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:


Enforcement of Representative Actions is Here

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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.

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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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Class Action Filings on the Rise in Europe, Especially in Product Liability Cases Ahead of Full Implementation of the EU’s Representative Actions Directive

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Under the timeline imposed by the EU’s Directive of the European Parliament and of the Council on Representative Actions for the Protection of the Collective Interests of Consumers, the EU’s 27 member states were required to provide a collective litigation option to consumers by December 25, 2022, including by adopting or amending national law in jurisdictions where mechanisms for such litigation were not previously established. By June 25, 2023, member states are required to implement and begin applying these new mechanisms. But while that process is still ongoing, multiple EU member states have already taken legislative action to permit greater collective litigation mechanisms than previously available in their respective jurisdictions. Additionally, legal industry observers have already noted the increased presence of plaintiffs’ firms and litigation funders in the EU in response to the greater and increasing availability of representative and collective redress actions. See K. Henderson, Z. Okanyi, et al., European Class Action Report 2022, at 2, CMS (2022), available at https://cms.law/en/int/publication/cms-european-class-actions-report-2022.

In particular, one study noted that class action filings in Europe had increased more than 120% over the last five years (from 49 in 2018 to 110 in 2021), propelled by greater attention to potential mass actions by plaintiffs’ firms and increased availability of litigation funding. The data confirms what practitioners in this space already know: the plaintiffs’ bar in the EU is not waiting for the full implementation of the Representative Actions Directive. Of particular note, this rise is fueled, in significant part, by product liability, personal injury, and consumer mass actions.

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European Commission Updates Liability Rules to the Digital Age

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The European Commission adopted two proposals that adapt liability rules to the digital age, circular economy and the impact of global value chains. These proposals are related to the Revised Product Liability Directive, fit for the green and digital transition and global value chains, and the AI Liability Directive to provide easier access to redress.

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Pathologist Stopped Short of Offering Could-Have, Should-Have Opinions

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In personal injury and wrongful death cases, the plaintiff bears the burden of proving medical causation, which almost universally requires testimony from a competent expert.  Some plaintiffs offer testimony from forensic pathologists—also known as medical examiners, or physicians specializing in postmortem cause-of-death determinations—to prove causation.  These forensic pathologists (or the parties proffering their testimony) may push evidentiary boundaries with respect to opinions corollary to their cause of death determinations. While some courts have allowed juries to hear these questionable corollary opinions, relying on cross examination to level the playing field, others have excluded such testimony on the basis of insufficient qualifications or lack of reliable methodology.  Recently, the Southern District of Georgia excluded a forensic pathologist’s opinions on both grounds in a wrongful death action. Although not a product liability case, the court’s well-reasoned holding is sure to affect product cases going forward.

In Griffin v. Coffee County et al., 2022 WL 2045650 (S.D. Ga. June 7, 2022), a man in custody at a county jail in Georgia died from a methamphetamine overdose. His estate brought claims for deprivation of rights and medical malpractice against the jail, the hospital, and various individuals associated with those entities. In support of its claims, the estate proffered testimony from a forensic pathologist who offered opinions about medical treatment.

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It’s not what happened, but why: First Circuit rejects conclusory, unsupported expert opinions

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It is not uncommon for an opposing expert to opine that the existence of injury alone implies negligence, nor is it unusual to find that such opinions are supported only by general reliance on “literature” with no discernible connection to the issue at hand. Certainly, Federal Rule of Civil Procedure 26(a)(2)(B) requires an expert’s report to contain “a complete statement of all opinions the witness will express and the basis and reasons for them.” And, Federal Rule of Evidence 702 requires that an expert not only base an opinion on sufficient facts or data but also reliably apply his or her methodology to those facts or data. Yet all too often, courts decline to hold an expert to task and instead find that these deficiencies go to the weight, but not the admissibility, of an expert’s opinion. But, as recently observed by the First Circuit, an expert must do more than merely cite the existence of an injury if a res ipsa loquitur argument is not available. And regardless, an expert’s failure to link the literature cited to the opinions offered is not a matter of insufficiency, but rather of unreliability.

In López-Ramírez v. Toledo-González, — F.4th —, 2022 WL 1261299 (1st Cir. 2022), Plaintiff experienced hearing loss, facial paralysis and loss of balance following a neurosurgical procedure performed by the defendant neurosurgeon. Plaintiff sued the physician and the hospital, alleging that the defendant neurosurgeon’s failure to properly evaluate, treat and monitor her condition during the surgery amounted to medical malpractice. In support of that claim, Plaintiff disclosed a neurology expert who opined that the defendant neurosurgeon deviated from the standard of care and included with his report articles from the medical literature that he felt “may be helpful” in understanding his opinions.

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