Remove 2010 Remove FDA Remove Fraud
article thumbnail

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.

Fraud 40
article thumbnail

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1] Originally enacted in 2010, the Online Prescribing Act has allowed health care providers to register with the State to prescribe and dispense certain FDA-approved drugs via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

Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

article thumbnail

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.

Medicaid 104
article thumbnail

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.

FDA 52
article thumbnail

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. . .,

Fraud 52
article thumbnail

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.

Fraud 52
article thumbnail

Stupid Expert Tricks Redux

Drug & Device Law

2010) (Matsen); Nelson v. While cosmetic talc is not a drug or medical device, the FDA also regulates it (the โ€œCโ€ in the FDCA). 3d 213, 222-23, 229-32 (S.D.N.Y. 2018) (Etminan); Gerke v. Travelers Casualty Insurance Co. , 316, 328-29 (D. 2013) (Painter); McClellan v. I-Flow Corp. , 2d 1092, 1119-25 (D. Tennessee Gas Pipeline Co.