2010, FDA and Fraud - Health Care Compliance Brief

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

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.

Fraud

Fraud FDA

Second Circuit Adopts At-Least-One-Purpose Rule For Anti-Kickback Statute Violations

NY Health Law

JANUARY 3, 2025

Since approving Gilenya in 2010, the FDA has imposed a first-dose observation requirement for new patients, who must be monitored by a doctor while attached to an electrocardiogram machine for six hours. Novartis Pharmaceuticals Corp.

Fraud

Fraud FDA Doctors Medicaid

States and Feds Signal Big Changes to Telehealth Prescribing

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1] Originally enacted in 2010, the Online Prescribing Act has allowed health care providers to register with the State to prescribe and dispense certain FDA-approved drugs via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

Telemedicine

Telemedicine COVID-19 Fraud Licensing

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Bridging Innovation & Patient Care: The Growing Role of AI

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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

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.

Medicaid

Medicaid Medicaid Medicare Medicare

Guest Post – Michigan Product Liability Law: Retroactivity of New Law and Primer

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reported , Michigan’s longstanding presumption of non-defectiveness applicable to FDA-approved drugs was recently repealed by the Michigan legislature in S.B. As this provision is newly applicable to FDA-approved products, it has not been tested by the courts on this issue.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

FDA

FDA Fraud Compliance Hospitals

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

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.

FDA

FDA Fraud Informed Consent

CPAP MDL Overinflates Plaintiffs’ Claims

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. . .,

Fraud

Fraud FDA Hospitals Doctors

An Abuse of Discretion So Vast…. Our Long-Delayed Critique of the Valsartan MDL Class Action Certifications

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.

FDA

FDA Governance Fraud

Another RICOdiculous Decision

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

Fraud FDA Doctors

Learned Intermediary — Not an Affirmative Defense in California

Drug & Device Law

JANUARY 24, 2023

It was not enough for plaintiff to cite to post-2010 studies; she has to plead what information was provided to the FDA and when. Plaintiff’s fraud claims (including consumer fraud) were dismissed for failing to plead that her physician relied on any alleged omission—another claim dismissed under the learned intermediary doctrine.

Fraud

Fraud FDA Governance

Fallacious FDA Reporting Claim Finally Falls

Drug & Device Law

DECEMBER 30, 2022

When you hear Class III medical device product liability case, you should look for all claims to be dismissed unless there is something as unusual as a basis to claiming the plaintiff’s particular device deviated from its FDA-approved specifications. An unfortunate fiction developed post- Buckman —particularly after Riegel v. Stryker Corp. ,

FDA

FDA Fraud

Stupid Expert Tricks Redux

Drug & Device Law

NOVEMBER 28, 2022

2010) (Matsen); Nelson v. While cosmetic talc is not a drug or medical device, the FDA also regulates it (the “C” 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.

Informed Consent

Informed Consent Fraud FDA HIPAA

Suing the Certifiers – A Dangerous Undertaking

Drug & Device Law

AUGUST 8, 2022

The unfortunate truth is that ECFMG was also a victim of this fake doctor’s fraud. Smith, LLC , 2010 WL 11566367, at *7 (N.D. May 14, 2010) (“Defendant [standards institute’s] standards are voluntary, consensus standards, and Defendant. . . 2010); In re Welding Fume Products Liability Litigation , 526 F. 471 (11th Cir.

Doctors

Doctors Fraud Licensing Compliance

TwIqbal And Punitive Damages

Drug & Device Law

MARCH 7, 2022

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. . ., at *8 (agreeing with Bouncing Angels, Inc. 2, 2020). “In

Fraud

Fraud FDA Licensing Pharmaceutical Industry

Health Care Compliance Brief

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

Second Circuit Adopts At-Least-One-Purpose Rule For Anti-Kickback Statute Violations

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Trending Sources

States and Feds Signal Big Changes to Telehealth Prescribing

Webinars

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

Guest Post – Michigan Product Liability Law: Retroactivity of New Law and Primer

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

CPAP MDL Overinflates Plaintiffs’ Claims

An Abuse of Discretion So Vast…. Our Long-Delayed Critique of the Valsartan MDL Class Action Certifications

Another RICOdiculous Decision

Learned Intermediary — Not an Affirmative Defense in California

Fallacious FDA Reporting Claim Finally Falls

Stupid Expert Tricks Redux

Suing the Certifiers – A Dangerous Undertaking

TwIqbal And Punitive Damages

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