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.
Category: Regulatory
In Case You Missed It – Summer 2023
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?
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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Experts Who Cannot Articulate a Standard Cannot Opine that a Defendant Failed to Meet the Standard
If you don’t know where a line is, you can’t say whether someone has crossed it. That principle applies in spades to expert witnesses, particularly when their role in the case calls on them to help the jury understand where the lines are drawn in their field. Thus, for example, a toxicology expert who cannot say how much chemical exposure is required to produce a toxic effect cannot opine that the plaintiff’s exposure was sufficient to cause that effect. Likewise, an expert who criticizes a product’s warnings but cannot articulate an adequate warning does not pass muster under Federal Rule of Evidence 702. See, e.g., Bourelle v. Crown Equip. Corp., 220 F.3d 532, 538-39 (7th Cir. 2000).
The Seventh Circuit recently gave yet another illustration of this principle at work. In Burns v. Sherwin-Williams Co., — F.4th —, 2023 WL 5210857 (7th Cir. 2023), a plaintiff truck driver was injured while making a delivery at defendant’s store using a “walkie” (i.e., an electric forklift that the operator walks behind) owned by defendant. Plaintiff was backing the walkie down a ramp and toward a dumpster with pallets laying on the ground nearby. Unfortunately, he underestimated the walkie’s stopping distance. He tried “plugging” – i.e., pushing the thumb switch in the opposite direction to slow and then reverse the walkie – and then engaged the emergency brake, but it was too late. He trapped his foot against the pallets, then fell over and broke his ankle.
Ethylene Oxide Alert: Where Is Your Warehouse?
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
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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