A California appeals court mostly agreed that Johnson & Johnson must pay the state hundreds of millions of dollars over misleading marketing around the risks of pelvic mesh products. The Fourth District Court of Appeals in California, in its April 11 ruling, reduced the size of the civil penalties against J&J’s Ethicon subsidiary by $42 […]
Product Liability
FDA says Philips knew about toxic foam for years before massive recall
The FDA said it observed potential violations of federal medical device safety rules when inspecting a Philips Respironics manufacturing facility connected to the Class I recall of more than 15 million respiratory devices. The FDA recently requested additional safety testing on replacement materials and issued a Form 483. The form details how Philips and its foam supplier were aware […]
FDA requests safety testing of replacement foam in Philips sleep devices recall
The FDA said it has requested additional safety testing on the material used to repair Royal Philips (NYSE:PHG) sleep therapy devices recalled for foam that could harm patients using them. The Class I recall that started in June covers more than 15 million devices, after hundreds of complaints and more than 100 injuries from polyester-based […]
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 there is now a whole ecosystem of specialized experts serving the […]
Cardinal Health subsidiary faces federal lawsuit over EtO plant in Georgia
Nearly two dozen people who have lived in the Augusta, Ga. area are suing Cardinal Health subsidiary Kendall Patient Recovery U.S. over ethylene oxide emissions from a medical device sterilization plant in the city. The people suing KPR U.S. in U.S. District Court in Southern Georgia lived and worked within miles of the Augusta facility […]
Abbott to pay $66M to settle suits involving St. Jude Medical and Alere
Abbott (NYSE:ABT) has reached settlements with the U.S. Department of Justice over False Claims Act lawsuits involving St. Jude Medical and Alere — two companies it spent billions of dollars to acquire in 2017. The Abbott Park, Ill.-based medtech giant will pay nearly $66 million as part of the settlements. Without admitting liability in either […]
Heater-Cooler suit against LivaNova revived
A Louisiana resident whose lawsuit against LivaNova (NSDQ:LIVN) was thrown out will have another chance to plead his case. A federal appeals court in Pennsylvania ruled last week that a Louisiana district court must reconsider the case of Kyle Hamer. Hamer underwent open-heart surgery at Children’s Hospital-New Orleans in 2017 using LivaNova’s 3T Heater-Cooler device. […]
Federal judge won’t let Boston Scientific avoid Watchman lawsuit
A federal judge in western North Carolina has declined to dismiss a wrongful death lawsuit against Boston Scientific (NYSE:BSX) over its Watchman stroke prevention device. Boston Scientific had sought to have the suit — brought by the Jean Penland estate — dismissed based on the Supreme Court’s decade-old Riegel v. Medtronic decision. The Riegel ruling […]
Boston Scientific settles host of state pelvic mesh lawsuits for nearly $189M
Boston Scientific (NYSE:BSX) has agreed to pay $188.6 million to 47 states and the District of Columbia to resolve claims that it deceptively marketed transvaginal surgical mesh devices, state AGs announced today. Pelvic mesh products have been one of the medical device industry’s worst failures so far in the 21st century. First cleared nearly two […]
Allergan must face breast implant class action
A federal judge in New Jersey has shut down part of a multi-district lawsuit against Allergan over its Biocell textured breast implants but kept most other parts of the litigation. Judge Brian Martinotti ruled on March 19 that some of the plaintiffs’ claims against Allergan (now part of AbbVie) were preempted by federal law while […]
Medtronic must face pain-pump lawsuit
A 70-year-old man may proceed with a lawsuit claiming that Medtronic’s SynchroMed II infusion pump is defective and that the company was negligent in manufacturing it. A U.S. District Court judge in West Virginia last week denied Medtronic’s motion to dismiss the lawsuit brought by John David Brumfield, who claims that the pump in the […]
