Podcast: Impact of COVID-19 on Pharmacist Scope of Practice: Before and After the PREP Act - Diagnosing Health Care
What Health Care Providers and Facilities Should Know About the PREP Act's "Covered Countermeasures"
COVID-19 Hospice How-To Series: The Latest on Testing and Vaccinating Employees
Addressing appellate jurisdiction in view of the collateral order doctrine, the US Court of Appeals for the Federal Circuit dismissed an appeal of a district court’s ruling denying a motion to dismiss because the district...more
From pharmaceuticals to cosmetics, preemption to expert preclusion, New York state and federal courts issued decisions in 2023, which further shaped the landscape in the medical and life sciences legal world. To prepare the...more
On May 9, 2023, HHS released a fact sheet announcing the expiration of the COVID-19 Public Health Emergency (PHE) on May 11, 2023. HHS also provided information on changes to the healthcare flexibilities issued during the...more
For the last three years, the federal government has taken considerable steps to aid providers in the fight against COVID-19. Although many of the waivers and flexibilities initiated in response to the pandemic have since...more
With the implementation of the largest adult vaccination program in U.S. history, with over 270 million people receiving at least one shot of a COVID-19 vaccine and 15 million courses of COVID-19 treatment administered, the...more
After three years, the federal public health emergency (PHE) will expire May 11, 2023. Most of the relaxed regulatory and payor standards will end on or within a few months after the deadline, including many relating to: ...more
A Federal Court has denied a nursing home’s Motion to Dismiss a claim brought by the daughter of a resident who passed away in April of 2020 due to complications from COVID-19. The facility in Pennsylvania allegedly had...more
For years, pharmacy advocates have urged policymakers to make changes to state scope of practice laws that would permit pharmacists to prescribe and administer certain tests and vaccines at the pharmacy. How has COVID-19...more
New York’s Litigation Coordinating Panel (the “Panel”) granted plaintiffs’ request to establish a coordinated proceeding for COVID-19 cases against nursing homes, skilled nursing facilities, and similar healthcare facilities....more
On July 6, the U.S. Food and Drug Administration (FDA) revised its emergency use authorization (EUA) for the COVID-19 antiviral treatment PaxlovidTM (nirmatrelvir and ritonavir) to allow prescribing by pharmacists for quicker...more
Who Needs to Know - Skilled nursing facility and nursing home operators....more
On February 22, 2022, the Ninth Circuit ruled a COVID-19 wrongful death suit brought against a nursing home is not preempted by a federal health emergency law. The court affirmed a district court’s remand order which stated...more
This week, the Ninth Circuit addresses the district court’s gatekeeping role for expert testimony and examines whether federal courts have jurisdiction over COVID-related suits against nursing homes. ELOSU v. MIDDLEFORK...more
Takeaways - Litigants will ask the Court to rule on an array of matters growing out of the COVID-19 pandemic, beyond challenges to Biden administration’s vaccine policies. The preemption of state employment laws by...more
When the estates of nursing home residents who died from COVID-19 brought negligence and wrongful death lawsuits in New Jersey state court, defendant nursing homes removed the suits to federal court under the Public Readiness...more
Why It Matters - This is the first federal circuit court ruling to address federal removal jurisdiction based on PREP Act immunity. Although the nursing home lost its removal argument, the Third Circuit’s opinion may...more
The U.S. Food and Drug Administration's ("FDA") approval of the Pfizer vaccine under a new brand name, Comirnaty, created a cascade of legal and regulatory issues for prescribers, pharmacies, and other vaccine administrators....more
Vaccine mandates are the subject of much discussion and controversy in nearly every industry, both in America and abroad. As protests rage across the country, many workers question the ability of employers to mandate...more
During the past 12 months, we’ve published several articles on the 10 March 2020, Public Readiness and Emergency Preparedness Act (PREP Act) Declaration related to COVID-19 as well as covering the five amendments to the PREP...more
To account for legal developments since our last FAQ concerning employer COVID-19 vaccination policies, we provide updated answers to questions and address additional questions about discrimination, wage and hour, collective...more
The Public Readiness and Emergency Preparedness Act (PREP Act) may provide immunity to product manufacturers and premises owners who face liability from their administration or use of antivirals, drugs, biologics,...more
The Secretary of the U.S. Department of Health and Human Services (HHS) has issued the Eighth Amendment to the Declaration Under the Public Readiness and Emergency Preparedness Act (“PREP Act”) for Medical Countermeasures...more
New Sustainable Batteries Regulation: Reflections from our Global Products Law team Following the closure of the European Commission’s recent consultation period, the European Parliament and Council are set to consider a...more
On July 19, 2021, the U.S. Department of Health & Human Services (HHS) issued a Renewal of Determination that a Public Health Emergency Exists extending the federal COVID-19 public health emergency (PHE) for another ninety...more
As COVID-19 disproportionately impacted our most vulnerable populations, long-term care facilities (LTCFs) were placed in the unenviable position of triaging around the novel virus, combatting supply shortages, and coping...more