2005, 2022 and FDA - Health Care Compliance Brief

Monthly Round-Up of What to Read on Pharma Law and Policy

Bill of Health

OCTOBER 28, 2022

2022 Sep 19. 2022 Sep;40(9):1319-1325. 2022 Sep 1;9(2):lsac022. 2022 Sep 27:10234184. 2022 Sep 29;16:11782218221126972. Dose modification rules and availability of growth factor support: A cross-sectional study of head-to-head cancer trials used for US FDA approval from 2009 to 2021. 2022 Sep;172:349-356.

FDA

FDA Medicaid Medicaid

Unpacking Averages: Assessing the Racial Composition of Drug Clinical Trial Subjects

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.

FDA

FDA Compliance

SQA Regulatory Surveillance Summary | Monthly Update 2023 – May And June

SQA

AUGUST 8, 2023

The rules of RDC 786/2023 correspond to a normative update, which replaces RDC 302/2005. In August 2022, ANVISA published Resolution RDC 741/2022 , which sets the framework to consider other medical device market regulators’ authorizations. The affected lots of Emerade were distributed in Canada between April 2022 and May 2023.

FDA

FDA Compliance COVID-19 World Health

Can Children Consent to the COVID Vaccine? The Case of Foster Care and Juvenile Justice

Bill of Health

AUGUST 29, 2022

Victoria Kalumbi received her JD from Harvard Law School in 2022. 325, 338 (2005). [21] A full form of this Article is forthcoming in the Minnesota Journal of Law & Inequality Vol. 1] E.g., Anna Edney, Kids’ Covid Hospitalizations Hit Record in U.S. Omicron Surge , Bloomberg (Dec. Barnette , 319 U.S. 624, 63 S.Ct.

COVID-19 Vaccine

COVID-19 Vaccine COVID-19 Informed Consent Governance

CPAP MDL Overinflates Plaintiffs’ Claims

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. 2022) (“[i]n making that prediction, the decisions of intermediate Pennsylvania appellate courts receive significant weight”) (citations and quotation marks omitted).

Fraud

Fraud FDA Hospitals Doctors

Confident Learned Intermediaries Defeat Warning Causation

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. . . 2022 WL 800879, at *21 (E.D. Johnson & Johnson , 2022 WL 1566117, at *6-7 (D. 2022 WL 468051, at *5 (W.D.

FDA

FDA Doctors Malpractice Medical Personnel

Maybe New Rule 702 Can Rein in Bradford-Hill Abuse

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. 2005); United States v. 2d 147, 165 (E.D.N.Y. 2001), aff’d , 303 F.3d Exxon Mobil Corp.

FDA

Comment K, Presumptions, and Medical Device Design Defects Under Texas Law

Drug & Device Law

FEBRUARY 2, 2023

Wyeth , 2005 WL 544222, at *6 (N.D. March 4, 2005), rev’d on other grounds , 462 F.3d 2022 WL 17443711, at *2 (5th Cir. 6, 2022) (applying Texas law), applying this standard in a Texas medical device decision. Genentech Inc. 2012 WL 956192, at *5 (S.D. March 19, 2012); Holland v. Hoffman-La Roche, Inc. 3d 364 (5th Cir.

FDA

FDA Licensing Fraud

The Problem with Pietrantoni – Unraveling Undertaking Liability

Drug & Device Law

FEBRUARY 13, 2023

3d , 2022 WL 16857262 (D. 10, 2022), has troubled us ever since we first noticed the opinion. 2022 WL 16857262, at *8 (design claim), *11-15 (warning claim). 2022 WL 16857262, at *17. 2005) (emphasis original). One aspect of Pietrantoni v. Corcept Therapeutics Inc. , Mandell , 525 N.E.2d 2d 375, 378 (Mass.

FDA

Twombly and Iqbal Taken Seriously: Express-Preemption Dismissal

Drug & Device Law

APRIL 21, 2022

2022 WL 1076173 (C.D. 2022), illustrates why defendants and plaintiffs have contrary views of Twombly and Iqbal. 2022 WL 1076173, at *2 (quoting Twombly , 550 U.S. 2022 WL 1076173, at *4. 2022 WL 1076173, at *4. 2022 WL 1076173, at *4. 2022 WL 1076173, at *6. 2022 WL 1076173, at *5.

FDA

FDA Fraud

California Federal Court Holds Onto Purported Class To Dismiss It Under The PREP Act

Drug & Device Law

MARCH 7, 2024

We recall that FDA was so impressed with the first published studies supporting PrEP that it asked the manufacturer of the study drugs—a three-in-one pill—to apply for the novel indication. The manufacturer of tenofovir and the original PrEP drugs also manufactures remdesivir, which has been one of the main antivirals to treat COVID-19.

COVID-19

COVID-19 FDA Hospitals

On Expert “Adulteration” and “Misbranding” Opinions

Drug & Device Law

MARCH 28, 2022

In a recent post , we discussed a decision that, among other things, excluded an FDA expert’s “opinion” that the defendant’s medical device was “adulterated” and/or “misbranded.” 2022 WL 614919 (S.D. Here, we’re focusing on expert opinions misusing these FDA terms of art. In Robinson v. Ethicon, Inc. of Bexis’ book.

FDA

Expert Witness Cannot Opine on Legal Terms of Art

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.” Xue , 2022 WL 1027634 (E.D. April 6, 2022), was being prosecuted for “conspiracy to steal trade secrets.” 2005 WL 730688, at *4 (E.D. March 29, 2005) (same).

FDA

FDA Governance

For Preemption, “Newly Acquired” Does Not Mean “By Plaintiff”

Drug & Device Law

AUGUST 9, 2022

However, when it comes to federal preemption of a failure to warn claim involving a prescription pharmaceutical, the only new knowledge that counts is the FDA’s. Bristol-Myers Squibb Company , 2022 WL 3012519 (C.D. The first thing defendant asked the court to do was take judicial notice of the drug’s labels from the FDA website.

FDA

FDA Governance

A Texas Mess

Drug & Device Law

JANUARY 4, 2024

That Complaint alleges various antivax conspiracy theories concerning COVID-19 vaccines, the FDA, emergency use authorizations, and the media that have circulated since these vaccines first became available. The FDA, however, did not and does not share that belief. FDA (8/23/21) press release (emphasis original).

COVID-19 Vaccine

COVID-19 Vaccine COVID-19 FDA Public Health

Health Care Compliance Brief

Monthly Round-Up of What to Read on Pharma Law and Policy

Unpacking Averages: Assessing the Racial Composition of Drug Clinical Trial Subjects

Trending Sources

SQA Regulatory Surveillance Summary | Monthly Update 2023 – May And June

Can Children Consent to the COVID Vaccine? The Case of Foster Care and Juvenile Justice

CPAP MDL Overinflates Plaintiffs’ Claims

Confident Learned Intermediaries Defeat Warning Causation

Maybe New Rule 702 Can Rein in Bradford-Hill Abuse

Comment K, Presumptions, and Medical Device Design Defects Under Texas Law

The Problem with Pietrantoni – Unraveling Undertaking Liability

Twombly and Iqbal Taken Seriously: Express-Preemption Dismissal

California Federal Court Holds Onto Purported Class To Dismiss It Under The PREP Act

On Expert “Adulteration” and “Misbranding” Opinions

Expert Witness Cannot Opine on Legal Terms of Art

For Preemption, “Newly Acquired” Does Not Mean “By Plaintiff”

A Texas Mess

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