On September 8 and 9, 2011, the Food & Drug Administration will convene a panel of experts to provide advice to the Agency with regard its regulation of gynecological medical devices. The Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee will focus on evaluating the safety and […]
Category: Mass Torts
Diabetes is a scourge that has prematurely taken my father and other dear members of my family. It is a disease that many others in my family deal with each and every day. We leave in fear of the devastating complications suffered by our loved ones – amputations, heart attacks, […]
On August 8, 2011, the Judicial Panel on Multi-District Litigation (JPML) announced a new MDL would be created for all of the Zimmer NexGen high-flex knee implant cases that have been filed in the federal court system. At the time the petition was filed with the JPML requesting that multi-district […]
What happened? 1.5 million current and former female Wal-Mart employees alleged Wal-Mart discriminated against them in violation of Title VII of the Civil Rights Act of 1964. They said that local managers disproportionately exercised their discretion over pay and promotions in favor of men, which was unlawful. The employees were […]
Tragically, it is too late for 2-year old Harrison Kothari. Harrison died as a result of using a anit-bacterial wipe that was contaminated with life-threatening bacteria. Wipes manufactured by Triad and H&P have been linked to very serious illnesses in the cases of four patients with multiple sclerosis. A […]
Johnson & Johnson has been ordered by a South Carolina court to pay $327 million for minimizing the links between its antipsychotic drug, Risperdal, and diabetes. The case centers on allegations that Johnson & Johnson marketed Risperdal in a way that was misleading in product labels, “Dear Doctor letters” and […]
Is it possible that four studies have demonstrated that certain birth control medications, like Yaz, Yasmin, and Ocella, are dangerous and the manufacturer, Bayer, knew nothing about the dangers? It is reasonable to conclude that if the manufacturer did not actually know, through reasonable and prudent drug evaluation; those dangerous […]
According to new studies, the latest generation of birth control pills, including Yaz, Yasmin, and Ocella, put women at a higher risk of blood clots than other types of birth control pills. These fourth-generation birth control pills carry a two-to-three times greater risk of venous thrombosis, also known as blood […]
What was Bayer thinking when they came out with the birth control pill Yaz? Based on another study, this one published in the British Medical Journal, demonstrates that the key ingredient in Yaz (also in Yasmin and Ocella) causes a six times increase for the incidence of clots in users. […]
Bloomberg has an interesting article today discussing medical device approval and where the fault lies for bad devices being approved for use. The Food & Drug Administration (FDA) “approves” medical devices and often (some say too often) grants review and approval under Section 510(k) of the Food, Drug & Cosmetic […]
