Adrienne Franco Busby
Adrienne Franco Busby puts science and strategy to work for companies facing product liability litigation. She is an experienced litigator in product liability, commercial, employment, class action and mass tort matters.
View the full bio for Adrienne Franco Busby at the Faegre Drinker website.
Articles by Adrienne Franco Busby:
The countdown has begun towards the transformed European product liability landscape! The recently adopted European Union Product Liability Directive (PLD) was published in the Official Journal of the European Union today. Transposition of the PLD into domestic law of the EU member states must be completed by December 9, 2026. As we previously discussed, products put on the market after December 9, 2026, will be subject to the new PLD, while products placed on the market prior to this date will be subject to the laws currently in place.
Further information about the new PLD (including new risks and opportunities for businesses operating in the EU) can be found in our previous updates here and here. Faegre Drinker will continue to monitor developments as the member states transpose the PLD and the new rules take shape.
On October 10, the European Council adopted the European Union’s new Directive on Liability for Defective Products (PLD). The Council’s adoption of the new PLD represents a momentous step towards a complete restructuring of the EU’s product liability landscape as it will replace the current 40-year-old directive and soon become the EU’s new governing regime. The new PLD will enter into force 20 days after its publication in the Official Journal of the European Union. Thereafter, member states will have two years to transpose the directive into national law. Alongside the new Representative Actions Directive implemented last year, the product liability legal landscape is in the process of a great transformation in Europe.
Read the full article on the Faegre Drinker website.
The U.S. Environmental Protection Agency (EPA) recently released their long-awaited final rule regulating ethylene oxide (EtO) emissions from commercial sterilizers. The final rule comes after five years of development, over 1,000 comments, and with estimated compliance costs for industry of up to $900 million.
The final rule differs significantly from EPA’s initial proposed rule. See initial proposal back in April 2023. The changes result in a still restrictive and costly rule, but with more time and options for compliance. These changes come after significant interagency discussions, including discussions with the U.S. Food and Drug Administration (FDA) about the impact of these rules on the medical devices, about half of which are currently sterilized by EtO. According to EPA, there will be no need for companies to revalidate their medical devices due to this final rule. It seems likely, however, that a facility’s ability to comply with the new regulation ultimately may affect sterility validation, so revalidation concerns should not be completely discounted just yet.
Continue reading “EPA’s Final EtO Rule Has Landed: What Now?”
Federal preemption can be a very powerful defense. For example, claims concerning Class III medical devices requiring pre-market approval are generally preempted by the Medical Device Amendments of 1976, 21 U.S.C. § 360c, et seq. (“MDA”). In Regwan v. Abbott Laboratories, Case No. B319606, 2023 WL 8818748 (Cal. App. 2d Dec. 21, 2023), the California Court of Appeal relied on that principle in holding preempted a negligent failure to warn claim premised on a sales representative’s intraoperative communications and presented as a “negligent undertaking” claim. This holding continues a California trend that federal law may preempt negligence-based claims regarding Class III PMA medical devices even if they are not presented as traditional design defect or failure to warn claims.
In Regwan, the plaintiff alleged she suffered serious injuries following implantation of a MitraClip that the defendant manufactured. During the procedure, the saline bag ran dry, causing the plaintiff to allegedly suffer an air embolism and brain injuries. The plaintiff asserted negligence and products liability causes of action against the defendant after discovering a defendant representative attended the surgery and was allegedly “responsible for the flow of saline.” The defendant demurred, arguing federal law preempted the plaintiff’s products liability claims.
Continue reading “California Appellate Court Upholds Federal Preemption of Negligent Undertaking Claim Under the Medical Device Amendments of 1976”
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.
Continue reading “EU Reaches Legislative Deal on Proposed ‘Digital Age’ Updates to Product Liability 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.
Continue reading “Something to Celebrate: A Brief Guide to the FRE 702 Amendments”
