Jim Frederick

With a sophisticated background leading litigation, Jim Frederick defends innovative life sciences companies in pharmaceutical and medical device product liability, mass tort and consumer fraud lawsuits. Jim also represents clients in commercial litigation and appellate matters. A former Assistant U.S. Attorney in the District of Maryland, Jim wields his background investigating and prosecuting civil and criminal fraud cases to inform his defense strategy for clients.

View the full bio for Jim Frederick at the Faegre Drinker website.

Articles by Jim Frederick:


Significant Drug & Device Developments of 2025

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As we welcome the new year, it is time to reflect on some of the most significant legal developments in the drug and device space in 2025.

1. Navigating a New Skepticism in Science

Not long ago, the average American likely could not name the U.S. secretary of health and human services. Yet, following this year’s change in administration and major shakeup in the regulatory landscape, skepticism in science has become the elephant in the room for anyone working in the drug and device sphere. Practitioners should start thinking about how to present scientific evidence to juries in 2026 as the old norms may no longer apply.

Read the full article on the Faegre Drinker website.

New EU Product Liability Directive Published in Official Journal

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The countdown has begun towards the transformed European product liability landscape! The recently adopted European Union Product Liability Directive (PLD) was published in the Official Journal of the European Union today. Transposition of the PLD into domestic law of the EU member states must be completed by December 9, 2026. As we previously discussed, products put on the market after December 9, 2026, will be subject to the new PLD, while products placed on the market prior to this date will be subject to the laws currently in place.

Further information about the new PLD (including new risks and opportunities for businesses operating in the EU) can be found in our previous updates here and here. Faegre Drinker will continue to monitor developments as the member states transpose the PLD and the new rules take shape.

FDA Publishes New Artificial Intelligence & Medical Products White Paper

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On March 15, the United States Food & Drug Administration published a white paper entitled “Artificial Intelligence & Medical Products: How CBER, CDER, CDRH, and OCP are Working Together.” FDA announced the paper by sharing a short letter from Commissioner Califf, where he reaffirmed the Agency’s commitment to “promoting the responsible and ethical development, deployment, use, and maintenance of safe and effective medical products that incorporate or are developed with AI.” The white paper does not contain any new pronouncements of FDA position, but refers to existing guidance and serves as a reinforcement for existing FDA policy regarding AI.

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Pressure is Rising: Continued Moves to Ban or Limit Natural Gas Appliances

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We continue to track litigation and legislations involving proposed or enacted bans or limitations on natural gas appliances. As anticipated, this area continues to evolve, and we are finding increased litigation regarding the enforceability of such laws, as well as the safety of natural gas appliances. We previously discussed the efforts to electrify America’s natural gas infrastructure in various markets here. This article provides updates and explains several nuances to these electrification efforts.

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Enforcement of Representative Actions is Here

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It’s finally here.  Enforcement of the Collective Redress / Representative Actions Directive (RAD) in the EU has now begun.  At this time, six member states have adopted a national translation of this law and nineteen states are engaged in ongoing discussion and drafting.  The landscape is changing rapidly and our team is tracking these developments.

Are you ready for this shift in litigation culture?  Backed and supported by the growing EU third party litigation funding industry, the RAD will provide an unprecedented procedural mechanism to bring class and consumer actions on a mass scale against EU traders.  These actions can be premised upon one or more of 66+ substantive regulations that cover everything from the finance industry to environmental regulations to product and artificial intelligence liability.  If you have not prepared, now is the time.

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EU Publishes General Product Safety Regulation – Full Enforcement to Commence in December 2024

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On May 23, 2023, the European Commission formally published the new General Product Safety Regulation, which reforms a variety of product safety regulations for manufacturers doing business in the European Union (EU) and its 27 member states. The European Parliament adopted the text of the regulation on March 30, 2023, and the European Council adopted it on April 25, 2023, but its official publication yesterday triggers the implementation and enforcement deadlines. Specifically, the regulation takes effect on June 12, 2023 (20 days from yesterday) and will include an 18-month transitionary period for EU member states, companies subject to the regulation and other actors to implement the new and revised regulations. Full enforcement begins December 13, 2024, after the conclusion of the transition period.

The regulations have been under consideration for many years and represent a major overhaul of product safety regulation in Europe. Product manufacturers should review the full set of regulations carefully and make any necessary adjustments to their procedures and processes to be in compliance with the new regulations before full enforcement takes effect on December 13, 2024. Among other things, the new General Product Safety Regulations include new requirements related to adverse event reporting, pre-market risk assessments, safety recalls, and product labeling and documentation. For example, manufacturers will be required to report “accidents caused by a product” “without delay” if the product is involved in an incident resulting in death or “serious adverse effects on health and safety.” Meanwhile, operators of online marketplaces are subject to an even more broadly worded requirement to report “accidents caused by a product … resulting in serious risk or actual damage of the health or safety of a consumer,” which extends the reporting requirement beyond incidents of actual injury.

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