Often plaintiff attorneys decide on medical device cases by taking ones where the FDA has not made a safety and efficacy determination under 510(k), and declining cases where the device is subject to the more rigorous FDA Premarket Approval (PMA) process. The latter category typically may be dismissed or summary judgment for the device manufacture […]
Safe Medical Devices and the FDA
FDA Commissioner Scott Gottlieb recently emphasized that “the most impactful way that we can promote innovation and improved safety in the 510(k) program is to drive innovators toward reliance on more modern predicate devices or objective performance criteria when they seek to bring new devices to patients.” Common sense indicates that when conducting comparative testing […]
Transvaginal Mesh and the FDA
The Food and Drug Administration (FDA) Commissioner Scott Gottlieb first announced the agency would meet on surgical mesh safety and effectiveness of transvaginal pelvic organ prolapse repair in a statement November 20, 2018. The FDA reported approximately 2, 874 adverse events from January 1, 2008 until December 31, 2010. The most common adverse events for […]
Hypoxic Ischemic Encephalopathy
Hypoxic-ischemic encephalopathy (HIE), is a brain injury caused by a lack of oxygen-rich blood in the baby’s brain. HIE results in infant seizures, difficulty feeding, low muscle tone, limpness, organ dysfunction, and breathing problems. HIE can also lead to cerebral palsy, intraventricular hemorrhages, hydrocephalus, and learning disabilities. HIE often occurs in utero, during labor and […]
Cerebral Palsy Medical Malpractice
Cerebral Palsy is a dangerous medical condition that occurs when oxygen cannot reach an infant’s brain during delivery. the birth injury can range from mild to severe and will be affected for the rest of their lives. Specifically, Cerebral Palsy is a neurological disorder that effects body movement and muscle coordination. There are three main […]
Stryker hip implant lawsuits
Stryker hip lawsuits claim faulty hip implants caused severe pain and other complications that required surgery to repair. Over 3,400 people sued Stryker after problems with its Rejuvenate and ABG II hip implants led to recalls. Stryker Corporation is a major manufacturer of medical devices including hip implant systems. They published a release about “higher […]
Mirena IUD
Millions of women choose Mirena IUD for birth control because it requires no surgical procedure, and you do not have to remember to take it every day like you do with the pill. But thousands of women nationwide sued Bayer Pharmaceuticals over Mirena. The first Mirena lawsuits claimed the birth control device perforated organs, […]
Johnson & Johnson & Ethicon Transvaginal Mesh Case — Update
In April of 2018, an Indiana jury found Johnson & Johnson and Ethicon, a subsidiary of Johnson & Johnson, liable to Barbara Kaiser, an Indiana native, for injuries sustained after Barbara was implanted with the Prolift transvaginal mesh, a product of Johnson & Johnson, and experienced severe discomfort, pain, and injuries. Aside from such discomfort […]
Defective DePuy Attune Knee System
Lawsuits are being filed over the DePuy Attune Knee System. David Love received the DePuy Attune Knee System, including a fixed tibial insert and a fixed tibial baseplate, in December 2015. He filed a complaint in the U.S. District Court, Western District of Missouri, on September 4th. (Case No. 4:18-cv-00695-BP) After the procedure, Love experienced […]
Zimmer hip implant manufacturing subject to FDA action
Zimmer Holdings Inc. has a documented history of releasing flawed hip replacement implants onto the U.S. market. Two of its products, the Zimmer M/L Taper Prosthesis and the Zimmer Durom Acetabular Component, have been linked to health problems and the need for additional surgeries in some patients. According to the FDA notice, the Zimmer devices […]