Drug & Device Law

NOVEMBER 28, 2022

2001) (Kilburn); and Wade-Greaux v. I-Flow Corp. , 2d 1092, 1119-25 (D. 2010) (Matsen); Nelson v. Tennessee Gas Pipeline Co. 1998 WL 1297690, at *4, 7-8 (W.D. 31, 1998), aff’d , 243 F.3d 3d 244 (6th Cir. Whitehall Laboratories, Inc. , 1441, 1559-62 (D.V.I. 1994), aff’d mem. , 3d 1120 (3d Cir. 1994) (Gilbert).

Informed Consent 59

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Drug & Device Law

DECEMBER 30, 2022

In 2001, the Supreme Court made getting past motions to dismiss harder when it held in Buckman that plaintiffs could not recover claims predicated on violations of FDA regulations. An unfortunate fiction developed post- Buckman —particularly after Riegel v.

FDA 59

FDA Fraud 59

Drug & Device Law

JANUARY 4, 2024

Finally, while PREP Act preemption is the focus of today’s post, to the extent that the Texas Complaint can be read to allege – and we think it can – either: (1) direct fraud on the FDA or (2) that the FDA’s approvals (both emergency and/or final) of the defendant’s vaccine should not have been granted, Buckman Co.

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Drug & Device Law

JUNE 19, 2023

As discussed here , the primary allegations asserted the same sort of “fraud on the FDA” claim that, when brought as a common-law tort claim, were held preempted in Buckman Co. DePuy False Claims Act litigation was a particularly abusive misapplication of the FCA for legal reasons. Plaintiffs Legal Committee , 531 U.S.

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FDA Fraud 59

Drug & Device Law

FEBRUARY 15, 2024

2022) (recognizing the following product defect liability theories: “(1) negligent design of the product; (2) negligent manufacture of the product; (3) negligent failure to warn about some aspect of the product; (4) breach of express or implied warranty; or (5) misrepresentation or fraud”). Lynch & Co. Flex Techs., 2d 180, 182 (Mich.

FDA 52

FDA Fraud Compliance Hospitals 52

Drug & Device Law

SEPTEMBER 18, 2023

341 (2001). So, if a plaintiff contends that a defendant abused the ASR program, that is a Buckman -preempted fraud on the FDA claim. Conversely, violation claims involving the ASR program are paradigmatic examples of agency fraud/private FDCA enforcement that are impliedly preempted by Buckman.

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FDA Fraud Governance Compliance 59

Drug & Device Law

FEBRUARY 24, 2022

341 (2001), stands for the proposition that only the federal government may enforce the Food, Drug, and Cosmetic Act and that any state-law claim that depends on the existence of the FDCA is impliedly preempted by 21 U.S.C. § Plaintiffs’ Legal Committee , 531 U.S. Plaintiffs constantly try to evade Buckman. Medtronic, Inc. , 3d 1026, 1034 n.22

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FDA Governance Fraud 72

Drug & Device Law

DECEMBER 9, 2022

2001), aff’d sub nom. Accordingly,” the court concluded “the opinion of Dr. Rosenzweig does not demonstrate a genuine issue of material fact that Defendants acted with ‘malice, oppression or fraud’ under California Civil Code § 3294.” Id. Pfizer, Inc ,196 F. 2d 984 (C.D. Pfizer Inc. Roerig Div.) 3d 659 (9th Cir.

Doctors 64

Doctors Fraud Informed Consent 64

Drug & Device Law

SEPTEMBER 29, 2022

341 (2001). Regardless of its underpinnings, Buckman clearly proscribes as preempted state-law fraud-on-the-FDA claims. Albrecht , 139 S. 1668, 1672 (2019). Whether or not the Frye court properly understands Albrecht , it flatly misconstrued Buckman Co. Plaintiffs’ Legal Committee , 531 U.S. 2022 WL 4305656, at *5, *7.

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FDA Licensing Fraud 59

Drug & Device Law

JUNE 9, 2022

In our initial post, we focused on the exception to the presumption, which allows liability to be imposed if a plaintiff alleges and ultimately proves that the defendant manufacturer committed fraud on the FDA. We explained that the exception is contrary to Buckman Co. Plaintiffs’ Legal Committee , 531 U.S.

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Compliance FDA Fraud 59

Drug & Device Law

AUGUST 11, 2023

Plaintiff asserted various fraud and breach of warranty claims, and alleged that “hydrogen peroxide is ineffective in treating minor cuts and abrasions because, contrary to popular belief, it does not reduce rates of wound infection… and does more harm than good because it also destroys beneficial bacteria and healthy cells that promote healing.”

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FDA Fraud Doctors 52

Drug & Device Law

JANUARY 30, 2023

341 (2001), with the rejection of the so-called “purposes and objectives” prong of implied preemption by the most conservative justices (at least in terms of federalism) on the Court. Plaintiffs Legal Committee , 531 U.S. Plaintiffs Legal Committee , 531 U.S. Mensing , 564 U.S. Mensing , 564 U.S. Lohr , 518 U.S.

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FDA Fraud Governance Medicare 72

Drug & Device Law

MAY 5, 2022

Stated differently, the rebuttal provision makes allegations and evidence of fraud on the FDA a prerequisite to state-law liability. But state-law claims that rest on alleged fraud on the FDA are contrary to Buckman Co. Plaintiffs’ Legal Committee , 531 U.S. 21 U.S.C. § McNeil Consumer & Specialty Pharms., 3d 372 (5th Cir.

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Compliance FDA Fraud 52

Drug & Device Law

JANUARY 31, 2024

Plaintiff’s fraud claims in Collyer allege that the packaging of four keto-friendly cereals was misleading because the cereals do not contain an ingredient pictured on the package. 341 (2001). 4th 1040 (9th Cir. 2022), as being our third best decision of 2022, we have been waiting for a court to apply it to a food labeling case.

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Fraud FDA 52

Drug & Device Law

FEBRUARY 1, 2022

Her claims included negligence, strict liability, breach of implied and express warranty, and fraud. 341 (2001) as impermissible attempts at private enforcement of the FDCA. Plaintiff also failed to plead her fraud claims with the specificity required by Rule 9(b). Plaintiffs’ Legal Comm. , The court agreed.

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