HIT Consultant

JANUARY 23, 2023

In 2020, growth in federal government spending on healthcare increased 36 percent , compared to the 5.9 Collaboration between the government and the biotech industry will be essential for creating a portfolio of therapies to treat a variety of patient profiles who experience a range of Covid-19-related health issues. About Eugene Y.

COVID-19 52

COVID-19 Public Health Hospitals Nurses 52

Health Populi

MARCH 15, 2019

in December 2007, and tracked “self-care” searches to today, 15 March 2019. I’ll be speaking about the “disruptive” new retail health era in the larger context of the evolution of self-care. Caity talks about the therapeutic benefit of stacking loose change.

World Health 113

World Health Governance 113

Hall Render

JUNE 7, 2023

held that the mental state required by the False Claims Act (“FCA”) refers to the defendant’s actual knowledge and subjective beliefs about the truth of claims for payment submitted to federal payors. Liability under the FCA now focuses on what a defendant actually believed about the validity of their claims at the time of submission.

Fraud 40

Fraud Medicaid Medicaid Governance 40

Health Populi

OCTOBER 22, 2019

In the 2019 dictionary next to the word “stress,” we would find variations of a definition all deriving from Americans’ current worries about their money, the economy, and health care costs…then, family responsibilities and jobs. That’s quite a large chasm between these two numbers, about $2,400.

Prescription Drug Pricing 52

Prescription Drug Pricing Health Insurance Doctors Governance 52

Pharmacy Law Blog

FEBRUARY 13, 2018

Supreme Court decision in her case holding that the government could not freeze untainted assets. Her case continued in 2017 following a 5-3 ruling by the Supreme Court holding that the government could not freeze assets belonging to her that were not tied to the alleged fraud scheme. To read more on the U.S.

Fraud 40

Fraud Medicare Medicare Governance 40

Healthcare Law Blog

FEBRUARY 13, 2023

Inside and outside healthcare counsel should know that the way they guide clients through legal and business issues may need to change based on a recent Ninth Circuit case governing the protections afforded to attorney-client communications, In re Grand Jury. [1] His work would not be privileged. Would the return then be privileged?

Compliance 52

Compliance Fraud Governance 52

Health Populi

NOVEMBER 22, 2019

Several key data points under this macro finding tell the more granular story about low ROI in health spending in the U.S.: Health Populi’s Hot Points: This last chart compares gains in life expectancy (longevity) between two periods, 2002-2007 and 2012-2017. Look all the way to the left of the chart, and see that in the U.S.

Health Insurance 96

Health Insurance Doctors Governance Hospitals 96

HIT Consultant

JULY 28, 2022

Smaller companies that were raising large amounts of capital and feeling bullish about going up against the large incumbents may struggle to access capital and become prime acquisition targets for the incumbents. The healthcare IT unit is located within 3M’s larger health group, which contributed about $9B of 3M’s 2021 revenue.

US Department of Health and Human Services 98

US Department of Health and Human Services COVID-19 Health Insurance Telemedicine 98

Health Populi

JANUARY 17, 2023

For the third year in a row, citizens in most of the world see business as the most-trusted institution, above government, media, and NGOs, found in the 2023 Edelman Trust Barometer , unveiled this week at the annual World Economic Forum in Davos, Switzerland. insights along with those touching on health. In the U.S.

Public Health 85

Public Health Governance World Health Hospitals 85

Kaiser Health News

JUNE 29, 2022

Congress should crack down on Medicare Advantage health plans for seniors that sometimes deny patients vital medical care while overcharging the government billions of dollars every year, government watchdogs told a House panel Tuesday. CMS is scheduled to release the audits later this year.

Medicare 105

Medicare Medicare Governance Overpayments 105

Drug & Device Law

MAY 19, 2023

In 2007 (during the Bush Administration), Congress amended the FDCA to provide for Risk Evaluation and Mitigation Strategy (“REMS”), “to assure safe use,” which the FDA applied to mifepristone. That argument contravened the standing holdings of just about every other abortion case in history. See also GenBioPro, Inc. Sorsaia , C.A.

FDA 111

FDA Medical Personnel Telemedicine Licensing 111

Drug & Device Law

OCTOBER 23, 2023

Despite that waiver, subsequent plaintiffs have successfully converted Riegel ‘s dictum about parallel claims – that “a damages remedy for claims premised on a violation of FDA regulations” would be “‘parallel,’ rather than add to, federal requirements” – into a widely recognized exception to the broad express preemption recognized in Riegel.

FDA 59

FDA Governance Nurses Hospitals 59

Drug & Device Law

JULY 31, 2023

We have blogged several times about the somewhat esoteric issue of whether intangible items – chiefly computer software, website algorithms, and other electronic information – is treated as a “product” for purposes of imposing strict liability on their creators. 2007 WL 2460776, at *6 (D. 2007 WL 218242, at *4 (N.D. at 1291-92.

Governance 52

Governance Payment Systems Hospitals Licensing 52

Drug & Device Law

JUNE 1, 2023

2007) (quotation marks and footnote omitted). Thus, Illinois Supreme Court precedent on whether a trial court undertakes a gatekeeping role for expert witnesses is about a clear as mud. Bayside Health Ass’n Chartered , 942 A.2d 2d 579, 584 (Del. So, gatekeeping was back in Illinois, at least for qualifications. Matthews , 277 A.3d

Governance 59

Governance Hospitals 59

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. A procedural rule, such as Rule 23 governing class actions, should not, and legally cannot , change that result. Valsartan , 2023 WL 1818922, at *24.

FDA 59

FDA Governance Fraud 59

Drug & Device Law

AUGUST 8, 2022

Recently, we have become concerned about personal injury plaintiffs deciding to sue these kinds of organizations because they don’t like some standard that stands between them and the pot of gold at the end of the litigation rainbow. Furthermore, trade associations often serve to assist the government in areas that it does not regulate.

Doctors 52

Doctors Fraud Licensing Compliance 52

Drug & Device Law

FEBRUARY 20, 2023

Yet another vaccine case addressed at length the reasons why viable design alternatives for products governed by the FDCA must be limited to those that the FDA has allowed onto the market. Finally, there is no evidence in the record about the feasibility of increasing the costs of [the drug]. 2d 839, 851 (N.Y.

FDA 59

FDA Licensing Hospitals Governance 59

Drug & Device Law

APRIL 25, 2022

Back in 2010, we examined one restrictive judicial gloss on Rule 407 – a “policy” based exception that the rule somehow doesn’t apply to government-mandated measures. 2007) (quoting text of Rule 407). But [defendant’s] motive for making the change is irrelevant. Federal Insurance Co. , 3d 692, 700 (7th Cir. Earlier, in Mills v.

FDA 52

FDA Governance 52

Drug & Device Law

MAY 26, 2023

Are we down to talk about NPP and its impact on reproductive rights litigation? The oldest Supreme Court decisions we know about relating to products regulated by the FDCA or its predecessor, the Pure Food Act, are McDermott v. Both talk a fair amount about “commerce” and the respective roles of the states and federal government.

FDA 59

FDA Licensing Doctors Governance 59

Drug & Device Law

JANUARY 25, 2024

142 (2007), mere regulation of the product or conduct at issue—the medical walker is a non-prescription, Class I medical device with general controls only—is not a basis for removal under this statute. That is how plaintiff bought his medical walker and why we are talking about federal officer removal. Philip Morris Cos. ,

Medicare 52

Medicare Medicare FDA Regulatory Compliance 52

Drug & Device Law

APRIL 19, 2022

The prosecution offered up perfectly well-qualified expert witnesses who proposed to testify about a variety of things, but the one that matters for present purposes is that they intended to characterize the material at issue as “trade secrets.” July 3, 2019) (expert may not opine about “proximate cause”); Perez v. E.g. , Dalgic v.

FDA 72

FDA Governance 72

Drug & Device Law

MARCH 16, 2022

The MDL court was wrong about that because 510(k) clearance means the device was found to be substantially similar to another device with proven safety and efficacy. We have written about this excellent Arizona statute several times, including here and here. Any right to punitive damages could not have vested until she filed lawsuit.

FDA 69

FDA Governance Licensing 69

Drug & Device Law

JUNE 23, 2023

We’ve blogged before about the plaintiffs’ self-defeating “injury” definition in the Taxotere mass tort litigation. T]he applicable body of law that governs these motions is identical. She completed her therapy in 2007, more than ten years before she filed suit – that suit having been solicited by a p-side lawyer. Sanofi U.S.

Governance 59

Governance 59

Drug & Device Law

FEBRUARY 22, 2024

This “keep selling” theory found some traction in two 2007 decisions, Abigail Alliance for Better Access to Developmental Drugs v. 2007) (en banc), and CareToLive v. Ohio 2007), but has generally failed to expand that foothold since. This is not the first time we have written about litigation related to this shortage.

FDA 52

FDA Governance 52