Recall Litigation Report

The second half of 2022 proceeded much like the first, with manufacturers busy navigating recalls and related litigation, although not necessarily in that order.

Philips CPAP/ BiPAP Machines Still Under Fire

Philips is still battling an onslaught of cases stemming from a June 2021 recall of CPAP and BiPAP breathing machines, including a consolidated consumer class action, In re Philips Recalled CPAP, Bi-Level PAP, & Mechanical Ventilator Products Liability Litigation, No. 2:21-mc-01230 (W.D. Pa.), MDL No. 3014, and a medical device supplier suitBaird Respiratory Therapy, Inc. v. Philips, 2:22-cv-00886 (E.D. Pa.). Since early 2021, there have been reports of over 260 deaths and thousands of health problems associated with the degrading polyurethane foam found in these devices, which was used inside millions of CPAP and BiPAP machines for over a decade. Philips claims that it has produced over 3.95 million repair kits and replacement devices to date and continues to research potential health risks to users from its machines. Despite these efforts, its legal troubles will continue into 2023, with even more consumer-facing lawsuits, including Braverman v. Koninklijke Philips N.V., No. 2:22-cv-7927, which was first filed at the end of December 2022 in the U.S. District Court for the Eastern District of New York and is one of the first CPAP/BiPAP suits to allege the inhalation of the toxic foam particles caused mouth and tongue cancer. Continue Reading Recall Litigation Report: Year in Review (2022)

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.Continue Reading Recall Litigation Report: Plaintiffs Seek to Consolidate Recall-Related Lawsuits Against  Exactech

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.Continue Reading Litigation Recall Report: Nationwide Lawsuit Follows 4moms Recall of MamaRoo Baby Swing and RockaRoo Baby Rockers

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.Continue Reading Litigation Recall Report: Daily Harvest Sued After Recall of French Lentil + Leek Crumbles

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