Manufacturers start with good intentions. They endeavor to create and develop safe products, advertise them accurately, and equip consumers with sufficient warnings and instructions to enable safe and proper use of their products. But despite these efforts, consumers will occasionally find ways to misuse or abuse products in ways that the manufacturer neither intended nor, in some cases, even contemplated.

Continue Reading When Do Manufacturers Need to Anticipate Misuses – and Abuses – of Their Products?

“Smart luggage” is truly smart. Companies have created sleek, stylish bags that also contain practical, convenient accessories. Although smart luggage solves all sorts of problems, it has grabbed the attention of airlines and authorities due to the use of lithium batteries.

When companies develop new products, they can often turn to existing regulations to inform the plan and design, ensuring that it complies with the regulations when it is released. But sometimes innovation can make things a bit more complicated. Incorporating new features like an internal scale, GPS tracking, TSA-approved locks, and USB ports to charge electronics, smart luggage perfectly illustrates this tricky situation. Continue Reading Speed and Flexibility: A Smart Approach to Developing Policies

You put countless dollars and hours into making the best possible product, and it becomes a hit. But something goes wrong, and consumers may be getting hurt. A recall becomes necessary. As part of our series on managing product recalls, this post focuses on important steps companies can take during a product recall.

The first step, as we wrote last week, is to be prepared for a recall. We explained some strategies for how to get prepared in our last blog post on this topic. Continue Reading Managing Product Recalls: What to Do During a Recall

Many people will show their love this Valentine’s Day with a gift of jewelry or chocolate, but others will decide their warm, fuzzy feelings are best expressed through the glow of their favorite consumer product. Companies will enjoy seeing their merchandise fly off the shelves and make people happy. But what should a company do when that success – and the millions of uses that may come with it – suggests a product may pose an unforeseen risk? Continue Reading Managing Product Recalls: What to Do Before a Recall

The Consumer Product Safety Commission (CPSC) issued a final rule in October prohibiting the manufacture for sale, offer for sale, distribution in commerce, or importation of toys and child care products containing more than 0.1 percent of five phthalate chemicals. Phthalates make plastics soft and pliable, and are contained in many toys and other products intended for young children. The rule will take effect on April 25, 2018.

Continue Reading CPSC Issues Final Rule on Phthalates in Toys and Child Care Products

Under the recently enacted FDA Reauthorization Act of 2017, drug and device manufacturers will have more time to report device malfunctions to the U.S. Food and Drug Administration (FDA).

Current standards require medical device malfunction reports to the FDA within 30 days. The 2017 Act maintains the 30-day deadline for reporting events that have already resulted in serious medical consequences to users—“adverse events.” But the Act expands the quarterly reporting function, allowing 90 days to report issues that may cause harm in the future but have not yet resulted in patient complications, injuries, or deaths—“malfunctions.” The Act also allows companies to submit summary malfunction reports when the incident reported is already known and understood by the FDA, rather than reporting incidents individually. Continue Reading New Legislation Gives More Time for Medical Device Reporting

Last week, Home Depot became the latest mass retailer to pay a civil penalty for selling products previously recalled by the U.S. Consumer Product Safety Commission (CPSC).

By our count, this is the third such penalty to be imposed, at least in recent years. In 2014, Meijer was penalized $2 million for selling 1,700 units of 12 different recalled products. In 2016, Best Buy agreed to pay $3.8 million for selling 600 units of 16 different products. Now, Home Depot has agreed to pay $5.7 million, having distributed just over 2,800 units cutting across 33 different recalls.

The size of these penalties should be sufficient to put other retailers on notice that the presence of a recalled product cannot be treated as just another inventory issue. Continue Reading Selling Recalled Products: CPSC Fines Home Depot

A Chicago jury awarded a single plaintiff $150 million in punitive damages, finding that AbbVie, Inc. fraudulently misrepresented the safety risks of its drug used to treat low testosterone, AndroGel. But the jury also decided in AbbVie’s favor on the plaintiff’s strict liability and negligence claims—meaning that they determined that AndroGel did not cause the plaintiff’s alleged injury. As a result, the jury awarded no compensatory damages. Continue Reading Who Won? The Verdict in the AndroGel Trial

Consumer product companies that suspect a product either contains a defect or poses an unreasonable risk of injury are required to report that fact to the Consumer Product Safety Commission (CPSC) within 24 hours of reaching that conclusion – or risk a civil penalty, like Kawasaki received earlier this month. Continue Reading The Dangers of Partial CPSC Reports: The Kawasaki Penalty