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CPSC Issues Unilateral Recall Press Release Involving “Uncooperative” Retailer Of Smoke Detector

On May 16, 2024, the United States Consumer Product Safety Commission (CPSC) took an unconventional action, unilaterally issuing a recall announcement urging consumers to dispose of CHZHVAN Combination Smoke and Carbon...more

Himes v. Somatics – California’s New Causation Standard for the Learned Intermediary Doctrine

In Himes v. Somatics, LLC, No. S273887, 2024 WL 3059637 (Cal. June 20, 2024), the Supreme Court of California delivered a win to the defense, upholding the learned intermediary doctrine in cases involving prescription drugs...more

Cases to Watch: Gilead Life Sciences v. Superior Court

The California Supreme Court granted review in Gilead Life Sciences v. Superior Court—a hopeful turn of events after lower courts issued decisions that resulted in an unprecedented expansion of negligence liability for...more

CPSC at ICPHSO: Office of Compliance Activity

This second installment of our series highlights CPSC’s Office of Compliance Activity and continued aggressive enforcement efforts. Multiple presenters emphasized CPSC’s continued aggressive enforcement. Commenters...more

CPSC at ICPHSO: 2024 Enforcement Priorities

The Consumer Product Safety Commission (CPSC) was well represented at the International Consumer Product Health and Safety Organization’s annual symposium in Orlando, which took place in February. Agency representatives...more

Consumer Product Safety Enforcement To Heat Up Under Biden Administration

More aggressive enforcement actions and increased regulatory activities under the Biden Administration are here. In President Biden’s first weeks, he is making good on his promise to reverse course from the previous...more

CPSC Recall Remedies In The Time Of COVID-19

The Consumer Product Safety Commission (CPSC) recognizes that companies everywhere are in the midst of responding to the impact of COVID-19 on business operations, including government stay-at-home orders that could see some...more

FDA Inspires Modifications And Quick Authorizations For Ventilators

As the number of COVID-19 cases in the U.S. grows, the potential shortage of ventilators has become an increasing concern. This week, the U.S. Food and Drug Administration (FDA) took two important steps to keep medical...more

FDA Calls “All Hands On Deck” To Keep Hand Sanitizer Stocked

Last week, the U.S. Food and Drug Administration (FDA) took yet another step to encourage production of basic medical supplies in the battle against COVID-19. On Friday, March 20, FDA published two new guidance documents...more

Supreme Court Decides Prescription Drug Preemption Case in Favor of Drug Manufacturer

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

Will High Court Provide Clarity On 'Clear Evidence'?

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

3D Printing Meets Medical Devices: FDA Weighs In On Additive Manufacturing

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

Makeup Shake Up: Potential New Federal Cosmetics Regulations

“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

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

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

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

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

FDA Embraces Internet of Things: New Draft Guidance on Postmarket Cybersecurity for Medical Devices

The FDA’s recently issued draft guidance on “Postmarket Management of Cybersecurity in Medical Devices” seeks to address some of the increasing concerns that medical device providers, regulators, and consumers have about...more

Recall, Enforce, Repeat! CPSC and DOJ Team Up for Another Enforcement Action

The United States Consumer Product Safety Commission (CPSC) continues to escalate its enforcement efforts. Last week, the United States Department of Justice, on behalf of CPSC, filed suit against Spectrum Brands, Inc....more

CPSC Civil Penalty Trend Continues

At the end of last year, we reported that the U.S. Consumer Product Safety Commission issued $12.2 million in civil penalties in 2014, more than double the amount issued in 2013. The number of companies fined increased as...more

FDA Proposed Rule in Flux?

On Tuesday, the U.S. Food and Drug Administration (FDA) announced that it has reopened the comment period for its proposed rule on generic drug labeling. It has also scheduled a day-long public meeting to hear comments and...more

Looking to Litigate in Secret? Fourth Circuit Creates Hurdles for Product Manufacturers

In April, the Fourth Circuit ruled in Company Doe v. Public Citizen that a manufacturer could not hide behind a veil of secrecy even after successfully enjoining the Consumer Product Safety Commission (CPSC) from publishing...more

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