Topic Archives: Product Liability + Class Action

May 8, 2020 - COVID-19, FDA, Medical Devices + Diagnostics, Product Liability + Class Action, United States

COVID-19 Alert: FDA updates antibody test policy

By: Bethany J. Hills, Erin M. Bosman, Julie Y. Park, and Daniela Peinado Welsh

Serology tests could play a critical role in the fight against COVID-19. Serology tests may help determine who can donate convalescent plasma—a part of the blood containing antibodies—which is currently being explored as an investigational treatment for those with COVID-19. Convalescent plasma has been …›

April 22, 2020 - Biotech, COVID-19, FDA, Healthcare, Medical Devices + Diagnostics, Pharma, Product Liability + Class Action, United States

FDA Uses EUAs Broadly In The Fight Against Covid-19

By: Bethany J. Hills, Julie Y. Park, Anastasiya V. Menshikova, Anthony Michael Parenti, and Hilary R. Hoffman

On February 4, 2020, the Secretary of the Department of Health and Human Services (HHS) determined, pursuant to section 564 of the Federal Food, Drug and Cosmetic (FD&C) Act, that there is a significant potential for a public health emergency related to the novel …›

April 21, 2020 - COVID-19, FDA, Healthcare, Product Liability + Class Action

HHS Guidance Broadens PREP Act Immunity, Tightens Focus on Public/Private Cooperation

By: Erin M. Bosman, Julie Y. Park, and Alexander A. Najarian

On April 14, the U.S. Department of Health and Human Services (HHS) issued an advisory opinion on the Public Readiness and Emergency Preparedness (PREP) Act to clarify the scope of immunity that accompanies developing and deploying countermeasures to COVID-19. The PREP Act grants tort liability …›

April 9, 2020 - Biotech, COVID-19, FDA, Healthcare, Medical Devices + Diagnostics, Pharma, Product Liability + Class Action, United States

CARES Act of 2020: Guide for Drug and Device Companies

By: Stephanie L. Blij and Bethany J. Hills

The Coronavirus Aid, Relief, and Economic Security (CARES) Act (or “the Act”) is an unprecedented $2 trillion economic stimulus package passed to help mitigate the economic and health consequences caused by the COVID-19 pandemic and to strengthen the U.S. health system going forward. …›

March 31, 2020 - COVID-19, FDA, Healthcare, Medical Devices + Diagnostics, Product Liability + Class Action, United States

FDA Inspires Modifications and Quick Authorizations for Ventilators

By: Erin M. Bosman, Julie Y. Park, Bethany J. Hills, Hilary R. Hoffman, and Alexander A. Najarian

As the number of COVID-19 cases in the U.S. grows, the potential shortage of ventilators has become an increasing concern. This week, the U.S. Food and Drug Administration (FDA) took two important steps to keep medical facilities equipped with life-saving ventilators. Read our Class Dismissed …›

March 23, 2020 - COVID-19, FDA, Medical Devices + Diagnostics, Product Liability + Class Action

Prep Act Declaration Emboldens Drug and Device Industry to Innovate In the Face Of a Growing Crisis

By: Erin M. Bosman, Julie Y. Park, and Alexander A. Najarian

COVID-19 is, quite literally, putting the medical supply industry to the test. Manufacturers are being pushed to develop novel products like therapies and vaccines to combat the disease as quickly as possible. The Public Readiness and Emergency Preparedness (PREP) Act encourages drug and medical …›

March 22, 2020 - COVID-19, Healthcare, Product Liability + Class Action, United States

FDA and FTC Send Warning Letters to Companies Marketing Products to Treat Coronavirus (COVID-19); State Attorneys General Follow Suit

By: Erin M. Bosman, Julie Y. Park, Bethany J. Hills, Suzy Marinkovich, and Daniela Peinado Welsh

The rapid spread of coronavirus has spawned prolific marketing claims that any number of products can treat or prevent coronavirus. It comes as no surprise then that the Food and Drug Administration (FDA) and Federal Trade Commission (FTC) recently issued their first round of …›

September 19, 2019 - AI + Robotics, Data Analytics, FDA, Pharma, Product Liability + Class Action, Regulatory, United States

Artificial Intelligence and Pharma

By: Bethany J. Hills

Bethany Hills authored an article for PHARMAnetwork, covering how the pharmaceutical industry has been adopting artificial intelligence and machine learning. Bethany discusses that the pharmaceutical sector has been one of the more robust areas where private partnerships with artificial intelligence-based technology companies have developed. …›

July 2, 2019 - Medical Devices + Diagnostics, Product Liability + Class Action, Regulatory

Committed to Clarity: FDA’s Dedication to Transparency with the End of ASR

By: Erin M. Bosman, Bethany J. Hills, and Julie Y. Park

On June 21, the Food and Drug Administration (FDA) released a report titled “Statement on agency’s efforts to increase transparency in medical device reporting.”[1] This report describes updates to FDA’s Medical Device Reporting (MDR) Program, namely the conclusion of the Alternative Summary Reporting (ASR) …›

June 5, 2019 - Litigation, Pharma, Product Liability + Class Action, United States

Supreme Court Decides Prescription Drug Preemption Case in Favor of Drug Manufacturer

By: Erin M. Bosman, Julie Y. Park, and Benjamin S. Kagel

The United States Supreme Court finally clarified its 11-year-old “clear evidence” standard for pharmaceutical preemption. In its much-anticipated opinion delivered by Justice Breyer, the Court unanimously reversed the Third Circuit’s holding that questions of pharmaceutical preemption should be decided by juries. Merck …›