Health Care

By David Archer on June 17, 2019

There are now only three weeks before the Fifth Circuit Court of Appeals is scheduled to hear oral arguments in Texas v. United States, the latest legal front in the ongoing battle over the future of the Patient Protection and Affordable Care Act (ACA). Texas v. United States is a lawsuit focusing on the indispensability of the individual mandate, which required most Americans to maintain “minimum essential” health insurance coverage, to the rest of the…

Legal Topics in Healthcare

Does the Dodd-Frank Act Impact Healthcare?

By Linda M. Mancini, Esq. on June 17, 2019

The Dodd-Frank Wall Street Reform and Consumer Protection Act of 2010, (Public Law 111-203), contains a “sweeping series of core provisions” to reform federal oversight of the financial services industry. The Act includes amendments to exiting consumer protection, banking, derivatives and securities industries. Dodd-Frank was not written with the healthcare sector in mind and does not contain any general provisions applicable to healthcare. However, there may be a “spillover” effect. This Act was a…

BioSlice Blog

EMA releases draft guidelines on drug-device combinations

By Jackie Mulryne & Daisy Bray on June 17, 2019

On 3 June 2019, the European Medicines Agency (EMA) launched a public consultation on a draft guideline providing guidance on the quality dossier requirements for Drug-Device Combinations (DDCs) in the context of a marketing authorisation or post-authorisation application. DDCs are human medicines that include a medical device. The guideline covers those devices that are necessary for the administration, dosing or use of the medicine. They can be integral, co-packaged or referred to in the product…

DC Medical Malpractice & Patient Safety Blog

For Insys, infamy in two opioid crisis firsts: convicted founder and bankruptcy

By Patrick A. Malone on June 16, 2019

Insys Therapeutics, a drug maker that peddled powerful and addictive painkillers in sordid ways, entered yet another phase of its penalties for its criminal conduct: The firm in quick fashion agreed first to pay $225 million to resolve federal bribery charges, then promptly sought bankruptcy protection. Federal prosecutors, who earlier had won criminal racketeering convictions against the firm’s CEO and other Insys executives, emphasized that the Big Pharma firm hasn’t declared itself insolvent in its…

DC Medical Malpractice & Patient Safety Blog

For Insys, infamy in two opioid crisis firsts: convicted founder and bankruptcy

By Patrick A. Malone on June 16, 2019

Bill Madden's Blog

Expert evidence complaints: HCCC NSW

By Bill Madden on June 15, 2019

An article by Robertson, Clark & Davoren (ABC news) suggests that the Health Care Complaints Commission (NSW) has said that it does not have the power to investigate complaints about medical practitioners providing reports, in the context of Family Court proceedings. The article states: In the case of the Sydney psychiatrist, up to a dozen parents made complaints to the Health Care Complaints Commission (HCCC), accusing him of “placing the public at risk” with his Family Court…

Bill Madden's Blog

Notice to produce: Facebook records

By Bill Madden on June 15, 2019

Gavan v FSS Trustee Corporation [2019] NSWSC 667 arose in the context of a TPD insurance claim. The interlocutory decision considered an application to be excused from compliance with a Notice to Produce for: 1. A copy of this Notice to Produce and the notice and declaration completed by you. 2. All ‘Records’ from your Facebook account, irrespective if it is currently active, de-activated or suspended, from 17 March 2009 to date, irrespective of what ‘screen name’ you…

Bill Madden's Blog

Whether NDIS can fund supports more appropriately provided but not actually offered by other health services

By Bill Madden on June 15, 2019

Burchell and National Disability Insurance Agency [2019] AATA 1256 concerned funding for an eating plan for an applicant with dysphagia as a result of cerebral palsy and cannot swallow properly. The NDIA declined to fund the eating plan and before the Tribunal argued that the support requested is health-related, and that health-related supports will not be funded under the National Disability Insurance Scheme Act 2013 (Cth) (the Act), even if the health system does not…

Bill Madden's Blog

Identification of practitioners at high risk of complaints to health profession regulators: A further study.

By Bill Madden on June 14, 2019

A new paper by Matthew Spittal, Marie Bismark & David Studdert covers all health professions (not just medical practitioners) and uses data from AHPRA rather than the health complaints commissioners. Identification of practitioners at high risk of complaints to health profession regulators reports on a study of 715,415 registered health practitioners (55% nurses, 15% doctors, 6% midwives, 5% psychologists, 4% pharmacists, 15% other). The algorithm, PRONE-HP (Predicted Risk of New Event for Health Practitioners),…

Bill Madden's Blog

Funds management: Private or public trustee

By Bill Madden on June 14, 2019

Jane Campbell has recently written on the matter of Williams v Hoang [2019] ACTSC 144. A settlement between the parties had been approved, so the issue before the court was whether the settlement amount should be managed by a specific private trustee, or whether the monies should be managed by the default public trustee. The court accepted that long term fund management by a private trustee may be significantly more expensive than if the Public Trustee were…

Health Care

Three weeks to go until Oral Arguments in Texas v. United States

Does the Dodd-Frank Act Impact Healthcare?

EMA releases draft guidelines on drug-device combinations

For Insys, infamy in two opioid crisis firsts: convicted founder and bankruptcy

For Insys, infamy in two opioid crisis firsts: convicted founder and bankruptcy

Expert evidence complaints: HCCC NSW

Notice to produce: Facebook records

Whether NDIS can fund supports more appropriately provided but not actually offered by other health services

Identification of practitioners at high risk of complaints to health profession regulators: A further study.

Funds management: Private or public trustee

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