NEW YORK, Sept. 15, 2016 /PRNewswire/ -- Bernstein Liebhard LLP is investigating potential legal claims involving Baxter International, Inc.'s Vascu-Guard Peripheral Vascular Patch. The Firm's investigation was prompted by Baxter's decision to recall several lots of the Vascu-Guard Patch product, following reports of intraoperative or postoperative bleeding and hematomas in patients undergoing carotid endarterectomy (CEA) surgery. According to the U.S. Food& Drug Administration (FDA), some of these incidents required additional clinical intervention. Three patient deaths may also be linked to the Vascu-Guard Patch recall.
In a Letter to Health Care Providers dated September 1, 2016, the agency expressed concern that the Vascu-Guard Patch "may not be performing as intended and that patients who are treated with the product may be at risk for serious adverse health consequences, such as severe bleeding, hematomas, and death." Severe arterial bleeding in the neck following CEA surgery may result in airway obstruction, hypoxia, diminished brain perfusion, stroke and/or cardiac arrest, the FDA warned. The agency has classified this action as a Class II recall, which indicates that the affected Vascu-Guard Patches might cause a temporary health problem, or pose a slight threat of a serious nature or death.
"We are concerned that numerous patients may have suffered serious complications related to the Vascu-Guard recall. We urge anyone who experienced severe bleeding, blood clots or other complications following surgery with this device to contact our office as soon as possible, to ensure that their legal rights are protected," says Sandy A. Liebhard, a partner at Bernstein Liebhard LLP, a nationwide law firm representing victims of defective drugs and medical devices.
Vascu-Guard Patch Complications
The Vascu-Guard Patch was cleared for sale by the FDA in November 2014, and is indicated for use in peripheral vascular reconstruction and arteriovenous access revisions. The device is constructed from bovine pericardium sourced from U.S. cattle.
This is not the first time that Baxter has announced a Vascu-Guard recall. In May 2015, a Class I recall was issued for several lots of the Vascu-Guard Patch, following reports that customers were having difficulty distinguishing the smooth from rough surface of the patch as described in the labeled instructions for use. Incorrect orientation of the patch with the rough side toward the bloodstream can increase the risk of blood clots and embolism, placing patients at risk for serious complications including reduced blood flow, stroke, organ failure, or death. According to the FDA, Baxter reported 51 complaints related to this issue and one serious injury. A Class I recall is the agency's most serious type of recall, and indicates that there is a reasonable probability that use of these products will cause serious adverse health consequences or death.
Individuals who suffered serious complications allegedly related to either of these Vascu-Guard Patch recalls may be entitled to compensation for medical bills, lost wages, pain and suffering and more. To learn more about filing a Vascu-Guard Patch lawsuit, please visit Bernstein Liebhard LLP's website, or call 800-511-5092 to arrange for a free, no obligation case review.
About Bernstein Liebhard LLP
Bernstein Liebhard LLP is a New York-based law firm exclusively representing injured persons in complex individual and class action lawsuits nationwide since 1993. As a national law firm, Bernstein Liebhard LLP possesses all of the legal and financial resources required to successfully challenge billion dollar pharmaceutical and medical device companies. As a result, our attorneys and legal staff have been able to recover more than $3.5 billion on behalf of our clients. Bernstein Liebhard LLP is honored to once again be named to The National Law Journal's "Plaintiffs' Hot List," recognizing the top plaintiffs firms in the country. This year's nomination marks the thirteenth year the firm has been named to this prestigious annual list.
Bernstein Liebhard LLP
10 East 40th Street
New York, New York 10016
ATTORNEY ADVERTISING. © 2016 Bernstein Liebhard LLP. The law firm responsible for this advertisement is Bernstein Liebhard LLP, 10 East 40th Street, New York, New York 10016, 800-511-5092. Prior results do not guarantee or predict a similar outcome with respect to any future matter.
Sandy A. Liebhard, Esq.
Bernstein Liebhard LLP
To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/vascu-guard-patch-lawsuits-being-investigated-by-bernstein-liebhard-llp-following-recent-recall-and-reports-of-severe-bleeding-300328844.html
SOURCE Bernstein Liebhard LLP