Multidistrict litigation (MDL) is a consolidation of civil cases transferred from different jurisdictions around the country to a single U.S. District Court to achieve certain pre-trial efficiencies. All transferred cases must be marked by common fact questions, and are overseen by a federal judge. The aim of this consolidation is to preserve […]
Category: Defective Medical Devices
Transvaginal mesh is a medical device implanted to treat stress urinary incontinence (SUI) and pelvic organ prolapse (POP) in women. Transvaginal mesh is a semi-permeable barrier implanted into a woman as a reinforcing structure to keep her internal organs in place. The device is known as vaginal mesh because it is now […]
Transvaginal mesh was first developed from surgical mesh used in hernia repair surgeries since the 1950s. Traditionally, surgical mesh used for hernia repair was constructed of collagen extracted from bovine or human tissue and formed into a mesh that could be implanted in humans. Physicians used the same mesh to treat […]
In 2010, doctors in the United States inserted more than 70,000 mesh devices in patients, threading them through incisions in the vagina to fortify pelvic muscles that failed to support internal organs or to treat incontinence, according to court filings. Sometimes the failure of these devices is masked by other symptoms, […]
The Food and Drug Administration (FDA) first approved the Synchromed II Implantable Infusion Pump System manufactured Medtronic, Inc. in 2004. The pump infuses pain medication, Baclofen, through a catheter into a patient’s spine. This medical device is used to treat primary or metastatic cancer, chronic pain and severe spasticity. There […]
The FDA recently announced that it is investigating allegations of improprieties in conjunction with clinical trials that were conducted by Bayer and Conceptus with regard to the Essure device, which is utilized in sterilization procedures. Bayer Corporation, a German pharmaceutical giant, purchased Conceptus, the original designer of the Essure device, […]
In August of 2010, DePuy shocked the orthopedic community and thousands of patients by announcing the recall of its ASR metal-on-metal hip implant due to an excessive failure rate. Following this product recall, more than 13,000 individual lawsuits were filed on behalf of patients who suffered significant injuries, including the […]
The power morcellator, a surgical device used to mince large masses of tissue inside the body so the material can be extracted through small incisions, has been the center of a debate in the medical community since the Food and Drug Administration (“FDA”) discouraged its use in April, 2014. The FDA discouraged the use […]
When did Olympus first learn about the design problems inherent in the specialized medical scopes it peddles? Did they have plans to redesign these scopes to make them safer for patients? These are the questions at the top of U.S. Representative Ted Lieu’s (D-CA) mind after he sent a letter […]
Safeguarding, streamlining, strengthening the clinical trial process is one of three of the Food and Drug Administration’s primary goals for 2015. So states an 11-page document titled 2014 – 2015 Strategic Priorities. The other two goals focus on 1) striking a better balance between data collection requirements and the time […]