Recall Litigation Report

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