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News Archives

January 27, 2016: One Hundred Twenty Million Paid In J&J Mesh Settlement

Johnson & Johnson (J&J), in their first effort to address the over 40,000 suits it faces for allegedly harming women with their vaginal mesh, agreed to pay more than $120 million to resolve 2,000 to 3,000 of these suits. The New Brunswick, New Jersey-based company had previously resolved only a handful of vaginal mesh suits. Vaginal Mesh Lawsuit Help The Weinberg Law Firm, based in New Brunswick, NJ, is currently assisting women who have been injured by vaginal mesh products. Mr. Weinberg currently serves as local counsel for more than 400 vaginal mesh cases pending in New Jersey State Court. Filed against vaginal mesh manufacturers C. R. Bard and Johnson & Johnson, these cases were consolidated in New Jersey Superior Court in Atlantic County, and recently moved to Bergen County. If you have experienced complications following a vaginal mesh surgery, Read More

January 26, 2016: Optisure Dual Coil Defibrillation Leads Recalled Due to Manufacturing Error

Defibrillation Leads Recalled St. Jude Medical recalled their defibrillator connecting wires, called Optisure Dual Coil Defibrillation Leads, due to the possibility that the technology will fail and prevent the defibrillator from delivering electrical therapy to the patient. This risk of device failure depends on device programming and the depth of the cut, since the problem was caused by a manufacturing error that may have caused damage to the insulation layer of one of the shock coils. The use of affected products may cause serious adverse health consequences, including patient injury or death. This recall was identified as a Class I recall by the U.S. Food and Drug Administration (FDA), meaning that use of these devices may cause serious injuries or death. Defibrillation Leads Recalled – Product Information According to the FDA Recall Press Release, “The Optisure Dual Coil Defibrillation Leads Read More

January 22, 2016: Baystate Noble Hospital Endoscopes Potentially Infect Hundreds

Baystate Noble Hospital Endoscopes News Due to a potential colonoscope contamination, patients of Baystate Noble Hospital in Westfield, Massachusetts were possibly exposed to blood-borne illnesses such as hepatitis and HIV. The hospital informed all 293 patients who underwent a colonoscopy between June 11, 2012 and April 17, 2013 of the contamination risk, urging all to get tested for hepatitis B, hepatitis C, and HIV, at no cost. The potential for contamination arose after health care professionals at the hospital did not properly disinfect the colonoscopes after use. This oversight in device sterilization occurred during a switch to new colonoscopes; the new colonscope had a different disinfection process than the previous coloscope required, leading to an error in staff training. According to the letter sent to exposed patients from Baystate Noble Hospital, “the disinfection of those endoscopes between procedures did not Read More

January 13, 2016: FDA, Hospitals, Manufacturers at Fault According to Duodenoscope Superbug Outbreak Report

Duodenoscope Superbug Outbreak Report News After several nationwide duodenoscope superbug outbreaks, Senator Patty Murray (D-WA) initiated an investigation and subsequently released a report analyzing the U.S. Food and Drug Administration’s (FDA), hospitals’, and medical device manufacturers’ role in causing and response to the epidemics. Sen. Murray was motivated to generate this duodenoscope superbug outbreak report, which was released January 13, 2016 and titled “Preventable Tragedies: Superbugs and How Ineffective Monitoring of Medical Device Safety Fails Patients,” by a duodenoscope superbug outbreak in Murray’s home state of Washington. Duodenoscope Superbug Outbreaks Duodenoscopes may be used in procedures to drain fluids from blocked pancreatic and biliary ducts, inject contrast dyes, obtain tissue samples for biopsy, or to treat certain medical conditions. The design of certain duodenoscopes may interfere with the ability to sterilize these reusable medical devices, putting patients at risk for Read More

January 5, 2016: FDA Recommends Hospitals Desist Usage of Customed Surgical Packs and Trays

Customed Surgical Packs and Trays The U.S. Food and Drug Administration (FDA) issued a Safety Communication cautioning hospitals and health care facilities in Puerto Rico to desist using Customed, Inc. Surgical Convenience Packs and Trays. The FDA asks these facilities to avoid these products due to unassured “integrity, safety, and efficacy”. Specifically, the FDA has not been able to test: • The sterility of the products, • That endotoxin and ethylene oxide levels are within safe limits, • That package integrity can withstand stresses during transport, and • That the products will be effective up to their expiration dates. Customed Surgical Packs and Trays The Surgical Convenience Packs and Trays manufactured by Customed, Inc are used during any surgical procedure, and include many surgical tools and assist items. The packs include exam gloves, absorbent towels, suture bags, surgical table covers Read More

January 4, 2016: FDA Strengthens Vaginal Mesh Safety Requirements For Pelvic Organ Prolapse Repair

According to a previous U.S. Food and Drug Administration (FDA) announcement, between the years 2008 and 2010 there were 1,503 adverse event reports identified for women implanted with vaginal mesh products while undergoing transvaginal pelvic organ prolapse (POP) surgery. These adverse events included reports of injury, death, and mesh failure. The FDA has reported that “serious complications associated with surgical mesh for pelvic organ prolapse transvaginal repair of are not rare”. In response to this growing safety concern, today the FDA alerted the public and mesh manufacturers that it had issued two orders that include a mesh medical device reclassification, and more stringent data requirements for the vaginal mesh used to transvaginally repair pelvic organ prolapse. New Transvaginal Mesh Data Requirements To address safety concerns regarding the mesh products used in transvaginal POP repair, the FDA issued an order to Read More

December 22, 2015: Olympus Corp. May Have Known of Duodenoscope Superbug Outbreak Risk

According to a December 19, 2015 L.A. Times exposé, Olympus Corp. may have knowingly continued to sell its duodenoscopes even after learning of an alleged design flaw that could lead to the spread of dangerous infections. The risk of a duodenoscope superbug outbreak was first detected in 2012, in a hospital in the Netherlands in which 22 patients were sickened by the “superbug”, a kind of multidrug-resistant bacteria. Investigation of the duodenoscope superbug outbreak in this Dutch hospital found the Olympus devices to be the source of the infection. Olympus Corp., however, never chose to share these findings with the U.S. hospitals to which they supplied duodenoscopes. Over the next three years, at least 65 people were sickened, of which 21 died, from infections related to duodenoscopes in Pittsburgh, Seattle and Los Angeles. So far, the U.S. Food and Drug Read More

December 7, 2015: eVent Medical Inspiration Ventilator Recall, As Device May Turn Off Without Alarm

Inspiration Ventilator Recall News On December 7, 2015, the U.S. Food and Drug Administration (FDA) announced that eVent Medical had issued a recall of their LS, 5i, or 7i Inspiration ventilators due to a device flaw that may cause the machine to turn off without alarm. For a device that may provide breath for people who have lost ability to breathe on their own, a device failure such as this could have been especially hazardous; however, the company received only one report of this issue occurring, with no reported injuries or deaths. The Inspiration ventilator recall was initiated due to a faulty switch on the ventilators’ power board, which caused the ventilator to shut down without sounding an alarm. OBTAIN A FREE MEDICAL DEVICE LAWSUIT EVALUATION FROM THE WEINBERG LAW FIRM If you are a loved one has been seriously Read More

December 1, 2015: Dräger Baby Ventilator Power Supply Unit Recall Due to Software Flaw

December 1, 2015, Dräger initiated a recall of the PS500 Power Supply Unit, used with two models of ventilators, the Evita V500 and the Babylog VN500. The Dräger baby ventilator power supply unit recall was triggered by a software flaw in the battery power supply, in which the device may misinform the user of its amount of battery charge. In this case, the ventilator may deplete its battery, to the point that the machine turns off, in which case the patient may not receive necessary oxygen. Since this risk is so dire, the U.S. Food and Drug Administration has identified this as a Class I recall, the most serious type of recall, because use of this device may cause serious injury or death. OBTAIN A FREE MEDICAL DEVICE LAWSUIT EVALUATION FROM THE WEINBERG LAW FIRM If you are a loved Read More

November 23, 2015: FDA Warns Of Lubricious Coating Separation from Intravascular Medical Devices

In a November 23, 2015, Safety Communication, the U.S. Food and Drug Administration (FDA) reported that intravascular medical devices may pose the risk of harming patients due to the possibility of lubricious coating separation. This means that the slippery coating on the device that is necessary to reduce friction between the device and blood vessels during an endovascular procedure may peel or flake off of the device, leaving coating fragments in the patient. According to the FDA, lubricious coating separation from intravascular medical devices can be the result of several factors, such as the practitioner technique, using the wrong device for the procedure, improper preconditioning of the device, improper storage conditions, and/or issues with device design or manufacturing processes. Cases of lubricious coating separation has been found mostly in guidewires, but there have also been cases associated with sheaths, retrieval Read More

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