IVC Filter Lawsuit Claimants Concerned With Report Employee's Signature Forged On FDA Application
(EMAILWIRE.COM, September 17, 2015 ) Birmingham, Alabama -- IVC Filter Lawsuit News: A former regulatory specialist hired by C.R. Bard Inc. in 2002 told NBC News that she had concerns about the companys Recovery IVC filter and refused to sign off on an application asking the U.S. Food and Drug Administration (FDA) to approve the medical device designed to stop blood clots from reaching the heart or lungs. Kay Fuller said in Part 2 of an NBC News investigation of Bards IVC Recovery filter, that Bard submitted the application anyway with her name on it. Fuller claimed the signature was not hers. The NBC News investigation questioned whether Ms. Fullers signature was forged. Ms. Fuller said a human clinical trial conducted on the filter raised red flags and Bard did not give her the performance safety results. When she asked questions, Ms. Fuller said Bard officials told her that if she continued with her questioning, she was going to be asked not to be on the team. Ms. Fuller told NBC News she resigned but not without submitting her concerns to the FDA. Bard took the Recovery IVC filter off the market in 2005 and replaced it with a modified version called, G2. Southern Med Law notes that IVC filter lawsuits filed against Bard over IVC filter injury claims that the medical device is prone to tilt, break and migrate which places patients at an increased risk of a pulmonary embolism. (In Re: Bard IVC Filters Product Liability Litigation MDL No. 2641)
[nbcnews.com/health/heart-health/did-forged-signature-clear-way-dangerous-medical-device-n417246, September 4, 2015]
NBC News mentioned in the first part of its investigation that the Recovery filter was associated with 27 deaths and 300 non-fatal injuries. Bard IVC filter lawsuits also contain similar allegations that patients have been seriously injured after having an IVC filter implant, says Dr. Franois Blaudeau, founder of Southern Med Law.
The Firm is currently evaluating legal claims on behalf of men and women across the country who believe they have experienced life-threatening complications associated with Bard IVC filters. To schedule a free, no obligation case review, contact one of our experienced attorneys at the Firm today by calling 205-547-5525 or visit http://www.southernmedlaw.com and fill out the form on our website.
According to the FDA, IVC filters are small, wire devices implanted in the inferior vena cava (a major vein that returns blood from the lower part of the body to the heart) to catch or filter blood clots that move from the lower portion of the body to the heart and lungs. In August 2010, the FDA issued a safety alert involving IVC filters after having received 921 adverse events reports since 2005 about the devices. The reports included complaints about the filters moving around, fracturing, perforating the IVC, and the filters components detaching from the device which can cause serious or fatal injuries to the patients. The FDA recommended that physicians consider removing retrievable IVC filters as soon as protection from pulmonary embolism is no longer needed.
[fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm396377.htm, May 6, 2014]
Court documents indicate that 22 federally filed Bard IVC filter lawsuits were recently consolidated in the U.S. District Court, District of Arizona for coordinated pretrial proceedings. The complaints purport that the Bard IVC Recovery and G2 filters have manufacturing and design defects that cause the medical devices to experience a significant rate of fracture and migration. The Bard ICV lawsuits accuse Bard of failing to conduct adequate clinical testing to ensure that the device would perform safely and effectively for short-term or long-term use. (In Re: Bard IVC Filters Product Liability Litigation MDL No. 2641
About Southern Med Law And Filing An IVC Filters Lawsuit
Throughout his career, Dr. Blaudeau has worked hard to develop a strong reputation in healthcare litigation. His first-hand knowledge of medicine has made the Southern Med Law team an aggressive and effective advocate for those who were harmed due to negligent medical device manufacturers. If you or a loved one were injured by a Bard retrievable IVC filter, please contact Southern Med Law today to learn more about your legal rights. Call today for a free, no obligation Bard IVC filter lawsuit review by filling out our online form, or by calling the office directly at 205-547-5525.
Southern Med Law
Franois M. Blaudeau, MD JD FACHE FCLM Esquire
2224 1st Avenue North
Birmingham, Alabama 35203
Medical Negligence/MedicalDevice/Pharma/Qui Tam
Like us on Facebook
Follow us on Twitter
Join us on Google++
Southern Med Law
Dr. Franois Blaudeau
firstname.lastname@example.org This is a press release. Press release distribution and press release services by EmailWire.Com: http://www.emailwire.com/us-press-release-distribution.php. Source: EmailWire.Com