Covidien Under Fire for Not Immediately Addressing Serious Complaints About its DUET TRS System
- Ennis & Ennis
06/28/2012 - Covidien, a health care supply and device company, is under fire from the FDA for not hastily addressing concerns about one of its products the Duet Tissue Reinforcement System (TRS) Reload.
The FDA has now warned Covidien and requested an investigation. The FDA is quoted in a letter dated June 14th to the CEO of Covidien stating that “Despite receiving numerous complaints, adverse event, and serious adverse event information since May of 2009 regarding use of the DUET TRS, a corrective and preventative action (CAPA) investigation was not initiated until January 19, 2012 and after the FDA inspection team requested to review the CAPA file related to these complaints and adverse events.”
Covidien recalled its DUET surgical staples devices in January, after the company received reports of 13 serious injuries and three deaths. The FDA has received further complaints about other products related to the TRS system since the recall and Covidien failed to properly investigate many complaints. The FDA has threatened sanctions for non-compliance if Covidien does not take the actions requested. Covidien has put many patients at risk for not properly addressing concerns in compliance with FDA regulations.
Ennis & Ennis is offering free, nationwide, confidential consultations to anyone who has suffered as a result of the Covidien Duet TRS by calling toll free 1-800-856-6405 or by going to www.ennislaw.com and completing an online case evaluation form.
Ennis & Ennis, P.A. is a nationwide law firm with offices in Ft. Lauderdale, Miami and Washington D.C. that concentrates its practice in mass torts and represents individuals against pharmaceutical companies as well as medical device makers.
Ennis & Ennis, P.A. has been representing clients individually since 1986 and has recovered over $100 million in settlements for its clients.
Ennis & Ennis, P.A. is also investigating cases involving Actos, Fosamax, Plavix, Pradaxa, Paxil, Zoloft, Prozac, Depuy Hip Recall, Wright Conserve Hip Devices, Wright Profemur Hip Devices, Zimmer Hip Recall, Medtronic Infuse Bone Graft, Depakote, Reglan, SJS/Dilantin, Yaz, Yasmin, Ocella Birth Control Pills, and Transvaginal Mesh Devices.
Remember the law limits the time in which you can file a claim, so don't wait to explore your legal rights.
Covidien Duet TRS Lawsuit - Free Nationwide Case Evaluations
If you or a loved one have suffered serious side effects of the Covidien Duet TRS, Covidien Duet TRS injury or death while using the Covidien Duet TRS you may be entitled to compensation. Contact the Covidien Duet TRS side effects lawyers of Ennis & Ennis, P.A. today for a free nationwide case evaluation. Our experienced Covidien Duet TRS attorneys can answer any questions you may have about Covidien Duet TRS side effects or a potential Covidien Duet TRS lawsuit. Fill out the case evaluation form on this page or call toll free: 1.800.856.6405.