Sean Burke – Duane Morris Products Liability

September 4, 2024 by Duane Morris

Third Circuit Roundup Ruling Splits with Ninth and Eleventh Over Pesticide Product Labeling Preemption Issue

On August 15, 2024, the United States Court of Appeals for the Third Circuit held in Schaffner v. Monsanto that the plaintiff’s Pennsylvania state-law claims, which asserted that Monsanto failed to warn about alleged cancer risks presented by glyphosate (the active ingredient in the weed killer Roundup), were expressly preempted by the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA). In so holding, the Third Circuit disagreed with earlier decisions issued by the Ninth Circuit (Hardeman v. Monsanto) and the Eleventh Circuit (Carson v. Monsanto), both of which held that FIFRA did not preempt state failure-to-warn claims regarding glyphosate product labeling. This circuit split makes it more likely that the Supreme Court of the United States will ultimately take up the issue―and its eventual ruling will have significant implications on the scope of FIFRA preemption nationwide.

Read the full Alert on the Duane Morris LLP website.

August 5, 2024 by Duane Morris

CPSC Finds Amazon Liable for “Fulfilled by Amazon” Products

The U.S. Consumer Product Safety Commission (CPSC) recently found Amazon to be a “distributor” with product liability responsibility for products sold on its website. In a July 29, 2024, ruling, the CPSC said Amazon is legally responsible for over 400,000 allegedly hazardous items sold by third-party sellers on its site. Amazon.com, Inc., CPSC Dkt. No. 21-2 (July 29, 2024). This decision and order adopted many, but not all, of the determinations made by an administrative law judge during an administrative proceeding in 2023, highlighting public safety as paramount. Read the full Alert on the Duane Morris website.

June 28, 2021 by Duane Morris

The Importance of 510(k) Evidence to Ensuring a Fair Trial

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.

To read the full text of this article co-authored by Duane Morris partner Sean Burke, please visit the AdvaMed website.

January 12, 2021January 12, 2021 by Duane Morris

3D Printing and its Implications for the Auto Industry

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.

To read the full text of this article by Duane Morris partners Sean Burke and Alex Geisler, please visit the 3DPrint.com website.

October 20, 2020 by Duane Morris

Mitigating Litigation Risks with 3D Printing in Life Sciences

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.

To read the full text of this article by Duane Morris partner Sean Burke, please visit the 3DHeals website.

April 29, 2020April 29, 2020 by Duane Morris

HHS Offers Details on Liability Immunity of PREP Act Following Passage of CARES Act

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.

April 16, 2020 by Duane Morris

Personal Protective Devices Available Through 3D Printing Process

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.