medical device liability News

FDA Classifies Recall of J&J’s Electrosurgical Tools as Most Serious

The U.S. Food and Drug Administration (FDA) on Tuesday classified the recall of certain electrosurgery tools manufactured by a Johnson & Johnson unit as “most serious,” saying their use could lead to injuries or death. The U.S. health regulator said …

Lead Paint Testing Firm Executives Accused of Marketing Faulty Devices

Three former executives of a company that makes machines that test lead levels in humans deliberately concealed a problem with the devices that produced falsely low results for tens of thousands of children, federal prosecutors in Boston said last week. …

Philips Expects to Reach Settlements This Year for Global Recall of Respiratory Devices

Dutch health technology company Philips expects to reach settlements this year relating to its global recall of respiratory devices, CEO Roy Jakobs said in an interview with Dutch financial daily FD published on Thursday. “I think we can at least …

Philips Says Tests on Recalled Respiratory Devices Show Limited Health Risks

AMSTERDAM — Dutch health technology company Philips said on Wednesday independent tests on its respiratory devices involved in a major global recall had shown limited health risks. The company rocked investors last year by recalling millions of breathing devices and …

FDA Seeks More Tests of Foam Used in Philips Ventilators

Philips, the medical equipment maker that is recalling ventilators due to use of parts containing a potentially hazardous foam, said on Sunday it is in discussions with U.S. regulators after a new inspection of one of the company’s facilities. Philips …

Potentially ‘Massive’ Litigation Over Recalled Philips Sleep Apnea Devices Advances

Royal Philips NV will face more than 100 U.S. lawsuits gathered in a Pennsylvania court over its recall of more than 3 million devices used to treat sleep apnea that are linked to cancer concerns. Amsterdam-based Philips, maker of respiratory …

Court Revives 6,000 Lawsuits Against 3M Over Surgical Device

A federal appeals court on Monday revived nearly 6,000 lawsuits alleging that a widely used device produced by 3M Co. to keep surgical patients warm caused them to develop infections. The 8th U.S. Circuit Court of Appeals said the Minnesota …

Boston Scientific Settles States’ Surgical Mesh Device Marketing Claims for $189M

Boston Scientific Corp. agreed to pay $188.7 million to settle claims by most U.S. states that it deceptively marketed its surgical mesh devices to consumers. The settlement with 47 states and Washington, D.C. was announced on Tuesday by several state …

Bayer to Pay $1.6 Billion to End 90% of U.S. Claims for Essure Birth Control Device

German drugs and pesticides group Bayer said on Thursday it will pay around $1.6 billion to settle the majority of U.S. claims involving its Essure birth-control device. The agreement follows a $10.9 billion settlement in June of U.S. lawsuits claiming …

FDA Bans Electrical Shock Medical Device in Rare Regulatory Action

The U.S. Food and Drug Administration on Wednesday banned electrical stimulation devices (ESDs) used in curbing self-injurious or aggressive behavior, citing substantial risks of illness or injury to patients. The agency’s final decision comes after the devices were found to …