Recall Litigation Report

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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

Class actions following a product recall often focus on what the company allegedly knew before its products were taken off the market. But this is not always the case. A company can also come under fire for its actions after the recall and, specifically, what recourse it offers to consumers of recalled products.

On October 5, 2021, the U.S. Food and Drug Administration (“FDA”) alerted the public of a manufacturing issue with certain lots of Ellume USA LLC’s (“Ellume”) COVID-19 Home Tests that had could lead to false positive results, and several weeks later, the FDA announced a Class I recall of these tests based on the higher-than-acceptable false positive test result. When it comes to COVID-19, a false positive could lead to delayed diagnosis and treatment of the actual cause of illness; further spread of COVID 19 when presumed positive people are grouped based on false test results; unnecessary COVID-19 treatment from health care providers, such as antiviral treatment, convalescent plasma, or monoclonal antibody treatment, which can result in side effects; disregard for the recommended precautions against COVID-19, including vaccination; and isolation, monitoring household or close contacts for symptoms, limiting contact with family or friends, and missing school or work.
Continue Reading Recall Litigation Report: Consumers Bring Class Action Lawsuit Against Ellume Refusing to Refund Recalled COVID-19 Home Tests

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

The emergence of different COVID-19 variants and the corresponding surge in COVID-19 cases brings with it an increased demand for COVID-19 tests, particularly those that offer immediate results and can be done from the comfort of home. Unfortunately, like many other products on the market, at-home COVID tests are not immune to false claims or false results.

Earlier this month, the U.S. Food and Drug Administration (“FDA”) announced a Class I recall of at-home COVID-19 rapid antigen tests manufactured by E25Bio Inc. According to the FDA, E25Bio marketed and distributed its SARS-CoV-2 Antigen Test Kits (“E25Bio Tests”) to customers throughout the United States without authorization, clearance, or approval from the FDA and with insufficient data demonstrating that the E25Bio Tests performed accurately. Rapid antigen tests are designed to detect proteins called antigens from the SARS-CoV-2 virus in patient samples. And according to the FDA, the E25Bio Tests contained inaccurate claims and instructions, including a statement misrepresenting the test as FDA-authorized.
Continue Reading Recall Litigation Report: E25Bio Inc. COVID-19 Rapid Antigen Tests

The practice of law has changed in many ways during the COVID-19 global pandemic, but a slow-down in class action lawsuits was not one of those changes. In the second half of 2021, consumers filed quite a few lawsuits following a wide range of highly-publicized recalls, involving everything from pharmaceuticals to automobiles.

For example, as previously reported, on June 14, 2021, Philips Respironics voluntarily recalled several different models of CPAP and BiPAP breathing machines because the polyester-based polyurethane (PE-PUR) foam in the machines has the potential to break down, be inhaled or ingested by users, and increase their risk of cancer and other injuries. In the weeks and months that followed the recall, a number of putative class action lawsuits emerged, seeking compensation for injuries, risks, and disrupted use. Generally speaking, plaintiffs allege that Philips Respironics knew about the serious risk of injury caused by its devices long before it warned the public about potential hazards in April 2021 and finally recalled the machines in June 2021. Over a hundred lawsuits have now been consolidated in the U.S. District Court for the Western District of Pennsylvania in the CPAP multi-district litigation, In Re: Philips Recalled CPAP, Bi-Level PAP, and Mechanical Ventilator Products Liability Litigation, MDL No. 3014, and discovery is ongoing.
Continue Reading Recall Litigation Report: Year in Review (2021)

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