Lawyer Monthly Magazine - September 2021 Edition

Marie Napoli has been an attorney for over twenty-five years. She has experience handling personal injury, medical malpractice litigation, pharmaceutical litigation, employment discrimination, civil rights, and mass tort matters. Marie earned her JD from St John’s University Law School and her LLM degree from New York University (NYU) School of Law. She has worked for the New York Appellate Division, 2nd Department and has taught CLE courses on Tort and Civil Procedure at St John’s University School of Law. As a founding partner of Napoli Shkolnik PLLC, Marie is involved in many depositions and has tried multiple cases to verdict. She is also bringing her considerable skillset and experience to a collaboration with Ben Crump on numerous social injustice litigations. Napoli Shkolnik is a national law firm based in New York City. Their personal injury attorneys represent victims across the country in litigation, mediation and arbitration across a range of practice areas, including medical malpractice, environmental litigation and civil rights. With additional offices in Long Island, New Jersey, California, Delaware, Florida, Illinois and Texas, Napoli Shkolnik’s team boasts 30+ years of experience and more than $3 billion secured for their clients through verdicts and settlements. Similarly, the makers of the birth control device NuvaRing were also sued for failing to adequately warn consumers about the heightened risk of blood clots and other injuries associated with the product. In 2013, NuvaRing paid a $100 million settlement to Napoli Shkolnik clients harmed by the product. Premarket Approval and Classification. FDA-approved drugs and medical devices are categorized as Class I, II, or III. Class III is the highest risk class, and as such has strict research and safety requirements for premarket approval (PMA). Transvaginal mesh, EXPERT INSIGHT 55 SEP 2021 | WWW.LAWYER-MONTHLY.COM which is used to treat urinary incontinence and pelvic organ prolapse (POP), was upgraded from Class II to Class III in 2016. The FDA has since found several surgical mesh implant PMA applications to have insufficient proof of safety. Thousands of women are experiencing devastating, even fatal complications from transvaginal mesh as manufacturers shell out huge settlements. Had the product been correctly classified and tested from the beginning, irreparable harm could have been avoided. Conclusion As a leader in pharmaceutical litigation and a woman myself, I am heartbroken by the number of women currently suffering because of the malfeasance and negligence of money-hungry companies. We must reform the way cosmetics, drugs and medical devices get on the market, how they are marketed, and the process by which to get them recalled, or countless other people will be put at risk of serious injury or even death. It is time for us to prioritise the health and safety of women and not lining the pockets of companies. Medical devices are subject to more regulation than cosmetic products, but harmful medical devices still make it onto the market. Marie Napoli, Founding Partner Napoli Shkolnik PLLC 360 Lexington Avenue, 11th floor, New York, NY 10017 Tel: +1 212 397 1000 www.napolilaw.com