Category: Regulatory

In Case You Missed It – Summer 2023

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Catch up on the latest developments of interest for product manufacturers. Here’s a quarterly compilation of the most popular blog posts on Faegre Drinker on Products.


Experts Who Cannot Articulate a Standard Cannot Opine That a Defendant Failed to Meet the Standard

By Eric M. Friedman

Burns v. Sherwin-Williams Co. is the latest in a line of cases that apply variations on a simple, common-sense theme — an expert who cannot articulate the applicable standard should not be allowed to opine that a defendant failed to meet the applicable standard. Such testimony is not a “shaky but admissible” opinion to be attacked on cross-examination; it is internally inconsistent, is inherently unreliable, and should be excluded under Rule 702.

Courts Are Citing the Rule 702 Amendments — And Litigants Should, Too

By Christin Jaye Eaton and Eric M. Friedman

Though the pending amendments to Federal Rule of Evidence 702 have not officially taken effect yet, courts already have begun to cite them, echoing the Advisory Committee’s sentiment that the amendments will not change the substance of the law as it was meant to be applied, but that many courts have not been applying it correctly. Litigants should follow suit, citing both the amendments and the Advisory Committee’s notes to alert courts that old precedent — particularly “weight, not admissibility” cases — may not be consistent with newly amended Rule 702.

Can a Treating Physician Opine on Causation? Eleventh Circuit Says It’s About Intent, Not Content

By Eric M. Friedman and Ross W. Johnson

Rule 26(a)(2)(B) requires witnesses who are “retained or specially employed to provide expert testimony in the case” — i.e., “retained” experts — to prepare and sign a report that discloses “a complete statement of all opinions the witness will express and the basis and reasons for them.” In contrast, Rule 26(a)(2)(C) imposes less arduous disclosure requirements on non-retained experts and calls on the party, not the expert, to make those disclosures. As the Eleventh Circuit recently noted in Cedant v. United States, “an expert’s status as a retained witness depends on the original purpose of his retention.” As was the case before Cedant, litigants would be wise to support critical elements of their claims and defenses with testimony from a retained expert and not assume a court will allow a non-retained expert to supply what is needed.

EU’s Proposed Product Liability Directive – More Trick than Treat?

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Americans love a good scare on Halloween.  But, of course – with ancient castles, centuries of folklore, and actual Transylvania, our friends in the European Union know how to celebrate the spooky season just as well as we do.  Unfortunately, there’s more than ghost stories to send a shiver down your spine in the EU these days.  This month, a joint committee of the European Parliament voted on new amendments to the proposed “digital age” update of the Product Liability Directive, which was initially enacted in the 1980s.  On the one hand, the proposal seems like a treat with its efforts to modernize the product liability framework to account for the changing product landscape and to address access issues for consumers.  But many European business leaders caution that this is more trick than treat.  Among other things, there are concerns that the traditional burden of proof requirements and safeguards on evidentiary disclosures will vanish into thin air.  Concerns abound that the proposals won’t benefit consumers or industry, but rather lawyers and litigation funders.  Scary stuff, indeed.

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Ethylene Oxide Alert: Where Is Your Warehouse?

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For over a year now, the U.S. Environmental Protection Agency (EPA) has been focused on reducing or eliminating ethylene oxide (EtO) emissions from industrial sites, commercial sterilizing facilities, and even hospitals. After a brief extension, the comment period for new proposed Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and National Emission Standards for Hazardous Air Pollutants (NESHAP) regulations closed at the end of June with over 1,000 unique written comments.  It is anticipated that EPA is going to take some time to sort through those comments before issuing final rules, which are expected in March 2024.  At the same time, EPA has forecasted releasing a proposed rule specific to hospital sterilizers in early 2024.

Next up on EPA’s agenda appears to be warehouses that store products sterilized with EtO.  The looming question appears to be “where is your warehouse?”  Onsite warehouses are the first to be in EPA’s crosshairs, but in classic agency style they are leaving the option to expand that focus open for the time being.  Meanwhile, environmental groups are asking EPA not to wait to expand that focus, and states like California and Georgia are taking matters into their own regulatory hands.

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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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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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