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Federal Appeals Court Rules Investors can Continue to Bring Claims Against KV Pharmaceutical

The Health Law Firm

(KV) for making false or misleading statements to the US Food and Drug Administration (FDA). Appeals Court Ruling Revives Securities Fraud Class Action Lawsuit. In making this decision, the appeals court has renewed a securities fraud class action that was dismissed by a trial court in 2010.

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States and Feds Signal Big Changes to Telehealth Prescribing

Health Law Advisor

1] Originally enacted in 2010, the Online Prescribing Act has allowed health care providers to register with the State to prescribe and dispense certain FDA-approved drugs via online pharmacies and utilization of telehealth visits. Utah Code ยง 58-83-306.

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President Biden Signs End-of-Year Legislation Including Telehealth, Medicare & Medicaid, Mental Health, Pandemic Preparedness, and Other Health Care Provisions

C&M Health Law

hospitalizations and emergency department visits) and to audit Medicare claims to assess potential fraud. Section 1001 of the Act delays the 4% Statutory Pay-As-You-Go Act of 2010 (PAYGO) sequester for two years, through the end of calendar year 2024.

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CPAP MDL Overinflates Plaintiffsโ€™ Claims

Drug & Device Law

2010) (citations and quotation marks omitted). โ€œ[W]e have exercised restraintโ€ and โ€œopt for the interpretation that restricts liability, rather than expands it, until the Supreme Court of [the affected state] decides differently.โ€ 2010). โ€œ[E]ven if we were torn between two competing yet sensible interpretations of [state] law. . .,

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Malarkey ? The Ten Worst Prescription Drug/Medical Device Decisions of 2023

Drug & Device Law

FDA , 78 F.4th 2023), was the Fifth Circuitโ€™s blatantly politicized attack on the FDAโ€™s regulation of abortion-related drugs. The questionable allegations of that single complaint thus effectively trumped many years of the FDAโ€™s science-based decision-making. The FDA, for one, advised patients to keep using these drugs.

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Another RICOdiculous Decision

Drug & Device Law

Nonetheless, the Ninth Circuitโ€™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.

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An Abuse of Discretion So Vastโ€ฆ.ย  Our Long-Delayed Critique of the Valsartan MDL Class Action Certifications

Drug & Device Law

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, โ€œ Statement on the agencyโ€™s ongoing efforts to resolve safety issue with ARB medications โ€ (Aug. 18, 2019) (emphasis added). 2023 WL 1818922, at *36.

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