Johnson & Johnson’s Ethicon subsidiary was ordered to pay plaintiff Ella Ebaugh $57 million dollars for injuries she suffered from their transvaginal mesh implants. The verdict, rendered in Philadelphia Common Pleas Court, was the largest verdict in the Philadelphia  mass tort litigation. … Read More


The FDA has issued a final order reclassifying transvaginal mesh used to repair Pelvic Organ Prolapse (POP) from class II (moderate-risk) to class III (high-risk). The FDA will also require manufacturers of every surgical mesh used to treat POP to conduct a PreMarket Approval application demonstrating the safety and effectiveness of their mesh product for treating POP. Manufacturers have 30 months — two and one half years — to show that their products are safe and effective for POP. These new FDA orders do not apply to mesh sold for Stress Urinary Incontinence (SUI) or abdominal repair.… Read More


Posted by Marilyn McGoldrick on Jul 1, 2013 4:06:00 PM Newly-unsealed confidential records show that C.R. Bard, Inc., knowingly ignored a part supplier’s direct warning that the plastic Bard was supplied with was unsuitable for human implantation. The revelation about Bard’s behavior comes as the surgical mesh manufacturer is embroiled in litigation over its defective… Read More