Patrick Reilly

Patrick Reilly represents multinational and Fortune 500 clients in complex litigation, regularly acting as national coordinating counsel to manufacturers in product liability actions. He also advises on sports law matters.

View the full bio for Patrick Reilly at the Faegre Drinker website.

Articles by Patrick Reilly:


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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Smart Medical Devices Open New Treatment and Litigation Doors While Confirming Age-Old Balancing Acts

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Telemedicine and telehealth have significantly reshaped how consumers access health care services. Even before the COVID-19 pandemic, online portals were jockeying to replace visits to primary care providers and urgent care clinics for minor illnesses or simple-to-prescribe medications. The last two years shifted that race into high gear, particularly with new products and platforms being introduced that range from virtual clinic platforms that allow patients—and their programmable implanted medical devices—to connect with their providers from the comfort of their own homes, to passive smart devices that remotely monitor patient vital signs, analyze that data using proprietary algorithms, and evaluate whether a patient is having a medical emergency or needs to schedule an appointment with their provider. These technologies are now so ubiquitous that they are being showcased at the 2022 Consumer Electronics Show.

To be sure, regulatory changes in response to the COVID-19 pandemic made telemedicine more permissible—and reimbursable—than in the past. But that alone is not driving medical device companies forward. Instead, medical device manufacturers are rapidly developing smart or algorithm-driven medical devices that take advantage of the ever-increasing power of those technologies and leveraging telemedicine to make the remote treatment and management of medical conditions less complicated. A recent article in Nature’s npj Digital Medicine confirmed the growth in this area, counting 64 separate smart- or algorithm-driven medical devices currently on the market as of 2020. See Stan Benjamens, et al., The State of Artificial Intelligence-Based FDA-Approved Medical Devices and Algorithms: An Online Database, 3 npj Digital Medicine Article No. 118 (2020). Each of these new devices endeavor to enable physicians to practice more effectively and efficiently than they could before. The future for smart or algorithm-driven medical devices looks promising.

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Foreign Manufacturer Dismissed for Lack of Personal Jurisdiction in the Southern District of Indiana

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Case:

Patterson v. Chiappa Firearms, USA, LTD, No. 1:20-cv-01430-JPH-MG, 2021 WL 4287431 (S.D. Ind. Sept. 21, 2021).

Significance:

  • First Indiana case to apply the “relate to” standard articulated in Ford Motor Co. v. Mont. Eighth Jud. Dist. Ct., 141 S. Ct. 1017 (2021).
  • Rejects a broad, unlimited stream of commerce theory for establishing personal jurisdiction.
  • Denied plaintiff jurisdictional discovery, noting that foreign nationals should not be subjected to extensive discovery in order to determine whether personal jurisdiction over them exists.

Case Analysis:

In Patterson v. Chiappa Firearms, the plaintiff, an Indiana citizen, bought a handgun from an online gun seller in Kentucky and had it delivered to Indy Arms Company in Indianapolis. The gun subsequently exploded in Indiana when the plaintiff test-fired it, fracturing the plaintiff’s finger. The gun was manufactured by Chiappa Italy and distributed by Chiappa USA.

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En Banc Third Circuit Sends Online Marketplace Liability Issue to Pennsylvania Supreme Court

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Last week the Third Circuit made its most recent move in the Oberdorf v. Amazon case: asking the Pennsylvania Supreme Court whether an e-commerce business – such as Amazon – is strictly liable for a defective product that was sold on its platform by a third-party vendor that the e-commerce business did not possess or own. Given the lack of clarity, and the “substantial public importance” of this issue, the Third Circuit asked the Pennsylvania Supreme Court to weigh in.

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