Nitrous Oxide Lawsuit Individuals who suffered harm, or families who lost a loved one after using nitrous oxide products may be eligible for financial compensation through a nitrous oxide lawsuit.
Depo-Provera Lawsuit Depo-Provera lawsuits are being investigated for women who developed meningioma brain tumors after receiving Depo-Provera birth control shots, claiming that Pfizer failed to adequately disclose side effects.
Hair Relaxer Lawsuit Regular exposure to chemicals in hair relaxer may cause uterine cancer, ovarian cancer and other injuries. Women diagnosed with cancer may be eligible for settlement benefits.
Sports Betting Addiction Lawsuit Sports betting addiction lawsuits are being investigated for college students and young adults who developed gambling problems after using apps like FanDuel and DraftKings, alleging that the platforms failed to warn about the addictive nature of their features and marketing practices.
Roblox Lawsuit Families are filing Roblox lawsuits after children were targeted by predators for grooming, sextortion, sexual abuse, or exploitation on the platform. Learn who qualifies, what cases allege, and how to file a confidential claim.
Dupixent Lawsuit Dupixent lawsuits are being investigated for patients who developed rare blood cancers such as cutaneous T-cell lymphoma (CTCL) after receiving injections, alleging that Sanofi and Regeneron failed to warn about the potential risks of immune suppression and delayed cancer diagnosis.
Tabletop Fire Pit Lawsuit Individuals who suffered severe burns, or families who lost a loved one in a tabletop fire pit explosion, may be eligible for financial compensation through a fire pit injury lawsuit.
Ozempic Lawsuit Lawyers are pursuing Ozempic lawsuits, Wegovy lawsuits and Mounjaro lawsuits over gastroparesis or stomach paralysis, which can leave users with long-term gastrointestinal side effects
Suboxone Tooth Decay Lawsuit Lawsuits are being pursued by users of Suboxone who experienced tooth loss, broken teeth or required dental extractions. Settlement benefits may be available.
Change Healthcare Lawsuit Lawyers are reviewing Change Healthcare class action lawsuits for individuals who had their personal information stolen due to the data breach.
Recalled Medical Devices Fast-Tracked Through FDA Approval Process Were Often Based on Flawed, Older Designs: Study Many recalled medical devices, fast-tracked through the FDA approval process, are based on devices which have been subjected to major recalls, and are more likely to be recalled themselves January 16, 2023 Irvin Jackson Add Your Comments For quite some time, critics have raised concerns about the FDA’s fast-track approval program, which allows new medical devices to be introduced with very limited research and clinical trials, if the design is deemed to be a substantial equivalent of earlier devices. But now, a new study appears to show the inherent dangers of the process. The U.S. Food and Drug Administration (FDA)’s 510(k) approval process has been used to introduce a wide variety of widely marketed medical devices, which were approved with limited testing to ensure they are safe and effective. The process also allows new devices to be introduced based upon designs of prior devices, which were themselves often approved through the fast-track process. The agency has received sharp criticism for expanding the definition of “substantially equivalent,” allowing manufacturers to use the process even when they go on to market the new devices as an innovative or breakthrough technology, which may be radically different from their predecessors. In findings published last week in the Journal of the American Medical Association (JAMA), researchers found that many devices approved through this program are based on devices that actually had to be recalled from the market due to potential design problems. Researchers found that the devices based on those designs had a higher risk of being recalled themselves. Learn More About Vaginal Mesh / Bladder Sling Lawsuits Complications from transvaginal mesh may cause severe injuries. Learn More SEE IF YOU QUALIFY FOR COMPENSATION Learn More About Vaginal Mesh / Bladder Sling Lawsuits Complications from transvaginal mesh may cause severe injuries. Learn More SEE IF YOU QUALIFY FOR COMPENSATION Researchers from a collection of medical schools around the country, including Harvard, University of California San Francisco, Yale and others conducted a cross sectional analysis of 156 cases of medical devices that were authorized through the 510(k) program, which were later subjected to Class I recalls between 2017 and 2021. The FDA issues a Class I recall, the most serious recall classification, when the agency determines a problem with a medical device could lead to serious injury or death. The study looked at these recalled medical devices and evaluated the older devices that were used to gain approval through the 510(k) process, and found that 44.1% of the devices were based on an older device that was also subject to a Class I recall. The findings indicate that if a 510(k) approved medical device is based on a device which had a previous Class I recall, the new device is more than six times more likely to be subjected to a Class I recall itself. “Many 510(k) devices subjected to Class I recalls in the US use predicates with a known history of Class I recalls. These devices have substantially higher risk of a subsequent Class I recall,” the researchers concluded. “Safeguards for the 510(k) pathway are needed to prevent problematic predicate selection and ensure patient safety.” FDA 510(k) Fast-Track Approval Process Concerns Many critics say that since the 510(k) program’s inception in the 1980s, the term “substantially equivalent” has become nearly meaningless. At the same time, concerns have emerged about problems with several devices implanted into the human body, such as metal-on-metal hip replacements and transvaginal surgical mesh, many of which were introduced under the “substantial equivalent” test, with little pre-market testing to ensure they were safe. These same manufacturers engaged in marketing for their products that extolled the virtues of the devices, claiming that they involved “revolutionary” designs and provide vast improvements over older devices. The fast track approval process was originally intended for non-critical medical devices, such as band-aids and tongue suppressors. However, the “substantially equivalent” program has expanded over the years to include numerous medical implants, including surgical mesh, artificial joint implants, defibrillators, stents and other critical devices that are permanently implanted into the human body. It is only after these newer devices are on the market for several years, and often widely used among thousands of patients, that critical safety flaws may be identified through post-marketing adverse event data. Written by: Irvin Jackson Senior Legal Journalist & Contributing Editor Irvin Jackson is a senior investigative reporter at AboutLawsuits.com with more than 30 years of experience covering mass tort litigation, environmental policy, and consumer safety. He previously served as Associate Editor at Inside the EPA and contributes original reporting on product liability lawsuits, regulatory failures, and nationwide litigation trends. Tags: Medical Device Recall, Medical Devices More Vaginal Mesh Lawsuit Stories Study Finds Some Transvaginal Mesh Degrades Within 2 Months After It Is Implanted October 29, 2024 Supreme Court Rejects J&J Bid to Overturn $302M Vaginal Mesh Lawsuit Award February 23, 2023 FDA Still Feels Transvaginal Mesh Products Too Risky After Final Postmarketing Study October 20, 2022 0 Comments InstagramThis field is for validation purposes and should be left unchanged.Share Your CommentsFirst Name*Last NameEmail* Shared Comments*This field is hidden when viewing the formI authorize the above comments be posted on this page Yes No Post Comment I authorize the above comments be posted on this page Weekly Digest Opt-In Yes, send me a weekly email with the latest lawsuits, recalls and warnings. Want your comments reviewed by a lawyer?To have an attorney review your comments and contact you about a potential case, provide your contact information below. This will not be published.Contact Phone #Alt Phone #Private CommentsNOTE: Providing information for review by an attorney does not form an attorney-client relationship.CAPTCHAGA SourceGA CampaignGA MediumGA ContentGA Term Δ MORE TOP STORIES Marshalls Tabletop Fire Pit Explosion Led to Skin Grafts, Lawsuit (Posted: 2 days ago) A couple who were severely burned the first time they tried to use their Marshalls Tabletop Fire Pit, say the design is defective and the instructions for use are dangerous. MORE ABOUT: TABLETOP FIRE PIT LAWSUITExploding Isopropyl Bottles Make Smokeless Fire Pits Inherently Dangerous, Lawsuits Claim (09/24/2025)Tabletop Fire Pit Recall Announced by Five Below Amid Growing Number of Burn Injury Lawsuits (09/18/2025)Lawsuit Alleges Portable Fire Pit Sold on Amazon.com Caused Flashback Burn Injuries (09/12/2025) Dupixent Wrongful Death Lawsuit Filed Over T-Cell Lymphoma Diagnosis (Posted: 3 days ago) A Dupixent lawsuit blames the atopic dermatitis drug for causing a woman to develop a deadly form of cancer, which caused her death. MORE ABOUT: DUPIXENT LAWSUITDupixent Cutaneous T-Cell Lymphoma Warning Label Update Being Evaluated by FDA (09/15/2025)Dupixent T-Cell Lymphoma Lawsuits May Follow Recent Studies Linking Drug to Cancer Risks (09/04/2025)Dupixent Side Effects May Increase Cutaneous T-Cell Lymphoma (CTCL) Risks (08/26/2025) Roblox Sextortion Lawsuit Alleges Teen Committed Suicide After Being Groomed, Blackmailed (Posted: 3 days ago) A California mother has filed a sextortion lawsuit against the makers of Roblox and Discord, alleging her son took his own life after an adult predator used the platforms to blackmail him. MORE ABOUT: ROBLOX LAWSUITMDL Sought for Roblox Lawsuits Over Child Sexual Exploitation and Assault Epidemic (09/23/2025)Safety Problems With Roblox and Discord Endangered Young Girl: Lawsuit (09/16/2025)Lawsuit Alleges Roblox Lacks Safeguards To Protect Children From Sexual Predators (09/11/2025)
FDA Still Feels Transvaginal Mesh Products Too Risky After Final Postmarketing Study October 20, 2022
Marshalls Tabletop Fire Pit Explosion Led to Skin Grafts, Lawsuit (Posted: 2 days ago) A couple who were severely burned the first time they tried to use their Marshalls Tabletop Fire Pit, say the design is defective and the instructions for use are dangerous. MORE ABOUT: TABLETOP FIRE PIT LAWSUITExploding Isopropyl Bottles Make Smokeless Fire Pits Inherently Dangerous, Lawsuits Claim (09/24/2025)Tabletop Fire Pit Recall Announced by Five Below Amid Growing Number of Burn Injury Lawsuits (09/18/2025)Lawsuit Alleges Portable Fire Pit Sold on Amazon.com Caused Flashback Burn Injuries (09/12/2025)
Dupixent Wrongful Death Lawsuit Filed Over T-Cell Lymphoma Diagnosis (Posted: 3 days ago) A Dupixent lawsuit blames the atopic dermatitis drug for causing a woman to develop a deadly form of cancer, which caused her death. MORE ABOUT: DUPIXENT LAWSUITDupixent Cutaneous T-Cell Lymphoma Warning Label Update Being Evaluated by FDA (09/15/2025)Dupixent T-Cell Lymphoma Lawsuits May Follow Recent Studies Linking Drug to Cancer Risks (09/04/2025)Dupixent Side Effects May Increase Cutaneous T-Cell Lymphoma (CTCL) Risks (08/26/2025)
Roblox Sextortion Lawsuit Alleges Teen Committed Suicide After Being Groomed, Blackmailed (Posted: 3 days ago) A California mother has filed a sextortion lawsuit against the makers of Roblox and Discord, alleging her son took his own life after an adult predator used the platforms to blackmail him. MORE ABOUT: ROBLOX LAWSUITMDL Sought for Roblox Lawsuits Over Child Sexual Exploitation and Assault Epidemic (09/23/2025)Safety Problems With Roblox and Discord Endangered Young Girl: Lawsuit (09/16/2025)Lawsuit Alleges Roblox Lacks Safeguards To Protect Children From Sexual Predators (09/11/2025)