News & Analysis as of

Patient Safety

Economists’ Rx for MDs’ legal wellbeing? Practice better medicine

In the battles between lawyers and doctors over malpractice lawsuits filed by patients harmed while seeking medical services, it may be worth heeding economists’ prescription for caregivers: Physicians, heal thy selves....more

What Does the Cures Act Really Mean for Patients?

When signed by President Obama last December, the 21st Century Cures Act—which was the culmination of seven revisions written after the House of Representatives first introduced it in January 2015—was applauded by some as a...more

Health Care Perspectives

With deep experience in the health care industry and a comprehensive understanding of its diverse participants, Katten attorneys serve as conference moderators and panelists, host accredited events, and produce webinars to...more

Florida Supreme Court Rejects PSQIA Preemption of Florida Constitution

On January 31, 2017, the Florida Supreme Court held that adverse medical incident reports produced in accordance with Florida law cannot constitute confidential and privileged patient safety work product (PSWP) under the...more

And Now – From the Same Court That Gave Us Engle….

by Reed Smith on

That’s Engle v. Liggett Group, Inc., 945 So. 2d 1246 (Fla. 2006), the most bizarre use of res judicata that we’ve ever seen – giving preclusive effect to a class action verdict despite also finding that the class was not...more

Advocating for Patient Safety: Coalition for Patient Vision Care Safety submits comments in response to FTC Proposed Rule...

The Coalition for Patient Vision Care Safety (“Coalition”) is a group of health care providers, medical device manufacturers and academic institutions dedicated to ensuring the safe and appropriate use of contact lens so that...more

Amendment 7 Stands Its Ground Against the Federal Patient Safety and Quality Improvement Act

by BakerHostetler on

It is well known in Florida that Article X, Section 25 of the Florida Constitution (Amendment 7) provides patients with access to any adverse medical incident report (even involving other patients) created by healthcare...more

Client Alert: Florida Supreme Court Broadens Patient Access to Adverse Incident Reports

A recent decision by the Florida Supreme Court has significant implications regarding certain adverse incident reports previously viewed as outside the scope of permitted discovery. Florida health care providers currently...more

Amendment 7 Prevails Over Patient Safety Work Product Protections

by Carlton Fields on

On January 31, the Florida Supreme Court ruled that the “Patient Safety Work Product” privilege cannot shield Florida health care providers from Amendment 7 requests. The court’s decision in Charles v. Southern Baptist...more

Florida Supreme Court: Federal PSQIA Does Not Pre-empt State's Constitution

by Holland & Knight LLP on

In Charles v. Southern Baptist Hospital of Florida, Inc., published on Jan. 31, 2017, the Florida Supreme Court held that the federal Patient Safety and Quality Improvement Act (PSQIA) is not and was never intended to be a...more

FDA bans powdered gloves in human, animal medicine

by Thompson Coburn LLP on

Effective Jan. 18, 2017, the federal Food and Drug Administration has, by implementation of a final rule, banned the use of powdered gloves by a physician when treating humans or animals. Powdered gloves are now added to the...more

The AHA’s Letter to Santa Claus

The American Hospital Association, after having been “nice” all year, penned its letter to Santa Claus with its wish list for Christmas. Its four page letter (actually addressed to President-Elect Donald Trump at 1717...more

What are experts saying about Stryker Accolade V40?

Stryker Accolade V40 LFIT Hip Implant Dissociation - Over the past few years, various orthopedic surgeons around the country and their patients have faced a catastrophic failure of Stryker’s Accolade and V40 LFIT hip...more

Are Stryker V40 Femoral Heads (CoCr) Defective?

Stryker V40 Femoral Heads (CoCr) Associated With Spontaneous and Catastrophic Head-Neck Dissociation - Stryker may face yet another crisis associated with their total hip replacement medical devices – and this time it...more

Australia Concerned About Stryker Made LFIT Femoral Heads

On September 27, 2016, the Department of Health Therapeutic Goods Administration (the Australian equivalent of the Food & Drug Administration) issued a hazard alert relating to LFIT Anatomic CoCr V40 femoral heads...more

Missed Opportunity by The Supreme Court to Address the Erosion of Hospital Self-Review Privileges

by Barley Snyder on

In Tibbs v. Bunnell, the U.S. Supreme Court recently denied a hospital’s petition for certiorari to review the scope of the patient safety work product privilege. The hospital appealed from a Kentucky Supreme Court decision...more

OIG Examines Adverse Events in Rehab Hospitals

by Reed Smith on

According to a recent HHS Office of Inspector General (OIG) report, about 29% of Medicare beneficiaries experienced adverse or temporary harm events during their rehabilitation hospital stay, based on sample of 417...more

HHS guidance seeks to clarify scope of PSQIA

On May 24, 2016, the Department of Health & Human Services (HHS) issued guidance (Guidance) to health care providers and patient safety organizations (PSOs) in an attempt to clarify the definition of patient safety work...more

EU Reaches Deal on New Medical Device Regulations

The European Parliament and European Council recently jointly announced an agreement regarding new rules on medical devices and in vitro diagnostic medical devices. The process that lead to the agreement began in 2012. ...more

Illinois Supreme Court Upholds "Willful and Wanton" Immunity Protection in Peer Review Cases

Background - Dr. Steven Valfer is a licensed OB-GYN who was a member of the medical staff at Evanston Northwestern Hospital ("Hospital") until March 16, 2005 when the Hospital's board of directors approved the...more

Dental Malpractice May Be Painfully Underreported

by Howard Ankin on

Dental malpractice cases are often unreported because patients may not understand how to report dental mistakes. Insurance companies that represent dentists do not release details about cases. The statute of limitations also...more

CMS Releases Nursing Home Action Plan for 2016/2017

by Reed Smith on

The CMS Survey and Certification Group has released its 2016/2017 Nursing Home Action Plan, which details the agency’s strategy for continuing to improve nursing home quality. The plan focuses on five strategies for quality...more

Is Sponsor-Submitted Clinical Data Safe?

The U.S. Food and Drug Administration has a tricky task at hand when it comes to reviewing, evaluating, investigating and eventually approving prescription medications. Yes, the agency has a mission to ensure patient safety,...more

Safety Troubles in Hospital Compounding Pharmacies

We wrote yesterday about contamination at the pharmacy of the NIH Clinical Center in Bethesda. Other big hospitals, judging by media reports, also may need to look at their pharmacy operations, especially when they compound...more

NIH takes stronger steps to improve patient safety at Bethesda Clinical Center

Federal officials have decided to sweep out the executive ranks at the flagship hospital of the National Institutes of Health in Bethesda, this after a blue-chip investigating committee rebuked the institution and declared...more

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