Stephanie Koltookian

Stephanie A. Koltookian is a Products Liability associate residing in our Des Moines, Iowa office. Stephanie focuses on medical device products liability defense.

View the full bio for Stephanie Koltookian at the Faegre Drinker website.

Articles by Stephanie Koltookian:


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

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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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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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Not Just a Rubber Stamp: FDA Revises Its 510(k) Refuse to Accept Policy

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Is the decision to submit a 510(k) application versus a Premarket Application (PMA) at the sole discretion of a medical device manufacturer? The answer is not always clear to product liability lawyers, judges, and juries. FDA recently published revised guidance on its “Refuse to Accept Policy for 510(k)s” that reinforces and clarifies that the regulatory path may be analyzed multiple times by FDA before it clears a 510(k) device. This clarification underscores the reality that the type of application submitted is largely dictated by the agency, not the applicant. This post discusses some key takeaways from this new guidance before briefly discussing how this guidance may be implicated in medical device litigation.

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Ninth Circuit Asks California Supreme Court to Clarify the Causation Standard Applicable When the Learned Intermediary Doctrine Applies

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How demanding is the causation standard in a California failure to warn claim when a learned intermediary testifies that he would have read and incorporated more stringent warnings if they had been available? Is the plaintiff required to show that the stronger warning would have altered the physician’s decision to prescribe the product? Or may the plaintiff establish causation by showing that the physician would have communicated the stronger warnings to the patient and that a prudent person in the patient’s position would have declined the treatment as a result?

The Ninth Circuit isolated this undefined causation standard in Himes v. Somatics, LLC, and certified the question to the California Supreme Court. After confirming that the learned intermediary doctrine is alive and well in California and that a failure to warn claim cannot survive when the learned intermediary does not read the warnings at all, the Ninth Circuit stopped short of defining the causation standard that applies when a learned intermediary does read the warnings.

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Snapchat’s ‘Speed Filter’: Georgia Supreme Court Revives Negligent Design Claim

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On March 15, 2022, the Georgia Supreme Court revived a negligent design claim that had been brought against Snapchat, Inc. (n/k/a Snap, Inc.) involving Snap’s “Speed Filter.”  As one of the few decisions across the country addressing products liability law in the context of platform “products” (more accurately categorized as services) such as Snapchat, the opinion provides a glimpse of the sort of issues that other courts may soon be required to address.

The Factual & Procedural Background:

Plaintiffs Wentworth and Karen Maynard alleged that Defendant Christal McGee was using Snapchat’s “Speed Filter” and driving over 100 miles per hour when she rear-ended them, causing severe injuries.  The “Speed Filter” is a feature that allows the user to record their real-life speed on a photo or video and share it with other users.  Plaintiffs sued Snap as well, alleging that Snap had negligently designed the “Speed Filter” because the filter promoted unsafe driving and encouraged dangerous behavior.

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