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Cheryl A. Falvey is a partner in Crowell & Moring's Washington, D.C. office. She provides litigation and counseling services, with a focus on consumer protection matters, including product safety, privacy, sweepstakes, promotions, and advertising. Cheryl concentrates on the defense of consumer class action, toxic tort, mass tort, and other tort claims arising out of consumer, occupational, and environmental exposures, as well as trade secret, intellectual property, and other technology litigation, representing clients in the food and beverage, consumer product, technology, energy and chemical industry sectors. Cheryl helps clients protect their brand and reputation, avoid liability in the marketing of their products, build safety into their products with science-based risk assessment, and successfully navigate product safety challenges with rapid response. Prior to joining Crowell & Moring, Cheryl served as the general counsel of the CPSC.

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Do not assume a government shutdown means that reporting obligations at the CPSC are on hold. While the Commission’s staff designated as essential personnel are dedicated to protecting against substantial, immediate or “imminent threats to human safety” under the Commission’s shutdown directive[1], they will be reviewing reports to make that determination. The obligation to report is not suspended during the shutdown, even if there may be slower than normal response on matters that do not present an immediate threat. The filings are tracked by date and time electronically, and with 15 million in penalties at stake for failure to timely report, it is important not to confuse a partial shutdown of government operations with a stay on statutory obligations. There is no stay of the reporting obligations If you are a manufacturer, importer, distributor, and/or retailer of consumer products, you continue to have a legal obligation under the Consumer Product Safety Act (CPSA) and other statutes administered by the CPSC to report the following types of information to the CPSC:

  • A defective product that could create a substantial risk of injury to consumers;
  • A product that creates an unreasonable risk of serious injury or death;
  • A product that fails to comply with an applicable consumer product safety rule or with any other rule, regulation, standard, or ban under the CPSA or any other statute enforced by the CPSC;
  • An incident in which a child (regardless of age) chokes on a marble, small ball, latex balloon, or other small part contained in a toy or game and that, as a result of the incident, the child dies, suffers serious injury, ceases breathing for any length of time, or is treated by a medical professional; and
  • Certain settlements of lawsuits.

Notably, the government shutdown has no impact on the timely reporting of lawsuit settlements. The New Year brings a new time period for an additional and separate reporting requirement under Section 37 of the Consumer Product Safety Act. It requires manufacturers of consumer products to report information about settled or adjudicated lawsuits during specific 24-month periods. Specifically, companies are required to report when at least three civil actions filed in federal or state court involve the same model of a product and each suit alleges the product was involved in death or grievous bodily injury.  15 U.S.C. § 2084(a). The products at issue in the three cases must involve the same particular model, distinctive as to functional design, construction, warnings, and instructions, i.e. the characteristics that affect the product’s safety related performance.

The CPSC regulations define grievous bodily injury to include certain categories of injury, including, but not limited to:

  • Mutilation or disfigurement including permanent facial disfiguration or non-facial scarring that results in permanent restrictions in motion;
  • Dismemberment or amputation;
  • The loss of important bodily function or debilitating internal disorder such as the permanent injury to the loss of an organ, or blindness or permanent loss, to any degree, of vision.
  • Injuries requiring extended hospitalization, including in-patient care of 30 days in acute care facility or 60 days in a rehabilitation facility;
  • Severe burns or severe electrical shock.[2]

Section 37 sets forth specific statutory time periods within which three settlements involving the same product would trigger reporting. Each of the 24-month statutory periods begin every odd year.  For purposes of this analysis, the applicable statutory periods are:

  • January 1, 2015 – December 31, 2016;
  • January 1, 2017 – December 31, 2018; and starting now
  • January 1, 2019 – December 31, 2021.[3]

In addition to Section 37 reporting, lawsuits should be reviewed with an eye towards whether they contain information reportable under Section 15, such as if the allegations reasonably support the conclusion that a product contains a defect which could create a substantial product hazard or an unreasonable risk of injury. In-house counsel should keep these intersections in mind and make sure they bridge the gap between litigation and this regulatory reporting obligation.

It is a common tendency to think about product safety issues in separate buckets depending on whether they raise litigation or regulatory risks. But each should not be considered in isolation as they can overlap in various ways, including within the Consumer Product Safety Act.

 

[1] Order No. 0921.1

[2] 16 C.F. R. §1116.2

[3] See 15 U.S.C. § 2084(b); see also 16 C.F.R. § 1116.2(a); CPSC Recall Handbook at page 9 (found at https://www.cpsc.gov//PageFiles/106141/8002.pdf).

 

 

Join Us For A Complimentary Webinar – Thursday, October 25, 2018 – 12:00 – 1:00 PM ET

Two years into the Trump Administration and:

  • The Consumer Product Safety Commission finally has a Republican majority,
  • the Department of Transportation has released its 3.0 guidance on autonomous vehicles,
  • NIST has published a 375 page recommendation on medical device security,
  • the FTC is holding a series of hearings on the transformative nature of the digital transformation on markets.
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What does all this activity in the United States mean for companies following the rapidly evolving regulations globally related to the safety and security of products?

This PLAC webinar will describe the current landscape at the federal agencies setting policy for product safety and security. With all the recent talk of regulatory humility in the face of great technological change, we’ll discuss whether regulators practice what they preach and if recent actions encourage or stifle innovation. Our session will compare and contrast activities across the federal government relevant to consumer products broadly defined with a particular focus on product safety and security.

Presenters:

Cheryl Falvey, Partner, Crowell & Moring, Washington, DC
John Fuson, Partner, Crowell & Moring, Washington, DC
Peter Miller, Senior CounselCrowell & Moring, Washington, DC

Please click here to register for this webinar.

You may have received an e-mail notice this week from the CPSC about the FOIA office’s new “Electronic Manufacturer Notification Collaboration Portal.”  The main purpose of the Portal is to reduce costs by using e-mail instead of snail mail for Section 6(b) and other FOIA-related notifications. 

Generally, automation of this process shouldn’t result in any meaningful changes in the FOIA notification and objection process.  The Commission’s regulations allow firms to submit information with a request for confidential treatment.  If the Commission receives a FOIA request for information previously designated confidential, the person who previously submitted the request for confidentiality is notified of the FOIA request and the need for quick response to protect that information from disclosure.

Given the quick turnaround time on requesting exemption from disclosure under FOIA, it is imperative for all industry players to make sure that the right contact is assigned – including someone in the Legal Department – to receive Portal notifications so your team can make quick decisions and take action if filing an objection with the CPSC is necessary.  The same contact person used for the Clearinghouse or Saferproducts.gov is a good bet.  But requesting an exemption under FOIA takes some analysis of the regulations.  Was the information submitted under section 15?  Is it a trade secret?  And so, companies would be well advised to make sure they have a process in place and conduct a training program to protect confidential data from disclosure.

If you haven’t yet received any notifications about the new automated Portal, you should check in with the CPSC at cpsc-foia@cpsc.gov and provide contact information for the proper registration person.  The full text of the notification recently sent by the CPSC is below:

Continue Reading Check Your Spam Filters!: CPSC Has Automated FOIA Communications

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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

The big takeaways from The Autonomous Vehicle Safety Regulation World Congress centered on the importance of a federal scheme for AV regulation and the reality of the states’ interest in traditional issues such as traffic enforcement, product liability, and insurance coverage. In keeping with those messages, the World Congress kicked off with NHTSA Deputy Administrator and Acting Director, Heidi King, speaking about NHTSA’s goals and interest followed almost immediately with wide participation from the states including California, Michigan, and Pennsylvania, among others.

Deputy Administrator King emphasized NHTSA’s desire to foster an environment of collaboration among all stakeholders, including the states.  Ms. King emphasized that safety remains the top priority at NHTSA.  NHTSA has provided some guidance, and looks forward to hearing from stakeholders about the best way to support and encourage growth in autonomous vehicles.  NHTSA wants to provide a flexible frame work to keep the door open for private sector innovation.  It is necessary to build public trust and confidence in the safety of autonomous vehicles, and that can only accomplished by all stakeholders working together.

Continue Reading Report on the Autonomous Vehicle Safety Regulation World Congress 2017

The regulation of e-cigarettes and other electronic nicotine delivery systems (“ENDS”) presents complex regulatory and scientific challenges. Two key federal agencies with product safety mandates and overlapping jurisdiction – the Consumer Product Safety Commission and the Food and Drug Administration – have turned their attention onto the specific area of e-cigarette battery-related fires and explosions in the last few months.

In August 2016, the Food and Drug Administration finalized its so-called Deeming Rule to bring e-cigarettes and ENDS, as well as their components and parts such as batteries, under its authority to regulate tobacco products. Under this newly granted authority to regulate e-cigarettes and ENDS, FDA held a public workshop in April on “Battery Safety Concerns in Electronic Nicotine Delivery Systems.” Through the workshop and also through other channels, FDA is seeking data and other information on explosions, fires, and overheating of e-cigarettes. FDA also has initiated a public safety campaign of “Tips to Help Avoid Vape Battery Explosions.”

Continue Reading Dueling Interests at CPSC and FDA “Deem” E-cigarette Battery Safety a Priority

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The U.S. Department of Justice and Consumer Product Safety Commission recently announced that they had entered into consent decrees with three New York-based toy companies and five individuals for importing and selling products that violate the Federal Hazardous Substances Act and the Consumer Product Safety Act. The consent decrees enter permanent injunctions against the companies from importing and selling toys until certain remedial actions are implemented and monitored by the CPSC. The decrees can be read here and here.

The DOJ and CPSC alleged that the individuals and companies – Everbright Trading Inc., Lily Popular Varieties & Gifts Inc., and Great Great Corporation – imported and sold numerous children’s toys and products that contained high levels lead content, lead paint, and phthalates; contained small parts; and violated the mandatory toy safety standard (ASTM F-963), bicycle helmet safety standard, and labeling of art material (LHAMA) requirements.

Continue Reading Government Blocks Companies from Importing and Selling Children’s Products after Alleged Non-Compliance with Product Safety Laws

On June 7, the U.S. Consumer Product Safety Commission provided administrative law followers a fascinating case study. For the first time in two decades, the CPSC’s five Commissioners heard an appeal put on by CPSC staff in administrative litigation. In its appeal, the staff seeks to overturn an administrative law judge’s opinion finding that Zen Magnets’ controversial high powered, small rare earth magnets (SREMs) are not defective and are not a substantial product hazard when sold with appropriate warnings. Novel already, what made this argument all the more interesting was an additional wrinkle:  four of the five Commissioners who heard the appeal had voted previously to approve a final safety standard that has the practical effect of banning such magnets outright.

Continue Reading CPSC Hears Rare Oral Argument in Zen Magnets Recall Litigation

CPSC Reaches Civil Penalty Agreement with Viking Range and Middleby Corporation; Firms to Pay $4.65 Million to Resolve Late Reporting Allegations Over Defective Gas Ranges

StoveThe U.S. Consumer Product Safety Commission (CPSC) has announced a civil penalty settlement with Viking Range, LLC of Greenwood, Mississippi and its parent company, The Middleby Corporation of Elgin, Illinois. The companies have agreed to pay a civil penalty of $4.65 million to resolve charges that they knowingly failed to immediately report allegedly defective gas ranges to the Commission under Section 15(b) of the Consumer Product Safety Act (CPSA). This civil penalty, the second of 2017, follows the Commission’s $5.8 million civil penalty levied against Keurig Green Mountain in February. Both penalties underscore that the Commission’s general approach to civil penalties, and desire to increase the amount of penalties imposed for violations, will not change overnight with new agency leadership. Indeed, the Acting Chairman actually voted against the settlement agreement, proposing instead an amendment to reduce the amount of the civil penalty to $2 million.

Continue Reading CPSC Announces Second Civil Penalty Of Year

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Historically, as administrations change at the safety agencies, new priorities and shifting judgments on risk-based hazard assessment drive regulatory burdens up or down. The effect of President Trump’s executive order requiring the repeal of two rules for every one promulgated is yet to be seen when it comes to rulemaking at consumer facing safety agencies such as the National Highway Traffic Safety Administration, Food and Drug Administration, and Consumer Product Safety Commission.

The CPSC, as an independent agency, could take the position that the E.O. simply does not apply to them.  The White House agrees.  But the reality is that very few $100 million rules have been issued by the CPSC over the entire life of the agency.  That is because its enabling statute favors voluntary industry standards over mandatory rules.  Indeed, many of the CPSC rules affecting product performance have been mandated by Congress and could not be repealed by the agency absent an act of Congress.  Still others may require some APA process before they can be legally repealed or changed.

Continue Reading Safety Agencies after Trump’s “2 for 1” Executive Order: What it May Mean for Regulating the Safety of IoT and other Emerging Technologies