Faegre Drinker on Products

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Articles by Faegre Drinker on Products:


FDA Finalizes Voluntary Recall Guidance Imploring Companies to Be “Recall Ready”

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FDA recently issued final guidance regarding the initiation of voluntary product recalls and its related suggestions on how to be “recall ready.” The guidance – covering voluntary recalls of food, drugs, devices, biological products, cosmetics, and tobacco – emphasizes the importance of a company’s recall readiness at all stages of a product’s distribution chain and provides companies with suggested measures to prepare for and implement voluntary recalls. It also advises companies on best practices for working with FDA to initiate a timely voluntary recall.

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Tenth Circuit Affirms Dismissal of Pet Food False Ad Proposed Class Action

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The Tenth Circuit recently affirmed dismissal of a proposed class action against a dog food manufacturer, finding that the putative class claims were nonactionable puffery and overly subjective.

In Renfro, et al. v. Champion Petfoods USA, Inc., et al., No. 20-1274, pet owner plaintiffs brought a proposed class action against Champion Petfoods alleging that the packaging for some of its dog food brands were false and misleading. Specifically, plaintiffs asserted claims for violation of the Colorado Consumer Protection Act, breach of express and implied warranty, fraudulent misrepresentation, fraudulent concealment, unjust enrichment, and negligence.

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The Rule 702 Toolbox: Proposed Amendments Seek to Reset the Application of FRE 702

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Litigators! Substantive amendments have been proposed to Federal Rule of Evidence 702. The public comment period closes February 16.

Rule 702 was last amended substantively in 2000, soon after the concluding chapter in the Daubert trilogy, Kumho Tire. Those amendments were intended to reset the Rule based on the post-Daubert experience.

Lower courts had read snippets of language in Daubert through variable lenses, influenced by their level of enthusiasm or reluctance to keep flawed expert opinions from the jury. Though Daubert mandated rigorous gatekeeping, it also included Delphic comments about the “liberal thrust” of the federal rules (compared to the “rigid’ and “austere” Frye rule they replaced) and about the ability of the adversarial process to limit the impact of “shaky but admissible” evidence. Some courts misread these comments to limit the scope and depth of their gatekeeping obligation and adopted standards consistent with this vision.

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Eastern District of Virginia Denies Motion to Certify Class, Sheds Light on Rule 23(b)(3) Predominance and Superiority Requirements for Class Actions

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The U.S. District Court for the Eastern District of Virginia analyzed Federal Rule of Civil Procedure 23(b)(3)’s predominance and superiority requirements for class actions in a recent decision denying a motion to certify a purported class of motor vehicle purchasers.  The decision underscores that plaintiffs seeking to certify classes asserting claims that will render the process of identifying class members to be a mere series of individualized inquiries will not pass muster under Rule 23.

The Facts in Dispute

Garcia, et al. v. Volkswagen Group of America, Inc., et al. involved a purported class of plaintiffs residing in multiple states who purchased vehicles manufactured by defendants within the last 14 years.  The plaintiffs sued a group of auto manufacturers alleging damages resulting from defendants’ alleged fraudulent misrepresentations about the vehicles, and asserting claims for violations of the Federal Odometer Act, fraud, breach of contract, and unjust enrichment, in addition to state law claims under the laws of California, Colorado, Florida, Illinois, New Jersey, and Washington.

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Software Liability: Why a Michigan Federal Court Decision is Relevant to Product Manufacturers Nationwide

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Numerous products in our day-to-day lives incorporate or consist of software. The legal system, however, has been hesitant (at best) to bring software within traditional product liability regimes. Courts have grappled with whether to consider software a product and have largely found that it is not. However, a recent decision in the Western District of Michigan holds that software is a product—Holbrook v. Prodomax Automation Ltd., No. 1:17-cv-219, 2021 U.S. Dist. LEXIS 178325 (W.D. Mich. Sept. 20, 2021). While Holbrook may be an outlier, it is significant. It bucks the trend, and potential defendants should be aware of it.

Background: Holbrook involved a wrongful death suit arising out of an accident on a robotic assembly line. The decedent’s estate (Plaintiff) brought a common-law negligence claim against multiple defendants, including the manufacturer who designed, built, and installed the assembly line. Plaintiff’s claim was based, among other things, on the software controlling the robots.

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Pennsylvania Rejects Corporate Registration as Basis for Personal Jurisdiction

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A recent Pennsylvania Supreme Court opinion provides out-of-state corporations more protection from litigation tourists, bringing the state’s general personal jurisdiction rules in line with U.S. Supreme Court precedent. In Mallory v. Norfolk Southern Railway Co., a unanimous court invalidated part of Pennsylvania’s corporate registration statute, holding that corporations that are not incorporated and do not have a principal place of business in Pennsylvania cannot be subject to general personal jurisdiction simply because they have registered to conduct business in the Commonwealth.

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