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

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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Court Finds Ship Has Sailed for Seaman to Disclose Expert’s Opinions, Resulting in Summary Judgment

Discovery deadlines exist for a reason.  Although there are exceptions to every rule – and often a rule dictating how to handle such exceptions – litigants in federal court are expected to show their evidentiary cards in a timely, orderly fashion that avoids surprise.  In the context of expert discovery, this means inter alia that witnesses who have been retained specifically to offer expert opinion testimony must author a written report (i.e., a Rule 26 report) setting out their opinions and the bases for those opinions.  Fed. R. Civ. P. 26(a)(2)(B).  Opinions that are inadequately disclosed may be excluded at trial.  Fed. R. Civ. P. 37(c).  In some cases, this can leave a litigant unable to make a prima facie case and survive summary judgment.

One recent example is Adkins v. Marathon Petroleum Company LP, — F. Supp. 3d. —, 2023 WL 3242432 (S.D. Ohio 2023).  In Adkins, Plaintiff alleged that his exposure to hydrogen sulfide (H2S) fumes while working as a tankerman on Defendant’s barge caused him permanent pulmonary injuries.  He sued his employer, asserting three causes of action based on this theory:  (1) a claim under the Jones Act, (2) Unseaworthiness, and (3) Maintenance and Cure.  But each of these causes of action required Plaintiff to establish that his exposure to H2S fumes caused his alleged injuries.  Both parties agreed that H2S fumes can cause pulmonary injuries at high enough concentrations, but there was a problem in Plaintiff’s case – both he and his coworkers routinely wore badges designed to alert the wearer if H2S levels exceeded a certain threshold (which threshold was undisputedly below the OSHA regulatory limit and NIOSH short-term exposure limit), and there was no documentation that Plaintiff’s badge had ever alarmed.  In short, it was not at all obvious that Plaintiff had been exposed to enough H2S to cause his claimed injuries.  Defendant moved for summary judgment, arguing Plaintiff was unable to establish general and specific causation.

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

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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What Dose Makes the Poison? Where Expert Cannot Say, Eleventh Circuit Affirms Summary Judgment

A central tenet of toxicology is that “the dose makes the poison.” Every chemical is toxic if enough of it is consumed, and every chemical has some dose – even if miniscule – at which it poses no significant risk. A chemical must be given in sufficient amount – something exceeding the “threshold dose” – before it will cause effects. This has obvious implications for toxic tort litigation, where a plaintiff who alleges injury from exposure to a toxic chemical must prove at minimum that he or she was exposed to enough of the chemical to produce the alleged injury. This poses a problem for plaintiffs who have been exposed only to very small doses of the chemical at issue. What is a plaintiff to do when their exposure falls below the threshold dose? One approach that generally does not work is to reject the very concept of a threshold dose altogether.

In Pinares v. Raytheon Technologies Corporation, 2023 WL 2661521 (11th Cir. Mar. 28, 2023), Plaintiff alleged that she had developed kidney cancer after chemical compounds from the defendant’s facility made their way into the groundwater near her home. Plaintiffs relied on three experts to prove causation – a toxicologist to establish general causation and two physicians to establish specific causation. The district court excluded Plaintiffs’ toxicology expert, holding that the expert had not conducted a reliable dose-response assessment. The district court then also excluded each of Plaintiffs’ specific causation experts, noting that they had not performed an independent dose-response assessment of their own and therefore relied on the toxicology expert’s deficient opinion. Plaintiffs could not establish causation without expert opinion, and the district court therefore granted summary judgment.

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Dismissal of a Broken Chair Claim Shows That Expert Testimony May Be Essential Even for a “Simple” Product

In Mehner v. Furniture Design Studios, Inc., 2023 WL 2351688 (D. Neb. Mar. 3, 2023), the court granted summary judgment on product defect claims by a plaintiff allegedly injured by the collapse of a restaurant chair eight years after the manufacturer delivered it.  This well-reasoned decision reminds us that even for fairly simple products, expert proof may be required to establish a defect – and failure to develop the factual predicate in discovery may leave the plaintiff without an opinion (and without a case).  It also highlights important limitations in the “malfunction theory” that sometimes allows a plaintiff to proceed without expert proof or identification of a specific defect.

Plaintiff was eating at a restaurant in Omaha when his chair allegedly collapsed.  He sued Furniture Design Studios (FDS), which designed, manufactured and sold the chair, asserting strict liability and negligence design defect claims.

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Tort Reform Comes to Florida

The new law should limit the overall tort liability confronted by all types of companies and individuals who find themselves facing a lawsuit in Florida. This update focuses on the changes for statutes of limitation, comparative negligence and the admissibility of evidence of medical charges at trial. Florida courts will undoubtedly see many challenges to the new law over the next few years.

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