This week, Acting Chairman Ann Marie Buerkle withdrew her nomination to serve as Chairman of the U.S. Consumer Product Safety Commission (CPSC). She will wrap up her tenure as Acting Chairman, a position she has held since...more
The United States Supreme Court finally clarified its 11-year-old “clear evidence” standard for pharmaceutical preemption. In its much-anticipated opinion delivered by Justice Breyer, the Court unanimously reversed the Third...more
6/6/2019
/ Agency Disapproval ,
Clear Evidence Standard ,
Failure To Warn ,
FDA Approval ,
Federal v State Law Application ,
Food and Drug Administration (FDA) ,
Judicial Authority ,
Jury Trial ,
Manufacturers ,
Merck Sharp & Dohme Corp. v. Albrecht ,
Preemption ,
Prescription Drugs ,
Question of Fact ,
Question of Law ,
Remand ,
SCOTUS ,
State Law Claims ,
Vacated ,
Warning Labels
Consumer products companies are familiar with the reporting requirement under Section 15(b) of the Consumer Products Safety Act (the Act), but when does that obligation kick in for statute of limitations purposes? The...more
At a recent product safety conference, Ann Marie Buerkle, Acting Chair of the U.S. Consumer Product Safety Commission (CPSC), announced CPSC’s priorities for 2019. These include technology—both for consumers and within the...more
Updating and building on guidance issued one year ago, the U.S. Department of Transportation published a new federal guidance document entitled Preparing for the Future of Transportation: Automated Vehicles 3.0 (“AV 3.0”)....more
Safety standards for booster seats will no longer be a polite suggestion. On June 26, 2018, the U.S. Consumer Product Safety Commission (CPSC) voted 4-0 to approve a new mandatory safety standard for children’s booster seats....more
Developing and maintaining consumer trust is central to operating a successful consumer products company. Product recalls, contamination issues, product defects, privacy violations and data breaches can all undermine consumer...more
Running a successful consumer products company has never been easy. Rapidly evolving technologies, an uncertain economy and changing government regulations appear primed to complicate the already challenging task of...more
On June 4th, President Trump nominated Peter Feldman to fill the fifth seat on the U.S. Consumer Product Safety Commission (CPSC) and serve out the remainder of prior Commissioner Joe Mohorovic’s vacated seven-year term...more
After months of anticipation, the U.S. Senate finally confirmed Dana Baiocco as a Commissioner of the U.S. Consumer Product Safety Commission (CPSC) on May 22, 2018. President Trump first nominated Commissioner Baiocco on...more
The Consumer Product Safety Commission (CPSC) announced today that on May 16, 2018, it will hold a public hearing on “potential safety issues and hazards associated with internet-connected consumer products.” The Commission...more
The U.S. Supreme Court may soon revisit one of its seminal decisions defining products liability law for pharmaceutical manufacturers. That decision — Wyeth v. Levine — addressed whether a branded manufacturer could be held...more
With the start of the new year, President Trump again nominated Republican Ann Marie Buerkle to chair the U.S. Consumer Product Safety Commission (CPSC). Her expected confirmation will continue to push the CPSC in a more...more
In December, the U.S. Food and Drug Administration (FDA) issued guidance on Technical Considerations for Additive Manufactured Medical Devices. The guidance represents FDA’s efforts to provide regulatory direction about...more
"My Google Home Mini was inadvertently spying on me 24/7 due to a hardware flaw,” wrote a tech blogger who purchased Google Inc.’s latest internet of things (IoT) device. Following the incident, a pact of consumer advocacy...more
“Make fine lines and wrinkles disappear!” “Reduce the visibility of fine lines and wrinkles!” At first read, these claims sound one in the same. But for decades, a slight difference in phrasing of cosmetics claims—created...more
“The rise of powerful AI will be either the best or the worst thing ever to happen to humanity. We do not know which.” –Stephen Hawking
Artificial Intelligence (AI) and autonomous technology will shape the future, affect...more
Nearly ten years after the first three phthalates were banned from children’s toys by Congress, the U.S. Consumer Product Safety Commission (CPSC) issued a final rule on October 27 prohibiting five more. The rule bans the...more
A federal district court in Wisconsin recently hit Spectrum Brands Inc. (Spectrum) with civil penalties of $1.9 million for violations of the Consumer Products Safety Act (CPSA). The court’s 23-page opinion is a strong...more
In the coming years, we expect to see an explosion in the number of interoperable medical devices. These are connected medical devices that have the ability to connect to different technologies and devices, even from other...more
On October 4, the U.S. Senate Committee on Commerce, Science, and Transportation approved Ann Marie Buerkle’s (R-NY) nomination to the position of Chair of the Consumer Product Safety Commission (CPSC) after a two-day...more
In a split across party lines, the U.S. Consumer Product Safety Commission (CPSC or the “Commission”) recently voted on a largely unprecedented course of action: to ban an entire class of chemicals from popular consumer...more
President Trump announced on September 21, 2017, that his intent to nominate Jones Day partner Dana Baiocco to the position of Commissioner of the Consumer Product Safety Commission (CPSC) for a 7-year term starting next...more
In a unanimous vote, the U.S. Consumer Product Safety Commission (CPSC) eliminated third-party testing for compliance with CPSC’s phthalates prohibitions for seven plastics. The Commission decided that these plastics with...more
Last month, the U.S. Supreme Court clarified the scope of specific personal jurisdiction in Bristol-Myers Squibb Co. v. Superior Court of California, San Francisco Cty., 137 S. Ct. 1773 (2017) (“BMS”). Mass tort defendants...more