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.
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.
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.
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.
AngioDynamics Port Catheter Lawsuit Serious and life-threatening injuries have been linked to problems with Bard PowerPort. Lawsuits are now being pursued by individuals who suffered injuries from the implantable port catheter fracturing or migrating.
Bard PowerPort Lawsuit Serious and life-threatening injuries have been linked to problems with Bard PowerPort. Lawsuits are now being pursued by individuals who suffered injuries from the implantable port catheter fracturing or migrating.
Processed Food Lawsuit Lawsuits are being pursued against the food industry over their manufacturing and advertising of ultra-processed foods, which have caused a generation of children to face an increased risk of developing childhood diabetes and other chronic illnesses.
AFFF Lawsuit Exposure to firefighting foam chemicals may result in an increased risk of cancer for firefighters, military and airport personnel.
FDA System For Approving New Drugs Found Lacking By Study September 24, 2021 Irvin Jackson Add Your Comments A new study by federal researchers is highly critical of the U.S. Food and Drug Administration (FDA) process for approving new medications, such as the recent approval of the Alzheimer’s disease drug, Aduhelm, indicating that the agency regularly fails to rely on reasoning or precedents set in previous drug approvals. According to findings published on September 21 in the Annals of Internal Medicine, FDA researchers indicate their own agency lacks an apparatus for looking at how it ruled on previous drug approvals, when the approval of a new drug is in doubt. In the standard drug approval process, new medications must go through a series of clinical trials and FDA reviews, as well as advisory committee hearings to show safety, efficacy and need before gaining final approval by the FDA. In this study, researchers with the FDA sought to “understand the FDA’s evidentiary standards when flexible criteria are employed.” In other words, they sought to determine how the FDA makes decisions on drug approvals when the drug’s safety or efficacy are in question. Do You Know about… hair dye cancer lawsuits For Salon Professionals Hair dye lawsuits are being pursued for salon professionals who were routinely exposed to hair dye chemicals and diagnosed with bladder cancer or breast cancer. See if you qualify for a hair dye cancer lawsuit settlement. Learn More SEE IF YOU QUALIFY FOR COMPENSATION Do You Know About… hair dye cancer lawsuits For Salon Professionals Hair dye lawsuits are being pursued for salon professionals who were routinely exposed to hair dye chemicals and diagnosed with bladder cancer or breast cancer. See if you qualify for a hair dye cancer lawsuit settlement. Learn More SEE IF YOU QUALIFY FOR COMPENSATION The researchers looked at applications submitted from 2013 to 2018, which went through multiple review cycles due to a lack of evidence for clinical efficacy, to see how the FDA made its final approval decisions. This involved looking at advisory committee minutes, approval packages, FDA reviews and complete response letters. According to the findings, which involved 912 application reviews, 117 went through multiple review cycles. Of those, 22 faced additional reviews due to issues related to clinical efficacy. When these drugs were rejected, it was usually due to concerns about the clinical meaningfulness of the observed effects of the drug, concerns about the primary endpoint of the studies, and inconsistent results. However, the researchers found that seven of the 22 cases resulted in approvals which did not require new evidence, but just re-interpretations of the original evidence. They found no cases where the FDA decisions cited reasons used in previous drug approval decisions. Aduhelm Approval Concerns Researchers noted the recent controversy over the approval of the Alzheimer’s drug Aduhelm as an example of the confusion and lack of trust such “bespoke” decisions may cause. The FDA granted accelerated approval of Aduhelm in early June, as the first Alzheimer’s disease therapy drug. However, the decision came after an FDA advisory panel nearly unanimously recommended against approval. The agency’s approval led to several members of the FDA’s Peripheral and Central Nervous System Drugs Advisory Committee resigning in protest, and several congressional committees are looking into the decision. The agency has since faced a number of serious questions, such as why the FDA approved the drug when its own experts said it should not, and whether there was an improper working relationship between the agency and the drug’s manufacturer, Biogen. Aduhelm’s approval has led to inquiries into the FDA’s approval process, and its relationship with manufacturers, by outside critics, lawmakers, and the agency itself. “The FDA has no mechanism to find or tradition to cite similar cases when weighing evidence for approvals, resulting in standalone, bespoke decisions. These decisions show highly variable criteria for ‘substantial evidence’ when flexible evidential criteria are used, highlighted by the recent approval of aducanumab (Aduhelm),” the researchers determined. “A precedential tradition and suitable information system are required for the FDA to improve institutional memory and build upon past decisions. These would increase the FDA’s decisional transparency, consistency, and predictability, which are critical to preserving the FDA’s most valuable asset, the public’s trust.” Tags: Aduhelm, Alzheimer's Disease, Biogen, Clinical Trials, FDA Image Credit: | More Lawsuit Stories Four BioZorb Breast Tissue Marker Lawsuits Selected for Bellwether Trials April 2, 2025 Nitrous Oxide Class Action Lawsuit Filed Over Fatal Side Effects of Flavored Gas Sold In Vape Shops April 2, 2025 Artificial Stone Cutter Files Lawsuit Over Silicosis Lung Disease April 2, 2025 0 Comments 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 TermPhoneThis field is for validation purposes and should be left unchanged. Δ MORE TOP STORIES Four BioZorb Breast Tissue Marker Lawsuits Selected for Bellwether Trials (Posted: today) As new BioZorb lawsuits continue to be filed over complications with the recalled breast tissue markers, lawyers indicate they are on track for the first of four test cases to go before a jury in September 2025. MORE ABOUT: BIOZORB LAWSUITCourt Clears BioZorb Lawsuit Design Defect Claims Over Recalled Breast Tissue Marker (03/26/2025)Group of 7 BioZorb Injury Lawyers Appointed to Leadership Positions in Lawsuits Over Recalled Breast Tissue Marker (03/19/2025)Breast Cancer Survivors File Lawsuit Over Recalled BioZorb Tissue Marker (03/12/2025) Depo-Provera Meningioma Diagnosis Information Required To Qualify for Lawsuit: Order (Posted: yesterday) Women pursuing Depo-Provera meningioma lawsuits will have to provide documentary proof of their diagnosis and the versions of the birth control shot they received within 120 days of filing their case. MORE ABOUT: DEPO-PROVERA LAWSUITDepo-Provera Lawsuit Timeline for Preparing Pilot Trial Cases Outlined by MDL Judge (03/24/2025)Women Can File Depo-Provera Brain Tumor Lawsuits Directly in MDL: Court Order (03/18/2025)75 Lawyers in Depo-Provera Lawsuits Seek MDL Leadership Roles (03/10/2025) Cartiva SCI Lawsuit Alleges Toe Implant Worsened Pain, Decreased Range of Motion (Posted: 2 days ago) An Indiana woman has filed a Cartiva SCI implant lawsuit, indicating that the toe implant failed due to a defective design, resulting in the need for revision surgery and recommendations to permanently fuse her big toe. MORE ABOUT: CARTIVA IMPLANT LAWSUITCartiva Implant Injury Lawsuit Set for Trial in February 2026 (03/07/2025)Lawsuit Indicates Cartiva Implant Fails in 2 Out of 3 Patients, But Continued To Be Sold in U.S. (02/13/2025)Cartiva Toe Implant Lawsuit Filed Over Worsened Pain, Reduced Range of Motion and Need for Surgical Removal (02/07/2025)
Nitrous Oxide Class Action Lawsuit Filed Over Fatal Side Effects of Flavored Gas Sold In Vape Shops April 2, 2025
Four BioZorb Breast Tissue Marker Lawsuits Selected for Bellwether Trials (Posted: today) As new BioZorb lawsuits continue to be filed over complications with the recalled breast tissue markers, lawyers indicate they are on track for the first of four test cases to go before a jury in September 2025. MORE ABOUT: BIOZORB LAWSUITCourt Clears BioZorb Lawsuit Design Defect Claims Over Recalled Breast Tissue Marker (03/26/2025)Group of 7 BioZorb Injury Lawyers Appointed to Leadership Positions in Lawsuits Over Recalled Breast Tissue Marker (03/19/2025)Breast Cancer Survivors File Lawsuit Over Recalled BioZorb Tissue Marker (03/12/2025)
Depo-Provera Meningioma Diagnosis Information Required To Qualify for Lawsuit: Order (Posted: yesterday) Women pursuing Depo-Provera meningioma lawsuits will have to provide documentary proof of their diagnosis and the versions of the birth control shot they received within 120 days of filing their case. MORE ABOUT: DEPO-PROVERA LAWSUITDepo-Provera Lawsuit Timeline for Preparing Pilot Trial Cases Outlined by MDL Judge (03/24/2025)Women Can File Depo-Provera Brain Tumor Lawsuits Directly in MDL: Court Order (03/18/2025)75 Lawyers in Depo-Provera Lawsuits Seek MDL Leadership Roles (03/10/2025)
Cartiva SCI Lawsuit Alleges Toe Implant Worsened Pain, Decreased Range of Motion (Posted: 2 days ago) An Indiana woman has filed a Cartiva SCI implant lawsuit, indicating that the toe implant failed due to a defective design, resulting in the need for revision surgery and recommendations to permanently fuse her big toe. MORE ABOUT: CARTIVA IMPLANT LAWSUITCartiva Implant Injury Lawsuit Set for Trial in February 2026 (03/07/2025)Lawsuit Indicates Cartiva Implant Fails in 2 Out of 3 Patients, But Continued To Be Sold in U.S. (02/13/2025)Cartiva Toe Implant Lawsuit Filed Over Worsened Pain, Reduced Range of Motion and Need for Surgical Removal (02/07/2025)