A wrongful death lawsuit has been filed against the manufacturer of GranuFlo®, Fresenius Medical Care North America. The lawsuit was filed in federal court in Boston on February 27, 2013, by Bettye Alexander, whose late husband Gary Alexander suffered a heart attack and died following hemodialysis treatment using GranuFlo®. Mrs. Alexander alleges that Fresenius failed to warn that GranuFlo®, which has been used as part of a dialysate prescription at thousands of dialysis clinics over the last decade, puts patients at a substantially higher risk of cardiac arrest, stroke, and sudden cardiac death. Thousands of people alleged to have suffered cardiac arrest, stroke, or sudden cardiac death following the use of GranuFlo® or a similar Fresenius dialysate product, NaturaLyte®
It’s alleged in the lawsuit that Fresenius was aware of the risk for years, long before Mr. Alexander underwent his hemodialysis treatment. An internal memo written by Fresenius in November 2011 warned that the use of GranuFlo® was associated with a six- to eight-fold greater increase of cardiopulmonary arrest and sudden cardiac death in the dialysis facility. That internal memo, which covered only a single year and a third of Fresenius’s clinics, identified 947 cardiac deaths. Fresenius sent that internal memo to its own network of dialysis clinics.
But Fresenius sells GranuFlo® to thousands of other dialysis clinics as well. It did not share this information with any of them until almost five months later. The internal memo was leaked anonymously to the FDA in March, 2012. A recall of GranuFlo® and a similar product, NaturaLyte®, was issued later that month. For more information on the recall, you can visit http://www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm309990.htm.
Fresenius Medical Care North America recently received a warning letter from the FDA over its artificial kidneys, also known as dialyzers, which are used in dialysis machines to filter a patient’s blood. The FDA’s March 14th warning letter claims that Fresenius failed to do adequate studies to make sure the dialyzers match their design. The FDA stated in the letter that “the organization did not conduct adequate design verification studies of its electron beam sterilized polysulfone dialyzers manufactured” and that “the process for design validation of these dialyzers has been incomplete.”
The lawsuit seeks compensatory and punitive damages for the unnecessary and unfortunate death of Mrs. Alexander’s husband. Plaintiffs with cases against Fresenius have filed with the Judicial Panel of Multidistrict Litigation (JPML), seeking to consolidate all GranuFlo® lawsuits in a single federal court in order to coordinate pretrial proceedings and efficiently manage the litigation. Fresenius has joined in that request. If you need help or information on the subject, contact Frank Woodson, a lawyer in our Mass Torts Section, at 800-898-2034 or by email at Frank.Woodson@beasleyallen.com.
Sources: PR Newswire and Law360.com
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