Drug & Device Law

FEBRUARY 11, 2024

FDA litigation that is now before the Supreme Court. FDA , 78 F.4th quoting FDA appellate brief ). Congress created an FDA approval process that is both rigorous and thorough, and pharmaceutical companies invest billions of dollars in research and development to meet FDA’s scientific standards. 4th 210 (5th Cir.

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Drug & Device Law

DECEMBER 29, 2023

2023) ( Buckman preemption barred MDL asserting fraud on EPA), cert. 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. Monsanto Co. ,

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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. We saw more of the same with the discussion of consumer fraud claims in CPAP II. Plaintiffs Legal Committee , 531 U.S. 341 (2001). 2023 WL 7019287, at *7.

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Drug & Device Law

OCTOBER 13, 2023

2015), and the Supreme Court’s opinion in Mutual Pharmaceutical Co. It makes no difference in our view that the FDA ultimately approved TAF-based drugs. The plaintiffs’ submission of internal studies, case reports, and scientific literature did not show “newly acquired” information—the FDA was already aware of it all.

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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. 25, 2023), is one we have been talking about for a long time.

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Drug & Device Law

FEBRUARY 2, 2023

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. 2015 WL 11120857, at *2 (N.D. 23, 2015) (same); Lewis v. manufacturer, . . manufacturer, . .

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Drug & Device Law

JANUARY 30, 2023

470 (1996), was decided – removing express preemption as a defense for manufacturers of §510(k) products So defendants moved on fraud on the FDA under an implied preemption theory and won. Plaintiffs Legal Committee , 531 U.S. Mensing , 564 U.S. Mensing , 564 U.S. Mensing , 564 U.S. Lohr , 518 U.S. Lohr , 518 U.S.

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Drug & Device Law

AUGUST 8, 2022

The unfortunate truth is that ECFMG was also a victim of this fake doctor’s fraud. 2015 WL 6393869 (S.D. 21, 2015): Mississippi does not recognize any cause of action against a voluntary non-profit trade association like TMA. . . . [T]he Such power rests solely with the FDA.” Big Dog Treestands, Inc.

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Drug & Device Law

MAY 13, 2022

472 (2013), as readers of this blog are aware, the United States Supreme Court held that a state law design defect claim against a generic drug manufacturer was pre-empted because the manufacturer could not “redesign” a drug to comply with state law tort duties without first obtaining FDA approval. Bartlett , 570 U.S. 3d 281 (6th Cir.

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Drug & Device Law

MARCH 7, 2022

Here, Plaintiffs fail to supply factual support showing Defendant acted with “oppression, fraud, or malice,” relying instead upon conclusory allegations. These allegations lack any contention or inference that [defendant] withheld or misrepresented information to the FDA. . ., at *8 (agreeing with Bouncing Angels, Inc. 2, 2020). “In

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Drug & Device Law

FEBRUARY 24, 2022

One tack they take is to argue that Buckman is limited to its facts and thus applies only to state-law fraud-on-the-FDA claims. Still, the Chong court should be commended for taking “a fresh look at the governing FDA regulations” and acknowledging that it had previously “incorrectly decided” a “nearly identical” case.

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