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
Health Canada is making changes (via legislative amendments) to the manner in which medical devices and pharmaceutical products are recalled under the Medical Device Regulations, SOR/98-282 (MDR) and the Food and Drug...more
Since the fall 2023, the United States has been facing a massive recall of apple cinnamon fruit purees (like apple sauce) due to the presence of elevated levels of lead which caused the product to be considered adulterated...more
During September 2024’s “Baby Safety Month,” the Consumer Product Safety Commission (CPSC) published its annual report detailing injuries and deaths associated with nursery products among children under the age of five. CPSC...more
Thousands of lawsuits have been filed against the Ireland-based medical device company Allergan for a unique type of blood cancer that has been linked to its textured breast implant. The U.S. Food and Drug Administration...more
Conducting a recall is a time-sensitive process that requires an informed, strategic, and measured approach. When conducting recalls, companies must take the necessary steps to protect patients or consumers and comply with...more
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
TO SEIZE OR NOT TO SEIZE: CAMPUS PROTESTS AND POLICE USES OF FORCE - Dozens of college and university campuses experienced protests in April and May of 2024 due to the ongoing conflict in the Middle East. Many were...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