General – Page 3 – Duane Morris Products Liability

September 17, 2021 by Nicholas M. Centrella, Jr.

3rd Party Litigation Funding Must Be Disclosed Under Recent New Jersey Local Rule

On June 21, 2021, the U.S. District Court for the District of New Jersey announced that it would amend Local Rule 7.1.1 to require disclosure of any third-party litigation funding received by any party. The rule requires that, within 30 days of filing an action or of transfer into the district, all parties file a statement identifying “any person or entity that is not a party and is providing funding for some or all of the attorneys’ fees and expenses” in exchange for either “a contingent financial interest based upon the results of the litigation” or “a non-monetary result” not in the nature of a monetary loan.

The statement must contain the identity of the funder, including the name, address, and (if the funder is a corporate entity) its place of incorporation. Parties must also disclose whether the funder’s approval is necessary for “litigation decisions or settlement discussions.” If the funder’s approval is necessary, the nature of the terms and conditions of approval must also be disclosed.

Continue reading “3rd Party Litigation Funding Must Be Disclosed Under Recent New Jersey Local Rule”

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.

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 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 17, 2020 by Nicholas M. Centrella, Jr.

Order Requires Disclosure of 3rd Party Funding Information in Zantac MDL

On April 3, 2020, the United States District Court for the Southern District of Florida issued an order in the pending Zantac multidistrict litigation (”MDL”) requiring disclosure of funding arrangements and funding documentation between plaintiffs’ counsel and third-party litigation financiers. This order represents some increased traction in favor of arguments seeking to require disclosure of third-party funding arrangements in MDLs.

The Zantac MDL, In re Zantac (Ranitidine) Prods. Liab. Litig., MDL No. 2924, was originally formed by the Judicial Panel for Multidistrict Litigation on February 6, 2020. The plaintiffs sued various defendants, including manufacturer Sanofi and its distributors, alleging that the active ingredient in the heartburn medication Zantac breaks down to form a carcinogen that caused personal injuries. Included in the MDL are also six putative classes of consumers who sought refunds and economic damages based on their purchase of Zantac. Due to a number of actions already pending in the Southern District of Florida, the Panel transferred the remaining actions to that court to be assigned to the Honorable Robin L. Rosenberg.

Continue reading “Order Requires Disclosure of 3rd Party Funding Information in Zantac MDL”

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.