C&M Health Law

JANUARY 25, 2023

hospitalizations and emergency department visits) and to audit Medicare claims to assess potential fraud. The Act’s health care offset title includes Section 4163, which extends the 2% Budget Control Act of 2011 Medicare sequester for six months into FY 2032 and lowers the payment reduction percentages in FYs 2030 and 2031.

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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

JULY 24, 2023

Nonetheless, the Ninth Circuit’s PATDC82 I allowed a RICO claim alleging that, between 1999 and 2011, defendants concealed that risk from the FDA and that, as a result, every TPP in the country paid for Actos prescriptions that it otherwise would not have reimbursed. But the FDA has concluded just the opposite. 3d 1243 (9th Cir.

Fraud 52

Fraud FDA Doctors 52

Drug & Device Law

DECEMBER 12, 2022

223, 231-33 (2011), holding that the Vaccine Act preempted all design defect claims asserted by claimants who rejected Vaccine Act awards and sought to litigate their claims instead. The Supreme Court did its part in Bruesewitz v. Wyeth LLC , 562 U.S. Now comes DeCostanzo v. Olin Corp. , 3d 148, 154 (2d Cir. 300aa-22(b)(1). . §§349-50,

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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

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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FDA US Department of Health and Human Services COVID-19 COVID-19 Vaccine 105

Drug & Device Law

OCTOBER 7, 2022

One particular “permanent” implantable contraceptive device has been the subject of litigation for years, even though it was approved by FDA as a class III device. (Our Plaintiff had the device implanted in 2011 and explanted more than seven years later, apparently not because of any symptoms or known injury. 2022 WL 4536240, *1.

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