HIT Consultant

JUNE 27, 2023

New research from Mayo Clinic Proceedings found that 63% of physicians report at least one symptom of burnout, a drastic increase from 46% in 2011. About Jordan Messler, MD SFHM, FACP Jordan Messler, MD, SFHM, FACP is the Chief Medical Officer with Glytec.

Doctors 97

Doctors Hospitals COVID-19 Nurses 97

The Digital Health Corner

NOVEMBER 29, 2023

The objective of my blog, which began in 2011, was and remains educating the reader (clinicians, healthcare IT community, patients and caregivers, and other healthcare stakeholders about digital health technology and how it is relevant to the changing healthcare environment. Clinical tools require studies with outcome data.

FDA 68

FDA 68

Dot Compliance

FEBRUARY 8, 2022

What about other medical non-device software? Regulatory bodies, namely the FDA and IMDRF, have issued regulations that apply to given software applications used on mobile applications and general-purpose platforms alike. Medical software that operates on a general-purpose platform, such as a patient’s digital camera.

FDA 52

FDA Compliance 52

HIT Consultant

JULY 24, 2023

Then, in 2011, the FDA issued its draft guidance of human factors and evaluations of medical devices to enhance safety and effectiveness. When we talk about human factors and diagnostic devices, complex interventions have multiple components that must be implemented to deliver a health benefit. Distinct from drugs, for example.

FDA 52

FDA Hospitals 52

Healthcare Law Blog

JANUARY 20, 2023

The Food and Drug Administration (the “FDA”) has approved a modification to the Mifepristone Risk Evaluation and Mitigation Strategy (“REMS”) Program, increasing the accessibility of mifepristone for patients with a prescription. [1] Supreme Court held in Dobbs v. Jackson Women’s Health Organization that the U.S.

FDA 52

FDA Hospitals 52

SQA

FEBRUARY 15, 2023

” The reason: The existing document of the EU GMP Guideline dates back to 2011 and no longer corresponds to the state of the art in various areas or does not consider increasingly important new technologies for the GMP field, according to the EMA. ” The requirements for providers (e.g.,

US Department of Health and Human Services 40

US Department of Health and Human Services FDA COVID-19 World Health 40

CMS.gov

APRIL 15, 2019

Going forward, SSAs will be armed with clearer procedures so, as they conduct their review of each nursing home, dangerous issues will be discovered and promptly reported to CMS so residents are kept safe through appropriate enforcement actions intended to bring about rapid and sustainable compliance. percent to a national prevalence of 14.6

Nursing Homes 51

Nursing Homes Nurses Compliance Medicare 51

Healthcare IT News - Telehealth

MARCH 18, 2022

Healthcare IT News sat down with this digital health investor to talk about digital health investment trends during the pandemic and where he sees funding trending in 2022 and beyond. Norden is particularly passionate about funding companies focused on the Medicaid population – a traditionally tricky and often ignored area.

Medicaid 199

Medicaid Medicaid COVID-19 Telemedicine 199

SQA

DECEMBER 10, 2021

Pilot Program: EMA-FDA Parallel Scientific Advice for Hybrid/Complex Generic Products – General Principles, 15 September 2021. The agencies conduct PSA meetings under the auspices of the confidentiality arrangement between the European Commission, the EMA, and the FDA. European Medicines Agency (EMA). The EMA and the U.S.

FDA 52

FDA Compliance Public Health Hospitals 52

HIT Consultant

FEBRUARY 6, 2023

For example, only 3% of the 2,728 US digital health deals since 2011 have focused on women’s health. A lack of clear guidelines and misperceptions about menopause have hindered innovation in this field. It will take more advocating, female tech representation, and financial and emotional support for it to come to fruition.

FDA 98

FDA Health Insurance Hospitals Doctors 98

Health Law Advisor

AUGUST 10, 2023

But the question is, to what extent do health care providers need to worry about FDA requirements as they use AI? FDA has been regulating machine learning algorithms used in a clinical context for decades. That’s broad, although arguably not as broad as FDA’s interpretation of it. The allure is obvious. Very brief.

FDA 98

FDA Licensing Hospitals Medicaid 98

C&M Health Law

JANUARY 25, 2023

The Act’s health care offset title includes Section 4163, which extends the 2% Budget Control Act of 2011 Medicare sequester for six months into FY 2032 and lowers the payment reduction percentages in FYs 2030 and 2031. FDA is required to finalize this guidance no later than one year after the public comment for the draft guidance ends.

Medicaid 104

Medicaid Medicaid Medicare Medicare 104

Health Law Advisor

MAY 3, 2022

Further, from a warning letter standpoint, without inspection data, FDA focused in other compliance realms than it typically might. As a result, I start by looking at the rate of inspection citations compared to the rate of warning letters to see what it might tell us about the underlying data. That produced about 40,000 inspections.

FDA 52

FDA Compliance 52

Drug & Device Law

OCTOBER 23, 2023

312 (2008), that essentially all product liability claims against manufacturers of FDA pre-market approved (“PMA”) medical devices were preempted. 604, 624-25 (2011) (FDCA preemption case). That rationale is about as far from the Supreme Court’s holdings in TwIqbal , quoted above, as it is possible to be. [T]he Partnership v.

FDA 59

FDA Governance Nurses Hospitals 59

Drug & Device Law

MAY 19, 2023

The core premise of Bexis’ article is very simple: Once the FDA has said “yes” and approved a particular drug for a particular indication (“intended use”) for sale in the United States, federal preemption precludes any state from saying say “no” and trying to ban that same FDA-approved drug. T]he growing market for mifepristone. . .

FDA 111

FDA Medical Personnel Telemedicine Licensing 111

Drug & Device Law

DECEMBER 21, 2023

FDA , 78 F.4th 2023), was the Fifth Circuit’s blatantly politicized attack on the FDA’s regulation of abortion-related drugs. The questionable allegations of that single complaint thus effectively trumped many years of the FDA’s science-based decision-making. The FDA, for one, advised patients to keep using these drugs.

FDA 52

FDA Fraud Informed Consent 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 10, 2023

Two of your intrepid bloggers took shots at writing blogposts about Valsartan shortly after it was decided – but found the opinion simply too complicated, verbose, and depressingly wrong for us to wrap our hands, or our brains, around. FDA, “ Statement on the agency’s ongoing efforts to resolve safety issue with ARB medications ” (Aug.

FDA 59

FDA Governance Fraud 59

Drug & Device Law

DECEMBER 12, 2022

223, 231-33 (2011), holding that the Vaccine Act preempted all design defect claims asserted by claimants who rejected Vaccine Act awards and sought to litigate their claims instead. That’s about the only thing that DeCostanzo got right. “[P]laintiff alleges she suffered a physical injury in the form of defective immunity, among others.

FDA 115

FDA Public Health Fraud Hospitals 115

Drug & Device Law

FEBRUARY 25, 2022

We return to a theme we’ve repeated twice before, in 2011 and in 2014 – that in addition to industry-specific groups, manufacturers of prescription medical products should definitely consider joining the Product Liability Advisory Council (“PLAC”). allegations of failure to report adverse events to the FDA. The appeal remains pending.

FDA 59

FDA 59

Drug & Device Law

JANUARY 15, 2024

First , the none of what you just read about the Supreme Court decision in Sullivan is precedential in Pennsylvania. We have discussed how exclusion of FDA compliance in pelvic mesh cases, based on a false equivalence between preemption and evidentiary admissibility, has hampered the defense in that litigation. 3d 1245 (N.J.

Compliance 52

Compliance FDA Governance State Policy 52

Drug & Device Law

MARCH 25, 2022

Even before the anti-osteoporosis drug Fosamax was FDA approved, its manufacturer was aware of a biologically plausible mechanism for that class of drug (“bisphosphonates”) to cause low-energy – later renamed “atypical” ? The manufacturer informed the FDA, but no evidence then established that risk as anything more than hypothetical.

FDA 52

FDA Governance 52

Drug & Device Law

DECEMBER 29, 2023

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. There was nothing new or different about them. Another year bites the dust.

FDA 105

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

Drug & Device Law

AUGUST 2, 2022

223 (2011), product liability litigation over childhood vaccines is rare but not extinct. Missing is any allegation about the condition of the vaccine at the time it was administered and, more importantly, it is only a conclusory allegation that a defect exists. Since the Supreme Court decided Bruesewitz v. Wyeth LLC , 562 U.S.

FDA 59

FDA 59

Drug & Device Law

MAY 10, 2022

It is hard to ignore a television ad that sounds like a red flag warning about a medication you are currently taking. 552 (2011), believing that case stands for the proposition that content-based laws are subject to strict scrutiny. That’s especially true for drugs and medical devices. Public Service Comm’n , 447 U.S. Recht at *3.

Governance 52

Governance FDA Doctors Public Health 52

Drug & Device Law

JUNE 6, 2022

The prescriber] provided explicit, uncontroverted testimony that, even when provided with the most current research and FDA mandated warnings, as well as the information found in [defendant’s] updated. . . 2011) (no causation where “at the time of her deposition ? May 23, 2011) (no causation where prescriber “testified. . .

FDA 59

FDA Doctors Malpractice Medical Personnel 59

Drug & Device Law

DECEMBER 28, 2023

It is not uncommon that terms are used without knowledge of their origin and that the origin is instructive about the meaning or proper application of the term. But note that this was not about evaluating whether there was any association between an exposure and an outcome each drawn from the proverbial hat. We offer two examples.

FDA 52

FDA World Health Public Health 52

Drug & Device Law

APRIL 25, 2022

Fortunately, that 2010 decision has been a pro-plaintiff anomaly, and FDA required label changes, recalls, etc. 2015) (“we will not consider evidence of a subsequent improvement to a drug label as evidence of prior failure to warn, even in cases such as this in which the FDA mandated the change in labeling”) (citing Rule 407).

FDA 52

FDA Governance 52

Drug & Device Law

MARCH 7, 2022

2011 WL 2149095, at *5 (N.D. May 31, 2011). “[I]n These allegations lack any contention or inference that [defendant] withheld or misrepresented information to the FDA. . ., That’s a start, but what about the federal courts of appeals? 2011), and Fowler v. Stryker Corp. Medtronic, Inc. , 3d 1166, 1240 (D.N.M.

Fraud 59

Fraud FDA Licensing Pharmaceutical Industry 59

Drug & Device Law

DECEMBER 19, 2022

We last mentioned the Blackburn litigation, here , where we were not very happy about the Alabama Supreme Court’s loosening of the warning causation standard applicable that state’s learned intermediary rule. Since FDA requires medication guides only for safety reasons, most changes to them can affect safety and effectiveness. (C)

FDA 59

FDA 59

Drug & Device Law

AUGUST 22, 2022

The plaintiff in Jacob sued the manufacturer of a Class III, FDA premarket-approved medical device. First, the plaintiff’s non-parallel claims were “preempted to the extent” that they would have imposed “alleged labeling or manufacturing requirements that are different from, or in addition to, those imposed by the FDA.” Jacob , 40 F.4th

Informed Consent 59

Informed Consent FDA Doctors 59

Drug & Device Law

SEPTEMBER 22, 2023

Over the years, this blog has come to serve as an important resource for our drug and defense bar colleagues, and Bexis regularly identifies—if not invents—new legal issues and ideas, then proselytizes about them until they become part of the fabric of our legal lives. 604 (2011), and Mutual Pharmaceutical Co. at 1276.

FDA 105

FDA Public Health 105

Drug & Device Law

MARCH 30, 2023

About two months ago, we marveled at the notion that challenges to facially neutral state and local government vaccine requirements were still percolating through the legal system. The side it picked was against public health and the authority of FDA, which is charged by Congress with protecting public health. IMS Health, Inc. ,

COVID-19 75

COVID-19 Public Health FDA Governance 75

Drug & Device Law

FEBRUARY 2, 2022

So we will write about a fact pattern we’ve written about before. A 2020 statutory change (the CARES Act) deemed these tentative monographs to be final FDA action, thus creating an avenue for express OTC preemption in non-personal injury cases such as this. Our argument about same-ingredient, etc. It is Groundhog Day.

Fraud 59

Fraud FDA 59

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 had the device implanted in 2011 and explanted more than seven years later, apparently not because of any symptoms or known injury. 2022 WL 4536240, *1.

FDA 59

FDA Fraud Doctors Public Health 59

Drug & Device Law

MARCH 2, 2023

Plaintiffs alleged that they had these contraceptive devices implanted between 2011 and 2013 (presumably in Georgia), and later suffered some combination of a wide range of symptoms that they attributed to “migration” of the device. That should not pass the smell test, but the court did not analyze (sniff?) as to each claim by each plaintiff.

FDA 59

FDA Public Health 59

Drug & Device Law

FEBRUARY 22, 2024

The history of litigation over a June 2009 to March 2012 shortage of a drug called Fabrazyme, which was at the time the only FDA-approved drug to treat a nasty thing called Fabry’s disease, helps to explain our view. We do not even need to call out the emphasis that plaintiff lawyers place on FDA approval when it suits them.

FDA 52

FDA Governance 52