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
COVID-19- AG Coalitions Tackle PPP, Price Gouging Concerns- •Eighteen Democratic AGs, led by Illinois AG Kwame Raoul, sent a comment letter to the Small Business Administration (“SBA”) opposing the SBA’s proposed rule...more
The Eight Circuit has rejected a plaintiff’s claim that an arbitration clause in a retainer agreement she signed with a law firm after receiving a call from a purported agent of the firm informing her of a purported...more
Most 21st century Americans would condemn dated practices damaging to women like neck stretching, foot binding, and ritual genital mutilation. Does modern medicine, however, need its own reckoning now for what the profession...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
About a month ago, we reported on a Delaware trial court decision reducing a $75 million punitive award to $7.5 million in a transvaginal mesh case. Last week, in what we believe to be the first appellate decision in one of...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
On December 17, 2015, the Ontario Superior Court of Justice denied certification in a proposed multiple-model product liability class action (Vester v Boston Scientific Ltd, 2015 ONSC 7950). The plaintiffs alleged that the...more
Last week, we posted about a $10 million award of punitive damages in a product liability action against a manufacturer of hip implants. We explained our view that the award was excessive, in part because hundreds of similar...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
Multidistrict litigation (MDL) is a consolidation of civil cases transferred from different jurisdictions around the country to a single U.S. District Court to achieve certain pre-trial efficiencies. All transferred cases...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
Reuters recently reported that a California state court jury (in the case of Perry et al v. Luu et al, Superior Court of the State of California, Kern County, No. 5-1500-CV-279123) awarded $5.7 Million to plaintiff Coleen...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 2011 Endo Health Solutions bought American Medical Systems for $2.9 billion. That may have been a mistake because since then, the number of product liability lawsuits naming AMS over its transvaginal mesh has grown to...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