From contraceptives to mesh implants, shampoos to pasta, New York state and federal courts issued decisions in 2020 which further shaped the landscape in the medical and life sciences legal world. To prepare the best product...more
In the Southern District of West Virginia, Johnson & Johnson and its subsidiary, Ethicon, Inc., were sued for defective design and failure to warn for their transvaginal mesh TVT-O, in addition to a loss of consortium claim....more
The U.S. Food and Drug Administration issued two final orders on Monday, January 4, 2016 to strengthen the data requirements for transvaginal surgical mesh devices that repair pelvic organ prolapse (POP). First, the agency...more
Summer is in full swing and certain topics are (staying) hot—especially regulatory issues, from new proposed rules to challenges to case law to strategic considerations. Generic preemption remains a hot topic. In Storm...more
Mesh products have been regularly used to repair abdominal hernias since the 1950s. In the 1970s, gynecologists used surgical mesh products designed for abdominal hernia repair to repair prolapsed organs....more
It really doesn’t sound like a question we need to be asking because it should be a matter of common sense. Shouldn’t any medical device that is permanently implanted in the human body be put through a high degree of...more
A major move toward public safety may be one step closer with the U.S. Food and Drug Administration announcing this week that it will put a proposal out for public comment that would reclassify pelvic organ prolapse (POP)...more
In this Issue: ..Massachusetts Federal Court Rejects Exception to “Learned Intermediary” Rule for Prescription Drug Advertised Directly to Consumers, and Excludes Expert Opinion of Inadequate Warnings as Unqualified...more