SQA

AUGUST 8, 2023

TR 43 was originally published in 2007 and revised in 2013 to address industry feedback. Although this Toolkit provides PCPC’s current thinking on MoCRA, companies should be mindful that MoCRA represents meaningful new authorities that FDA has yet to interpret and apply. TR 43 applies solely to empty glass containers.

FDA 40

FDA Compliance COVID-19 World Health 40

HIT Consultant

AUGUST 18, 2021

Food and Drug Administration (FDA), along with greater flexibility around mandates on alternatives to traditional clinical information. These approaches have combined to help accelerate FDA review and study commencement timelines to as low as 30 days. As mentioned, they also began accepting submissions in pieces on a rolling basis.

COVID-19 52

COVID-19 COVID-19 Vaccine Pharmaceutical Industry FDA 52

HIT Consultant

MAY 31, 2023

Common industry practice today allows small groups of large, powerful pharmaceutical manufacturers to drive new drugs through regulatory processes, acting as the gatekeepers to achieve FDA approval. A study on hospital market concentration found between 2007 and 2017, one single hospital system was serving 19% of the market — 11.2

Pharmaceutical Industry 96

Pharmaceutical Industry Hospitals Telemedicine FDA 96

Health Law Advisor

FEBRUARY 1, 2022

The United States Food and Drug Administration (FDA) for many years has been trying to increase the participation of minorities in clinical trials to help ensure that regulated products are tested and labeled in an appropriate cross-section of Americans. National Library of Medicine, with support from FDA.

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FDA Compliance 52

Bill of Health

AUGUST 29, 2022

Hill, A n Analysis of Racial/Ethnic Disproportionality and Disparity at the National, State, and County Levels , Casey-CSSP Alliance for Racial Equity in Child Welfare 1, 1 (2007), [link]. [3] 3] Bell, supra note 99 at 26. [4] 8] Young people under age 18 in California detention centers need parental consent to receive the vaccine.

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COVID-19 Vaccine COVID-19 Informed Consent Governance 130

Health Populi

MAY 30, 2018

Data provided to the FDA from patients who have used the product demonstrate a variety of side effects including but not limited to nausea, headache, slowed breathing, and amnesia — but not racism as far as the post-marketing surveillance has revealed. .”

FDA 89

FDA Health Outcomes Public Health 89

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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FDA Medical Personnel Telemedicine Licensing 111

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. 544, 559 (2007). [T]he Back in 2008, the United States Supreme Court held, in Riegel v. Medtronic, Inc. , Twombly , 550 U.S. at 1206.

FDA 59

FDA Governance Nurses Hospitals 59

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.

FDA 52

FDA Fraud Informed Consent 52

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. A hundred years later, we detailed three rounds of litigation over Massachusetts’ serial efforts to ban, or at least substantially limit, the use of FDA-approved pain medications.

FDA 59

FDA Licensing Doctors Governance 59

Drug & Device Law

APRIL 21, 2022

544 (2007), and Ashcroft v. Plaintiffs alleged that manufactured had failed to investigate and report the event to the FDA as purportedly required. For example, the court took judicial notice of an FDA recall notice. Defendants love and plaintiffs hate Bell Atlantic Corp. Twombly , 550 U.S. Iqbal , 556 U.S. Medtronic Inc.

FDA 59

FDA Fraud 59

Drug & Device Law

AUGUST 8, 2022

Ohio 2007) (“courts have repeatedly held that trade associations, themselves, have no duty to users of products in that trade”); Commerce & Industry Insurance Co. Such power rests solely with the FDA.” May 14, 2010) (“Defendant [standards institute’s] standards are voluntary, consensus standards, and Defendant. . . 471 (11th Cir.

Doctors 52

Doctors Fraud Licensing Compliance 52

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. 124 (2007), which would also be knocked out by Dobbs if it sticks. 472 (2013).

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FDA Licensing 127

Drug & Device Law

MARCH 7, 2022

544 (2007), and Ashcroft v. These allegations lack any contention or inference that [defendant] withheld or misrepresented information to the FDA. . ., The ruling in question was that the TwIqbal ( Bell Atlantic Corp. Twombly , 550 U.S. Iqbal , 556 U.S. the threshold for permitting punitive damages. Medtronic, Inc. , 2, 2020). “In

Fraud 59

Fraud FDA Licensing Pharmaceutical Industry 59

Drug & Device Law

MARCH 31, 2022

We discussed these concerns – which have since crystallized into what is called either the “municipal cost recovery rule” or the “free public services doctrine” – more detail back in one of the Blog’s early(2007) posts. In other words, the generic manufacturers are not allowed to change the FDA-approved label. citation omitted).

Governance 52

Governance FDA Doctors Hospitals 52

Drug & Device Law

NOVEMBER 10, 2023

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. . . FDA, “ Statement on the agency’s ongoing efforts to resolve safety issue with ARB medications ” (Aug. 18, 2019) (emphasis added). 2023 WL 1818922, at *36.

FDA 59

FDA Governance Fraud 59

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. . . 2007 WL 2526402, at *3 (D. 2007 WL 5861354, at *4 (C.D. 2007 WL 5861354, at *4 (C.D. 3d 1223, 1233 (11th Cir.

FDA 59

FDA Doctors Malpractice Informed Consent 59

Drug & Device Law

APRIL 25, 2022

Fortunately, that 2010 decision has been a pro-plaintiff anomaly, and FDA required label changes, recalls, etc. 2015) (“we will not consider evidence of a subsequent improvement to a drug label as evidence of prior failure to warn, even in cases such as this in which the FDA mandated the change in labeling”) (citing Rule 407).

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FDA Governance 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.” 2007) (precluding expert witness from testifying that a product was “defective,” “unreasonably dangerous,” or was the “proximate cause” of injury); Gallatin Fuels, Inc.

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FDA Governance 72

Drug & Device Law

JANUARY 25, 2024

142 (2007), mere regulation of the product or conduct at issue—the medical walker is a non-prescription, Class I medical device with general controls only—is not a basis for removal under this statute. In those cases , the question is often whether the claims put FDA compliance at issue or whether the defenses do. Philip Morris Cos. ,

Medicare 52

Medicare Medicare FDA Regulatory Compliance 52

Drug & Device Law

MAY 26, 2022

After attending a patient education class, seeking a second opinion, being warned that she was at increased risk for revision as a woman, and being warned of a risk of metal ions accumulating in her blood, she went forward with the BHR implant in her left hip on June 25, 2007. at *7 (citing the case discussed here ).

Fraud 59

Fraud FDA Doctors 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. 2007 WL 1164832, at *7 (S.D. April 19, 2007). 2d 712, 743 (N.D. 359 (6th Cir.

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FDA 52

Drug & Device Law

FEBRUARY 2, 2023

2007 WL 4042757, at *3 (N.D. 15, 2007); McNeil 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. Novartis Pharmaceuticals Corp. , & Rem.

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FDA Licensing Fraud 59

Med League

NOVEMBER 23, 2022

In 2007, the US Food and Drug Administration issued a post market Alert “Carbamazepine significantly increases the risk of dangerous or even fatal skin reactions [SJS and TEN] in certain patient populations…the allele is almost exclusively found in patients with ancestry across broad areas of Asia, including South Asian Indians.”

Nurses 52

Nurses FDA COVID-19 52

Med League

NOVEMBER 23, 2022

In 2007, the US Food and Drug Administration issued a post market Alert “Carbamazepine significantly increases the risk of dangerous or even fatal skin reactions [SJS and TEN] in certain patient populations…the allele is almost exclusively found in patients with ancestry across broad areas of Asia, including South Asian Indians.”.

Nurses 52

Nurses FDA COVID-19 52

Drug & Device Law

OCTOBER 3, 2022

We discussed those issues at length here , and the FDA also acknowledges them: The submission of an MDR itself is not evidence that the device caused or contributed to the adverse outcome or event. . . . [T]his FDA, “ Overview of Medical Device Reporting.” T]his passive surveillance system has limitations.

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FDA 59

Drug & Device Law

MARCH 16, 2022

As you must know by now, the pelvic mesh MDL court ruled that the FDA 510(k) regulatory clearance of pelvic mesh devices was irrelevant because such clearance was not probative of safety. After some FDA inquiries, the defendant eventually submitted a separate 510(k) application for the product, and it was cleared in May of 2008.

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FDA Governance Licensing 69

Drug & Device Law

FEBRUARY 22, 2024

This “keep selling” theory found some traction in two 2007 decisions, Abigail Alliance for Better Access to Developmental Drugs v. 2007) (en banc), and CareToLive v. Ohio 2007), but has generally failed to expand that foothold since. von Eschenbach , 495 F.3d 3d 695 (D.C. von Eschenbach , 525 F. 2d 952 (S.D.

FDA 52

FDA Governance 52

Drug & Device Law

OCTOBER 26, 2023

Indeed, one of Bexis’ very first blogposts , back in 2007, was a comprehensive review of non-preemption defenses to negligence per se. The very first non-preemption defense to negligence per se mentioned in Bexis’ 2007 post was legislative intent. Bexis’ 2007 post , though dated, is a good place to begin that familiarization.

FDA 59

FDA 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