Articles in Medical Devices
DePuy Lawsuit Emphasizes High ASR Failure Rate
Lieff Cabraser attorneys Wendy Fleishman and Lexi Hazam have announced that George Evans of Remington, Virginia, and James Mechaley of Bakersfield, California have filed suit against DePuy Orthopaedics for injuries suffered from their faulty DePuy …
Senators Call for Medical Device Makers to Disclose Post-Market Safety Monitoring Procedures
U.S. Senators Charles Grassley, Richard Blumenthal and Herb Kohl have introduced the Medical Device Patient Safety Act, designed to give the Food and Drug Administration (FDA) tools to better monitor post-market performance of new medical …
Congressmen Seek Review of Medical Device Regulation
Bloomberg Businessweek reports, House Democrats on the Energy and Commerce Committee, led by Representative Henry Waxman of California, sent a letter to Republicans leaders urging an investigation on the safety of metal-on-metal medical devices.
FDA Advisory Panel to Discuss Safety of Transvaginal Mesh
Bloomberg reports that transvaginal mesh lawsuits are on the rise, and that a two-day hearing on their safety and effectiveness will begin tomorrow. An advisory panel “won’t take any formal votes,” but the “FDA will poll the panel of researchers and physicians on whether to reclassify the devices and gather thoughts on how to conduct clinical studies.”
Medical Device Industry Seeks to Discredit Report by Institute of Medicine
As reported in the New York Times, allies of the medical device industry are waging an extraordinary campaign in Washington to discredit a coming report by one of the country’s pre-eminent scientific groups that examines possible new regulations on the industry.
Infuse Spine Product and Possible Link to Male Sterility
Infuse, Medtronic’s best-selling spinal product, could pose the risk of male sterility, reported a new study from The Spine Journal.
Durom Cup Implant Replacement Lawsuit Filed
John Chisnell, age 58, of Raleigh, North Carolina, has filed a personal injury lawsuit against Zimmer Inc., for manufacturing and selling an allegedly defective hip implant under the brand name Durom Cup.
Patients Nationwide File Lawsuits Against Zimmer For Defective Hip Implants
Today and yesterday, patients from Arizona, Connecticut and Ohio filed lawsuits against Zimmer Inc., the nation’s largest producer of orthopedic devices, for alleged defective hip implants manufactured and sold by Zimmer under the name Durom Cup.
Zimmer Hip Recall: Artificial Hip Recipient Charges Defect Has Caused Extreme Pain And Hardship
Franklin Tennessee resident, Walter Thomas, filed a personal injury lawsuit against Zimmer Inc., manufacturer of his Durom Cup artificial hip.
Patients Left Disabled File Suit Against Zimmer For Defective Hip Implant
National plaintiff law firm Lieff Cabraser has filed separate personal injury lawsuits against Zimmer Holdings, the nation’s largest producer of orthopedic devices, for multiple surgeries and debilitating injuries plaintiffs suffered due to the defective Durom Acetabular Component, an artificial hip socket known as the Durom Cup
NY Times: Radiation Errors Reported in Missouri
The New York Times reports a Missouri hospital has overradiated 76 patients, the vast majority with brain cancer, during a five-year period because its powerful new radiation equipment had been set up incorrectly — even with a representative of the manufacturer watching as it was done.
Medtronic Heart Lead Recall Update: “[Sprint] Fidelis lead fracture rate is increasing exponentially with time”
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In March 2009, Medtronic disclosed that at least 13 Sprint Fidelis patients may have died, including four patients whose deaths were related to efforts by doctors to surgically remove the product. In February 2010, the Wall Street Journal reported that the FDA database includes at least 12 additional deaths allegedly linked to the recalled device.
Boston Scientific Pays $22 Million to Settle Claims
The world’s biggest maker of heart stents, has agreed to pay $22 million to settle allegations that the company’s Guidant unit used clinical studies to pay kickbacks to doctors for using its products
Tens of Thousands of Heart Patients May Be at Risk from Defective Device
Tens of thousands of patients may be at risk of suffering repetitive and devastating electrical shocks from the defective Sprint Fidelis manufactured by Medtronic, Inc.
Studies spotlight problems in FDA device approvals for devices like pacemakers, heart stents
Two new studies find shortfalls in the Food and Drug Administration’s approval process for heart devices such as pacemakers and stents
