“Plaintiff Was Hypersensitive,” DePuy Lawsuit Defense Witness States
The jury in the second DePuy hip implant lawsuit to go to trial (Carol Strum v. DePuy Orthopaedics, Inc. et al, case no. 2011-L-009352) has recently heard testimony from an expert witness for the defense alleging that: The plaintiff was likely hypersensitive to a normal amount of debris shed from the DePuy ASR XL metal-on-metal hip implant. The device, upon …
Medical device makers pressured to foot bill in wake of recalls
The dramatic increase in recent years of medical device recalls and resulting litigation has put a financial burden on the insurers, who are, in turn, forcing manufacturers to share the costs. Experts are looking at the 2010 recall of St. Jude Medical’s Riata defibrillators as the next battleground between insurers and manufacturers. The Food and Drug Administration has advised nearly …
Group: Nearly 123 million medical devices recalled in last quarter
The bad news is that nearly 123 million medical devices, from ultrasound gels to hip implants, were recalled in the last quarter. According to ExpertRecall, a company that tracks recalls, while the number of recalled devices has dropped from the previous quarter, the number of units that were affected topped the 100 million mark for the first time since the …
FDA warns medical device maker Medtronic to correct violations
The U.S. Food and Drug Administration sent a warning letter to medical device maker Medtronic, saying it lacks adequate complaint procedures and its response to complaints and an FDA investigation were inadequate. Medtronic manufactures implantable drug infusion systems, deep brain stimulation systems, spinal cord neurostimulation systems, nerve monitoring products and other neurological medical/surgical products. The devices in question are intended …
Transvaginal mesh maker Bard to pay $5.5 million in civil verdict
A California woman was awarded $5 million and her husband $500,000 after a jury found that transvaginal mesh manufacturer C.R. Bard Inc.’s negligence caused the woman’s injuries including incontinence and chronic pain. The jury ruled on July 23, 2012, that Bard was 60 percent responsible and the surgeon 40 percent responsible for negligent handling of Bard’s Avaulta Plus vaginal mesh …
FDA: Patients with Riata defibrillators should get X-rays
The U.S. Food and Drug Administration recommends that patients with Riata or Riata ST heart defibrillator implants have X-rays or other scans to check for abnormalities in the lead insulation. The manufacturer, St. Jude Medical of Minnesota, recalled the leads in November 2011 due to premature erosion of the insulation around the electrical conductor wires. The company says about 79,000 …
Consumer Reports Incensed over Bad Medical Devices
The publication Consumer Reports has been long known for it’s reviews of products including automibiles and home appliances, but has now taken on medical devices. Cosnumer Reports President, Jim Guest wrote an email to 1 Million Americans earlier this year stating, “The implant that fixed your knee or your heart may acutally be a ticking time bomb that could disable …
Important Reminder from FDA: Defective AEDs Recalled
The Food and Drug Administration is reminding owners of automatic external defibrillators (AEDs) to check whether their devices are subject to a Jaunary recall. Certain AEDs contain a defective component that could cause the AED to not delvier defibrillation. Because of the seriousness of this issue the agency has classified this recall as class I, the most serious category of …
