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.
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.
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.
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.
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.
FDA Creates New Fast-Track Program for Critically Necessary Medical Devices April 10, 2015 Irvin Jackson Add Your Comments Federal health regulators have released new guidelines that would pave the way for medical device makers to obtain rapid approval for products that fill an unmet need for life-threatening conditions. This month, the FDA has issued guidance for its Expedited Access Pathway Program (EAP) (PDF), which the agency says will fast-track medical devices to the market without bypassing its premarket approval (PMA) application process. The guidance attempts to address critical medical device needs without putting the devices through the agency’s highly criticized 510(k) fast track approval process, which requires virtually now pre-market testing. Do You Know about… SPORTS BETTING ADDICTION LAWSUITS FOR YOUNG ADULTS Gambling addiction and severe financial losses have been linked to popular sports betting platforms like DraftKings, FanDuel, and Caesars. Lawsuits are being filed by young adults and students who were targeted by deceptive promotions, addictive app features, and aggressive marketing tactics. See if you qualify for a sports betting addiction lawsuit. Learn More SEE IF YOU QUALIFY FOR COMPENSATION Do You Know About… SPORTS BETTING ADDICTION LAWSUITS FOR YOUNG ADULTS Gambling addiction and severe financial losses have been linked to popular sports betting platforms like DraftKings, FanDuel, and Caesars. Lawsuits are being filed by young adults and students who were targeted by deceptive promotions, addictive app features, and aggressive marketing tactics. See if you qualify for a sports betting addiction lawsuit. Learn More SEE IF YOU QUALIFY FOR COMPENSATION On April 8, Dr. Jeffry Shuren, the director of the FDA’s Center for Devices and Radiological Health, published a blog on FDA Voice, explaining how the EAP program is supposed to work. According to Shuren, the voluntary program involves the FDA working with the medical device’s developers during the approval process. It also requires the creation of a Data Development Plan that shifts some PMA data collection requirements from premarket to postmarket, meaning the companies will not have to provide some data on safety and effectiveness until the devices are already on the market. There would still be some premarket data requirements, however, Shuren noted. “The premarket data must be adequate to support FDA’s high standard for premarket review but can include data based on an intermediate endpoint or a surrogate endpoint reasonably likely to predict clinical benefit,” he wrote. “Under the EAP, FDA may accept a greater degree of uncertainty if it is sufficiently balanced by other factors, including the probable benefits to having earlier access to the device.” The program goes into effect on April 15. To be eligible for the program a medical device has to be intended to treat or diagnose a life-threatening or irreversible and debilitating disease or condition. The device’s sponsor has to submit an acceptable draft Data Development Plan and the device has to meet one of the following criteria: There is no other appropriate alternative treatment or means of diagnosis The device uses breakthrough technology that gives it a clinically meaningful advantage that existing technology does not have It offers significant, clinically meaningful advantages not achievable by existing technology Having the device available is in the best interest of patients. Postmarket Data and Fast-Track Approval Concerns The guidance comes as the FDA already faces fire over what many say is a poor track record in actually collecting postmarketing data and in ensuring the quality of that data. A study published last year by researchers with the Pew Charitable Trusts found that most FDA approved medical devices classified as high to moderate risk do not have publicly available scientific data proving their safety or effectiveness. Critics have complained that in many cases, the FDA approves products and then requires the manufacturers to conduct postmarketing surveillance studies, known as postapproval studies (PAS). However, it appears that the companies typically begin selling their products after getting the FDA approval, but simply do not complete the studies. Researchers with the Pew Charitable Trusts suggest that most of the time the FDA does not even ask for the postapproval studies and does little in the way of oversight of those studies. The report found that from 2005 through 2011, the FDA ordered 223 studies for 158 medical devices. Only 48% of those devices deemed high risk were subject to such a study. When the FDA does get adequate PAS data, it results in a label change in more than half of all cases, the researchers found. Fast-Track Approvals Many medical devices are fast-tracked through the FDA’s 510(k) approval process, which allows devices deemed “substantially equivalent” to existing medical devices to the market with little to no clinical testing. The agency has received criticism for expanding the definition of “substantially equivalent” to products that advertise using new technologies and techniques, which are radically different from their predecessors. Many critics say that since the 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. Originally designed for non-critical medical devices, such as band-aids and tongue suppressors, 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. The program has come under increasing fire over the last several years, due to the number of recalls involving 510(k) approved devices, which were only found to carry unacceptable risks after they had already been implanted in thousands of patients. On July 28, the FDA issued new guidance on which medical devices should be considered substantially equivalent to older devices. Shuren said the agency is attempting to address those concerns through other means as well. “We consider this balancing of premarket and postmarket data collection to be so important that we made it one of our three 2014-2015 strategic priorities, along with strengthening the clinical trial enterprise and providing excellent customer service,” Shuren wrote, announcing a guidance on balancing premarket and postmarket data collection. “It describes the circumstances under which postmarket data collection is appropriate for PMAs, whether or not they meet the criteria for the EAP, and provides many useful examples.” Shuren said that EAP’s priority review process and the other elements of the EAP program should reduce the development cycle for critically necessary medical devices without a lowering of the FDA’s safety and efficacy standards. Tags: Medical Device Image Credit: | More Lawsuit Stories Lawsuit Alleges Depo-Provera DMPA Injection Increases Brain Tumor Risks June 20, 2025 Retired Talcum Powder Judge May Be Appointed To Address Renewed Expert Motions June 20, 2025 New Study Links Ultra-Processed Foods Intake With Multiple Adverse Health Effects June 20, 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 TermNameThis field is for validation purposes and should be left unchanged. Δ MORE TOP STORIES Lawsuit Alleges Depo-Provera DMPA Injection Increases Brain Tumor Risks (Posted: yesterday) A Depo-Provera lawsuit blames the active ingredient, DMPA, for an increased risk of the development of brain tumors. MORE ABOUT: DEPO-PROVERA LAWSUITOrtho-Cept, Similar Birth Control Pills Linked to Intracranial Meningioma Risks, Study Warns (06/17/2025)Status of Depo-Provera Shot Lawsuits Outlined by MDL Judge (06/13/2025)Pfizer Requests Depo-Provera Lawsuit Coordination as Mass Tort in Pennsylvania State Court (06/10/2025) Zantac Cancer Lawsuits Continue To Be Filed More Than 5 Years After Recall (Posted: 3 days ago) A man diagnosed with multiple forms of cancer has filed a Zantac lawsuit, blaming Boehringer Ingelheim for failing to adequately warn about the recalled heartburn drug’s health risks. MORE ABOUT: ZANTAC CANCER LAWSUITSJury Hears Zantac Cancer Evidence in Illinois Trial Against Boehringer Ingelheim (02/05/2025)Zantac Bladder Cancer Lawsuit Trial Ends With Hung Jury in California (11/22/2024)GSK To Pay $2.2 Billion To Settle Zantac Cancer Lawsuits Brought by 80,000 Consumers (10/10/2024) Enfamil NEC Lawsuit Filed After Newborn Suffers ‘Nearly Total Bowel Necrosis’ (Posted: 4 days ago) Necrotizing enterocolitis caused by Enfamil resulted in a newborn suffering life-long bowel injuries, according to a lawsuit filed by his mother. MORE ABOUT: ENFAMIL AND SIMILAC BABY FORMULA LAWSUITReckitt Benckiser Faces Class Action Lawsuit Over Enfamil NEC Risks (06/12/2025)NEC Infant Formula Lawyers To Meet With MDL Judge Following Dismissal of First Bellwether Trial (05/29/2025)FDA To Investigate Whether Infant Formula Products Provide Enough Nutrition (05/16/2025)
Lawsuit Alleges Depo-Provera DMPA Injection Increases Brain Tumor Risks (Posted: yesterday) A Depo-Provera lawsuit blames the active ingredient, DMPA, for an increased risk of the development of brain tumors. MORE ABOUT: DEPO-PROVERA LAWSUITOrtho-Cept, Similar Birth Control Pills Linked to Intracranial Meningioma Risks, Study Warns (06/17/2025)Status of Depo-Provera Shot Lawsuits Outlined by MDL Judge (06/13/2025)Pfizer Requests Depo-Provera Lawsuit Coordination as Mass Tort in Pennsylvania State Court (06/10/2025)
Zantac Cancer Lawsuits Continue To Be Filed More Than 5 Years After Recall (Posted: 3 days ago) A man diagnosed with multiple forms of cancer has filed a Zantac lawsuit, blaming Boehringer Ingelheim for failing to adequately warn about the recalled heartburn drug’s health risks. MORE ABOUT: ZANTAC CANCER LAWSUITSJury Hears Zantac Cancer Evidence in Illinois Trial Against Boehringer Ingelheim (02/05/2025)Zantac Bladder Cancer Lawsuit Trial Ends With Hung Jury in California (11/22/2024)GSK To Pay $2.2 Billion To Settle Zantac Cancer Lawsuits Brought by 80,000 Consumers (10/10/2024)
Enfamil NEC Lawsuit Filed After Newborn Suffers ‘Nearly Total Bowel Necrosis’ (Posted: 4 days ago) Necrotizing enterocolitis caused by Enfamil resulted in a newborn suffering life-long bowel injuries, according to a lawsuit filed by his mother. MORE ABOUT: ENFAMIL AND SIMILAC BABY FORMULA LAWSUITReckitt Benckiser Faces Class Action Lawsuit Over Enfamil NEC Risks (06/12/2025)NEC Infant Formula Lawyers To Meet With MDL Judge Following Dismissal of First Bellwether Trial (05/29/2025)FDA To Investigate Whether Infant Formula Products Provide Enough Nutrition (05/16/2025)