Generic pharmaceutical drugs are versions of brand-name counterparts with one major difference:  they typically cost a lot less. By FDA regulation, the two have the same active ingredients, dosage forms and strengths, and routes of administration.[1] And while federal law generally regulates pharmaceutical approval, states can regulate pharmaceutical distribution. Why is this significant? All states permit pharmacies to substitute generic drugs for the brand name equivalent, and some states require substitution in certain circumstances.[2] But a generic pharmaceutical company cannot change the brand company’s product label, so a person’s ability to sue a drug manufacturer is limited to the brand company who created the label.[3] Continue Reading Generically Speaking: Liability is Limited in Failure to Warn Claims

In many mass tort cases, and particularly in cases involving exposure to a substance with a long latency period, defendants and plaintiffs must rely on documents created decades ago. That’s challenging, of course, because many of these documents are hearsay and often there’s no one around with personal knowledge of their authenticity or contents. But there is hope for parties trying to admit these documents: they may be able to call on the ancient document hearsay exception. Continue Reading Time Marches On, Memories Fade, and Witnesses Die: How Lawyers Can Use the Underutilized Ancient Document Hearsay Exception

Long-anticipated changes to California’s Proposition 65 warning requirements took effect on August 30, 2018, through amendments and new rules issued by the California Office of Environmental Health Hazard Assessment. Among other changes, the new rules now (1) require businesses to provide California consumers with product warnings at the time of purchase, including at the time of online purchases; and (2) change the text of the warnings that businesses may use to qualify for “safe harbor” protections. The new warning requirements apply only to products manufactured after August 30, 2018. Continue Reading New California Prop 65 Warning Requirements: What Businesses Should Consider Now

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

If a company facing a recall has managed it effectively, the hardest part is probably over. After writing about how companies can prepare for and manage an effective recall, here are strategies companies can use to restore order and maintain brand loyalty following a product recall. Continue Reading Managing Product Recalls: What to Do After a Recall

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

Product liability defendants often seek to remove cases to federal court. That’s because federal jurisdiction provides the federal pleading standards, robust expert discovery, efficiency through uniform procedural and evidentiary rules, and often more diverse jury pools. Sometimes defendants can use removal to leverage early case resolution.

But it’s not always clear when a defendant can remove to federal court because the rules vary among the circuit courts, the facts drive the decision, and the case law continues to develop.  This year several cases highlighted the evolving removal landscape and addressed four important questions. Continue Reading 2017 Removal Roundup: How Can Defendants Get Into Federal Court?

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