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Class actions following a product recall often focus on what the company allegedly knew before its products were taken off the market. But this is not always the case. A company can also come under fire for its actions after the recall and, specifically, what recourse it offers to consumers of recalled products.

On October 5, 2021, the U.S. Food and Drug Administration (“FDA”) alerted the public of a manufacturing issue with certain lots of Ellume USA LLC’s (“Ellume”) COVID-19 Home Tests that had could lead to false positive results, and several weeks later, the FDA announced a Class I recall of these tests based on the higher-than-acceptable false positive test result. When it comes to COVID-19, a false positive could lead to delayed diagnosis and treatment of the actual cause of illness; further spread of COVID 19 when presumed positive people are grouped based on false test results; unnecessary COVID-19 treatment from health care providers, such as antiviral treatment, convalescent plasma, or monoclonal antibody treatment, which can result in side effects; disregard for the recommended precautions against COVID-19, including vaccination; and isolation, monitoring household or close contacts for symptoms, limiting contact with family or friends, and missing school or work.
Continue Reading Recall Litigation Report: Consumers Bring Class Action Lawsuit Against Ellume Refusing to Refund Recalled COVID-19 Home Tests

The practice of law has changed in many ways during the COVID-19 global pandemic, but a slow-down in class action lawsuits was not one of those changes. In the second half of 2021, consumers filed quite a few lawsuits following a wide range of highly-publicized recalls, involving everything from pharmaceuticals to automobiles.

For example, as previously reported, on June 14, 2021, Philips Respironics voluntarily recalled several different models of CPAP and BiPAP breathing machines because the polyester-based polyurethane (PE-PUR) foam in the machines has the potential to break down, be inhaled or ingested by users, and increase their risk of cancer and other injuries. In the weeks and months that followed the recall, a number of putative class action lawsuits emerged, seeking compensation for injuries, risks, and disrupted use. Generally speaking, plaintiffs allege that Philips Respironics knew about the serious risk of injury caused by its devices long before it warned the public about potential hazards in April 2021 and finally recalled the machines in June 2021. Over a hundred lawsuits have now been consolidated in the U.S. District Court for the Western District of Pennsylvania in the CPAP multi-district litigation, In Re: Philips Recalled CPAP, Bi-Level PAP, and Mechanical Ventilator Products Liability Litigation, MDL No. 3014, and discovery is ongoing.
Continue Reading Recall Litigation Report: Year in Review (2021)

Last month, U.S. Representative Grace Meng (D-NY) announced that she has reintroduced legislation—the Total Recall Act—to change the way that businesses notify the public about recalls.  The text of the legislation can be found here.

H.R. 3724, entitled the “Total Recall Act,” requires firms engaged in a product recall to post recall notices on their websites and all social media accounts, and also spend a defined amount of money on publicizing the recall depending upon whether it is mandatory or voluntary.  For a mandatory recall, which is an incredibly rare event, businesses would be required to expend a sum of money that equals at least 25% of what the firm spent on marketing the product prior to its recall.  On the other hand, for common voluntary recalls, firms would be required to use at least 25% of the product’s original marketing budget as well as 100% of the product’s social media marketing budget on publicizing the recall.  The bill would also mandate that the U.S. Consumer Product Safety Commission provide an annual report to Congress on participation rates for each recall.
Continue Reading Product Recall Notification Legislation Reintroduced in Congress

On May 21, 2021, the U.S. Consumer Products Safety Commission (“CPSC”) published a report on artificial intelligence (AI) and machine learning (ML) in consumer products. The report highlights recent CPSC staff activity concerning AI and ML, proposes a framework for evaluating the potential safety impact of AI and ML capabilities in consumer products, and makes several recommendations that the CPSC can take in identifying and addressing potential hazards related to AI and ML capabilities in consumer products.

Concerning staff activity, CPSC recently hired a Chief Technologist with a background in AI and ML to address the use of AI in consumer products. The CPSC also recently established an “AI/ML Working Group” and held a virtual forum on AI and ML in March 2021.

Informed by the discussions held with various stakeholders at this forum, the CPSC staff has proposed a framework in the report for evaluating the potential safety impact of AI and ML in consumer products. The framework’s first step involves screening products for AI and ML “components.” The CPSC and stakeholders have identified the following components to be essential to producing an AI capability: data sources, algorithms, computations, and connections. Likewise, the CPSC and stakeholders have found the following components to define ML capabilities: assessing and monitoring outputs, analyzing and modeling changes, and adjusting and adapting behavior over time. The framework’s second step involves assessing the functions and features of consumer products’ AI and ML capabilities. The third step involves understanding how products’ AI and ML capabilities may impact consumers, which can be accomplished by studying the nature of the technology, how it is implemented in the product, and how the consumer might use the product. The final step involves ascertaining if, and to what extent, AI and ML capabilities may transform the product and/or its use over time.
Continue Reading CPSC Publishes Report on Artificial Intelligence and Machine Learning

Could the end of Section 6(b) of the Consumer Product Safety Act (CPSA) actually be near?  Time will tell.  But last week’s development on Capitol Hill in the saga of “Section 6(b)” is noteworthy, and, one day in the not-so-distant future, may be recognized as the beginning of the end for this controversial provision of the law.

On April 22, Senator Richard Blumenthal (D-CT) and Representatives Jan Schakowsky (D-IL) and Bobby Rush (D-IL) introduced legislation—the Sunshine in Product Safety Act—to fully repeal Section 6(b) of the CPSA.  This is the first time in recent memory that Members of Congress have introduced legislation to do away with Section 6(b) altogether.  For example, in the last Congress, Representative Rush introduced the “SHARE Act,” which sought primarily to scale back one of Section 6(b)’s most important protections for firms—allowing a company to judicially challenge the U.S. Consumer Product Safety Commission’s (“CPSC” or “the Commission”) decision to release information about a firm, or one of its products, prior to its disclosure.  But that legislation left the rest of Section 6(b)’s procedures and protections intact.  This current bill, therefore, is much more ambitious, and stakeholders should take note.

By way of background, Section 6(b) requires the CPSC to engage in certain procedural steps before publicly disclosing information from which the identity of a manufacturer of a product can be readily ascertained.  Those include taking reasonable steps to ensure that the information to be disclosed publicly is fair, accurate, and reasonable related to effectuating the purpose of the product safety laws.  Practically speaking, this means notifying the manufacturer of the potential disclosure, providing either a summary of what the agency intends to disclose, or the actual disclosure itself, and providing the company with the opportunity to comment, typically 15 days, though that time period can be shortened by the CPSC with a “public health and safety finding.”  Other regulators, like FDA and NHTSA, do not have similar statutory constraints on the release of product information nor do they have due process protections around data release, whether those be adverse events or vehicle accidents.
Continue Reading New Bills Seek to Repeal Controversial Provision of Product Safety Act

There have been recent calls for Congress to re-visit H.R. 2211, the “Stop Tip-overs of Un-stable, Risky Dressers on Youth Act” also known as the “STURDY Act.” Sponsored by Janice Schakowsky (Dem-IL 9th District), the bill was introduced in Congress last session and passed by the House on September 17, 2019 but never passed by the Senate. It would require the U.S. Consumer Product Safety Commission (“CPSC”) to promulgate a consumer product safety rule for free-standing clothing storage units to protect children from tip-over related death or injury.

As we indicated in our May 2020 analysis of dresser tip-overs, tip-overs have been a main focus for the CPSC and consumer advocacy groups in recent years. A CPSC report indicates that 571 people died from furniture tip-overs between 2000 and 2019, and 82% of those were children (ages ranged from 1 month to 14 years). A survey conducted by the CPSC showed that 41% of respondents did not anchor furniture in their homes.

Currently, there is no mandatory standard requiring manufacturers to test furniture to specific stability and safety standards. The current voluntary standard, ASTM F2057 – 19, is recognized by industry and the CPSC as required best practice in order to prevent tip-overs from dressers and other clothing storage units.
Continue Reading New Proposed Legislation to Prevent Furniture Tip-Over

The current process for creating voluntary product safety standards has recently been criticized in the media in connection with a debate over whether rare-earth magnets can be adequately regulated through the voluntary standard process in order to protect children from swallowing the magnets. Regardless of opinions about how the process works, the CPSC treats them

You’ve just received news that a consumer’s experience with your product did not go as expected. They’ve called, e-mailed, left a review, or even sent a tweet about a negative experience. As you address the consumer’s concerns, it is important to recognize if any reportable safety issues have been raised. If so, there is certain

  • Is an escalator in a shopping mall a consumer product? The Consumer Product Safety Commission thinks so; here’s their recommendation on escalator safety and the use of soft soled shoes.
  • Does the CPSC regulate the Internet of Things? To the extent networked products present safety risks, you bet they do. CPSC Commissioner Kaye has issued

As more organizations incorporate technology in newfound ways to increase efficiency and effectiveness, government agencies have done the same. Take, for instance, the CPSC’s new recall app, which makes recall information more accessible to consumers on their mobile devices. Now government agencies are looking towards companies to apply the latest technologies to protecting consumer