Health Law Advisor

MARCH 7, 2023

Should the final rules limit the issuance of prescriptions of controlled medications to the FDA-approved indications contained in the FDA-approved labeling for those medications? DEA has specifically requested feedback on whether it should limit telemedicine prescribing to only the drug’s FDA-approved indications.

Telemedicine 52

Telemedicine COVID-19 FDA Compliance 52

Hall Render

MAY 13, 2022

FDA limits J&J COVID-19 vaccine due to rare blood clot risk. Prism pays $650K to settle Medi-Cal fraud claims filed in San Diego. ‘So much is new’: ScionHealth launch presents wealth of opportunities, CFO says. Troubled NC nursing home set to lose nearly all its government funding — and patients.

COVID-19 40

COVID-19 Nurses Nursing Homes Hospitals 40

Hall Render

MARCH 3, 2023

Clair Health partners with Duquesne University College of Osteopathic Medicine UPMC sees lower operating income in 2022 as economic headwinds persist UPMC settles lawsuit with federal government for $8.5

Nursing Homes 40

Nursing Homes COVID-19 Nurses Hospitals 40

Hall Render

MARCH 25, 2022

FDA to revive facility visits. Moderna wants the FDA to authorize its COVID-19 vaccine for kids under 6. 2 sentenced for $48M medical reimbursement account fraud scheme. lawmaker presents plan to improve women’s healthcare. Massachusetts Doctor Faces Health Care Fraud Charges. NORTH DAKOTA.

COVID-19 40

COVID-19 US Department of Health and Human Services Nursing Homes Nurses 40

Hall Render

OCTOBER 6, 2023

government grant for maternal health care Alabama slides to 50th on nursing home and long-term care report card Ascension sells Alabama hospital Ascension St. medical school to revamp philanthropic efforts Sage Health opening 3 central Md.

US Department of Health and Human Services 40

US Department of Health and Human Services Nursing Homes Nurses Hospitals 40

Hall Render

OCTOBER 6, 2023

government grant for maternal health care Alabama slides to 50th on nursing home and long-term care report card Ascension sells Alabama hospital Ascension St. medical school to revamp philanthropic efforts Sage Health opening 3 central Md.

US Department of Health and Human Services 40

US Department of Health and Human Services Nursing Homes Nurses Hospitals 40

Hall Render

FEBRUARY 2, 2024

continues crackdown on nursing homes, 2 more cited for poor care and ‘massive fraud’ Wow! Inman College of Nursing FDA clears Collierville startup CircumFix’s medical device for surgery, marketing FTC opposes Novant Health’s $320M hospital deal with Community Health Systems HCA CFO to retire HCA nets $5.2B

Nursing Homes 40

Nursing Homes US Department of Health and Human Services Nurses Hospitals 40

Hall Render

DECEMBER 8, 2023

CT presents draft settlement in YNHH-Prospect hospitals sale Mandell-Braunstein family gifts $2.5M ’s Vanda Pharmaceuticals scores FDA review of key drug after multiyear battle D.C.’s CT presents draft settlement in YNHH-Prospect hospitals sale Mandell-Braunstein family gifts $2.5M NATIONAL 8.5M NATIONAL 8.5M

US Department of Health and Human Services 40

US Department of Health and Human Services Nursing Homes Nurses COVID-19 40

Healthcare IT Today

FEBRUARY 28, 2023

(President Biden, in his State of the Union speech, warned “we remain vigilant” while calling for an end to the emergency, but quickly switched the subject from the urgency of public health to prosecuting fraud.) The government could do that because they had a centralized patient data system and could reliably identify patients.

Public Health 101

Public Health COVID-19 FDA Governance 101

Drug & Device Law

NOVEMBER 10, 2023

These class certifications combined 428 different pharmaceutical products, produced and marketed by 28 separate defendants, with claims governed by the laws of 52 separate jurisdictions. FDA, “ Statement on the agency’s ongoing efforts to resolve safety issue with ARB medications ” (Aug. Valsartan , 2023 WL 1818922, at *24.

FDA 59

FDA Governance Fraud 59

Drug & Device Law

OCTOBER 10, 2022

The drug at issue was an FDA-recognized breakthrough drug that treats a relatively rare, but invariably fatal, condition – transthyretin amyloid cardiomyopathy (“ATTR-CM”). A little background is in order. ATTR-CM only affects about 150,000 Americans, who are mostly elderly. Pfizer , 42 F.4th This is ultimately what transpired. Nicholson v.

Medicare 52

Medicare Medicare FDA Prescription Drug Pricing 52

Drug & Device Law

NOVEMBER 1, 2022

Starting with the to-be-published Mixson I , this IVC filter case presented rather complex choice of law issues because the plaintiff implantee was in the military when the surgery in question occurred, and the army sent him to Texas for treatment, even though he was a Florida resident. 2022 WL 4364153, at *2. quoting Ariz. 12-689(A)(1)).

FDA 59

FDA Fraud Licensing Governance 59

Drug & Device Law

DECEMBER 29, 2023

2023) (federal government may unilaterally obtain dismissal of FCA claims, and calling the constitutionality of the FCA’s private enforcement mechanism into question) ( here ); Quishenberry v. 2023) ( Buckman preemption barred MDL asserting fraud on EPA), cert. The FDA’s five reviews of teratogenic risk all came to the same conclusion.

FDA 105

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

Drug & Device Law

AUGUST 8, 2022

The unfortunate truth is that ECFMG was also a victim of this fake doctor’s fraud. Furthermore, trade associations often serve to assist the government in areas that it does not regulate. Both state and federal governments allegedly relied on the defendant “accreditation process to help evaluate HCOs.” at 183 (quoting Meyers v.

Doctors 52

Doctors Fraud Licensing Compliance 52

Drug & Device Law

NOVEMBER 28, 2022

While cosmetic talc is not a drug or medical device, the FDA also regulates it (the “C” in the FDCA). The “reason” was “to allow for public access to data that undermines claims that plaintiffs’ experts and counsel continue to present to courts and factfinders.” 11-17 (Jan. It got worse. citation and quotation marks omitted).

Informed Consent 59

Informed Consent Fraud FDA HIPAA 59

Drug & Device Law

MARCH 4, 2022

their testimony does not present a genuine issue of medical fact.” 702; to the contrary, “expert testimony need not guarantee that a plaintiff prevail in order to be admissible.” In his negligence claim, the plaintiff asserted that, in violation of FDA regulations, the defendants did not seek FDA approval when the modified the modular hip.

FDA 59

FDA Fraud Governance 59

Drug & Device Law

JANUARY 30, 2023

What follows is a lightly edited (primarily adding full citations) version of a webinar presentation Bexis made recently for the “HLTh” Action Group of the Product Liability Advisory Council. Today’s post is a little different in its format from what our readers are used to. Plaintiffs Legal Committee , 531 U.S. Mensing , 564 U.S.

FDA 72

FDA Fraud Governance Medicare 72

Drug & Device Law

NOVEMBER 4, 2023

Bexis and Steve McConnell will be among your Reed Smith presenters. Our colleagues David Cohen and Mildred Segura will present “ You Be the Judge: Ethics Edition ,” a fun (we hope), interactive game that will test your knowledge of legal ethics rules surrounding e-discovery.

FDA 59

FDA Pharmaceutical Industry Licensing Fraud 59