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Delta Enterprise Corp. has recalled its 2-in-1 Outdoor Kids Swing due to reports of restraint strap failures, posing a fall risk. The recall affects over 43,000 units sold at Walmart and online from March to October 2022. The model numbers involved are SW86508MM, SW86516MN, SW86575MM, SW86576MN, and SW86577PW. Consumers should stop using the swings and contact Delta Enterprise for free replacement straps via recall@deltachildren.com. The recall is a voluntary action to ensure consumer safety.

SunSetter Products LP, based in Malden, Massachusetts, faces allegations of delaying the reporting of a hazardous defect in its motorized retractable awnings. The defect involved protective vinyl covers that, when unsecured, could cause the awnings to spring open unexpectedly, leading to injuries and one death. Despite receiving 14 reports of such incidents between 2012 and 2017, SunSetter did not inform the Consumer Product Safety Commission (CPSC) until October 2017. The covers were recalled in August 2019. The Justice Department and CPSC emphasize the importance of timely reporting to ensure consumer safety.

ProPublica's investigation reveals that Cigna uses a system called PXDX to deny medical claims without reviewing patient files, relying on algorithms to identify mismatches between diagnoses and procedures. This system allows medical directors to reject claims in bulk, often without using their medical expertise, leading to unexpected bills for patients. The report highlights the case of Nick van Terheyden, whose claim for a blood test confirming a vitamin D deficiency was denied. Cigna defends the system as efficient, but former employees and state regulators question its fairness and legality.

On April 4, 2023, PBS reported that the FDA found sterility issues at a Global Pharma Healthcare factory in India, which produced eyedrops linked to injuries and deaths in the U.S. The FDA inspection revealed inadequate sterility measures and a deficient manufacturing process. The eyedrops were associated with 68 bacterial infections, including three deaths and eight cases of vision loss. The bacteria showed resistance to standard antibiotics. The FDA and CDC are investigating the outbreak, and a formal report and warning letter to the company are expected.

The FDA has issued a safety announcement regarding Copiktra (duvelisib), a cancer drug used for chronic lymphocytic leukemia and small lymphocytic lymphoma. A clinical trial revealed a potentially increased risk of death and severe side effects, such as infections and organ inflammation, compared to another treatment. The FDA is informing the public and plans to hold a meeting to discuss these findings. Patients should consult healthcare professionals about the risks and benefits, while healthcare providers should consider alternative treatments.

The article discusses the increasing issue of truck driver accidents caused by drug use, highlighting the demanding nature of the profession and factors like long hours, stress, and drug availability. These accidents can lead to severe consequences, including fatalities, property damage, and legal repercussions. The article emphasizes the importance of legal assistance for victims, detailing how attorneys can navigate personal injury law, negotiate with insurance companies, and handle the complexities of drugged driving cases. It concludes by encouraging victims to seek legal help to secure compensation and justice.

The CDC has linked EzriCare artificial tears, imported from India, to an outbreak of antibiotic-resistant bacteria, affecting 68 people across 16 states. This has resulted in three deaths, eight cases of blindness, and numerous infections. The FDA has halted imports and issued a recall, highlighting regulatory gaps in foreign drug oversight. The bacteria, a drug-resistant strain of Pseudomonas aeruginosa, poses a significant threat, especially in healthcare settings. Efforts are underway to contain the spread, but concerns remain about its potential establishment in the US.

Drowsy truck drivers pose a major safety risk due to impaired reaction times and decision-making abilities. Factors like long hours, irregular sleep, and tight deadlines contribute to fatigue. Hours of Service (HOS) regulations aim to mitigate this by setting maximum driving times and mandatory rest periods. Despite these rules, fatigue can still occur due to sleep disorders or lifestyle choices. The trucking industry must prioritize rest and safety. Recent HOS updates offer more flexibility, such as expanded short-haul exceptions and revised break requirements, to help drivers manage fatigue without compromising safety.

Ford has recalled 98,550 Ranger pickup trucks from 2004-2006 due to improperly installed passenger airbags, which may not deploy in a collision, increasing injury risk. This follows previous Takata airbag recalls. Ford will reinstall the airbags for free and reimburse prior repair costs. Affected owners will be notified by March 31, 2023. Legal action for compensation is possible for those injured by the defect, with Parker Waichman LLP offering free case reviews and legal assistance.

An Alabama woman has filed a federal lawsuit against Instant Brands, claiming disfigurement from using an Instant Pot pressure cooker. The lawsuit, filed on March 14, 2023, alleges that the cooker released scalding hot food, causing burns. The complaint accuses Instant Brands of selling defective products and falsely advertising them as safe. The woman, represented by a product liability law firm, seeks damages for physical and emotional pain. The lawsuit claims negligent design allowed the lid to be opened while pressurized, prioritizing profit over safety. Instant Brands has not commented on the case.

A truck death wobble is an intense and uncontrollable shaking of a vehicle's front end, often occurring at higher speeds. It can result from worn suspension components, unbalanced wheels, or misaligned axles. Symptoms include violent steering wheel vibrations and loud noises. Preventive measures include regular maintenance of suspension and steering systems, wheel balancing, and axle alignment. Defective manufacturing and design can also contribute to this issue, necessitating quality control and consumer awareness. Legal assistance may be sought for accidents caused by death wobbles.

Philips Respironics is under scrutiny following a global recall of sleep aid devices due to toxic foam degradation, linked to 124 deaths according to FDA reports. The recall, affecting over 15 million devices, has left many users without replacements. Philips faces legal challenges, including subpoenas from the U.S. Department of Justice and numerous lawsuits. Despite efforts to replace affected devices, Philips has not met its goals, causing frustration among users. The company maintains there is no proven link between the foam and cancer risk, citing a study supporting this claim.

Emergency departments are vital for immediate medical care, but their complexity can lead to malpractice. A U.S. government study reveals frequent misdiagnoses in ERs, causing preventable harm, disability, or death. Annually, 7.4 million ER patients are misdiagnosed, with 2.6 million experiencing harm and 370,000 facing permanent disability or death. Commonly misdiagnosed conditions include stroke, heart attack, aortic aneurysm, spinal cord injury, and venous thromboembolism. Awareness and improved diagnostic accuracy are crucial for better patient outcomes.

Jeep has recalled 57,885 Wrangler vehicles manufactured from October 2019 to May 2022 due to a potential fuel leak risk caused by an unnecessary frame stud. This defect affects 2020-2023 models and could lead to a fire if a fuel leak occurs near an ignition source. No incidents have been reported, and Jeep will inspect and fix affected vehicles. Owners should contact dealers for assistance. Legal firm Parker Waichman LLP offers consultations for those affected by this defect.

Perrigo Company has voluntarily recalled Gerber Good Start SootheProTM Powdered Infant Formula due to potential Cronobacter sakazakii contamination at its Gateway Eau Claire, Wisconsin facility. The recall, coordinated with the FDA, affects products manufactured between January 2 and January 18, though no distributed products have tested positive, and no adverse events have been reported. Consumers should check lot codes and "use by" dates on products purchased after March 5. This recall does not affect other Perrigo products.

Food contamination affects millions annually, with the FDA's new Food Traceability Rule aiming to reduce foodborne illnesses by standardizing record-keeping across the food supply chain. This initiative targets foods prone to contamination, like soft cheeses and leafy greens, by assigning tracking codes. While meat and poultry are excluded, the rule, effective January 20, 2026, seeks to improve current fragmented systems. Despite some imperfections, it is seen as a step forward in identifying hazardous foods before reaching consumers, potentially preventing illnesses and deaths.

The USDA has announced a recall of approximately 3,436 pounds of boneless beef chuck due to E. coli contamination. The affected meat, packaged on February 16, 2023, by Elkhorn Valley Packing in Kansas, was distributed to Maryland and eight other states. The recall involves products with the establishment number "EST. M-19549." Symptoms of E. coli infection include vomiting and bloody diarrhea, with severe cases potentially leading to kidney failure. Consumers are advised to discard or return the recalled products and ensure meat is cooked to a safe temperature.

The FDA is a federal agency that ensures the safety and efficacy of medical products. It issues warning letters to companies violating regulations, such as non-compliance with good manufacturing practices or misbranding. Before issuing a warning letter, the FDA conducts inspections and may issue a Form 483 for observed violations. Companies must respond with corrective actions. Consequences of a warning letter include financial costs, reputation damage, and regulatory delays. Companies should investigate, develop a corrective plan, and maintain communication with the FDA to address violations and improve compliance.

The FDA has raised concerns about the safety of Olympus Medical Systems' duodenoscopes, highlighting issues with parts detaching during procedures, which have led to patient injuries. Since November 2020, Olympus received about 160 complaints regarding the "distal end cover" falling off, but failed to take corrective action. The FDA criticized Olympus for its slow response and packaging defects that could lead to contamination. Despite previous efforts to improve safety, the FDA's recent findings suggest ongoing risks with these medical devices.

The FDA plays a vital role in ensuring the safety and efficacy of pharmaceuticals and medical devices through inspections and issuing warning letters for compliance violations. These letters inform laboratories of significant issues, prompting corrective actions to protect public health. Consequences of receiving a warning letter include financial losses, regulatory delays, and legal actions. Warning letters promote good laboratory practices, transparency, and accountability, enhancing product quality and safety. They also encourage continuous improvement and collaboration with the FDA, ultimately fostering public trust in regulated products.

Section 501(a)(2)(B) of the FD&C Act ensures drug safety and quality by requiring adherence to current good manufacturing practices (CGMP). It deems drugs adulterated if manufacturing methods or facilities do not comply with CGMP, which cover personnel training, equipment maintenance, production controls, quality control, recordkeeping, laboratory testing, and stability testing. The FDA enforces these standards through inspections and can take action against non-compliance. This section is crucial for preventing adulterated drugs and maintaining public trust in pharmaceuticals.

The FDA issued Warning Letters to Cosmetic Science Laboratories LLC in Torrance, CA, and Formology Lab Inc. in Chatsworth, CA, for significant CGMP violations in pharmaceutical manufacturing. Cosmetic Science Laboratories failed to conduct identity tests for drug components and lacked adequate production procedures and batch records. Formology Lab's violations included inadequate procedures for component testing, insufficient validation of manufacturing processes, and lack of stability data for drug products. Both companies were criticized for inadequate corrective actions and oversight, emphasizing the responsibility of contract facilities to ensure drug quality and compliance with the FD&C Act.

Datascope/Getinge has recalled Cardiosave Hybrid and Rescue Intra-Aortic Balloon Pumps due to a coiled cord connection failure that may cause unexpected shutdowns, posing a risk of severe injury or death. The FDA classified this as a Class I Recall. The affected devices were distributed from March 6, 2012, to July 20, 2017. Approximately 2,300 units are involved. Users are advised to inspect cords for damage and follow specific actions if shutdowns occur. No injuries or deaths have been reported. A hardware correction is being developed, and affected parties are advised to contact Datascope/Getinge for support.

In 2022, the FDA recorded a 15-year high in Class I medical device recalls, with 70 incidents, up from a five-year average of 47. Mislabeling was the leading cause in three of the last five quarters. Companies like Abbott and Philips faced recalls, which are designated for issues potentially causing severe injury or death. The fourth quarter saw an 8.1% rise in overall recalls, with units increasing by 10 million. Sedgwick noted the FDA's use of Section 518 authority to mandate risk notifications, highlighting its significance in recall management.