• Posts by Kelly L. Faglioni
    Posts by Kelly L. Faglioni
    Partner

    Kelly practices as a commercial and regulatory litigator on products liability and post M&A disputes and issues and serves as one of the firm’s Deputy General Counsel focusing on law firm ethics, conflicts, and risk management ...

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The Recall Roundup is a monthly survey of regulatory activity affecting the manufacture, distribution, and sale of consumer products.  Subject matter may include the latest product recalls, major federal agency developments, and proposed or new federal rules.  The blog’s goal is to provide an overview, rather than a comprehensive report on every development that could potentially affect businesses or consumers.  Nothing herein constitutes legal advice.  If you have questions or comments about the blog, please reach out to the authors.

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The Recall Roundup is a monthly survey of regulatory activity affecting the manufacture, distribution, and sale of consumer products. In lieu of the usual monthly recap, this post summarizes key events from 2021. Subject matter may include the latest product recalls, federal agency major developments, and proposed or new federal rules. The blog’s goal is to provide an overview, rather than a comprehensive report, on every development that could potentially affect businesses or consumers. Nothing herein constitutes legal advice. If you have questions or comments about the blog, please reach out to the authors.

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The Recall Roundup is a monthly survey of regulatory activity affecting the manufacture, distribution, and sale of consumer products. Subject matter may include the latest product recalls, federal agency major developments, and proposed or new federal rules. The blog’s goal is to provide an overview, rather than a comprehensive report on every development that could potentially affect businesses or consumers. Nothing herein constitutes legal advice. If you have questions or comments about the blog, please reach out to the authors.

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The CPSC’s nine-year saga over magnet sets has finally concluded.  Magnet sets are clusters of small, separable, magnetic balls that a consumer can rearrange into countless shapes.  In 2012, a distributor refused to voluntarily recall the magnet sets, forcing the CPSC to file an administrative complaint alleging that the magnet sets were defective and presented a substantial ingestion hazard to young children.  In 2017, the CPSC concluded that the magnet sets posed a substantial product hazard that cannot be mitigated by package warnings and ordered the distributor to recall the magnet sets.  The distributor sued in federal court to block the CPSC’s order.  After multiple appeals, the Tenth Circuit Court of Appeals ultimately agreed with the CPSC.  Thus, this month the CPSC issued a rare mandatory recall of 10 million magnet sets.  The recall noted that two children who had ingested the magnets from the magnet sets required surgery to remove them and a 19-month-old child died after ingesting similar high-powered magnets.  The CPSC also issued a warning to consumers about the dangers of high-powered magnets, noting that from 2009 to 2018, there was an estimated 4,500 cases of children from 11 months old to 16 years old who were treated in US hospitals for ingestion of high-powered magnets.

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The CPSC (by a 3-1 vote) recently filed an administrative complaint against Amazon.com, Inc. (“Amazon”) seeking to force the characterization of Amazon as a “distributor” of products under the Consumer Product Safety Act.  If the CPSC prevails on that characterization, Amazon would become responsible under the CPSA for recalling potentially hazard products sold via its “fulfilled by Amazon” program.   Although Amazon has engaged in recalls on what it has characterized as a voluntary basis, it has not conceded CPSC authority over it as a distributor.  The Amazon complaint that tees this issue up for judicial resolution involves carbon monoxide detectors that fail to alert, children’s pajamas that do not meet flammability requirements, and hair dryers without required water immersion protection devices.  Amazon has stopped selling some of these products, notified consumers who purchased the products about the potential hazards, and offered refunds via Amazon gift cards.  The CPSC views these steps as insufficient and aims to force Amazon to issue recalls and destroy the returned products.  Under the CPSA, a “distributor” is “a person to whom a consumer product is delivered or sold for purposes of distribution in commerce.”  15 U.S.C. § 2052(a)(8).  Under the “fulfilled by Amazon” program, merchants keep title to their products but store them at Amazon fulfillment centers, where Amazon packs and ships the products for a fee.  Although the CPSC views Amazon as a “distributor,” Amazon argues it is merely an intermediary for other retailers because it does not hold title to the products and therefore cannot be held liable for them.

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The CPSC has recently focused its enforcement efforts on children’s products.  Fisher-Price recalled two of its infant sleep products—Rock ‘n Glide Soothers and Soothe ‘n Play Gliders—after four infant deaths were reported involving the first product.  All four infants were placed in the products unrestrained on their backs and were later found on their stomachs deceased.  This news comes after the CPSC’s actions last month to approve a new federal standard for infant sleep products and to recall two more products related to infant sleep.

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In the world of consumer products, the month of May was all about infant sleep products. The CPSC recently approved a new federal standard for infant sleep products for infants up to five months of age since such inclined sleepers, bassinets, and in-bed sleepers that have been linked to multiple infant deaths. Beginning in June 2022, infant sleep products must meet a new federal safety standard. The new federal standard incorporates a voluntary ASTM safety standard with further modifications to strengthen it. If the products do not already meet the requirements of an existing CPSC standard, then the products must pass testing to confirm that the sleep angle surface is 10 degrees or lower and comply with the CPSC’s safety standard for bassinets and cradles.

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The CPSC most commonly works with manufacturers, sellers, or those in the distribution chain to prompt them to issue warnings or recall notices to consumers. Recently, however, the CPSC has taken the far more unusual step of independently issuing its own warnings to consumers about dangerous products in three circumstances involving treadmills, youth ATVs, and bed rails.

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The Fifth Circuit recently issued an opinion concluding that the CPSC violated the APA when it issued a final rule in 2017 limiting phthalate content in children’s products. The Consumer Product Safety Improvement Act of 2008 (CPSIA) bans children’s toys and child care articles containing more than 0.1 percent of several phthalate chemicals because of concerns that ingestion can have harmful health effects on children. Phthalates are used to make soft and pliable plastics, such as vinyl. The CPSIA also directed the agency to promulgate a final rule regarding phthalates. In 2017, the CPSC issued a final rule expanding the list of phthalates covered by the ban.

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The CPSC recently announced its first civil penalty of 2021.  Cybex International, Inc. (Cybex) agreed to pay $7.95 million after the workout equipment manufacturer allegedly failed to immediately report to the CPSC the defects in two of its products.

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While the eleven January recalls are summarized below, this first “Roundup” focuses on the evolving use of cashierless technology and what role it may play in the context of product recalls.  Broadly speaking, cashierless technology refers to using technology at brick-and-mortar business locations that allows shoppers to enter the location and purchase consumer products without standing in a checkout line or interacting with a cashier.  Rather, cameras and sensors track the products selected and charge the shoppers upon exit.

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After a hiatus from civil penalties, the CPSC recently announced a $12 million penalty.  In November 2017, Walter Kidde Portable Equipment Inc. (“Kiddie”) recalled fire extinguishers for two issues.  First, the fire extinguishers could become clogged or require excessive force to discharge.  Second, the nozzle of the fire extinguishers could detach.  These issues could result in a failure of the fire extinguishers to discharge during a fire emergency.  In fact, a 2014 death was reported involving a car fire after emergency responders could not get the fire extinguishers to work.  By November 2017, Kiddie had received 391 reports of defects, including one fatality, 16 injuries, and 91 episodes of property damage.

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The CPSC recently posted guidance on its website for consumer products related to COVID-19, including personal protective equipment. The guidance covers four categories of products: (a) face coverings, (b) gowns, (c) gloves, and (d) disinfectant and cleaning products. The guidance emphasizes that personal protective equipment sold to consumers must comply with all CPSC regulations, which include testing, certification, labeling, and recordkeeping requirements. The guidance drew sharp criticism from CPSC Commissioner Dana Baiocco in a statement:

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The CPSC took proactive steps in October to address recent concerns with infant sleep products that pose suffocation hazards and could lead to Sudden Infant Death (SID).  This month the agency made a rare proposal for a mandatory consumer product safety standard to address the risks associated with crib mattresses.  The safety standard would incorporate by reference the voluntary standard ASTM F2933-19 (Standard Consumer Safety Specification for Crib Mattresses) with modifications to make the standard even more stringent.  These modifications include increased product performance testing to cover crib mattress firmness, coil spring issues, and face-in-mattress scenarios.  The new rule would also update the product’s warning labels, instructions, and packaging to remove unnecessary wording and emphasize the importance of positioning infants on their backs to sleep.  For example, the proposal compares the voluntary standard’s warning label to the proposed mandatory standard’s warning label:

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The upcoming election offers opportunities for leadership changes at the CPSC.  The agency currently has four commissioners and one vacancy:

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Even in a pandemic, some things do not change.  This month’s Recall Roundup finds the CPSC focusing on dangers that have been front and center for some time.  Specifically, the CPSC continues to focus its regulatory efforts on protecting consumers from product defects in all-terrain vehicles (ATV) and other recreational off-highway vehicles such as snowmobiles, golf carts, and utility vehicles.  The CPSC recently issued a warning to consumers about the risks associated with such products, especially as more consumers look for outdoor activities during the pandemic.  The warning cites to the CPSC’s Annual ATV Report of 2018, which identified almost 82,000 ATV-related injuries that required hospital treatment.  Nearly one-fourth of these injuries were sustained by children under 16 years old, the highest fraction of any age group.  There were also 264 ATV-related deaths in 2018, though this number is expected to rise as reporting is ongoing.  So far, the CPSC has issued 15 recalls for recreational off-highway vehicles in 2020.  In 2019, that figure was 20 recalls.

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With the prevalent spread of COVID-19, hand sanitizers have become this spring and summer’s “fidget spinners,” cycling through the process from market shortage to glut in short order.  With such a rush to meet the drastic spike in demand, product missteps seem inevitable.  Although the Recall Roundup generally focuses on recalls under CPSC jurisdiction, the numerous FDA recalls involving hand sanitizers merits mention here.  Since June 27, 2020, there have been 15 recalls noted on the FDA’s “Recalls, Market Withdrawals, & Safety Alerts” website.  Retailers looking to meet market demand should keep an eye on this FDA web site relative to the hand sanitizers they may have stocked for sale.

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At a June 16, 2020 hearing, the US Senate Committee on Commerce, Science and Transportation considered President Trump’s nomination of Nancy Beck to the CPSC.  In March, Trump announced his nomination of Dr. Beck to be Chairman and Commissioner of the CPSC.  The CPSC currently consists of two Republican appointees and two Democratic appointees with one of the Democratic appointees—Robert Adler—serving as Acting Chairman.  This month’s committee hearing included tough questions from Democrats and Republicans about how Dr. Beck would prevent unauthorized releases of confidential business information held by CPSC – a problem that has plagued the agency recently.  Dr. Beck was also quizzed about her prior experience as the Senior Director for Science Policy at the American Chemistry Council, which is a chemical industry lobbyist group.  Senate Democrats have expressed opposition to Dr. Beck’s confirmation as well as one Senate Republican on the committee – Shelley Moore Capito (R-WV).  If every Democrat on the committee plus Senator Capito oppose the nomination, then the committee’s vote count is at a 13-13 tie, signaling that the nomination may not proceed to a full Senate floor vote.

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Should you have to pay to see CPSC’s adopted safety standards?  That is the question raised by a lawsuit filed in the Third Circuit this month, which challenges the CPSC’s adoption of mandatory safety standards for consumer products that are not available for free to the public.  The American Society for Testing and Materials (“ASTM”) is a well-recognized independent organization that develops consensus-based, voluntary standards for children’s products.  In 2019, ASTM updated its safety specifications for infant bath seats, which includes changes to labeling, product performance, and safety testing (ASTM F1967-19).  The CPSC later promulgated an agency rule adopting the updated ASTM standard as legally binding on infant bath seat manufacturers (16 C.F.R. § 1215).  On behalf of a new mother, a civil rights group filed a petition with the U.S. Court of Appeals for the Third Circuit pursuant to 15 U.S.C. § 2060 challenging the CPSC’s rule.  The mother claims that she asked the CPSC for a copy of the standard and the CPSC instead directed her to buy a copy from ASTM.  ASTM charges $56 for a copy of the standard—almost double the price of an infant bath seat.  The petition asks the Third Circuit to vacate the rule, order the CPSC to make any binding standard freely accessible to the public whenever the CPSC proposes to promulgate a new rule, and order the CPSC to make any binding standard freely accessible to the public permanently after the CPSC adopts it in a final rule.

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A consumer recently filed a products liability lawsuit against Keurig regarding its mini plus brewing system—a coffee maker that Keurig recalled at the end of 2014. Keurig recalled the brewing system after receiving about 200 consumer reports, including 90 reports of burn-related injuries, regarding the brewing system’s pressurized water overheating and spraying out of the machine. The lawsuit alleges that Keurig waited too long to recall the brewing system and therefore failed to warn consumers of the product’s defects. This lawsuit serves as a reminder to manufacturers, distributors and retailers that actions or inactions prior to issuing a recall may be subject to scrutiny and litigation.

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The COVID-19 pandemic has changed most aspects of the economy. The world of consumer products is no exception to this trend. The CPSC has the following notice posted on its website warning that not all recall remedies may be currently available:

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This month’s Recall Roundup starts with the wish that the coronavirus could be recalled. Perhaps the would-be CPSC commissioner who could deliver that recall would be unanimously approved.

On the topic of would-be commissioners, President Trump recently announced his intent to nominate Dr. Nancy Beck to be Chairman and Commissioner of the agency. Beck currently serves as the Principal Deputy Assistant Administrator for the EPA’s Office of Chemical Safety and Pollution Prevention. She previously worked in various capacities at the EPA and Office of Management and Budget during the Clinton, Bush and Obama administrations. Beck also worked as the Senior Director for Science Regulatory Policy at the American Chemistry Council, which is a chemical industry lobbyist group.

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The new year ushered in a series of warnings from the CPSC about inclined infant sleepers posing suffocation risks and dressers posing tip-over risks to consumers. Both products have been under scrutiny by the CPSC over the past year.

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The theme for this Recall Roundup is effectiveness of recalls. In October, the US Senate Committee on Commerce, Science, and Transportation released an investigative report criticizing the CPSC’s data-handling breaches from the spring. This month, the Office of Oversight and Investigations Minority Staff from the same US Senate committee released a report criticizing the CPSC’s handling of three “high-profile failures to effectively recall dangerous products” last year. The report summarizes the CPSC’s actions related to jogging strollers, infant reclined sleeping products and home elevators. The report concludes that the CPSC’s “failures” are “the result of a pattern of inappropriate deference to industry that has characterized CPSC leadership in recent years.” The report recommends that the CPSC “at a minimum” increase the use of imminent health and safety warnings, fine companies that fail to timely report substantial products hazards and use refunds or consumer-friendly repairs as default remedies.

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Last month, the CPSC and three affiliated retailers issued a joint warning to consumers after the retailers discovered they sold nearly 1,200 units of 19 previously recalled consumer products between 2014 and 2019. The range of products at issue varied, including infant sleepers, scarves, portable speakers, barstools, children’s cardigan sets, hoverboards, beer mugs, coffee presses and infant rattles. It remains to be seen whether any further CPSC action, such as a civil penalty or a requirement to implement stronger recall systems and protocols, will be taken with respect to these three retailers.

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This month, the US Senate Committee on Commerce, Science, and Transportation released its investigative report on the CPSC’s data handling breaches from the spring. In April, the CPSC issued notices to multiple manufacturers explaining that “nonpublic manufacturer information” was released to the public without complying with Section 6(b) of the Consumer Product Safety Act. Section 6(b) prohibits the CPSC from disclosing information reported by product manufacturers without complying with the procedures for and restrictions on the commission’s public disclosure of such information. Section 6(b) aims to incentivize manufacturers to provide more safety information without fear of public backlash. The Senate committee’s report is troubling. It found that the CPSC made “improper disclosures to 29 unique entities” that “contained information on approximately 10,900 unique manufacturers, as well as street addresses, ages, and genders of approximately 30,000 consumers.” The Senate committee reviewed “hundreds of documents and emails and conducted multiple interviews” to conclude that the CPSC’s violations of Section 6(b) “were due to a lack of training, ineffective management, and poor information technology implementation.” The report cited several examples, such as that CPSC employees had “little to no Section 6(b) training” and were provided with “three different software applications to access and process relevant data without the necessary training on how to use these often confusing and idiosyncratic systems.” The Senate committee ended with a list of recommendations for the CPSC to remedy these problems and avoid future data-handling breaches.

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With Acting Chairman Ann Marie Buerkle’s earlier announcement  that she will leave the CPSC this fall, this month the commissioners elected Commissioner Robert Adler as the new acting chairman. Adler has been affiliated with the CPSC for more than 40 years. He has served as a commissioner since 2009 and previously served as the acting chairman from December 2013 through July 2014.

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This month serves as a reminder to manufacturers, distributors, retailers and importers that consumer products carry strong liability risks when they pose risks of serious injury or death. Steps should be taken to reduce that liability, including the issuance of alerts and recalls to remove the products from the stream of commerce.

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With summer in full swing, several U.S. senators have taken a public step to focus the CPSC’s efforts on dangers at the beach. Airborne umbrellas have become a serious hazard to beachgoers. In fact, CPSC data indicates that there have been over 31,000 beach umbrella-related injuries from 2008 to 2017, including the death of a vacationer after she was struck in the torso and killed by a rogue umbrella in Virginia Beach in 2016. In an unusual move, four senators recently issued a letter urging the CPSC to be more proactive about addressing the dangers posed by beach umbrellas. The senators requested more detailed information about umbrella-related injuries, asked about safety standards to prevent such injuries, and encouraged the creation of a public safety campaign to educate the public about the dangers of beach umbrellas.

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The balance of power at the CPSC will shift after Acting Chairman Ann Marie Buerkle’s surprising announcement that she will leave the CPSC this fall. Buerkle has served as a CPSC Commissioner for six years and the Acting Chairman of the agency for almost half that time. President Trump has nominated Buerkle to be the permanent Chairman three times (2017, 2018, and 2019), but each time the Senate failed to vote on her nomination. Buerkle announced she is withdrawing her 2019 nomination to become the permanent Chairman and to serve an additional seven-year term. She will continue as Acting Chairman until September 30 and will complete the remainder of her term as Commissioner until October 27. She says that afterward, she will “pursue new opportunities that will allow me to continue my life’s work of advocacy and public service as well as spend more time with my six children and eighteen grandchildren.”

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Court rulings interpreting the Consumer Product Safety Act (CSPA) are rare because parties subject to the act typically resolve any issues directly with the CPSC through administrative actions or settlements. This month, the Seventh Circuit issued such a rare ruling, which makes it more difficult for manufacturers, distributors or retailers to argue the statute of limitations has run on failure-to-report claims.

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The CPSC this month issued notices to multiple consumer product companies explaining that the CPSC “recently discovered that nonpublic manufacturer information identifying your company by name along with product model name and/or model number was released in error to the public without following the procedures of 15 U.S.C. § 2055,” which provides procedures for and restrictions on the Commission’s public disclosure of manufacturer and product-specific information. The notice offers few details about the unauthorized disclosure’s nature or scope, raising questions about whether the released data comes from inspections, product safety investigations, recalls, consumer safety complaints or other possibly confidential or commercially sensitive information. This kind of disclosure may have a chilling effect going forward on the candor encouraged between the CPSC and regulated companies by Section 6(b) of the Consumer Product Safety Act.

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The U.S. Department of Justice announced major news in the world of consumer products this month. A federal grand jury recently indicted two corporate executives for their roles in an alleged scheme involving residential dehumidifiers. The executives were charged with conspiracy to commit wire fraud, conspiracy to defraud the CPSC, and failure to furnish timely information under the Consumer Product Safety Act.

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With the partial federal government shutdown over, the CPSC appears to be quickly returning to normal—it issued 18 recalls in this month. The agency also took an unusual and noteworthy step by issuing notice that the CPSC would regard clothing storage units that do not meet the industry standard designed to reduce tip-over events to have a defect which could present a substantial product hazard.

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The partial federal government shutdown forced the U.S. Consumer Product Safety Commission (“CPSC” or “Commission”) along with other agencies to close for 35 days. In fact, the last recall on the Commission’s website is dated December 20, 2018—two days before the unprecedented shutdown began.

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December was a quiet month in the world of recalls for two reasons. First, there were only 19 product recalls—the second lowest number of monthly recalls in 2019. Second, the partial federal government shutdown has forced the CPSC along with other agencies to close until President Trump and Congress can resolve their well-publicized funding dispute.

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With a new commissioner confirmed in September, the Commission once again has five commissioners. A philosophical divide along party lines surfaced this month in two decisions.

The first decision involved the settlement of an administrative lawsuit filed by the CPSC in February. The lawsuit alleged that a distributor refused to recall three-wheeled jogging strollers after consumer complaints that the front wheel can detach suddenly during use, causing injuries to at least 50 children and 47 adults. To settle the lawsuit, the distributor agreed to notify dealers and retailers and to “develop and launch an information campaign that will include an instructional video demonstrating how to safely and correctly operate” the stroller.  Eligible consumers who participate in this campaign can receive “incentives,” such as hardware to repair the stroller or a 20% discount towards the purchase of a new stroller from the same distributor.

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October began with a CPSC announcement that a major retailer agreed to pay a $3.85M civil penalty for failing to report that a trash can it sold contained a defect or created an unreasonable risk of serious injury. The retailer sold 367,000 of the trash cans nationwide between December 2013 and May 2015. Allegedly the trash can’s plastic collar may dislodge, exposing a sharp edge and posing a laceration hazard to consumers. The retailer received 92 consumer complaints about this alleged defect but did not immediately notify the CPSC of the defect. The CPSC announced a recall of the trash can in July 2015. In addition to the civil penalty, the retailer agreed to maintain a compliance program and a system of internal controls and procedures to ensure it discloses information to the CPSC in accordance with applicable law. The Commission voted unanimously (4-0) to accept the settlement.

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September ushered in a shift in political power at the CPSC with the confirmation of a new commissioner. In June, the U.S. Senate confirmed President Trump’s nomination of Dana Baiocco—a Republican—to the CPSC. Commissioner Baiocco’s appointment created the potential for a 2-2 voting tie if issues presented to the CPSC give rise to voting along party lines. One CPSC vacancy remained for which President Trump nominated Peter Feldman—another Republican—in June to both complete the remainder of former Commissioner Joe Mohorovic’s term, which expires in October 2019, and to serve a full seven-year term starting in October 2019. 

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This month marks the 10th anniversary of the Consumer Product Safety Improvement Act (“CPSIA”), which was signed into law on August 14, 2008. CPSIA was a bipartisan response to unsettling events in the world of consumer products that occurred in 2007. During that landmark year, reports emerged about lead contamination in a wide range of consumer products—including children’s toys—that forced the CPSC into the national spotlight and facilitated over 400 recalls. The CPSIA aimed to significantly enhance the CPSC’s regulatory and enforcement power by doubling its budget, increasing its staff levels, prohibiting the sale of recalled products and increasing its civil penalties. For example, before CPSIA, the CPSC could impose civil penalties in the amount of $8,000 per violation, with a maximum of $1.825 million. But in 2008, CPSIA increased significantly the amount of civil penalties to $100,000 per violation, with a maximum of $15 million, adjusted for inflation.

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July served as another quiet month in the world of recalls. With only 11 recalls issued, July has had the fewest recalls for any month in over a year.

The CPSC made an important announcement this month regarding cedar chests. A company designed cedar chests with lids that automatically lock when closed. The company stopped making the cedar chests in 1987. From 1977 to 2015, 14 children have suffocated to death after climbing into the cedar chests and becoming locked inside. During this time, the company recalled 12 million cedar chests and offered a replacement latch to remedy the defect. Still, the CPSC predicts that millions of these cedar chests remain unfixed in consumers’ homes, posing a continuing danger to children. The CPSC’s announcement served as a plea urging consumers to immediately replace or remove the dangerous latches.

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It has been a quiet month in the world of recalls with only 13 product recalls issued in June. Still, other CPSC-related news is noteworthy.

Last month, the U.S. Senate confirmed President Trump’s appointment of Dana Baiocco to serve as a CPSC commissioner. If political ideology translates into voting trends on consumer safety issues—and it may not—Baiocco’s appointment creates a potential 2-2 voting “tie” at the CPSC, with two Republican and two Democratic commissioners. Now, Trump seeks to add a third Republican to the CPSC. On June 4, 2018, Trump nominated Peter Feldman to be a commissioner. Feldman is senior counsel to the U.S. Senate Committee on Commerce, Science and Transportation, and therefore advises on consumer protection, product safety, data and privacy issues. If confirmed, Feldman will complete the remainder of former Commissioner Joe Mohorovic’s term, which expires in October 2019. Feldman’s confirmation would mean that for the first time in nearly 12 years, Republican appointees would outnumber Democratic appointees at the CPSC. 

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The CPSC experienced a political shake-up this month when the U.S. Senate confirmed Dana Baiocco as the newest commissioner. In September, President Trump nominated Baiocco, a Republican and former partner at Jones Day, but the Senate did not act on the nomination by the end of the 2017 calendar year. So President Trump resubmitted his nomination of Baiocco in January. On May 22, 2018, the Senate confirmed Baiocco by a vote of 50-45, mostly along party lines. Her seven-year term will run through October of 2024.

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April was an historic month for the CPSC. The agency approved a $27.25 million civil penalty—the largest in CPSC history. The significance of this record amount cannot be overstated. The previous record was held by a $15.45 million civil penalty approved in March of 2016. In fact, except for in 2016, the CPSC has never approved civil penalties that totaled $27.25 million in each of the last ten calendar years. Now, it is has done so in 2018 with just one civil penalty.

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On the heels of a recent $5 million civil penalty, the CPSC recently secured a $1.5 million civil penalty with help from the U.S. Department of Justice (“DOJ”). The civil penalty concludes a long saga between the CPSC and a large arts and crafts retailer about vases with allegedly defective thin glass that rendered them prone to shattering.

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The CPSC has flexed its regulatory muscle during the first months of 2018 with respect to products that pose risks to children. With the U.S. Department of Justice’s (“DOJ’s”) help, the CPSC secured a $5 million civil penalty against a drug company for its allegedly deficient child-resistant packaging. In December, the DOJ filed a complaint in federal court against the drug company alleging that it knowingly violated the Poison Prevention Packaging Act and the Consumer Product Safety Act by distributing five household prescription drugs with non-compliant child-resistant packaging and failing to report the noncompliance to the CPSC. The complaint alleges that the drug company’s engineers drafted a “risk analysis” memo identifying the packaging as non-compliant. Rather than halt distribution and immediately report the non-compliance to the CPSC, the drug company continued distribution with non-compliant packaging while concurrently developing compliant packaging. The company also waited nearly 15 months before notifying the CPSC of its non-compliant packaging. In January, the federal court entered a consent decree for the matter. The drug company agreed to pay a $5 million civil penalty, implement and maintain a compliance program, and maintain and enforce a system of internal controls and procedures.

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With the arrival of 2018, President Trump resubmitted his nominations for CPSC leadership vacancies to the Senate. In 2017, Trump nominated Commissioner Ann Marie Buerkle to serve as CPSC Chair and Dana Baiocco to serve as a commissioner replacing Democrat Commissioner Marietta Robinson, whose term expired. But, under Senate rules, nominations not acted on are returned to the President. At the end of the Senate’s 2017 session, this meant that roughly 120 nominations were returned to Trump. Both nominees—Buerkle and Baiocco—are expected to receive Senate confirmation this year.

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A reflection on 2017 reveals several highlights showing that the CPSC is in a transition phase.

The CPSC’s composition has changed and will continue to do so. At the beginning of 2017, the agency was led by three Democrats and two Republicans. In October, Republican Commissioner Joseph Mohorovic resigned his seat to return to the private sector. Thus, the CPSC now has four commissioners: three Democrats and one Republican. But the Democrats’ grip on the agency will soon slip. Indeed, after the election of President Trump, Republican Commissioner Ann Marie Buerkle became the CPSC chair. Further, President Trump has nominated a private-sector lawyer named Dana Baiocco to replace Commissioner Marietta Robinson, a Democrat whose term has expired. Further, an additional Republican nominee is expected to fill Mohorovic’s resignation. Thus, 2018 will likely see a Republican majority leading the CSPC for the first time in over a decade.

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There is plenty of recall activity to report but no civil penalty news to report for November. Perhaps the holiday spirit prevails at the CPSC in this holiday season.

Hoverboards were last year’s hottest toy during the holiday season, but they also caused alarm due to the tendency of their lithium-ion battery packs to overheat while charging, causing the hoverboards to catch fire or explode. This year, the CPSC is taking a proactive approach to hoverboards. In May and again this month, hoverboards by the same manufacturer caused house fires and prompted the CPSC to warn consumers to stop using those hoverboards altogether. Further, a hoverboard by a different manufacturer recently caught fire and caused $40,000 of property damage to a consumer’s home. These serious reports culminated in the CPSC issuing seven recalls this month for hoverboards by different manufacturers due to their potential fire and explosion hazards.

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October ushered in a case that might, on one hand, provoke a sigh of relief for manufacturers, distributors and retailers concerned about the upward trend in multimillion dollar civil penalties from the CPSC or, on the other hand, raise some eyebrows of concern about the extent of a court’s authority to prospectively impose auditing, compliance and training measures. See United States v. Spectrum Brands, Inc., No. 15-CV-371-WMC, 2017 WL 4339677 (W.D. Wis. Sept. 29, 2017).

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Last month, the solar eclipse captivated the United States and many consumers flocked to purchase solar eclipse glasses to safely observe the astronomical phenomenon. We previously reported how NASA issued a safety alert advising consumers on the proper eye protection they should seek. Now, some consumers have filed a class action lawsuit against a major online retailer for allegedly selling “unfit, extremely dangerous, and/or defective” solar eclipse glasses. As a result, the consumers allege “varying degrees of eye injury ranging from temporary discomfort to permanent blindness.”

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August was a busy month in the world of recalls. First, the end of August ushered in a hefty $5.7 million civil penalty against a major retailer in the United States. The retailer was allegedly selling and distributing recalled products and has agreed, in addition to the civil penalty, to maintain a compliance program and a system of internal controls and procedures. The CPSC voted 4 to 1 to accept the settlement, with Acting Chairman Buerkle voting to accept a lower civil penalty.

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As an update to our Recall Roundup’s focus on the fidget spinning craze from June and July, the Consumer Product Safety Commission (“CPSC”) has released spinner safety tips. Although the CPSC still reports no fidget spinner recalls, Acting Chairman Ann Marie Buerkle used the CPSC’s bully pulpit to warn of the choking dangers that result when fidget spinners break and release small pieces. In addition, she references “reports of fires involving battery-operated fidget spinners.” 

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On July 26, 2017, an amusement ride named “Fire Ball” at the Ohio State Fair broke apart, killing one passenger and injuring seven others. This deadly incident may trigger a CPSC investigation into the matter.

Prior to 1981, the CPSC exercised jurisdiction over all amusement rides. But after several high-profile cases challenged the CPSC’s jurisdiction over amusement rides with mixed results, an amusement parks trade group successfully lobbied Congress to exempt stationary amusement rides from the CPSC’s jurisdiction. In 1981, Congress passed the Consumer Product Safety Amendments, which amended the definition of “consumer product” to explicitly exempt stationary amusement rides.

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June commenced with another massive civil penalty. A manufacturer agreed to pay a $5.2 million civil penalty and maintain a compliance program for allegedly failing to immediately report defective floorboards in recreational off-highway vehicles. In a three-year period, the manufacturer received over 400 reports of floorboards cracking or breaking in one vehicle model and over 150 similar reports in two other models. Once the manufacturer filed its report, it allegedly underreported the number of floorboard incidents associated with one model and failed to identify altogether the floorboard incidents associated with the two other models. These omissions, according to CPSC staff, constituted a material misrepresentation. The CPSC accepted the settlement by a 4-to-1 vote.

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May’s 30 recalls—more than any month thus far in 2017—cover furniture, toys, appliances, lithium batteries, recreational vehicles, kitchen gadgets and more. Conspicuously absent so far from the list are fidget spinners, the now viral children’s toy making headlines recently for choking-related dangers. Retailers catching up to the hot demand should keep an eye on those warnings to see if they convert into recall activity in case the gadget is deemed worthy of a market exit that rivals the pace of its entry. In light of the CPSC’s willingness to impose penalties on retailers who sell recalled items, retailers should take stock of their recall plans of action.

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April served as a microcosm for recent trends in the world of recalls. A gas range manufacturer agreed to pay a $4.65 million civil penalty to the CPSC. In a six-year period, the manufacturer received 170 incident reports that the gas ranges had turned on spontaneously and could not be turned off using the control knobs. But the manufacturer knowingly failed to notify the CPSC immediately. The manufacturer agreed to pay the massive penalty, maintain an enhanced compliance program and maintain a related system of internal controls and procedures.

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March was an eventful month in the world of recalls. Children’s products have always been a CPSC focus, and for good reason. A recent study by Nationwide Children’s Hospital examined data over a 21-year period and found that a young child visits the emergency room for an accident involving a nursey product about every eight minutes. That is roughly 66,000 children annually. Last month alone, children’s products were the subject of six recalls. That trend continued in March as six children’s products were again recalled—infant caps, toys, games, sleepwear, bibs and rattles. The CPSC also approved unanimously a new federal safety standard for infant bath tubs. This serves as a notable development because, under the 1981 Amendments to the Consumer Product Safety Act, the CPSC must defer to an existing industry standard if it adequately addresses the risk and fosters adequate compliance. Accordingly, the CPSC has only issued 37 safety standards and roughly one-third of them (14) are for children’s products. The new standard serves as additional evidence that the CPSC is taking a more proactive approach to regulating children’s products.

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The CPSC extracted another steep civil penalty this month from a manufacturer of coffee brewers that agreed to pay $5.8 million after it knowingly failed to report a defect or unreasonable risk of serious injury to the CPSC. Specifically, the manufacturer received roughly 200 reports in a four-year period about its coffee brewers spraying out hot liquids and coffee, inflicting burn-related injuries to consumers. As part of the settlement, the manufacturer also agreed to develop, implement and maintain a compliance program to avoid failure-to-report problems in the future. Perhaps the recent change in CPSC leadership will impact the frequency or amount of these civil penalties in the future.

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With a new administration in the White House comes new leadership at the Consumer Product Safety Commission (“CPSC”). The CPSC has five commissioners, all of which are Former President Obama appointees, though no more than three may share the same political party affiliation. Commissioner Elliot Kaye—a Democrat—served as the CPSC’s Chairman until this month, when Commissioner Ann Marie Buerkle—a Republican—was named Acting Chairman. Kaye will continue to serve as a commissioner and Buerkle will remain Acting Chairman until President Trump nominates and the Senate confirms a permanent replacement. Before joining the CPSC in 2013, Buerkle represented New York’s 25th Congressional District in the House of Representatives and served as the U.S. Representative to the 66th Session of the United Nations General Assembly.

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The beginning of the New Year experienced a drop off in recalls as the busy holiday season came to a close. Nevertheless, two important trends developed throughout January.

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As we previously reported, Kelly Faglioni, a partner in our Product Liability group, authored an article identifying and discussing approaches for managing risk that arises from complexity and ambiguity in product regulatory schemes including approaches to the question: “To recall or not to recall?”

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As we previously reported, Kelly Faglioni, a partner in our Product Liability group, authored an article highlighting the sources of ambiguity in the law that governs products in the U.S. and discusses that ambiguity as a purposeful tool in the regulatory tool belt. This post discusses Part 2 of her article. 

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Your product group is planning for the debut of the company’s most exciting new widget. Being responsible company citizens, the group checks in with the legal department to confirm the product regulatory and risk landscape. They start with the seemingly simple questions: “What are the applicable laws and regulations?” and “What are the foreseeable risk scenarios and associated damage potential?” Rather than answers, questions ensue. For example, what are the product components and/or ingredients? Will the product or its components contain anything toxic, corrosive, irritating, sensitizing, flammable or combustible? What are the foreseeable dangers associated with the product? What kind of product claims are envisioned? And so on.

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Civil penalties continue to serve as a reminder that noncompliance with the Consumer Product Safety Act can be costly. A major retailer agreed to pay a $3.8 million penalty for failure to implement an internal compliance program for the distribution and sale of recalled products. The retailer sold about 600 recalled products over a five-year period, a pattern of behavior that continued even after informing the CPSC that measures were in place to reduce this risk.

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November brought a reminder that civil penalties are the trend to watch from the CPSC when a pet goods retailer agreed to a $4.25 million penalty for failing to immediately report to CPSC an alleged defect in fish bowls at risk of breaking, which posed a risk to purchasers of cutting themselves. CPSC’s data shows a hefty increase in the amount of civil penalties extracted, ranging from a low of $700,000 to a high of $4.3 million in fiscal year 2015 and a low of $2 million to a whopping high of $15.45 million in fiscal year 2016. Virtually all of those instances involved a “failure to report” or delay in reporting.

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October was filled with frights as malfunctioning electronics took center stage. With personal panic devices failing to operate and diving computers posing drowning risks, manufacturers should keep in mind that life-threatening hazards dramatically increase their potential liability.

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Hunton & Williams LLP focuses on product issues ranging from compliance, recall issues, investigations and products-related litigation in state and federal courts and in various administrative forums. Our lawyers have managed and consulted on recall or potential recall issues for a number of clients requiring involvement with the Consumer Product Safety Commission, the Federal Trade Commission, the Food and Drug Administration, the Bureau of Alcohol, Tobacco, Firearms and Explosives, and the state attorneys general. Our lawyers have conducted broad-based federal and 50-state research to identify applicable regulatory schemes, consulted with clients regarding compliance strategy and litigation risk management issues, and litigated numerous products liability claims (gas controls, valves, water heaters, tires) in state and federal courts.

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