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

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

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

The CPSC has been very clear that protecting children from dresser tip over is a top priority.  The Commission actively monitors and tests furniture for compliance with stability standards, and frequently recalls products that present a tip over hazard.  As of today, the CPSC has recalled at least thirty dressers since 1996, and five already in 2020 alone.

 

A review of the recalls shows that the majority (61%) were conducted despite zero reported incidents involving consumers.  Most of those were based on noncompliance with the tipover standard, ASTM 2057.

ASTM 2057, the standard safety specification for clothing storage units, was revised in 2014, 2017, and most recently in 2019.  Importantly, even if a product is compliant with the current standard at the time of manufacture, it could still be recalled for noncompliance with a future revised version.  This has been the case in at least 2 recalls: here and here.

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About Recalls in Review: As with all things, but particularly in retail, it is important to keep your finger on the pulse of what’s trending with consumers. Regulatory enforcement is no different – it can also be subject to pop culture trends and social media fervor. And this makes sense, as sales increase for a “trending” product, the likelihood of discovering a product defect or common consumer misuse also increases. Regulators focus on popular products when monitoring the marketplace for safety issues.

As product safety lawyers, we follow the products that are likely targets for regulatory attention. Through Recalls in Review, we share our observations with you.

Our clients often ask us what happens after a recall has been completed and what to expect from a visit from a regional CPSC inspector. We advise to be prepared to demonstrate what actions were taken regarding the Corrective Action Plan (CAP). The main purpose of the inspection appears to be to provide confirmation that CAP tasks (such as distribution of retailer letters and posters) are underway and/or have been completed.

The Commission staff will check that notice of the recall is available on the company website and often go to retail establishments to look for posters.  The documents that an inspector may request at an on-site inspection include:

  1. Copies of all notifications to consumers and any other documents sent out regarding the recall;
  2. Copies or other demonstration that agreed social media was posted;
  3. If the company agreed to monitor wholesale/auction websites, records to show that such a process has been established;
  4. Records to demonstrate what the total number of units in the recall population, what inventory exists or what was done with any units under the company’s control at the start of the CAP;
  5. Incident records to confirm the total number of incidents, whether there have been new incidents discovered post-recall, and when the company first learned of incidents that gave rise to the CPSC filing.

Collecting and organizing these documents from the start can make the CPSC post-recall inspection much less time-consuming.  And the inspection can provide an opportunity to resolve any problems that may have arisen in recall execution. Much of the information requested is necessary for completion of CPSC monthly status reports and can make that process work smoothly as well.

The choices facing American consumers are no longer just “paper or plastic” or “do you want fries with that?” Today, when strolling the aisles of a grocery store, customers have the option to buy local, organic, gluten-free, low-carb, or any other of a dozen choices. The local coffee shop offers a selection of responsibly-sourced coffees, shade grown coffees, and beans from Ethiopia, Yemen, or Guatemala. What savvy companies and marketers have realized is that American consumers like choice and they like to feel good about the products they buy.

And global trends— like safety concerns about foreign-made products, interest in supporting a flagging U.S. economy, or just plain patriotism—may encourage consumers to change their buying patterns—in favor of American goods. Smart manufacturers and marketers understand this and know that customers may be willing to pay a premium for American quality goods. And so, unsurprisingly, smart companies are doing what they can to make and market products as “Made in America.”

Continue Reading “Made in America” Claims: the Landscape, FTC Guidance, and Tips for Manufacturers and Marketers

The Transatlantic Trade and Investment Partnership (TTIP) negotiations formally commenced on July 8, 2013. A little over a year later, the negotiators have held six rounds of negotiations. The most recent round of negotiations was held during the week of July 14-18 in Brussels, and the seventh round is now expected for D.C. in late September.

During July’s discussions, the two sides covered the full range of “market access” issues, including trade in goods, trade in services, investment, and government procurement. Negotiations included greater regulatory cooperation, widely considered to be the greatest value of the TTIP talks, with modest progress made in regards to several product sectors, including textiles and apparel (where they focused on labeling and safety issues), chemicals (where they discuss broad opportunities for cooperation), and automobiles (where talks advanced in areas like equivalence of technical regulations). Food safety also continued to be an important issue during negotiations, particularly with the leak of the EU’s proposed chapter on Sanitary and Phytosantiary Measures (SPS) prior to the start of the latest round.

Continue Reading Sixth Round of TTIP Negotiations Concludes in Brussels

In mid-March, the FTC continued to back consumers’ right to repair, submitting a comment with the DOJ’s Antitrust Division to the U.S. Copyright Office in support of renewing and expanding exemptions for repair in the Digital Millennium Copyright Act (DMCA). The Commission is refunding consumers who were misled into purchasing goods, making student loan payments, and charitable donations for cancer patients. In the first FTC enforcement action of its kind, a supplements company faces penalties for “hijacking” another product’s reviews as its own to boost sales. The Commission highlighted a Notice of Proposed Rulemaking for the EnergyGuide Labeling Rule and Telemarketing Sales Rule. Members of the public are invited to join an open Commission meeting on March 21, 2024. Finally, the FTC appointed a new Administrative Law Judge, Jay L. Himes. More news on the FTC’s busy week, after the jump.

Continue Reading FTC Updates (March 11–15, 2024)

As we move forward our clocks to adjust for daylight saving time and enter the season of spring, the FTC is keeping quite busy. The FTC held multiple events, proposed various settlement orders, and issued new rules covering a host of industries and topical areas, including healthcare, privacy, and telemarketing. Most importantly, the FTC welcomed Commissioners Ferguson and Holyoak.

Continue Reading FTC Updates (February 26 – March 11, 2024)

The FTC continued its focus on consumer protection matters this week, announcing both finalized orders and consumer refunds in enforcement actions ranging from student debt relief to telemarketing. This, and more, after the jump.

Continue Reading FTC Updates (February 5 – February 9, 2024)

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