The Health Law Firm

JANUARY 17, 2013

A group of doctors accused of performing an unusually high number of heart procedures on patients at an Ohio hospital has settled a whistleblower lawsuit, according to the Department of Justice (DOJ). Leider, J.D., Attorney, The Health Law Firm. Click here to read the press release from the DOJ.

Hospitals 40

Hospitals Doctors Medicare Medicare 40

HIT Consultant

JUNE 7, 2023

Clinical protocols improve the quality of clinical decisions by offering explicit recommendations for clinicians who are uncertain about how to proceed, overturning the beliefs of doctors accustomed to outdated practices, and providing evidence-based recommendations that reassure practitioners about the appropriateness of their treatment policies.

Hospitals 98

Hospitals Compliance Electronic Medical Records Patient Satisfaction 98

Health Populi

AUGUST 21, 2019

The most-trusted touch-point among Medicare Advantage members, by far, is the doctor or care provider valued by virtually everyone polled (94%). As digital immigrants, older people are, in the words of Prensky’s 2001 observation, “now in the process of learning a new language.”

Medicare 81

Medicare Medicare Health Outcomes HIPAA 81

Health Populi

JUNE 13, 2018

” That was written in the 2001-2010 period of healthcare spending, so an old story giving me feelings of déjà vu. In 2007, the year I launched Health Populi , the inaugural post focused on just this issue; the post was titled, “Health care is the #1 line item in our national economy…and taking more out of your pocket.”

Medicaid 63

Medicaid Medicaid Health Insurance Medicare 63

HIT Consultant

JANUARY 23, 2023

Prior to launching Snedden Campbell, in 2001, he held senior roles for some of the UK’s biggest recruitment companies. About Ivor Campbell Ivor Campbell is the CEO of Snedden Campbell , a UK-based recruitment agency for the global medical technology industry. IvorIvor has been in a candidate search for more than 30 years.

Telemedicine 97

Telemedicine Hospitals Doctors Governance 97

SQA

MAY 17, 2022

Requirements for classification and related issues established under RDC 185/2001, as well as other relevant medical device regulations, will apply for SaMD, as well. Patients currently taking the products should consult with their doctor or healthcare provider about alternative treatment options.

FDA 75

FDA Compliance Informed Consent Hospitals 75

Bill of Health

SEPTEMBER 1, 2023

While it is not compulsory for the employee to take these 4 months of unpaid leave, the Act states further that the woman cannot return to work earlier than 6 weeks after giving birth, unless her doctor certifies that she is able to do so.

Health Insurance 157

Health Insurance Public Health Doctors 157

Hall Render

JULY 14, 2023

Stephen Dolter, CMIO of Omaha’s Children’s Revised proposal for Lincoln senior living home satisfies planners, but not neighbors NEVADA Expanded hospital seeks to make dent in Southern Nevada’s mental health needs Doctor explains Southern Nevada medication shortage Nevada secures $285M opioid settlement with Walgreens Sen.

US Department of Health and Human Services 40

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

Drug & Device Law

AUGUST 28, 2023

341 (2001), is so important. Even worse is standing based on the “considerable mental and emotional stress on emergency-room doctors,” purported injury from “divert[ing] time and resources away from their ordinary practice to treat [adverse reaction] patients, and even the possibility of increased malpractice insurance costs.

FDA 52

FDA Doctors Malpractice COVID-19 52

Drug & Device Law

SEPTEMBER 11, 2023

341 (2001), is so important. Even worse is standing based on the “considerable mental and emotional stress on emergency-room doctors,” purported injury from “divert[ing] time and resources away from their ordinary practice to treat [adverse reaction] patients, and even the possibility of increased malpractice insurance costs.

FDA 59

FDA Doctors Malpractice COVID-19 59

Drug & Device Law

DECEMBER 4, 2023

2001). “[A] federal court in a diversity case should be reluctant to expand state common law.” Taking the good doctor first, In re Philips Recalled CPAP, Bi-Level Pap, & Mechanical Ventilator Products Litigation , 2023 WL 7019667 (Sp. 341 (2001). 2001), aff’d , 358 F.3d Camden County Board of Chosen Freeholders v.

Fraud 52

Fraud FDA Hospitals Doctors 52

Drug & Device Law

JULY 24, 2023

341 (2001). Without any consideration of what actual doctors did for actual patients with actual diseases, all that was proven was the maxim “garbage in, garbage out.” It is not clear that [defendants] will − or even can − avail themselves of a TPP-by-TPP causation defense using doctor-by-doctor testimony.

Fraud 52

Fraud FDA Doctors 52

Drug & Device Law

MARCH 31, 2022

2001) (“irrespective of the theory of recovery. . . Thus, the two sides of the Baltimore opinion remind us of the classic “ The Strange Case of Doctor Jekyll and Mister Hyde.” E.g. , Ford Motor Co. General Accident Insurance Co. , 2d 362, 370 (Md. The first part is rational, restrained, and full in accord with governing precedent.

Governance 52

Governance FDA Doctors Hospitals 52

Drug & Device Law

AUGUST 22, 2022

She also tried to sue three new defendants – a doctor, a medical society and the FDA itself. 341 (2001). This time, plaintiff pleaded “1) violation of [defendant’s] premarket approval; 2) breach of implied warranty; and 3) lack of informed consent (failure to warn).” Id. Plaintiffs Legal Committee , 531 U.S. 2019 WL 6766574, at *3.

Informed Consent 59

Informed Consent FDA Doctors 59

Drug & Device Law

JUNE 6, 2022

Because we encountered many stand up learned intermediary surgeons in the Bone Screw litigation, several of the relatively early decisions from the 1999-2001 timeframe are Bone Screw cases. Further, “both doctors testified that they still prescribe [the drug] for patients with conditions similar to plaintiff’s condition.”

FDA 59

FDA Doctors Malpractice Medical Personnel 59

Drug & Device Law

MAY 30, 2022

The law presumes that licensed doctors know what they are doing. 1978), where a hypertensive patient was injured after being injected with the defendant’s drug – despite warnings that “expressly directed the doctor administering the drug to refrain from giving it to a patient with hypertension.” 2001), aff’d , 358 F.3d

Doctors 59

Doctors Licensing Informed Consent Hospitals 59

Drug & Device Law

JANUARY 12, 2024

The FDA approved the defendant’s first TDF drug in 2001, and the company started its first clinical trial on a different compound—tenofovir alafenamide (“TAF”)—about a year later. By the time, however, the cases progressed to summary judgment, the plaintiffs were not claiming any defect in TDF.

FDA 105

FDA Doctors 105

Drug & Device Law

NOVEMBER 9, 2023

341 (2001)), calls “off-label use,” so we go with the majority naming convention. That’s a significant step forward, since it aligns the FDA’s view of permissible science more closely to what doctors (and Medicare) actually rely on in clinical situations. Plaintiffs Legal Committee , 531 U.S. T]he studies or analyses. . .

FDA 64

FDA Health Insurance Nurses Medicare 64

Drug & Device Law

FEBRUARY 11, 2024

Doctors Who Perform Abortions: Their Characteristics & Patterns of Holding & Using Hospital Privileges,” 6. 9 (“Longitudinal” for the proposition that “adverse events from chemical abortion drugs can overwhelm the medical system and place ‘enormous pressure and stress’ on doctors during emergencies and complications”), at *14 n.22

FDA 59

FDA Fraud Pharmaceutical Industry Doctors 59

Drug & Device Law

AUGUST 11, 2023

We’re not doctors, we just play them on TV.) 341 (2001), state tort claims are inappropriate vehicles for criticizing what the FDA considered in making a regulatory decision or the conclusion it reaches.) At least that was our take-away. Note: Don’t take medical advice from lawyers. Which brings us around to Novotney v.

FDA 52

FDA Fraud Doctors 52

Drug & Device Law

OCTOBER 26, 2023

341 (2001) (a Bone Screw case). Plaintiffs point to no FDCA requirement that such information be included in an order for medicine to be delivered to the doctor who ordered it. Moreover, “it would be nonsensical to require directions for patient use for a drug that is injected into the patient by a doctor in a clinical setting.”

FDA 59

FDA Doctors 59

Drug & Device Law

FEBRUARY 1, 2022

341 (2001) as impermissible attempts at private enforcement of the FDCA. The court did dismiss plaintiff’s breach of express warranty claim because plaintiff failed to allege that any of the “purported warranties” were made to her or her doctor and for lack of the required pre-suit notice. Plaintiffs’ Legal Comm. , The court agreed.

Fraud 59

Fraud FDA Doctors 59

Drug & Device Law

DECEMBER 9, 2022

And the court agreed, finding that “the undisputed facts reflected that [the doctor] testified she read the IFU, relied on the warnings provided by [the defendant], believed she had a comprehensive informed consent process, and would have passed on a warning about the risk of severe and chronic pain to patients. 2001), aff’d sub nom.

Doctors 64

Doctors Fraud Informed Consent 64