Since the onset of the COVID-19 pandemic, the Food and Drug Administration (“FDA”) has received more attention than perhaps ever before. While Americans anxiously awaited for approval of a COVID-19 vaccine, the FDA and its regulatory scheme were ever-present topics on the news and in social media. The American population’s newfound familiarity with the FDA is especially pertinent in a medical device litigation context. As litigators well know, jurors already enter a courtroom with preconceived notions of medical device companies, the FDA and the relationship between the two. So how will this newfound knowledge of the FDA influence juror opinions? Put another way, what would happen if a jury participating in a medical device trial failed to hear any reference to the FDA at all? Potentially, the results would be catastrophic to device manufacturers.
For as long as cars have existed, three fundamental truths appeared to be eternal. First, every car contains safety critical components, second these components are mostly metal and third, they are manufactured by one of two methods—stamping or cold forming. These eternal truths always led to an equally durable legal reality, that if the safety critical component fails the manufacturer will be liable to the injured party. It’s hard to think of a more trite and dependable set of principles. But these timeless precepts are about to become disrupted as the automotive industry continues to explore the innovation of 3D printing.
With each passing year, the long-predicted aspirational advantages of 3D printing in the life sciences industry become a reality. Forecasts of large scale printing operations at or near major hospitals are fulfilled. Visions of bioprinted organs have become a reality. 3D printing is reaching the lofty potential projected by the life sciences industry years ago. However, the topic of litigation risks with 3D printing in the life science industry is often overlooked. […]
Yet, the widespread use of additive manufacturing by companies and individuals outside of the life sciences industry also underscores the potential litigation risks with 3D printing.
The Department of Health & Human Services (HHS) has provided an omnibus advisory opinion in response to various requests for clarification of the scope of tort immunity provided by the declaration under the Public Readiness and Emergency Preparedness Act (PREP Act). The PREP Act declaration provides immunity from tort liability for various persons, products and activities in response to COVID-19, as explained in our March 17, 2020, Alert. The Coronavirus Aid, Relief and Economic Security Act (CARES Act) subsequently expanded these protections.
To read the full text of this Duane Morris Alert, please visit the firm website.
During the COVID-19 pandemic, the demand for personal protective equipment (PPE) has significantly outpaced the capabilities of the traditional supply chain. Gowns, gloves, facemasks, and face shields are valued commodities that even many healthcare providers cannot secure in this environment. While traditional supply and manufacturing chains struggle to keep up with production, industry leaders have turned to 3D printing, or additive manufacturing technology, to address this dire need. Unlike traditional manufacturing methods, companies with already established additive manufacturing technologies can more readily and efficiently adapt their productions to manufacture such PPE. 3D printing manufacturers may already have the powder or fabric necessary to manufacture PPE. They also have versatile printers. These companies simply need software and product design specifications, which allows them to begin production much more quickly than companies relying on traditional manufacturing methods that require additional raw materials and even machines and equipment.
For example, Superfeet, a shoe insert manufacturer, which typically uses 3D printing for manufacturing its products, was contacted about its ability to assist with a shortage of powered air purifying respirators (PAPR) hoods to hospitals in Washington state. The company had printers and fabric already. In just a few short days, Superfeet was making PPE.
To read the full text of the article by Duane Morris , visit the MD+DI website.