Ad Law Tool Kit Show – Episode 1 – Product Safety and Recalls
Foreign device manufacturers should anticipate greater chance of FDA inspection under new FDA leadership
Welcome to our fourth issue of The Health Record - our healthcare law insights e-newsletter. In this edition, we take a look at the Biden administration's proposed insurance rule regarding mental health and substance use...more
Welcome to our seventh 2024 issue of Decoded - our technology law insights e-newsletter. We have a few events we want to pass along to those interested in technology, but also other areas of law and business. ...more
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
Manufacturers should add “possible class action defense” to the list of considerations when evaluating whether to conduct a voluntary recall of a consumer product, particularly when class action litigation is threatened or...more
On July 30, 2024, the Consumer Product Safety Commission (CPSC) issued a Decision and Order against Amazon, finding that Amazon is a "distributor" of third-party products, as defined by the Consumer Product Safety Act (CPSA),...more
Abiomed, Inc., a subsidiary of Johnson & Johnson, is facing lawsuits across the country related to the company’s Impella heart pumps. Since June of last year, the company has issued multiple recalls for these implantable...more
On December 17, 2024, recent amendments to the Food and Drug Regulations (FDR) and the Medical Devices Regulations (MDR) relating to the recall of drugs and medical devices will come into force....more
In a closely watched case, the U.S. Consumer Product Safety Commission (CPSC) on July 29, 2024, found that Amazon's popular "Fulfilled by Amazon" program – in which products are listed by Amazon but sold by third-party...more
The U.S. Consumer Product Safety Commission (CPSC) announced on July 30, 2024, that it issued a Decision and Order against Amazon.com, Inc. (Amazon). CPCS states that, in a unanimous vote, it “determined that Amazon was a...more
Exactech has issued multiple recalls for its implantable joint replacement devices over the past few years. While Exactech has largely issued these recalls voluntarily, it has done so at the request—and with the oversight—of...more
In response to scrutiny from the U.S. Food and Drug Administration (FDA), Exactech has recalled hundreds of thousands of defective medical implant devices sold between 2004 and 2021. Despite these recalls—which began in...more
As the 2024 Minnesota Legislative Session came to a chaotic close on May 20, numerous changes to Minnesota Statutes Chapter 342 were sent to the Governor’s desk to build on the already existing cannabis regulatory structure....more
As we have reported at length, the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) imposed extensive new requirements related to cosmetic products marketed in the United States. As compliance deadlines for these new...more
Thursday, Microsoft announced its new line of Copilot Plus PCs would launch next week without the anticipated Recall feature. Originally part of Microsoft’s Copilot Plus suite, Recall was designed to take and store...more
The parents of a Gainesville, Georgia high school baseball player who died after he was hit in the head at baseball practice have filed a lawsuit against the school system and his coaches....more
The risk of a product recall has increased in recent years due to changing global regulatory standards. Contributing factors include geographically widespread supply chains and different manufacturing protocols among nations...more
In Palmer v. Teva Canada Limited, the Ontario Court of Appeal upheld the lower court’s decision to deny certification of a proposed product liability class action seeking damages for the alleged increased risk of being...more
The U.S. Consumer Product Safety Commission (CPSC or the “Commission”) has scheduled a public hearing on May 8, 2024, to hear stakeholders’ views on the Commission’s priorities for fiscal years 2025 and 2026. This annual...more
Over the past couple of decades, hundreds of thousands of patients in the United States have received defective medical implants manufactured by Exactech. While the U.S. Food and Drug Administration (FDA) has identified...more
Exactech has recalled hundreds of thousands of implantable ankle, knee, hip and shoulder replacement devices over the past few years. If you or a loved one received an Exactech implant in 2004 or later, it will be important...more
In this final installment of our series (see part 1, part 2, and part 3) discussing CPSC’s presence at the 2024 International Consumer Product Health and Safety Organization’s annual symposium, we present two smaller, but...more
This third installment of our series highlights regulators and other stakeholders’ growing focus on e-commerce platforms’ role in protecting consumers from unsafe products, as the percentage of online consumer product sales...more
Exactech is a manufacturer of medical implants, including ankle, knee, hip and shoulder replacement devices. Unfortunately, due to poor manufacturing practices and quality control issues, Exactech has been forced to recall...more
If you have had problems with an Exactech ankle, knee, hip or shoulder implant, you are not alone. At the request of the U.S. Food and Drug Administration (FDA), Exactech has recalled hundreds of thousands of defective ankle,...more
Robins Kaplan Secures Historic $12.2 Million Settlement in a Section 1983 Jail Deliberate Indifference Case - Scott County Jail officials failed to report detained man’s injuries and allowed video evidence to be deleted. ...more