When a product is recalled, class action lawsuits are not the only threat. Recalled products can also give rise to droves of individual actions. This is the case for Exactech, Inc., a manufacturer of implants, instruments, and technologies for joint replacement.

Following an initial pause in elective procedures at the start of the COVID-19 pandemic, the number of hip arthroplasty surgeries has grown at a steady pace. These procedures commonly use acetabular liners to increase the stability of the total hip arthroplasty. Now, Exactech, a manufacturer of acetabular liners, is under fire nine months after the U.S. Food and Drug Administration (“FDA”) announced a Class II recall of the Exactech Connexion GXL acetabular polyethylene liner in June 2021. A Class II recall involves situations in which consumers may experience temporary or medically reversible health consequences or the likelihood of serious adverse health consequences is remote.
Continue Reading Recall Litigation Report: Exactech Joint Replacement Products

Supply chain issues are a top concern for many companies across industries and markets. Please join Crowell & Moring for a webinar series that explores these issues and provides insights on the various legal and tactical considerations as companies think about supply chain disruption, impacts, and solutions.

Torts & Product Liability Issues
Wednesday, January 12,

Each year, thousands of products—from cosmetics to motor vehicles to children’s toys—are taken off the market over defects that pose potential safety concerns. Product recall announcements can generate a lot of publicity and quickly lead to class action or mass action lawsuits. Although a product recall does not automatically make a manufacturer liable, a quick and effective response can make all the difference. Product recalls are not necessarily “silver bullets” that defeat all civil claims, but a voluntary recall can serve as a strong defense in such suits, regardless of whether plaintiffs are claiming personal injury or only economic damage.
Continue Reading Recall Litigation Report: CPAP Class Action MDL

In one of the most significant developments in product safety law over the past decade, Gree Electric Appliances Inc. of Zhuhai, Hong Kong Gree Electric Appliances Sales Co. Ltd., and Gree USA Inc. (the “Gree Companies”), an appliance manufacturer and two of its subsidiaries, have pled guilty to willfully failing to report to the Consumer Product Safety Commission (CPSC) under Section 15(b) of the Consumer Product Safety Act (CPSA). According to the U.S. Department of Justice (DOJ) and the CPSC, the Gree Companies knew their dehumidifiers were defective, failed to meet applicable safety standards, and could catch fire, but failed to timely report that information to the CPSC. Section 19 of the CPSA makes it unlawful to fail to furnish information required by Section 15(b), and such failures are subject to both civil and criminal penalties. While CPSC civil penalties have become fairly routine—the Gree Companies also paid a then-record $15.45 million civil penalty in 2016—this is the first corporate criminal enforcement action brought under the CPSA, according to the DOJ. 
Continue Reading Silence Isn’t Golden: Failure to Report Consumer Product Safety Issues Results in Rare $91 Million Criminal Penalty

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Product liability suits and regulatory product defect enforcement actions associated with consumer foreseeable – and unforeseeable – misuse have become the norm. Consumer product companies can mitigate these risks by focusing on use-related hazards and user-centered designs in an effort to reduce injuries and improve the usability of products. But the real question is how far to go with these efforts — at what cost and for what incremental benefit.

On March 15, 2018, the Consumer Product Safety Commission published Draft Guidance on the Application of Human Factors to Consumer Products for industry comment by May 14, 2018. The draft guidance was developed in conjunction with Health Canada’s Consumer Product Safety Directorate. CPSC and Health Canada aim to increase product safety by explaining to product designers and manufacturers how to incorporate human factors[1] into the design process.

The draft guidance describes the product design process and provides guidance on human factors considerations at each stage and then summarized in the graphic depictions collected at the end of this post. Because the guidance is not an enforceable rule, no cost benefit analysis accompanies the myriad of product design recommendations proposed.


Continue Reading CPSC Reaction to Consumer Misuse – Human Factors Design Process