This is the company’s own medical office saying there’s a high risk of adverse, deadly events associated with their dialysis medications. There could be thousands of victims out there in real need of help.
Marlton, NJ (PRWEB) February 11, 2013
One in 10 adults in the United States has some form of chronic kidney disease, according to the Centers for Disease Control and Prevention. Hundreds of thousands are on dialysis, dependent on drugs manufactured by companies like Fresenius Medical Care to remove toxins from their blood. The procedure is time consuming and dangerous enough without the medications themselves doing more harm than good. A report made public just last year shows Fresenius may have withheld critical information from patients and doctors about the dangers of its dialysis meds, particularly GranuFlo and NaturaLyte, stated in an article from the New York Times. The potential for a massive number of patients to suffer life-threatening injuries has Philadelphia attorney Richard P. Console Jr. calling for greater accountability.
“To sit on the knowledge that your products could cause potentially lethal complications for patients is shocking behavior,” said Console. “It’s not as though it’s an independent report from an outside source. This is the company’s own medical office saying there’s a high risk of adverse, deadly events associated with their dialysis medications. There could be thousands of victims out there in real need of help.”
Fresenius Medical Care treats an estimated 400,000 dialysis patients in the United States, according to the New York Times. The company is also the leading supplier of dialysis machines and one-use dialysis products. Clinics around the country, including the company’s own facilities, use them every day. Fresenius’ internal memo, originally circulated in 2011, reportedly revealed a sharp increase in the number of sudden cardiac arrests in patients using GranuFlo.
The memo claimed 941 patients suffered cardiac arrest while inside Fresenius clinics in 2010, which the company’s medical team attributed to high levels of bicarbonate in their blood. Acetate ingredients in GranuFlo and other dialysis products made by Fresenius reportedly led to the spikes in bicarbonate, which caused a six-fold increase in the risk of cardiac arrest. Console, whose law firm has been practicing in the Philadelphia area since 1994, believes these events were preventable.
“The company had an opportunity to get out in front of this issue, warn patients, and inform doctors to alter dialysis treatment plans,” Console said. “From all the information available, it doesn’t appear that was done, and people may have suffered significantly because of that failure. Victims deserve compensation for the pain and serious injuries they’ve endured. Losing a loved one to a preventable condition is unacceptable, especially when there’s evidence to suggest the company knew the problem existed long before they did anything to stop it.”
On the heels of an investigation by the U.S. Food and Drug Administration (FDA) into Fresenius’ delay in informing the public about known risks of its products, the company issued a Class I recall of GranuFlo and NaturaLyte in June 2012. A Class I recall is the most serious form of drug recall, used only when a product presents a probable risk of harm to patients.
Richard P. Console Jr. is the managing partner of Console & Hollawell P.C., a personal injury law firm that has helped more than 5,000 victims in Philadelphia, including those affected by defective medical products, obtain the compensation they deserve.