Ex-Theranos CEO Elizabeth Holmes through her lawyers is blaming prosecutors’ “investigative failure” for the loss of a company database that would have shown the level of inaccurate blood-testing results. In a filing yesterday, Holmes’ lawyers claim that in the absence of information in the Laboratory Information System (LIS) database, the judge should not allow jurors […]
Product Liability
Federal lawsuit over Boston Sci pelvic mesh heads to trial
A federal judge in Arkansas has ruled that most counts in a pelvic mesh lawsuit against Boston Scientific can go to trial. Kortney Cline sued Boston Sci in 2014, claiming that she suffered injuries after implantation with the company’s Obtryx trans-obturator mid-urethral sling in 2009. Cline’s case was recently transferred to federal court in Arkansas […]
Zimmer Biomet wants federal court to throw out $3.55M hip implant judgment
Zimmer Biomet (NYSE:ZBH) wants either a judgment or a new trial after a federal jury’s $3.55 million award in a metal-on-metal hip implant case. The jury awarded the money to Lori Nicholson and her husband Willis in November for injuries sustained as a result of the M2A Magnum. In a brief filed Feb. 12, Zimmer Biomet claimed […]
Zimmer Biomet could pay millions after two hip implant lawsuit losses
A federal judge in Missouri has signed off on a $21 million judgment against Zimmer Biomet (NYSE:ZBH) involving the company’s much-litigated M2a Magnum metal-on-metal hip implant. U.S. District Judge Stephen R. Clark’s sign-off yesterday of the award — $20 million to Mary Bayes and $1 million to her husband Philip Bayes — came a day […]
BD is paying $60M to settle Bard pelvic mesh suits with most U.S. states
Becton Dickinson (NYSE:BDX) will pay $60 million to 48 U.S. states to resolve allegations that its C.R. Bard business deceptively marketed transvaginal surgical mesh devices, state attorneys general in California and Washington announced today. Mesh products were meant to treat the weakening of the muscles and ligaments supporting a woman’s pelvic organs, but they instead sparked […]
Everything you need to know about medical device creation
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 […]
