Last week, the European Union made a significant breakthrough towards its goal of overhauling the 40-year-old Product Liability Directive for the demands of the “digital” age and modern economy. To amend the directive, the elected European Parliament and the European Council (comprised of government representatives of the 28 member states) must agree on final language and separately pass the draft legislation through their respective bodies. After extensive legislative efforts and negotiations, the European Council (currently led by the Government of Spain) and the European Parliament issued press releases announcing that they have reached a political agreement regarding the proposed updates to the directive.
Fun fact: There are 23 holidays that can be celebrated today, December 1st. Some, like Rosa Parks Day and World AIDS Day, are solemn and serious. Others are silly and fun, like National Peppermint Bark Day and National Christmas Lights Day. And then there are those that are downright strange, like Bifocals at the Monitor Liberation Day. (No, we didn’t make that up.) But for those of us who practice in the federal courts, we can add one more celebration to this esteemed list.
Today, the long-anticipated amendments to Federal Rule of Evidence 702, governing admissibility of expert opinion evidence, finally take formal effect. The amendments were unanimously approved by the Advisory Committee over two and a half years ago. Courts have been citing the proposed amendments since shortly after they were first approved. On the surface, the amendments to the text of Rule 702 itself may appear relatively modest. Indeed, at least one court has observed that the new language “clearly echoes the existing law on the issue.” Sardis v. Overhead Door Corp., 10 F.4th 268 (4th Cir. 2021). But there is more to these new amendments than initially meets the eye. In order to understand and effectively use the amendments, parties and litigators must understand and use the history and the Committee Note explaining the amendments.
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.
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.
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.
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.