Medtech development is hard. Medical device creation can require manufacturing know-how in areas as wide-ranging as electrical components, high-performance polymers, molding and machining – and that doesn’t even include the required expertise in design, regulatory requirements and achieving reimbursement. The good news is that the companies serving the medical device industry have become specialized experts. […]
Federal appeals court rejects preemption argument from BD’s Bard
The 9th U.S. Circuit Court of Appeals has handed down an important medical device preemption opinion as it affirmed a $3.6 million award against Becton Dickinson & Co. (NYSE:BDX) subsidiary C.R. Bard in a bellwether lawsuit case over inferior vena cava filters. Bard’s lawyers had argued that when FDA reclassified intravascular filters as Class II devices, the […]
Bayer sets aside nearly $1.4B for potential Essure settlements
Bayer (ETR:BAYN) during its second quarter ended June 30 set aside €1.245 billion ($1.39 billion), mainly to provide for potential lawsuit settlements related to its Essure permanent birth control device. Some of the provision was also for litigation defense costs and other pharmaceutical matters. As of July 24, Bayer faced U.S. lawsuits from roughly 32,000 Essure […]
Bayer failed to report Essure problems, lawsuit claims
Bayer (ETR:BAYN) failed to tell FDA about thousands of injury complaints related to its Essure contraceptive device, according to newly unsealed lawsuit documents reported by Bloomberg. The lawsuit documents out of California claim that the underreporting went back before Bayer acquired Essure maker Conceptus for $1.1 billion in 2013. Bayer responded to Bloomberg last week that […]
Medical device litigation and COVID-19: What you need to know
The COVID-19 pandemic is creating a new set of medical device litigation challenges — but also a chance for an industry reset. One of Greenberg Traurig’s top medtech litigation lawyers shares her insights. Sara Thompson doesn’t take any guff when she tells people that she defends medical device and pharmaceutical companies from lawsuits. “I say, […]
Boston Scientific settles Canadian pelvic mesh case for $21.5m
Boston Scientific (NYSE:BSX) has agreed to settle a transvaginal mesh class action lawsuit brought by women in Canada for $21.5 million, according to a report by the Canadian Press. The proposed settlement involves about 325 women whose share of the money would depend on the severity of their medical issues, the news service reported. Final approval […]
Bayer wins N.J. Essure case on appeal
A New Jersey appeals court has thrown out a woman’s product liability lawsuit against Bayer (ETR:BAYN) over its Essure permanent birth control device. Arcelia Sandobal Gomez had the Essure metal coils implanted in her fallopian tubes in 2014 and claimed she suffered intermittent and severe abdominal pain and chronic and abnormal vaginal bleeding afterwards. Gomez […]
Court tosses J&J’s appeal in $20 million pelvic mesh case
This article has been updated with a comment from Ethicon. An Indiana federal appeals court yesterday upheld a $20 million jury award in a pelvic mesh case against Johnson & Johnson’s (NYSE:JNJ) Ethicon unit. Despite the “flurry of arguments” in its appeal, the company failed to convince the three-judge panel that it should overturn the […]
J&J’s Ethicon defeats all but 4 claims in Kentucky pelvic mesh case
A federal judge in Kentucky has dismissed all but four claims in a pelvic mesh lawsuit against Johnson & Johnson’s (NYSE:JNJ) Ethicon division. Jensesta Cutter had Ethicon’s Prolift pelvic mesh implanted in 2006 and complained to her doctor that year of pelvic pain, soreness and burning, constipation and urine leakage, according to the complaint. In […]
Medtronic sued over surgical staplers and injury reports
Medtronic (NYSE:MDT) faces lawsuits from three people who claim the company’s surgical staplers seriously injured them — and that the company knowingly sold defective devices and hid the risks, according to a report in the Star Tribune of Minneapolis. Cynthia Nicholson of Harris County, Texas and Robert Snyder of Gilman, Iowa separately sued Medtronic in Hennepin […]
4 medical device industry trends affecting innovation
Major medical device companies are increasingly outsourcing their innovation. Here’s what that means. The medical device industry is increasingly relying on small, young companies to provide innovations, but the early-stage medtech companies are mostly relying on angel investors. It’s also more important than ever to protect intellectual property and mitigate exposure to litigation. Those were […]
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