FDA Plans to Modernize Its Medical Device Approval Process
The Food and Drug Administration (“FDA”) oversees the approval, regulation and safety of drugs and medical devices. There are two ways for medical device manufacturers to have their products approved by the FDA: Premarket Approval and 510(k) Premarket Notification. This month, the FDA issued guidance and requested comments in its effort to strengthen and modernize […]
Update to FDA’s Regulation of Cosmetic Products
The U.S. Food and Drug Administration (“FDA”) oversees the regulation and safety of drugs, medical devices, many food items, and cosmetic products. Until recently, the FDA’s regulation of cosmetic products was minimal. There were very few measures in place to ensure the public’s safety when using cosmetics. What products are defined as cosmetics? As defined […]
Court Ruling Broadens Employment Discrimination Claims
Long-Standing Precedent In cases of employment discrimination, the Fifth Circuit has a well-established precedent in favor of employers. Plaintiffs in these cases needed to show that the adverse employment action in their complaint constituted an ultimate employment decision. The Fifth Circuit previously chose to limit these ultimate employment decisions to hirings, firings, promotions, or employee […]
Health Data Cyberattacks on the Rise
Health Data Breaches The healthcare industry has become a frequent victim of various cyber attacks in an attempt to steal patient data. Health data stolen in these attacks are frequently sold on the dark web and used for fraud. Because of this, the monthly average of class actions lawsuits filed against these companies has roughly […]
Supreme Court Rules Against Biden Student Debt Relief Plan
Student Debt Relief Generally President Biden attempted to relieve roughly $400 billion in student debt from borrowers around the nation. He announced his plan to do so in August of 2022, which would be supported by the HEROES Act of 2003. In the time following this announcement, the relief plan has been challenged by several […]
Google Maps Lawsuit
Unfortunate Death The family of a North Carolina man is suing Google for negligence relating to its updating of usable roads on its maps app. On September 30, 2022, state troopers found the man drowned in his overturned pickup truck beneath a collapsed bridge. This bridge had collapsed nearly a decade earlier and was flagged […]
$12.5 Billion 3M PFAS Settlement: Addressing ‘Forever Chemicals’
Introduction In a landmark development, the global manufacturing giant 3M has reached a groundbreaking settlement with U.S. cities and towns. Under the agreement, 3M will pay at the very least $10.5 billion and as much as $12.5 billion in settlement. Public water utilities around the country have filed claims accusing 3M of contaminating drinking water […]
Eligibility for the 3M PFAS Settlement: Who Qualifies?
Introduction In recent years, concerns about PFAS (per- and polyfluoroalkyl substances) contamination have surged, given their severe health implications. 3M Corporation, a prominent manufacturer of PFAS-containing products, faced extensive legal liability regarding its role in contaminating groundwater and other public drinking water sources. After years of hard-fought litigation in federal court, 3M agreed to pay […]
Understanding Radiation’s Impact
The British Medical Journal recently published a new study titled “Cancer Mortality and Low Dose Radiation.” The goal of the study was to explore effects of radiation, especially low doses, on the risk of developing cancer. Research Design: A Multinational Approach A comprehensive multinational cohort study forms the basis of this paper. This means that […]
FDA Issues Information on Hernia Mesh Medical Devices
The Food and Drug Administration (“FDA”) oversees the regulation and safety of drugs and medical devices. In doing so, it publishes important safety notices on its website. The FDA recently provided information on its website regarding the use of hernia mesh for hernia repair. Why did the FDA issue a hernia mesh notice? The communication […]