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.

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.

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.

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.

Liability Protections Under Consideration for Businesses Set to Reopen During the COVID-19 Pandemic

With the Senate set to return from recess on Monday, liability protections related to the COVID-19 pandemic are anticipated to be a hot button issue. While state and local governments are seeking financial aid from the federal government to assist in their battle against the COVID-19 pandemic, relief packages may also include protection from future legal actions against businesses.

As stay-at-home restrictions are beginning to be lifted, and businesses are starting to reopen, there are concerns that employees and customers will file suit against businesses, claiming that they were infected with COVID-19 as a result of the businesses’ failure to take appropriate measures to protect them once reopening occurs. This fear is likely in response to lawsuits that have already arisen against businesses related to COVID-19. For instance, earlier this month, a Celebrity Cruises crewmember, who contracted COVID-19 while working on a Celebrity ship, filed a proposed class action alleging that the cruise company failed to take adequate measures to protect the employees on its ships.[1] The crewmember filed the proposed class action in a Florida federal court, claiming that the cruise company failed to follow safety precautions after receiving notice that COVID-19 was or was likely present on the ships, such as permitting crewmembers to continue to eat in a buffet setting, and mandating crewmembers’ participation in shipboard drills.[2] Continue reading “Liability Protections Under Consideration for Businesses Set to Reopen During the COVID-19 Pandemic”

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.

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”

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.

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.

Read more in the Beauty and Cosmetics category of the Duane Morris Fashion, Retail and Consumer Branded Products blog.

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The opinions expressed on this blog are those of the author and are not to be construed as legal advice.

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