The Health Law Firm

JUNE 20, 2012

(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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Health Law Advisor

MARCH 1, 2023

1] Originally enacted in 2010, the Online Prescribing Act has allowed health care providers to register with the State to prescribe and dispense certain FDA-approved drugs via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 § 58-83-306.

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Telemedicine COVID-19 Fraud Licensing 52

C&M Health Law

JANUARY 25, 2023

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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Drug & Device Law

FEBRUARY 15, 2024

As the DDL blog has previously reported , Michigan’s longstanding presumption of non-defectiveness applicable to FDA-approved drugs was recently repealed by the Michigan legislature in S.B. As this provision is newly applicable to FDA-approved products, it has not been tested by the courts on this issue. See Prasol v.

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FDA Fraud Compliance Hospitals 52

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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FDA Fraud Informed Consent 52

Drug & Device Law

DECEMBER 4, 2023

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

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Fraud FDA Hospitals Doctors 52

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