In vitro fertilization (IVF) is one of the most common types of fertility treatment, but the process is also extremely sensitive, invasive, and expensive. All of these factors come into play in a series of recent lawsuits following CooperSurgical’s December 5, 2023 recall of three lots of its embryo culture media—a substance that allows for the development of fertilized embryos. According to the company’s announcement, CooperSurgical had received a high number of customer complaints indicating that its embryo culture media caused impaired embryo development.Continue Reading Recall Litigation Report: CooperSurgical Faces Multiple Lawsuits Following Recall of IVF Embryo Culture Media

Greetings from Orlando, FL! The Crowell product safety team is currently attending the annual meeting and training symposium of the International Consumer Product Health and Safety Organization (ICPHSO). We just heard keynote remarks from the Chair of the U.S. Consumer Product Safety Commission (CPSC), Alexander Hoehn-Saric, and wish to share some highlights. As he did in October 2023 at the ICPHSO International Conference in Sweden, Chair Hoehn-Saric focused his remarks on addressing products sold on or through online marketplaces.

Chair Hoehn-Saric first set the stage by sharing some important data points. In 2023, the CPSC announced more than 300 product recalls; levied more than $52 million in civil penalties; engaged in 14 new mandatory safety standard rulemakings; screened more than 60,000 harmful products at the ports; and participated in numerous safety education campaigns. He also noted the budget uncertainty at the CPSC and the need to “do more with less” and stated that the CPSC will always “put consumers first” as they prioritize their work should the CPSC budget decrease.Continue Reading CPSC Chair Hoehn-Saric Addresses Annual Product Safety Conference  

Products are commonly recalled due to a hazard (i.e., a risk of harm), even where large swaths of consumers have never had a problem with the products they purchased. When those consumers then file suit, they often seek to recover economic harm based on the “benefit of the bargain” theory—because the recalled products that they previously purchased are now worth less than what they paid for them. Where a consumer does experience the hazard (i.e., suffers personal injury or property damage) and subsequently files suit, that suit often seeks to recover not just economic harm but also for personal injury or property damage. Regardless of the nature of the harm, the alleged injury naturally precedes any recall of the product.Continue Reading Recall Litigation Report: Consumer Lawsuit Alleges Electrolux Dehumidifier Caused Church Fire Years After Recall

The second half of 2022 proceeded much like the first, with manufacturers busy navigating recalls and related litigation, although not necessarily in that order.

Philips CPAP/ BiPAP Machines Still Under Fire

Philips is still battling an onslaught of cases stemming from a June 2021 recall of CPAP and BiPAP breathing machines, including a consolidated consumer class action, In re Philips Recalled CPAP, Bi-Level PAP, & Mechanical Ventilator Products Liability Litigation, No. 2:21-mc-01230 (W.D. Pa.), MDL No. 3014, and a medical device supplier suitBaird Respiratory Therapy, Inc. v. Philips, 2:22-cv-00886 (E.D. Pa.). Since early 2021, there have been reports of over 260 deaths and thousands of health problems associated with the degrading polyurethane foam found in these devices, which was used inside millions of CPAP and BiPAP machines for over a decade. Philips claims that it has produced over 3.95 million repair kits and replacement devices to date and continues to research potential health risks to users from its machines. Despite these efforts, its legal troubles will continue into 2023, with even more consumer-facing lawsuits, including Braverman v. Koninklijke Philips N.V., No. 2:22-cv-7927, which was first filed at the end of December 2022 in the U.S. District Court for the Eastern District of New York and is one of the first CPAP/BiPAP suits to allege the inhalation of the toxic foam particles caused mouth and tongue cancer. Continue Reading Recall Litigation Report: Year in Review (2022)

Companies faced with a potential product recall are often concerned with possible adverse publicity and increased litigation risk. But a quick and comprehensive recall can be the very tool that stops a lawsuit in its tracks. In a recent Law360 article titled, “Quick and Comprehensive Recall Moots Claims and Proves an Effective Tool in Defeating

Companies take note: over the past month or so, the U.S. Consumer Product Safety Commission (CPSC) has issued four unilateral press releases instructing consumers to stop using a product. Since May of this year, that number rises to seven. If that number does not seem high, consider this: between 2011 and 2019—a nine-year period—the agency issued two. So, what exactly is a “unilateral press release” and what does the agency’s issuance of four over recent weeks mean for you?Continue Reading CPSC Enforcement Trend: Unilateral Press Releases

New parents have their hands full. Baby bouncy seats and swings offer busy caregivers a way to put an infant down but still allow him or her to see and interact with the surrounding environment. But recent recalls have led parents to think twice before going hands free.

On August 15, 2022, 4moms and the CPSC announced a recall of more than two million 4moms MamaRoo Baby Swings (versions 1.0  – 4.0) and over 220,000 RockaRoo Baby Rockers sold in the U.S. and Canada. According to the announcement, the restraint straps on the 4moms MamaRoo Baby Swing and RockaRoo Baby Rocker can dangle below the seat when the product is not in use, posing a strangulation hazard to crawling infants. On August 29, 2022, residents from North Carolina and South Carolina sued Thorley Industries, LLC (d/b/a 4moms) on behalf of nationwide class of purchasers of the recalled products in federal court in Pennsylvania.Continue Reading Litigation Recall Report: Nationwide Lawsuit Follows 4moms Recall of MamaRoo Baby Swing and RockaRoo Baby Rockers

Despite imposing onerous new compliance terms, the recently announced Vornado civil penalty was criticized by three commissioners as too low amid their urgent calls for larger penalties in the future. On July 7, the U.S. Consumer Product Safety Commission (CPSC) announced a $7.5 million civil penalty settlement with manufacturer of air circulation products, Vornado Air (Vornado). Vornado agreed to pay the civil penalty to resolve charges that the Company knowingly failed to immediately report allegedly defective electric space heaters to the CPSC under Section 15(b) of the Consumer Product Safety Act (CPSA). The Commission voted 4-0-1 to provisionally accept the settlement. Notably, three of the agency’s five commissioners published individual statements alongside the agency’s announcement of the penalty, which is atypical. The statements provide product safety stakeholders with insights on how the “new” Commission views civil penalties and its enforcement authority. Continue Reading “Wiping the Slate Clean”— CPSC Commissioners Signal Higher Penalties to Come in Wake of Vornado Penalty Resolution

Recalls in Review: A monthly spotlight on the trending regulatory enforcement issues at the CPSC.

With the winter holiday season approaching, many families are looking forward to hard-earned vacations and fun activities with their loved ones. And many will be looking to ride, rent, or purchase recreational vehicles for some fun—from all-terrain vehicles (“ATVs”) and golf cars to off-road motorcycles and snowmobiles. Thus, as we head into the winter season, we turn our attention to Consumer Product Safety Commission (“CPSC”) regulatory actions involving recreational and utility vehicles for this month’s installment of “Recalls in Review.”
Continue Reading Recalls in Review: Recreational and Utility Vehicles

Here’s a brief review of key developments concerning the U.S. Consumer Product Safety Commission (“CPSC”) from the past month or so to help you stay aware of important product safety legislative and regulatory happenings.

Commissioner Elliot Kaye Departs the Commission.  In late August, Commissioner (and former Chairman) Elliot Kaye announced his departure from the agency to assume a senior position at Jose Andres’ World Central Kitchen.  Kaye, whose term had expired in October 2020, was serving in his “hold-over” year pending the confirmation of a new commissioner.  As a result of Kaye’s departure, there are currently two Republicans on the Commission (Dana Baiocco and Peter Feldman) and one Democrat—Acting Chairman Robert Adler.  This political dynamic, similar to when the Democrats held a majority of commissioner seats during the Trump Administration, has already caused some partisan maneuvering and angst at the agency (see Vote on FY22 Operations Plan story below).  However, this 2-1 split in favor of the Republicans will not last for long.  Read on!
Continue Reading CPSC Insights – September 2021