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Product Liability

California appeals court orders Johnson & Johnson to pay $302M in pelvic mesh case

April 15, 2022 By Chris Newmarker

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 […]

Filed Under: Featured, Gynecological, Legal News, News Well, Product Liability, Women's Health Tagged With: Johnson & Johnson, pelvic mesh

FDA says Philips knew about toxic foam for years before massive recall

November 16, 2021 By Jim Hammerand

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 […]

Filed Under: Business/Financial News, Featured, Materials Testing, News Well, Outsourcing, Product Liability, Recalls, Regulatory/Compliance, Respiratory Tagged With: FDA, Philips Respironics, Royal Philips

FDA requests safety testing of replacement foam in Philips sleep devices recall

November 15, 2021 By Jim Hammerand

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 […]

Filed Under: Business/Financial News, Featured, Food & Drug Administration (FDA), Materials Testing, News Well, Product Liability, Recalls, Regulatory/Compliance, Respiratory Tagged With: FDA, Philips Respironics, Royal Philips

Everything you need to know about medical device creation

September 2, 2021 By Chris Newmarker

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 […]

Filed Under: Catheters, Contract Manufacturing, DeviceTalks Q&A, Featured, Materials Testing, Outsourcing, Patent Infringement, Product Liability, Regulatory/Compliance, Research & Development, Sterilization / Calibration Tagged With: Abbott, B. Braun, coolis tool holder, Freudenberg Medical, Heraeus, Medical Device Handbook, MedPlast, robin industries

Cardinal Health subsidiary faces federal lawsuit over EtO plant in Georgia

July 22, 2021 By Chris Newmarker

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 […]

Filed Under: Featured, Legal News, Product Liability, Sterilization / Calibration Tagged With: Cardinal Health, ethylene oxide

Abbott to pay $66M to settle suits involving St. Jude Medical and Alere

July 9, 2021 By Chris Newmarker

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 […]

Filed Under: Business/Financial News, Cardiac Implants, Cardiovascular, Featured, Legal News, Product Liability Tagged With: Abbott

Heater-Cooler suit against LivaNova revived

April 12, 2021 By Nancy Crotti

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. […]

Filed Under: Business/Financial News, Legal News, Product Liability Tagged With: LivaNova

Federal judge won’t let Boston Scientific avoid Watchman lawsuit

March 23, 2021 By Chris Newmarker

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 […]

Filed Under: Cardiac Implants, Cardiovascular, Featured, Legal News, Product Liability, Structural Heart Tagged With: Boston Scientific

Boston Scientific settles host of state pelvic mesh lawsuits for nearly $189M

March 23, 2021 By Chris Newmarker

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 […]

Filed Under: Business/Financial News, Featured, Gynecological, Legal News, Product Liability, Women's Health Tagged With: Boston Scientific, pelvic mesh, transvaginal mesh

Allergan must face breast implant class action

March 22, 2021 By Nancy Crotti

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 […]

Filed Under: Featured, Legal News, Product Liability, Women's Health Tagged With: Allergan, breast implants, FDA

Medtronic must face pain-pump lawsuit

March 15, 2021 By Nancy Crotti

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 […]

Filed Under: Drug Pumps, Featured, Legal News, Pain Management, Product Liability Tagged With: Medtronic

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