Postmarket Safety

ARTICLES

J&J Hit With $57 Million Judgment in Pelvic Mesh Case

A jury in Philadelphia awarded a $57.1 million judgment to a woman who claimed she has suffered years of pain from the failure of Johnson & Johnson pelvic mesh implants. Read More

Judge Dismisses Whistleblower Lawsuit Against Boston Scientific

A federal judge granted Boston Scientific’s motion to dismiss a 2011 lawsuit alleging False Claims Act violations related to the sale of certain models of its Cognis and Teligen defibrillators. Read More

Judge Rules Case Against St. Jude Defibrillators Can Go Ahead

A federal judge ruled St. Jude may not dismiss a patient’s allegations over manufacturing-defects and negligence related to the company’s implantable cardiac defibrillator (ICD) in a case filed with the U.S. District Court for the Northern District of California. Read More

Cyber Risk Prompts Abbott Recall of 465K Pacemakers

In the first ever recall for a cybersecurity risk, Abbott recalled 465,000 implantable pacemakers for a firmware update to reduce the risk of unauthorized access. The update requires an in-person visit with a healthcare provider. Read More

DHS Flags Hacking Risk in Philips’ Radiation Monitoring App

The Department of Homeland Security issued an advisory over major software vulnerabilities in two versions of Philips Healthcare’s web application DoseWise Portal (DWP) that can give hackers access to protected electronic patient health information. Read More

Australia Reports More Infections Associated with Heater-Cooler Devices

Australia’s Therapeutic Good Administration issued an update on its product review investigation of heater-cooler devices after more patients were found to be infected with Mycobacterium chimaera infections following heart surgery. Read More

Five Deaths from Obesity-Treatment Balloons Prompt New Labels

Two manufacturers of liquid-filled balloons for obesity treatment have revised their labeling to include warnings of the risks. Read More

Good News, Bad News for BD: OK on Lead Tests, But Other Problems

The FDA said it could find no evidence that tubes made by Becton Dickinson for Magellan Diagnostics’ blood lead-level testing devices contributed to inaccurate readings from the devices, which Magellan had suggested as a cause. Read More

FDA Classifies Datascope Balloon Pump Recall as Class I

The FDA has deemed Datascope and Maquet’s recall of their intra-aortic balloon pumps a Class I recall. Read More

MHRA Pelvic Mesh Group Finds Risk Information is Key Issue

The UK’s Medicines and Healthcare products Regulatory Agency released final recommendations from the Mesh Oversight Group, which concluded hospitals need to improve their processes for tracking data and patients need to be better informed about potential risks of pelvic mesh devices. Read More