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.
New parents have their hands full. Baby bouncy seats and swings offer busy caregivers a way to put an infant down but still allow him or her to see and interact with the surrounding environment. But recent recalls have led parents to think twice before going hands free.
On August 15, 2022, 4moms and the CPSC announced a recall of more than two million 4moms MamaRoo Baby Swings (versions 1.0 – 4.0) and over 220,000 RockaRoo Baby Rockers sold in the U.S. and Canada. According to the announcement, the restraint straps on the 4moms MamaRoo Baby Swing and RockaRoo Baby Rocker can dangle below the seat when the product is not in use, posing a strangulation hazard to crawling infants. On August 29, 2022, residents from North Carolina and South Carolina sued Thorley Industries, LLC (d/b/a 4moms) on behalf of nationwide class of purchasers of the recalled products in federal court in Pennsylvania.…
It is impossible to deny the convenience of having pre-made or ready-to-make meals delivered to your doorstep. Daily Harvest, which launched in 2015, has cornered the market on ready-to-eat, “actually healthy” meal delivery. Recently, however, a recent recall of one of its products after consumers fell ill, has led to several lawsuits against the company.
On June 17th, Daily Harvest initiated a voluntary recall after consumers reported adverse reactions after eating the “French Lentil + Leek Crumbles.” After an investigation, Daily Harvest announced that the source of the problem was tara flour, which is one of the ingredients. Just a short while later, on June 27th, a New York resident filed a putative class action lawsuit against Daily Harvest, Peni v. Daily Harvest, 1:22-cv-05443 (S.D.N.Y. filed June 27, 2022), alleging that she bought and consumed the French Lentil + Leek Crumbles and then “became violently ill with gastrointestinal illness and was hospitalized” for “fever, nausea, extreme abdominal pain, chills and joint pain,” which led in the removal of her gallbladder. The plaintiff seeks to assert strict liability, breach of express and implied warranties, and negligence claims against the company on behalf of a Nationwide and New York subclasses of persons who suffered “gastrointestinal illness” as a result of Daily Harvest’s French Lentil + Leek Crumbles.…
Despite imposing onerous new compliance terms, the recently announced Vornado civil penalty was criticized by three commissioners as too low amid their urgent calls for larger penalties in the future. On July 7, the U.S. Consumer Product Safety Commission (CPSC) announced a $7.5 million civil penalty settlement with manufacturer of air circulation products, Vornado Air (Vornado). Vornado agreed to pay the civil penalty to resolve charges that the Company knowingly failed to immediately report allegedly defective electric space heaters to the CPSC under Section 15(b) of the Consumer Product Safety Act (CPSA). The Commission voted 4-0-1 to provisionally accept the settlement. Notably, three of the agency’s five commissioners published individual statements alongside the agency’s announcement of the penalty, which is atypical. The statements provide product safety stakeholders with insights on how the “new” Commission views civil penalties and its enforcement authority. …
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.…
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
In one of the most significant developments in product safety law over the past decade, Gree Electric Appliances Inc. of Zhuhai, Hong Kong Gree Electric Appliances Sales Co. Ltd., and Gree USA Inc. (the “Gree Companies”), an appliance manufacturer and two of its subsidiaries, have pled guilty to willfully failing to report to the Consumer Product Safety Commission (CPSC) under Section 15(b) of the Consumer Product Safety Act (CPSA). According to the U.S. Department of Justice (DOJ) and the CPSC, the Gree Companies knew their dehumidifiers were defective, failed to meet applicable safety standards, and could catch fire, but failed to timely report that information to the CPSC. Section 19 of the CPSA makes it unlawful to fail to furnish information required by Section 15(b), and such failures are subject to both civil and criminal penalties. While CPSC civil penalties have become fairly routine—the Gree Companies also paid a then-record $15.45 million civil penalty in 2016—this is the first corporate criminal enforcement action brought under the CPSA, according to the DOJ. …
Continue Reading Silence Isn’t Golden: Failure to Report Consumer Product Safety Issues Results in Rare $91 Million Criminal Penalty