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:


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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It’s All Up in the Air: Recent Moves to Ban or Limit Natural Gas Appliances

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Citing the effects of carbon emissions on climate change and the potential for health risks, efforts to electrify America’s natural gas infrastructure are underway in various markets. Natural gas comprises primarily methane. Indoor appliances like gas stoves are also associated with emissions of nitrogen dioxide and carbon monoxide. The electrification efforts are making an impact at local, state, and federal levels.

At a local level, cities including Berkeley in 2019, San Francisco in 2020, and New York City in 2021, have banned certain natural gas hookups in all new building construction. San Francisco’s 2020 legislation applied to new residential and commercial building construction and required use of all-electric power. The ordinance was estimated to cover about 60% of the city’s development pipeline. It followed a similar ordinance requiring all-electric construction for new municipal projects in San Francisco.

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5 Major Drug and Device Developments of 2022

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As we ring in the new year, it is time once again to reflect on some of the most significant legal developments for drug and device companies this year. The list below is by no means exhaustive (who could forget the Rule 702 updates that took place this year, which will carry over into 2023?), but provides a brief recap and assessment of five of the most interesting and consequential developments affecting drug and device law in 2022.

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Updated EPA Analysis on Long-Term Health Effects of Formaldehyde Exposure Could Have Lasting Implications for Manufacturers

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On April 14, 2022, the Environmental Protection Agency (EPA) released draft conclusions in a report updating its analysis regarding formaldehyde exposure, suggesting that long-term exposures to small amounts of formaldehyde in the environment can increase the risk of rare head and neck tumors, leukemia, and other threats to health. The conclusions are not final agency action. Still, manufacturers should be aware of the potential for EPA’s analysis to influence both regulation and litigation at both the state and federal levels.

For over a decade, there has been much debate and study on the long-term effects of exposure to formaldehyde. The EPA’s new analysis is an update of a 2010 draft EPA report that was heavily panned by scientists, legislators, and chemical manufacturers and that drove the EPA back to the drawing board. For example, the National Academies of Sciences, Engineering, and Medicine criticized the 2010 draft EPA report for failing to describe the rationale behind its methodology and failing to sufficiently support its conclusions.

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