Duane Morris – Page 3 – Duane Morris Products Liability

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.

June 12, 2020 by Duane Morris

New FDA Compliance Program Details FDA Expectations for Inspections of CDER- or CDRH-Led Combination Product Manufacturers

On June 4, 2020, the U.S. Food & Drug Administration implemented a compliance program, which explains how CGMP requirements are to be applied to combination products, the subject of a final guidance issued in January 2017. In particular, the new program document focuses on providing a framework for conducting inspections of manufacturers of single-entity and co-packaged finished combination products—led by either the Center for Drug Evaluation and Research or the Center for Devices and Radiological Health—that include both (i) drug and device; or (ii) biological product and device constituent parts. In addition, because the underlying 2017 Guidance was issued by OPD, CBER, CDER and CDRH collectively, the same principals would like apply to inspections in which CBER is the lead center.

To read the full text of this Duane Morris Alert, please visit the firm website.

June 12, 2020 by Duane Morris

Third Circuit Seeks Help Deciphering Pennsylvania Strict Liability Law

On June 2, 2020, the Third Circuit, sitting en banc, took the unusual step of asking the Pennsylvania Supreme Court to decide a novel question of state law on strict liability for defective products sold through e-commerce websites in a case that will shape the future of products liability and online sales.

To read the full text of this Duane Morris Alert, please visit the firm website.

June 2, 2020 by Duane Morris

Two New Guidances from FDA for Investigational New Drug Applications and Clinical Trial Expectations for Drugs and Biological Products Proposed for Use Against COVID-19

On May 11, 2020, the FDA issued two new guidances for industry and investigators of drugs and biological products proposed for use against COVID-19. These two guidances, “COVID-19 Public Health Emergency: General Considerations for Pre-IND Meetings Requests for COVID-19 Related Drugs and Biological Products” and “COVID-19: Developing Drugs and Biological Products for Treatment of Prevention,” provide insight into the expectations of the FDA regarding new treatment drug development programs in the fight against COVID-19.

To read the full text of this Duane Morris Alert, please visit the firm 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 22, 2020April 23, 2020 by Duane Morris

Artificial Intelligence and Machine Learning-Based Medical Devices: A Products Liability Perspective

Artificial intelligence (AI), once little-known outside of academic circles and science fiction films, has become a household phrase. That trend will continue to expand as the public becomes more exposed to AI technology in everyday products, ranging from their cars and home appliances to wearable devices capable of tracking the metrics of their everyday routines. Perhaps no facet of AI has sparked observers’ imaginations more than machine learning (ML), which is precisely as it sounds: the ability of computer programs to “automatically improve with experience.” Machine learning lies at the heart of the kind of independent and superhuman computer power most people dream of when they consider AI.

While the public’s imagination is free to run wild with the promises of ML—creating an appetite that will no doubt be met with an equal and opposite response from businesses around the world—traditional policy and law-making bodies will be left with the task of trying to adapt existing legal and regulatory frameworks to it. Therefore it bears consideration how existing products liability norms might apply to AI/ML-based products, if at all, and what sort of uncertainties may arise for product manufacturers, distributors, and sellers. No enterprise better illustrates the careful balance between the endless potential of AI against the unique risks of products liability concerns than the medical device industry. This article discusses the uses and unique benefits of AI in the medical device context, while also exploring the developing products liability risks.

To read the full article by Duane Morris partner Matthew Decker, visit the MD+DI 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.

February 3, 2020February 5, 2020 by Duane Morris

Testing Methods for Asbestos in Talc Will Be Subject of FDA Public Forum

On January 9, 2020, the U.S. Food and Drug Administration announced that it will host an all-day public forum to discuss testing methods for asbestos in talc and cosmetic products containing talc on February 4, 2020.

According to the FDA, the purpose of the meeting is to discuss testing methods, terminology, and criteria that can be used to characterize and measure asbestos, as well as what the FDA preliminarily states may be “other potentially harmful elongate mineral particles (EMPs)” that may contaminate talc and cosmetics products that contain talc.

February 3, 2020February 3, 2020 by Duane Morris

The Business of 3D Printing: Medicine, Dentistry and Metals

Duane Morris partner Sean Burke will be speaking at the Additive Manufacturing Strategies’, “The Business of 3D Printing: Medicine, Dentistry and Metals,” on February 11, 2020.

To register for the event, visit the AMS website.

January 14, 2020 by Duane Morris

Why Reformers Want Disclosure Of 3rd-Party MDL Funding

It is no secret that third-party litigation funding, or TPLF, has become an increasingly common practice. One area particularly affected by this trend is that of mass tort actions and multidistrict litigations, where funding is now more than ever being utilized to finance voluminous and prolonged proceedings.

While courts have historically been reluctant to require disclosure of funding agreements and information, precedent suggests that different approaches may be warranted in the MDL context because of considerations unique to those proceedings — including potential for bias, distortions of control and decision-making as between litigants and funders, and conflicts of interest between funders and the judiciary.

Against this backdrop, advocates of disclosure have taken a proactive role in seeking further changes to rules of discovery and disclosure to address these issues. Litigants should be aware of these emerging efforts toward change, and the reasons underlying them, as the use of litigation funding continues to rise.

To read the full text of this article by Duane Morris attorneys Anne A. Gruner, Justin M. L. Stern and Nicholas M. Centrella Jr., please visit the firm website.