Category Archives: Recalled Medical Devices
First Bard Avaulta Transvaginal Mesh Lawsuit Scheduled for February Trial in MDL
The first test trials in the federal C.R. Bard Avaulta transvaginal mesh litigation will most likely start next year, according to a report from Bloomberg News. About 600 lawsuits involving Bard Avaulta transvaginal mesh products are currently pending in the multidistrict litigation underway Charleston, West Virginia. U.S. District Judge Joseph ...
DePuy ASR Hip Implants, Other Faulty Medical Devices Subject to Little FDA Oversight, Investigation Finds
A newly-published investigation from ProPublica has revealed that several questionable types of medical devices, including DePuy Orthopaedic’s recalled ASR hip implant, managed to make it to market without much scrutiny on the part of the U.S. Food & Drug Administration (FDA).
Actos Whistleblower Lawsuit Questions Avandia Researcher's Financial Ties to Takeda
A prominent researcher has been implicated in an alleged cover-up of Actos side effects, according to a report from TheHeart.org. An Actos whistleblower lawsuit unsealed earlier this year has alleged financial connections between the Cleveland Clinic’s Dr Steven Nissen and the maker of Actos “should be considered when analyzing Actos’s ...
Pennsylvania Health System Proposes Comprehensive Fracking Study
A proposed study would examine the health effects of hydraulic fracturing (fracking) drilling on the people living closest to active natural gas wells.
Lawsuit Alleges Bi-Lateral DePuy ASR Hip Implant Resulted in Elevated Chromium and Cobalt Levels, Need for Revision Surgery
DePuy Orthopaedics and its parent, Johnson & Johnson, continue to be named in lawsuits by metal-on-metal hip replacement recipients who suffered severe injuries, including elevated chromium and cobalt levels, allegedly due to recalled ASR hip implant devices. Most recently, the national law firm of Parker Waichman LLP filed suit on ...
Smith & Nephew Says Metal-on-Metal Hip Replacement Controversy Slowing Sales of Birmingham Hip Resurfacing System
Medical device maker Smith & Nephew has reported a drop in sales of its metal-on-metal hip implant devices. According to the company, hip implant sales were down 2 percent during the first quarter of 2012, largely because its Birmingham Hip Resurfacing System suffered from an association with other metal-on-metal hip ...
First DePuy ASR Hip Implant Lawsuits Head to Trial in December, January
The first trials involving lawsuits filed against DePuy Orthopaedics by recipients of its recalled ASR Hip Implants will begin later this year, and early next year. The first is slated to start on December 3, 2012 in state court in Las Vegas, Nevada. A second DePuy ASR hip implant lawsuit ...
Knee Replacement Patients Should Consider Nickel Allergies before Surgery
Individuals considering undergoing knee replacement surgery should ask their doctors to run a test to determine if they have a nickel allergy. Determining if a patient suffers from a nickel allergy will ensure the right knee implant is chosen for their surgery, and possibly save them from considerable pain and ...
Bayer Yaz, Yasmin Blood Clot Lawsuit Settlements Stand at $147 Million
Bayer AG reported yesterday that it continues to settle Yaz and Yasmin birth control pill lawsuits. According to a report from Bloomberg News, the company said in its latest Stockholder Newsletter that it has settled 651 Yaz and Yasmin blood clot lawsuits for a total of $147 million. The average ...
Waterpik to Replace SinuSense™ Water Pulsator Device Over Consumer Complaints
Waterpik, Inc., is replacing its SinuSense™ Water Pulsator device over consumer complaints, the U.S. Food & Drug Administration (FDA) just announced. Specific SinuSense™ Water Pulsator nasal irrigation devices Waterpik manufactured between May 2010 and July 2011 are involved in the … Continue reading
Roche Recalls Elecsys Troponin Immunoassays
Drug maker, Roche, is recalling two of its Elecsys Troponin Immunoassays, the U.S. Food & Drug Administration (FDA) just announced. The recall has been deemed a Class I by the agency, its most severe and involving a situation in which … Continue reading
Medtronic EnTrust Implantable Cardioverter Defibrillators Recalled In U.K.
Medtronic EnTrust Implantable Cardioverter Defibrillators (ICDs) have been recalled in the U.K., the Medicines and Healthcare products Regulatory Agency (MHRA) just announced. Medtronic issued a Field Safety Notice addressing this issue on March 6, 2012. A risk of loss of … Continue reading
Trilogy Ventilator Recall Deemed Class I
Risperonic’s Trilogy Ventilator recall has been deemed Class I by the U.S. Food and Drug Administration (FDA), its most serious type of recall. Class I medical device recalls involve situations in which there exists a reasonable probability that use of … Continue reading
Axxent FlexiShield Mini Recalled
Although approved in June 2009 through the U.S. Food and Drug Administration’s (FDA) 510(K) process, the < "http://www.yourlawyer.com/topics/overview/Axxent-FlexiShield-Mini-Breast-Device-Lawsuit">Axxent FlexiShield Mini was recalled in April 2010 in the agency’s most serious recall designation: the Class I. Class I recalls involve situations … Continue reading
Triad Alcohol Prep Pads, Swabs and Swabsticks Recalled for Macrobial Contamination
< "http://www.yourlawyer.com/practice_areas/defective_medical_devices">Alcohol Prep Pads, Alcohol Swabs, and Alcohol Swabsticks manufactured by Triad Group are being recalled because of concerns about potential contamination of the products with Bacillus cereus. Use of any of these products could lead to life-threatening infections, especially … Continue reading
Arrow Recalls Defective Balloon Catheters
< "http://www.yourlawyer.com/practice_areas/defective_medical_devices">Arrow Ultra 8 Intra-Aortic Balloon Catheters (IABS) 8 FR 30CC and < "http://www.yourlawyer.com/practice_areas/defective_medical_devices">40CC Universal and Arrow Intra-Aortic Balloon (IAB) Catheter with a Fiber Optic Sensor and Measurement System have been recalled, the U.S. Food and Drug Administration (FDA) just … Continue reading
Glucose Test Strips Recalled
Abbott Diabetes Care has initiated a recall of 359 lots—approximately 359 million strips—of < "http://www.yourlawyer.com/practice_areas/defective_medical_devices">Precision Xtra®, Precision Xceed Pro®, MediSense® Optiumâ„¢, Optiumâ„¢, OptiumEZ, and ReliOn® Ultima Blood Glucose Test Strips in the United States and Puerto Rico the U.S. Food … Continue reading
Fresenius Kabi, LLC issues Class I Recall for Red Blood Cell Exchange Sets
Fresenius Kabi, LLC has issued a recall for < "http://www.yourlawyer.com/practice_areas/defective_medical_devices">Red Blood Cell (RBC) Set (catalog number 9007601), lot numbers WKT252, YLT061, ZCT011, and ZGT052, manufactured from October 1, 2007 to July 30, 2010. 255 units are subject to this recall. … Continue reading
B. Braun Recalls addEASE Binary Connector
B. Braun just issued a recall of its < "http://www.yourlawyer.com/practice_areas/defective_medical_devices">addEASE Binary Connector, catalog numbers N7990 and N7933. The U.S. Food and Drug Administration (FDA) has labeled this a Class I Recall. The addEASE is used to transfer fluid between a … Continue reading
