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
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
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
6/14/2024
/ CA Supreme Court ,
Gilead Sciences ,
Healthcare ,
HIV ,
Liability ,
Life Sciences ,
Manufacturers ,
Negligence ,
Pharmaceutical Industry ,
Product Defects ,
Summary Judgment
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
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
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
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
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
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
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
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
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
“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 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
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
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
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
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
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
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
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
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
6/23/2015
/ Civil Monetary Penalty ,
Consumer Product Safety Act (CPSA) ,
Consumer Product Safety Commission (CPSC) ,
Department of Justice (DOJ) ,
Enforcement ,
Enforcement Actions ,
Manufacturers ,
Notice Requirements ,
Product Defects ,
Product Recalls ,
Spectrum
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
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
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