Health Blawg

NOVEMBER 15, 2018

Though, of course, at a certain point, an AI tool used in healthcare becomes subject to regulation by the FDA as a medical device ; folks need to be aware of those lines, and of the shifting regulatory landscape.) The hope, of course, is that the clinical uses can prove themselves out and become more widely adopted.

FDA 60

FDA Fraud Hospitals Doctors 60

Health Blawg

NOVEMBER 15, 2018

Though, of course, at a certain point, an AI tool used in healthcare becomes subject to regulation by the FDA as a medical device ; folks need to be aware of those lines, and of the shifting regulatory landscape.) The hope, of course, is that the clinical uses can prove themselves out and become more widely adopted.

FDA 60

FDA Fraud Hospitals Doctors 60

Health Law Advisor

MARCH 7, 2023

In 2018, Congress passed requirements under the Substance Use-Disorder Prevention That Promotes Opioid Recovery and Treatment for Patients and Communities (SUPPORT) Act, requiring DEA to create a special registration for opioid addiction treatment via telehealth by October 2019. Impact On Off-label Prescribing of Controlled Substances.

Telemedicine 52

Telemedicine COVID-19 FDA Compliance 52

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

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

Drug & Device Law

DECEMBER 4, 2023

2018) (quoting Sheridan v. 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. Petroleos De Venezuela, S.A. , 341 (2001).

Fraud 52

Fraud FDA Hospitals Doctors 52

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

NOVEMBER 28, 2022

2018) (Etminan); Gerke v. While cosmetic talc is not a drug or medical device, the FDA also regulates it (the “C” in the FDCA). 2019) (Zambelli-Weiner); In re 3M Bair Hugger Litigation , 924 N.W.2d 2d 16, 19 (Minn. 2019) (Augustine); In re Mirena IUD Levonorgestrel-Related Products Liability Litigation (No. II) , 341 F. 316, 328-29 (D.

Informed Consent 59

Informed Consent Fraud FDA HIPAA 59

Drug & Device Law

MARCH 3, 2022

2018), the third of the cases we are discussing here. A hearing took place in December 2017 and a ruling was issued in November 2018. That case is Kubicki v. Medtronic, Inc. , 3d 129 (D.D.C. The other two are Apton v. Volkswagen Group of Am., 3d 4 (D.D.C. 2017), and In re Air Crash Over the S. Indian Ocean, on March 8, 2014 , 352 F.

FDA 59

FDA Fraud Governance 59

Drug & Device Law

MAY 26, 2022

9(b), “[i]n alleging fraud or mistake, a party must state with particularity the circumstances constituting fraud or mistake.” In particular, MDLs seem to have an unfortunate habit of allowing general allegations to support fraudulent misrepresentation claims and other claims based on alleged fraud or mistake. Under Fed.

Fraud 59

Fraud FDA Doctors 59

Drug & Device Law

FEBRUARY 2, 2023

2018) (applying Texas law), that overturned a half-billion dollar verdict caused by a combination of attorney misconduct and judicial lassitude, we also recognized the problematic effects of certain other Fifth Circuit rulings in that decision. As much as we liked those parts of In re DePuy Orthopaedics, Inc., 3d 753 (5th Cir. & Rem.

FDA 59

FDA Licensing Fraud 59

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 59

Compliance FDA Fraud 59

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. 3d 546 (7th Cir.

FDA 59

FDA Fraud 59

Drug & Device Law

OCTOBER 12, 2022

The complaint included causes of action for negligence, strict liability, breach of various warranties, violation of the New Hampshire consumer protection statute, and common law fraud. Buckman preempts FDA-related claims when they would not exist if the FDCA did not exist. Goodbye, fraud. So far, so good. .

Fraud 69

Fraud FDA 69