2022), a short decision that came out the right way, but did so based on a problematic statute that creates a rebuttal presumption that warning labels approved by the FDA are adequate as a matter of state law. Stated differently, the rebuttal provision makes allegations and evidence of fraud on the FDA a prerequisite to state-law liability.

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Compliance FDA Fraud 52

Drug & Device Law

APRIL 19, 2022

Not too long ago we researched precedent that forbade persons claiming to be “FDA experts” from opining that products are “adulterated” or “misbranded.” 2006) (expert could not opine that an insurer acted in “bad faith”); McCrink v. Rather, “‘an expert witness is prohibited from rendering a legal opinion.’” Id. Colkitt , 455 F.3d

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FDA Governance 72

Drug & Device Law

APRIL 18, 2022

at *3 – which means, as we’ve discussed before , a manufacturer cannot include warnings about such off-label uses absent specific FDA approval. 2006) (rejecting distinction between “a case of no warning as opposed to an inadequate warning”), aff’d , 526 F.3d Even then Rennick ’s rationale didn’t do a very good job. 2d 739, 747 (E.D.

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FDA 59

Drug & Device Law

MARCH 22, 2022

The vaccine’s labeling is approved by the FDA and typically a change is allowed only upon FDA approval. Plaintiff also made a fraud-on-the-FDA claim which failed to meet Rule 9’s pleading requirements – but more importantly is preempted by Buckman. All plaintiff’s claims were either preempted or failed TwIqbal.

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Drug & Device Law

JANUARY 25, 2022

Indeed, we expressed the same sentiment when the FDA – after decades of inaction – decided that it could regulate tobacco products after all. “[W]hat Congress ratified was the FDA’s plain and resolute position that the FDCA gives the agency no authority to regulate tobacco products as customarily marketed.” 120, 159 (2000).

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COVID-19 COVID-19 Vaccine Public Health FDA 105