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.

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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.

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FDA Governance Fraud 59

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.

FDA 59

FDA Licensing Fraud 59

Drug & Device Law

AUGUST 8, 2022

The unfortunate truth is that ECFMG was also a victim of this fake doctor’s fraud. 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.” 471 (11th Cir. 2d 775, 799 & n.114

Doctors 52

Doctors Fraud Licensing Compliance 52

Drug & Device Law

MAY 26, 2022

9(b), “[i]n alleging fraud or mistake, a party must state with particularity the circumstances constituting fraud or mistake.” In particular, MDLs seem to have an unfortunate habit of allowing general allegations to support fraudulent misrepresentation claims and other claims based on alleged fraud or mistake. Under Fed.

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Fraud FDA Doctors 59

Drug & Device Law

APRIL 21, 2022

544 (2007), and Ashcroft v. The plaintiff asserted all the usual claims and then one: manufacturing defect; failure to warn; breach of warranty; and fraud. Plaintiffs alleged that manufactured had failed to investigate and report the event to the FDA as purportedly required. Twombly , 550 U.S. Iqbal , 556 U.S. Medtronic Inc.

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FDA Fraud 59

Drug & Device Law

MARCH 7, 2022

544 (2007), and Ashcroft v. 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. . ., Twombly , 550 U.S.

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