It is disturbing, to say the least, that Fresenius Medical Care apparently knew about the serious risk of cardiac arrest and death with use of its product for quite some time. - Peter J. Brodhead
Cleveland, OH (PRWEB) October 03, 2012
Cleveland, Ohio, law firm Spangenberg Shibley & Liber is now investigating claims on behalf of individuals who allegedly suffered heart problems, cardiac arrest, or death while undergoing kidney dialysis using Fresenius Medical Care’s GranuFlo or NaturaLyte products.
According to WebMD, the kidneys filter the blood. When they fail, waste and toxins accumulate in the bloodstream and raise the patient’s blood pressure. A dialysis machine filters bicarbonate through the bloodstream to prevent it from becoming too acidic.
The U.S. Food and Drug Administration granted Fresenius 510(k) clearance to market its GranuFlo dry acid concentrate for kidney dialysis in May 2003. It granted 510(k) clearance to the liquid version, NaturaLyte, in June 2007. However, both versions of the medical device "contain an ingredient that the body converts to bicarbonate,” New York Times writer Andrew Pollack wrote in June. “[A]nd it contains more of this ingredient than rival products.”
GranuFlo approval: fda.gov/medicaldevices/productsandmedicalprocedures/deviceapprovalsandclearances/510kclearances/ucm091163.htm
NaturaLyte approval: fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances/510kClearances/ucm083789.htm
What kidneys do: webmd.com/a-to-z-guides/kidney-dialysis
An August 1989 article in the New York Times reported that doctors have used bicarbonate to prevent acid buildup in heart attack patients’ blood since the 1920s. But a University of California at San Francisco study published in The American Journal of Medicine that year stated that “solutions of the sodium bicarbonate worsened heart and liver functions in patients.”
Chief researcher Dr. Allen I. Arieff said, “It seems intuitively reasonable that if you have acidosis, giving a base such as sodium bicarbonate will make it better, but probably in most cases it has made things worse. People who survived cardiac arrest probably did so despite the bicarbonate.''
Fresenius’ own safety data showed that “borderline elevated pre-dialysis bicarbonate levels and overt alkalosis are significantly associated with 6- to 8-fold greater risk of CP [cardiopulmonary] arrest and sudden cardiac death in the dialysis facility,” according to an internal memo the company sent its doctors. To be exact, 941 patients from 667 facilities suffered from cardiac arrest in 2010.
After learning this, Fresenius instructed doctors to gauge patients’ bicarbonate levels on a month-to-month basis and adjust the formulation accordingly. However, according to the New York Times, the company failed to notify clinics to which it supplied dialysis machines and products until March 2012.
“Personally, I’m troubled by the fact that Fresenius on its own initiative didn’t notify its entire customer base of this particular concern,” said Steven Silverman, director of compliance for the FDA’s medical devices division. “Candidly, I just think it’s bad business and not in the interest of public health to sit on information about risks.”
Early this year, the FDA issued a safety alert concerning elevated bicarbonate levels. A month later, it issued a class I recall notice for Fresenius Medical Care North America NaturaLyte Liquid Acid Concentrate and NaturaLyte GranuFlo (powder) Acid Concentrate. According to the FDA website, a class I recall is “a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.”
About Spangenberg Shibley & Liber
Spangenberg Shibley & Liber handles a broad range of defective medical device, dangerous drug, personal injury, medical malpractice, nursing home abuse, and civil rights cases. The firm also litigates a variety of property damage and insurance coverage cases. For more information about the firm, please contact marketing manager Miranda Miller at 216.696.3232 or visit spanglaw.com.