A recent article published by MedTech, “Could Bassinet Clearance Expand FDA Authority? Law Firm Expresses Concern,” quotes a Crowell client alert and Crowell attorney, Robbie Jost, on this development. According to the client alert, “To the extent the FDA considers the SNOO a medical device based on its intended impact on infant sleep position, many
On March 30, 2023, the FDA authorized marketing of Happiest Baby’s SNOO Smart Sleeper, an over-the-counter infant sleep system intended to keep infants on their back throughout sleep. This marks the first time we are aware of that the FDA has given de novo marketing authorization to a product designed to keep sleeping babies positioned on their backs,[1] and signals a potential expansion of what the FDA considers to be a “medical device” within its regulatory purview.
As previously reported, a number of consumers filed suit earlier this year against Exactech after it recalled the polyethylene liners in certain hip, knee, and ankle implants. As of February 2022, Exactech’s recall applied to hundreds of thousands of Connexion, Optetrak, Truliant and Vantage brand hip, knee, and ankle replacement liners manufactured as far back as 2004. According to Exactech, the polyethylene liners were packaged in non-conforming vacuum bags that lacked an additional protective layer and allowed air to come into contact with the inserts and increase the risk that the devices would fail once implanted in a patient.
In the first half of 2022, manufacturers have been as busy as ever navigating recalled products and fielding the class action lawsuit that often (but do not always) follow.
CPAP Litigation Finds New Defendant
For the last year, Philips Respironics (“Philips”) has been inundated with lawsuits brought by consumers and medical device suppliers, over its CPAP and BiPAP breathing machines. And in more recent months, SoClean, a manufacturer of sanitation machines specifically designed to work with CPAP and BiPAP sleep apnea equipment, has been defending itself against a lawsuit of its own.
Continue Reading Recall Litigation Report: 2022 Mid-Year Recap
When a product is recalled, class action lawsuits are not the only threat. Recalled products can also give rise to droves of individual actions. This is the case for Exactech, Inc., a manufacturer of implants, instruments, and technologies for joint replacement.
Following an initial pause in elective procedures at the start of the COVID-19 pandemic, the number of hip arthroplasty surgeries has grown at a steady pace. These procedures commonly use acetabular liners to increase the stability of the total hip arthroplasty. Now, Exactech, a manufacturer of acetabular liners, is under fire nine months after the U.S. Food and Drug Administration (“FDA”) announced a Class II recall of the Exactech Connexion GXL acetabular polyethylene liner in June 2021. A Class II recall involves situations in which consumers may experience temporary or medically reversible health consequences or the likelihood of serious adverse health consequences is remote.
Continue Reading Recall Litigation Report: Exactech Joint Replacement Products
Philips Respironics has seen an onslaught of litigation related to its CPAP and BiPAP breathing machines, which it recalled in June 2021. For months following the recall, Philips was inundated with hundreds of consumer class action lawsuits, which were consolidated in a CPAP MDL last fall in the U.S. District Court for the Western District of Pennsylvania.
Now, Philips faces off against a different kind of class action plaintiff—medical device suppliers. Earlier this month, Baird Respiratory Therapy, Inc., filed a putative class action lawsuit against Philips in the U.S. District Court for the Eastern District of Pennsylvania, seeking to represent a nationwide class of durable medical equipment suppliers who purchased Philips’ recalled breathing machines.
Continue Reading Recall Litigation Report: Philips Faces Supplier Class Action Following CPAP/BiPAP Recall
Each year, thousands of products—from cosmetics to motor vehicles to children’s toys—are taken off the market over defects that pose potential safety concerns. Product recall announcements can generate a lot of publicity and quickly lead to class action or mass action lawsuits. Although a product recall does not automatically make a manufacturer liable, a quick and effective response can make all the difference. Product recalls are not necessarily “silver bullets” that defeat all civil claims, but a voluntary recall can serve as a strong defense in such suits, regardless of whether plaintiffs are claiming personal injury or only economic damage.
Continue Reading Recall Litigation Report: CPAP Class Action MDL