Healthcare Law Blog

APRIL 19, 2023

Justice Kagan reasoned that the Court in Escobar noted the FCA is grounded in common law fraud principles under which a defendant’s subjective knowledge of the truth or falsity of its statement is relevant to the knowledge inquiry. Circuit, in a decision joined by then D.C. MWI Corp. , 3d 281, 290–91 (D.C.

Governance 52

Governance Fraud Compliance 52

Provider Trust

MAY 18, 2022

In January 2015, the OIG settled for $96,259 with a Minnesota Pharmacist, Joseph C. Moon In this enforcement example, an owner was excluded, but hid behind the corporate veil of a company, which eventually led to both individual and company fines and exclusions. Moon , for submitting claims while excluded from March 2006 through July 2013.

Compliance 52

Compliance Due Diligence Medicaid Medicaid 52

Health Law RX

JULY 18, 2023

The CMP Final Rule also addresses enforcement and CMPs for fraud, false claims, or similar conduct in HHS grants, contracts, and other agreements, which are not addressed in this article. As context, between 2015 and 2022, the DOJ reported FCA settlements with health IT vendors in an amount exceeding $500 million.

Fraud 52

Fraud Compliance Medicaid Medicaid 52

Hall Render

APRIL 6, 2022

However, some of the defendant’s customers typically paid less than the retail price for their medications through several discount programs that the defendant offered between 2006 and 2015. Regarding the PBM’s adoption of this definition, the Court stated that this may not serve as the basis of a fraud claim under the FCA.

Medicare 72

Medicare Medicare Medicaid Medicaid 72

Drug & Device Law

DECEMBER 4, 2023

Basically, CPAP II purported to do precisely what Buckman itself prohibited: using express preemption to limit the “ordinary working” of implied preemption of fraud on the FDA claims. We saw more of the same with the discussion of consumer fraud claims in CPAP II. 2023 WL 7019287, at *7 (twice), *8 (four times), *9 (twice).

Fraud 52

Fraud FDA Hospitals Doctors 52

Drug & Device Law

DECEMBER 29, 2023

2023) ( Buckman preemption barred MDL asserting fraud on EPA), cert. This year’s Drug & Device Law Blog top ten decisions of the year reinforced preemption – the most powerful defense we can assert. If any of these are your cases, the Blog congratulates you. Monsanto Co. , 4th 1261 (11th Cir. 4th 851 (6th Cir. 4th 696 (3d.

FDA 105

FDA US Department of Health and Human Services COVID-19 Informed Consent 105

Drug & Device Law

JANUARY 30, 2023

For those of you accessing the Blog on mobile devices, this post may be hard to read. 470 (1996), was decided – removing express preemption as a defense for manufacturers of §510(k) products So defendants moved on fraud on the FDA under an implied preemption theory and won. Plaintiffs Legal Committee , 531 U.S. Mensing , 564 U.S.

FDA 72

FDA Fraud Governance Medicare 72

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. But, as the Supreme Court has held and readers of this blog know, state-law requirements that parallel federal requirements can be impliedly preempted even if they are not expressly preempted. 3d 1026, 1034 n.22

FDA 72

FDA Governance Fraud 72

Drug & Device Law

FEBRUARY 11, 2024

We’ve blogged several times already about the Alliance for Hippocratic Medicine v. et al. , “A Longitudinal Cohort Study of Emergency Room Utilization Following Mifepristone Chemical & Surgical Abortions, 1999–2015,” 8 H. But the scientific fraud that has evidently been perpetrated in the AHM litigation is far worse.

FDA 59

FDA Fraud Pharmaceutical Industry Doctors 59

Drug & Device Law

OCTOBER 13, 2023

We blogged on similar cases here , here , and here. 2015), and the Supreme Court’s opinion in Mutual Pharmaceutical Co. As we explained here , “hindsight” claims like these should not be allowed. This is a “never should have sold” claim that is preempted under such authorities as Yates v. Ortho-McNeil-Janssen Pharmaceuticals, Inc. ,

FDA 59

FDA Fraud 59

Drug & Device Law

MAY 13, 2022

472 (2013), as readers of this blog are aware, the United States Supreme Court held that a state law design defect claim against a generic drug manufacturer was pre-empted because the manufacturer could not “redesign” a drug to comply with state law tort duties without first obtaining FDA approval. Ortho-McNeil-Janssen Pharms, Inc. ,

Fraud 59

Fraud FDA Nurses Hospitals 59

Drug & Device Law

MARCH 7, 2022

Thus, Bexis made a note to blog on it – but only after he finished his chapter update due at the end of February. Here, Plaintiffs fail to supply factual support showing Defendant acted with “oppression, fraud, or malice,” relying instead upon conclusory allegations. But even before that was done, Poozhikala v. Medtronic Inc.

Fraud 59

Fraud FDA Licensing Pharmaceutical Industry 59

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 both the blog and many of us defense practitioners can attest, the statute before repeal, Mich. 15-cv-10133, 2015 WL 8175256, at *3 (E.D.

FDA 52

FDA Compliance Fraud Hospitals 52