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Fortune Favors the Quick (to Report): Judge Slaps Spectrum Brands with $1.9 Million Penalty in DOJ/CPSC Tag-Team Enforcement...

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

Understanding FDA Guidance On Connected Medical Devices

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

Buerkle Poised to Take Her Seat

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

CPSC Heating Up Before New Commissioner Appointed: Approves a Petition for Rulemaking to Ban an Entire Class of Flame-Retardants

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

Trump to Nominate New Commissioner to CPSC

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

CPSC Removes Third-Party Testing Requirements for Children’s Products with Certain Plastics

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

Bristol-Myers Squibb: The Aftermath

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

Trump Nominates Buerkle as Permanent CPSC Chair

On July 24, 2017, the White House announced President Trump’s intent to nominate Ann Marie Buerkle (R-NY) as the next Chairman of the Consumer Product Safety Commission (CPSC) for a seven year term beginning October 27, 2018....more

Shift In CPSC Leadership Means More Changes To Come

At the midpoint of 2017, we look back on the U.S. Consumer Product Safety Commission’s activity under the new administration, including how recalls and penalties stack up against previous years, new focal points for safety...more

FDA’s Denial of Citizen’s Petition “Clear” Enough for Preemption of Failure-to-Warn Claims

The Tenth Circuit recently upheld a Utah district court’s finding that a branded drug manufacturer could not be held liable for failing to warn consumers about alleged birth defect risks when the FDA had previously rejected a...more

Court Declines to Certify Class in False Advertising Case Without Survey Evidence of a Common Consumer Definition

On June 7, 2017, a Central District Court of California declined to certify a class of consumers who alleged that 5-Hour Energy’s marketing of an energy drink was misleading, finding that individual factual questions...more

Closing the Door on Hybrid Product Defect-Fraud Claims

On April 13, 2017, in Azoulai v. BMW of N. Am. LLC (Case No. 16-cv-00589), the U.S. District Court for the Northern District of California dismissed a proposed consumer fraud class action against BMW of North America LLC...more

Rare Grable Removal Sighted In Missouri

Establishing federal jurisdiction over state-law claims through the Grable doctrine is rare, but a Missouri federal court recently reminded us that it is not impossible. In Bader Farms Inc. v. Monsanto Co., No....more

Closing the Door on Hybrid Product Defect/Fraud Claims

On April 13, 2017, in Azoulai v. BMW of N. Am. LLC (Case No. 16-cv-00589), the U.S. District Court for the Northern District of California dismissed a proposed consumer fraud class action against BMW of North America LLC...more

Another Step Toward Reasonable Preemption Case Law

Last month, the Sixth Circuit affirmed a complete defense verdict for Abbott Laboratories Inc. which was based in part on branded drug preemption. Rheinfrank v. Abbott Laboratories Inc., Case No. 16-3347, 2017 WL 680349 (6th...more

Trump’s Nominee for FDA Commissioner Likely Dooms Generic Drug Labeling Rule

President Trump recently announced his intent to nominate a new commissioner of the U.S. Food and Drug Administration (FDA), likely sealing the fate of FDA’s proposed generic drug labeling rule. The proposed rule would give...more

CPSC to Consider New Magnet Set Safety Standards Following 10th Circuit Decision in Zen Magnets

We have entered the next chapter in the ongoing saga of the Consumer Product Safety Commission’s (“CPSC”) regulation of high-powered, small, rare earth magnet sets (“SREMS”). On March 1, 2017, CPSC met and unanimously...more

A Changing of the Guard: Same Enforcement Trend under New CPSC Leadership?

Republican Ann Marie Buerkle was named Acting Chairman of the Consumer Product Safety Commission (CPSC) on February 9, 2017, replacing former Chairman and Democrat Elliott Kaye. This transition has many wondering whether the...more

What The Intuitive Ruling Means For Medical Device Makers

Last month, in Taylor v. Intuitive Surgical Inc., the Washington Supreme Court saddled medical device manufacturers with a new duty to warn under Washington law — the duty to warn hospitals about potential risks their...more

Expanding Duties and Eroding Protections for Medical Device Manufacturers

Earlier this month, the Washington Supreme Court saddled medical device manufacturers with a new duty to warn under Washington law—the duty to warn hospitals about potential risks their products may pose—and eroded exemptions...more

Plaintiffs’ Fraudulent Joinder Tactic Results in Dismissal

Defendants successfully argued “fraudulent joinder” in Bahalim v. Ferring Pharmaceuticals, Inc., winning dismissal of the case in its entirety. The case was decided on Plaintiffs’ motion to remand and Defendants’ motions to...more

New CPSC Safety Standard on Baby Slings

In early January, the U.S. Consumer Product Safety Commission (CPSC) adopted a new federal safety standard for infant sling carriers. 82 Fed. Reg. 2326-1 (Jan. 9, 2017). CPSC’s new rule follows its 2010 warning that baby...more

Small Magnets, Big Trouble – Zen Successfully Challenges CPSC Rulemaking in the 10th Circuit

The United States Court of Appeals for the Tenth Circuit recently vacated the Consumer Product Safety Commission’s (CPSC) 2014 rulemaking that prohibits the importation and distribution of high-powered, small, rare earth...more

Rare Court Decision in CPSC-Backed Enforcement Action

A federal district court in Wisconsin recently ruled against a product manufacturer, finding it liable for failing to report timely in a rare U.S. Consumer Product Safety Commission (CPSC)-backed lawsuit. United States v....more

California Adopts the Sophisticated Intermediary Doctrine

In a recent opinion, the Supreme Court of California formally adopted the Sophisticated Intermediary Doctrine, clarifying what circumstances may permit a raw materials supplier to discharge its duty to warn consumers. Webb...more

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