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. 1301.28.

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Hall Render

MARCH 11, 2022

FDA final guidance presses industry to be ‘recall ready’ Final vaccine mandate deadlines still in play, despite removal vote. Pandemic victims mourned at Tempe event as advocates call for COVID-19 memorial day. Kentucky clinic owner sentenced to 10-plus years for fraud. COVID-19 funding is tapped out, HHS says.

COVID-19 40

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

Hall Render

DECEMBER 1, 2023

fraud scheme Nursing home must face vaccine-related wrongful firing claim, but not $2M retaliation accusations Transgender woman sues employer, Harvard Pilgrim for discrimination MICHIGAN 48-unit senior housing development could go up next to Vicksburg Halls in Marysville Can ads help a Michigan nursing home fix a staffing crisis?

Nursing Homes 40

Nursing Homes Nurses Ransomware COVID-19 40

Hall Render

MARCH 8, 2024

DC Health moves to Anacostia with high hopes for community impact VIP health system for top US officials risked jeopardizing care for rank-and-file soldiers Health workers partner with churches to target kidney disease among DC’s Black residents DELAWARE ChristianaCare taps population health exec from Virtua ChristianaCare’s medical director takes (..)

Nursing Homes 40

Nursing Homes Nurses Hospitals COVID-19 40

Hall Render

NOVEMBER 17, 2023

Grifols gets FDA approval for new facility in Clayton Invitae pledged $115M, 374-job investment in North Carolina. Million Individuals Affected by MOVEit Hack MARYLAND Adventist HealthCare, Montgomery College form partnership to address need for qualified nursing workforce Harford Memorial Hospital closing set for Feb. Many more are waiting.

Nursing Homes 40

Nursing Homes Nurses Hospitals Doctors 40

Hall Render

OCTOBER 27, 2023

Million Health Care Fraud Conspiracy in Idaho Orthopedic activity in the 5 most underserved states St. Ransomware attacks against hospitals put patients’ lives at risk, researchers say States, FTC continue to target noncompetes: 3 updates The best hospital in each state, per Newsweek What to know about Stark law’s $9.2M

US Department of Health and Human Services 40

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

Hall Render

APRIL 15, 2022

FDA clarifies cybersecurity recommendations for device makers in new guidance. Huntsville Doctor Charged with Health Care Fraud Conspiracy. to settle fraud, kickback charges. of Iowa Hospitals and Clinics to hold second nurse recruiting event. Maryland physician to pay $500K billing fraud settlement.

COVID-19 40

COVID-19 Nursing Homes Nurses Hospitals 40

Hall Render

JULY 14, 2023

Vernon receives award to improve stroke care Health system to expand Illinois hospital after $23.5M renovation Reid Health details restructuring effort to reduce costs Cameron Hospital, Trine break ground on $10M nursing education center IOWA 26 Nursing Homes Close in the Past Year Across Iowa Groundbreaking set for new UnityPoint – St.

US Department of Health and Human Services 40

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

Hall Render

FEBRUARY 10, 2023

Blue Shield of California is counting on it. s Unity Health Care expanding services, adding staff in push for health equity A look back on the 2022 CRE themes in the health care industry in the D.C. million to UMass Memorial Health Care for COVID-19 costs Four Mass.

US Department of Health and Human Services 40

US Department of Health and Human Services COVID-19 Nursing Homes Nurses 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. California to lift vaccine, test verification at mega indoor events. 2 sentenced for $48M medical reimbursement account fraud scheme. Massachusetts Doctor Faces Health Care Fraud Charges.

COVID-19 40

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

Hall Render

MARCH 31, 2023

expansion Trident Medical Center to hold hiring event at Topgolf Thursday; 20K signing bonus for RNs Beaufort ranked healthiest county in SC, but the least healthy county is nearby SOUTH DAKOTA Avera and Sanford receive combined $3.5 buys industrial property in Rancho Cordova for $5.12

US Department of Health and Human Services 40

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

Hall Render

OCTOBER 6, 2023

Tammany Health System create new residency program CHRISTUS nationally recognized for high-quality heart care Behind Ochsner LSU Health’s multimillion-dollar tech upgrades MAINE Millinocket hospital schedules renovation after $3.5M 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

Tammany Health System create new residency program CHRISTUS nationally recognized for high-quality heart care Behind Ochsner LSU Health’s multimillion-dollar tech upgrades MAINE Millinocket hospital schedules renovation after $3.5M 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 9, 2024

s Dr. Mississippi’s oral health among worst in US House Democrats unveil Mississippi’s first major Medicaid expansion plan Lawsuits filed against Singing River Health System in 2023 cyberattack Merit Health Natchez CEO: Additional Medicaid payments will ‘go a long way’ MISSOURI FDA denies approval for St.

Nursing Homes 40

Nursing Homes Nurses Hospitals Medicaid 40

Hall Render

MAY 19, 2023

SOUTH CAROLINA Grand Strand hospitals hope to see positive impact from Certificate of Need repeal McMaster signs South Carolina’s certificate of need repeal Newly-passed bill allows MUSC to move forward with delayed Nexton Hospital build Prisma Health records $31.7M million to strengthen healthcare in WV Top Doctors Named Across W.Va.

Nurses 40

Nurses COVID-19 Hospitals Nursing Homes 40

Hall Render

JANUARY 7, 2022

FDA expands use of Pfizer vaccine, green-lights boosters for children 12-15. Empower Healthcare to pay $1 million penalty in Medicaid fraud settlement. fraud case in Arkansas. Funds misrouted to ‘unknown bank account’: Florida GI group hit with data breach, wire fraud. fraud case in Arkansas.

COVID-19 40

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

Hall Render

APRIL 7, 2023

5 moves to know Most hospital websites routinely transfer patient data via tracking tools Nonprofit hospitals that pay board members linked to less charity care Nurses, federal lawmakers push for staffing ratio legislation Reports of serious adverse events rose in 2022: Joint Commission Doctors are drowning in paperwork.

US Department of Health and Human Services 40

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

Hall Render

JUNE 9, 2023

NATIONAL As AI advances in healthcare, industry players wrestle with its risks AHA Comments on FY 2024 Proposed Rule for Skilled Nursing Facilities AHA rebukes ‘flawed’ study on hospital finances AHA urges CMS to consider inflation, staffing in light of proposed inpatient rehab rule AHCA prepared to sue over minimum staffing mandate AMA, (..)

Nurses 40

Nurses COVID-19 Nursing Homes Hospitals 40

Health Populi

SEPTEMBER 8, 2021

Artificial intelligence and health equity were two key themes discussed during #HIMSS21, and Dr. Halamka’s concerns echoed through the week-long event. The Pew Trusts recently discussed prospects for the FDA to regulate AI in health care.

FDA 68

FDA Governance Fraud World Health 68

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 52

Fraud FDA Doctors 52

Drug & Device Law

MAY 24, 2022

In response to the summary judgment motions, plaintiff abandoned 11 of those claims including various strict liability, fraud/misrepresentation, and warranty claims. The only evidence plaintiff offered to support her claim was a notice by the FDA that came out three years after plaintiff’s surgeries – making it immaterial.

FDA 52

FDA Regulatory Compliance Compliance Fraud 52

Drug & Device Law

AUGUST 8, 2022

The unfortunate truth is that ECFMG was also a victim of this fake doctor’s fraud. On remand, Russell turned into a significant decision on negligent infliction of emotional distress, holding that no such claim could lie where plaintiffs alleged only that “they learn[ed] new information about some prior event.” May 19, 2022).

Doctors 52

Doctors Fraud Licensing Compliance 52

Drug & Device Law

DECEMBER 29, 2023

2023) ( Buckman preemption barred MDL asserting fraud on EPA), cert. Since the FDA requires pre-approval of any warnings about off-label uses, preemption at some point should have been pre-ordained under the Mensing ( 2011+1 ) independence principle, but off-label use did not really figure in Zofran ’s analysis. Monsanto Co. ,

FDA 105

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

Drug & Device Law

JUNE 22, 2022

failure to test) or fraud or the usual ‘dollars over lives’ canard, the truth is that drug and device companies are careful, conscientious, and heavily regulated. Still, we learned that the FDA regulated nutraceuticals with a somewhat light touch. There is no doubt that there is something different about drug and device cases.

Fraud 59

Fraud FDA Governance 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 this provision is newly applicable to FDA-approved products, it has not been tested by the courts on this issue.

FDA 52

FDA Compliance Fraud Hospitals 52

Drug & Device Law

FEBRUARY 23, 2022

That alternative product was never cleared by FDA for the indication at issue and had far less testing to support its efficacy than the testing for the defendant’s product actually used in the case – and the plaintiff claimed that the testing for the defendant’s product was inadequate.

FDA 59

FDA Fraud 59

Drug & Device Law

APRIL 21, 2022

The plaintiff asserted all the usual claims and then one: manufacturing defect; failure to warn; breach of warranty; and fraud. by failing to properly report and investigate an adverse event. In support of that allegation, plaintiffs pointed to a particular adverse event that was noted in a recall notice. 2022 WL 1076173, at *5.

FDA 59

FDA Fraud 59

Drug & Device Law

MAY 3, 2022

But plaintiffs also alleged negligence and fraud claims which if arising “from the independent conduct of a defendant, which is unrelated to the inherent defect in the product itself,” may exist outside the NJPLA. Medication Guides are the FDA-approved warnings that are directed to the patient. Then there is the warning label itself.

FDA 52

FDA Fraud Governance Doctors 52

Drug & Device Law

JANUARY 23, 2023

In a happy coincidence, the event fell on the last weekend of a two-week stretch of dog shows in which our puppy’s sire, a spectacular white corded Standard Poodle named Joel, was being shown. We write from Tampa, Florida, where we attended the bridal shower of a lifelong friend’s daughter. In other words, “where a.

FDA 111

FDA Fraud Doctors Governance 111

Drug & Device Law

OCTOBER 7, 2022

One particular “permanent” implantable contraceptive device has been the subject of litigation for years, even though it was approved by FDA as a class III device. (Our Plaintiff also offered a claim based directly on failure to report adverse events to FDA. Our posts go back for more than six years.)

FDA 59

FDA Fraud Doctors Public Health 59

Drug & Device Law

OCTOBER 13, 2023

It makes no difference in our view that the FDA ultimately approved TAF-based drugs. It is undisputed that, at the time the FDA approved the first TDF-based drug, the plaintiff’s proposed “alternative” was not approved, and would not be approved for another 10+ years. Gilead Sciences, Inc. , 18-cv-06972, 2023 WL 6390598, at *3 (N.D.

FDA 59

FDA Fraud 59

Drug & Device Law

JANUARY 4, 2024

That Complaint alleges various antivax conspiracy theories concerning COVID-19 vaccines, the FDA, emergency use authorizations, and the media that have circulated since these vaccines first became available. The FDA, however, did not and does not share that belief. FDA (8/23/21) press release (emphasis original).

COVID-19 Vaccine 59

COVID-19 Vaccine COVID-19 FDA Public Health 59

Drug & Device Law

NOVEMBER 17, 2022

Second, the claim was legally meritless: Plaintiff’s complaint does not allege that the FDA has withdrawn [the device’s] premarket approval, and she provides no authority to support her assertion that the “FDCA and MDA are clear that the failure to comply with conditions of approval will invalidate [it].” emphasis original).

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FDA Fraud Doctors Compliance 59

Drug & Device Law

FEBRUARY 21, 2023

All of plaintiff’s claims were based on allegations that defendants failed to accurately and fully report adverse events to the FDA. And while adverse event reporting is a federal requirement, “North Carolina law does not recognize a parallel duty on manufacturers to report to the FDA.”

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FDA Fraud Doctors 72

Drug & Device Law

MARCH 19, 2024

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. Since the clips are PMA, the first prong is met—PMA devices have specific FDA requirements.

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FDA Fraud Doctors Governance 52

Drug & Device Law

FEBRUARY 1, 2022

Her claims included negligence, strict liability, breach of implied and express warranty, and fraud. As there is no common law duty in Missouri to [investigate the reports of serious adverse events], this allegation is based on a federal requirement with no correlative state law duty, and it is impliedly preempted.

Fraud 59

Fraud FDA Doctors 59

Drug & Device Law

JUNE 14, 2022

Because unfortunately, the Connecticut Supreme Court, responding to a certified question from the Second Circuit, found that Connecticut law allows a common-law claim for liability for failure to report adverse events to the FDA. In fact, isn’t failure to report just a version of fraud-on-the-FDA?

FDA 59

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