Subject: Recalls

Defective Logic: Why Recall Evidence Falls Short in Court

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In product liability litigation, plaintiffs often treat a product recall as though it is conclusive proof that the product is defective or that its warnings are inadequate. Some plaintiffs even cite clearly inapplicable recalls — for example, lot-specific recalls spurred by a manufacturing or labeling issue that did not impact the unit that the plaintiff received — in an effort to bolster their case before a court or in settlement discussions. Federal Rule of Evidence 407’s prohibition on the use of recall evidence to prove those points seems to do little to quell the enthusiasm. Of course, Rule 407 is grounded in part on “a social policy of encouraging people to take, or at least not discouraging them from taking, steps in furtherance of added safety.” Fed. R. Evid. 407 advisory committee’s note. But Rule 407 is not the only grounds on which recall evidence can (and should) be excluded.

For example, in Pecan Trust v. Nexus RVs, LLC, 2025 WL 1503940 (N.D. Ind. May 27, 2025), the plaintiffs sued the manufacturers of an RV and certain component parts alleging, among other things, that a defect in the brake pressure switch represented a fire risk. In support of that claim, they pointed solely to a safety recall for the part due to a possible fire risk and an expert witness who, based on the recall alone, concluded that the issue might pose a fire risk. The parts manufacturer moved for summary judgment, and the court granted the motion as to the breach of warranty claim after concluding that the plaintiffs had not proffered sufficient evidence of a defect. As the court noted: “That a recall has occurred may be evidence of certain things—namely as a subsequent remedial measure—but it cannot show a product defect. In reality, products subject to a recall might have a defect or might not, as a recall implements a safety campaign to ensure that none do or will manifest one.” (internal citations omitted). And, as the court noted in the specific context of the warranty claim, the fact that the plaintiffs had never presented the RV for work under the recall posed a second, equally problematic obstacle to their claim.

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The Zantac Rule 702 Order: TLBR (Too Long, But Read)

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On opening an opinion, lawyers habitually roll their eyes when they see a table of contents.  Even more so when they learn the opinion is over 300 pages.  The MDL order granting defense motions to exclude experts and for summary judgment in In re Zantac (Ranitidine) Products Liability Litig. (S.D. Fla. Dec. 6, 2022), however, is a worthwhile read.  The court’s analysis and prose is thorough, clearly reasoned, well-supported, … and highly readable.  It reveals a court willing to roll up its judicial sleeves, tackle and explain the fundamental science in detail, and rigorously apply Rule 702 to perform its essential gatekeeping function – to insulate the jury, and the defendants, from flawed advocacy masquerading as scientific evidence and holding retained experts to reasonable standards of intellectual rigor.

The Zantac litigation involves claims that the active ingredient in popular heartburn medication ranitidine breaks down to produce excessive levels of NDMA, a probable human carcinogen, under certain storage and biological conditions.  That sounds scary.  FDA has set a low daily intake limit of NDMA, a byproduct of, among other things, a common diet.

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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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Pushing Back Against the CPSC – Is a Mandatory Recall on the Horizon for Peloton’s Treadmills?

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The U.S. Consumer Product Safety Commission (CPSC) and Peloton Interactive, Inc. (Peloton) are clashing over whether the media, technology, and fitness company should issue a recall of its treadmill, the Peloton Tread+.  The disagreement came to a head on Saturday, April 17, when the CPSC and Peloton issued competing statements after failing to agree on language to be used in a joint announcement regarding the Tread+.  This dispute raises the question, “What now?”

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