2014, FDA and Fraud - Health Care Compliance Brief

Pharma Sales Rep Pleads Guilty to Healthcare Fraud and Criminal HIPAA Violations

HIPAA Journal

OCTOBER 21, 2022

A pharmaceutical sales rep has pleaded guilty to conspiring to commit healthcare fraud and wrongfully disclosing and obtaining patients’ protected health information in an elaborate healthcare fraud scheme involving criminal HIPAA violations. Alario pleaded guilty to his role in the healthcare fraud scheme earlier this month.

Fraud

Fraud HIPAA FDA Health Insurance

Migraine Company Fails to Avoid Own Headache: Jet Medical and Others to Pay $745,000 to Resolve Allegations that Medical Device was not Approved or Cleared before Commercialization

Healthcare Law Today

JANUARY 11, 2023

The government alleged that, between April 2014 and April 2019, Jet Medical introduced devices into interstate commerce that were misbranded under the Federal Food, Drug and Cosmetic Act (FDCA) because Jet Medical did not obtain approval or clearance from the U.S. Food and Drug Administration (FDA) prior to distribution.

FDA

FDA Governance Medicare Medicare

Hall Render Announces New Shareholders

Hall Render

JANUARY 3, 2024

He represents clients in actions and investigations initiated under the False Claims Act and has experience working closely with state and federal authorities to resolve fraud and abuse-related matters. from the University of Dayton School of Law in 2014. Matt graduated with his J.D. Jennifer received her J.D. McKinney School of Law.

Fraud

Fraud Hospitals Compliance FDA

A Thorny PMA Preemption Decision from Rhode Island

Drug & Device Law

MARCH 19, 2024

Plaintiff had surgery in 2014 in which the clips were used. Plaintiff’s primary allegation is that the clips have a migration rate higher than what was reported to the FDA. Plaintiff was missing any “indicia of fraud, wrongdoing, domination, misuse, or subversion of corporate formalities.

FDA

FDA Fraud Doctors Governance

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reported , Michigan’s longstanding presumption of non-defectiveness applicable to FDA-approved drugs was recently repealed by the Michigan legislature in S.B. As this provision is newly applicable to FDA-approved products, it has not been tested by the courts on this issue. 410 repeal in Law360 (i.e.,

FDA

FDA Fraud Compliance Hospitals

CPAP MDL Overinflates Plaintiffs’ Claims

Drug & Device Law

DECEMBER 4, 2023

CPAP II shrugs off plaintiffs’ repeated allegations that defendants “failed to apprise the FDA” of this or that, with the excuse that plaintiffs don’t really “rely” on them. We saw more of the same with the discussion of consumer fraud claims in CPAP II. Plaintiffs Legal Committee , 531 U.S. 341 (2001). 2023 WL 7019287, at *7.

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

Comment K, Presumptions, and Medical Device Design Defects Under Texas Law

Drug & Device Law

FEBRUARY 2, 2023

2014) (applying Texas law). Texas, unlike most states, enforces a strong statutory presumption that prescription medical product warnings complying with FDA requirements imposed by “pre-market approval or licensing of the product” are adequate as a matter of law. Toyota Motor Engineering & Manufacturing North America, Inc. ,

FDA

FDA Licensing Fraud

510(k) Devices, Compliance Presumptions, and the Long Shadow of Lohr

Drug & Device Law

JUNE 9, 2022

In our initial post, we focused on the exception to the presumption, which allows liability to be imposed if a plaintiff alleges and ultimately proves that the defendant manufacturer committed fraud on the FDA. The court held that the presumption applied because it was “undisputed that the [device] is subject to FDA oversight.”

Compliance

Compliance FDA Fraud

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. Gloucester County , 2014 WL 1599499, at *3 (D.N.J. April 21, 2014). the actions or omissions of the defendant demonstrate malice or aggravated or egregious fraud.

Fraud

Fraud FDA Licensing Pharmaceutical Industry

Reading Tea Leaves: Judge Brown Jackson’s Decisions Relevant To Product Liability

Drug & Device Law

MARCH 3, 2022

Indian Ocean, on March 8, 2014 , 352 F. Judge Jackson had not been on the bench very long when she was assigned this MDL, which related to “one of the greatest aviation mysteries of modern times: the disappearance of Malaysia Airlines Flight MH370 somewhere in the southern Indian ocean in the early morning hours of March 4, 2014.”

FDA

FDA Fraud Governance

Buckman Preempts Claims Despite State’s Adoption of the FDCA as State Law

Drug & Device Law

FEBRUARY 24, 2022

One tack they take is to argue that Buckman is limited to its facts and thus applies only to state-law fraud-on-the-FDA claims. Still, the Chong court should be commended for taking “a fresh look at the governing FDA regulations” and acknowledging that it had previously “incorrectly decided” a “nearly identical” case.

FDA

FDA Governance Fraud

Health Care Compliance Brief

Pharma Sales Rep Pleads Guilty to Healthcare Fraud and Criminal HIPAA Violations

Migraine Company Fails to Avoid Own Headache: Jet Medical and Others to Pay $745,000 to Resolve Allegations that Medical Device was not Approved or Cleared before Commercialization

Trending Sources

Hall Render Announces New Shareholders

A Thorny PMA Preemption Decision from Rhode Island

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

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

Comment K, Presumptions, and Medical Device Design Defects Under Texas Law

510(k) Devices, Compliance Presumptions, and the Long Shadow of Lohr

TwIqbal And Punitive Damages

Reading Tea Leaves: Judge Brown Jackson’s Decisions Relevant To Product Liability

Buckman Preempts Claims Despite State’s Adoption of the FDCA as State Law

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