OCTOBER 2015 - U.S. lawmakers are planning to launch an investigation into the FDA regulation of power morcellators. The U.S. Government Accountability Office has agreed to probe into FDA oversight of power morcellators. Although the GAO does not comment on ongoing investigations, it could take some time to complete the probe. Less than a year ago, the FDA stepped up its oversight of the surgical devices, due to the risk of previously undetected cancers spreading, such as uterine sarcoma following uterine surgeries. The investigation is leading some changes in the healthcare industry, such as private health insurers, such as Aetna dropping coverage for any surgeries using power morcellation.
SEPTEMBER 2015 - Johnson & Johnson's Ethicon Prosima device is the center of a trial in progress currently in Dallas. The testimony stated that although medical professionals were aware that there are safer natural alternatives to the mesh product, doctors proceeded to permanently implant a temporary vaginal support device that may be defective. Ethicon's victims, like Carol Cavness suffered chronic pain, bleeding, tissue erosion, and infections. Patients implanted with Ethicon's Prosima device risked the need for additional surgeries at a higher risk. The testimony also revealed defects in the Prosima mesh, as well as Ethicon's failure to provide sufficient instructions and information regarding the side effects, adverse effects, and potential complications. Ethicon responded in court that the pharmaceutical company is not liable, stating that the injuries were caused by pelvic floor disorder unrelated to the Prosima transvaginal mesh surgery. The previous trial in April 2014 resulted in a $1.2 million verdict. A New Jersey court awarded $3.35 million in 2013 in a similar case.
image credits obitsforlife.com
SEPTEMBER 2015 - Four trial dates are set for early 2017 for the consolidated multidistrict litigation (MDL) against Bayer AG and a Johnson and Johnson subsidiary regarding injuries sustained by Xarelto patients. U.S. District Judge Eldon Fallon in the Eastern District of Louisiana issued the order for trial dates of February 6, 2017 and March 13, 2017. Mississippi's Xarelto trials will be held on April 24, 2017. In Texas, the Xarelto trial will occur on May 30, 2017. The MDL allows the large number of individual cases of Xarelto injuries to benefit from certain streamlined class action processes, without becoming a class, including pre-trial motions, discovery, and settlement conferences. All plaintiffs will reap the benefits of all of the available evidence. The consolidated lawsuits allege that Xarelto causes severe internal bleeding, serious injuries, and death.
humanized antibodies - image credits Wikipedia