Popular dialysis products, GranuFlo and NaturaLyte, have been linked to an increased risk of cardiopulmonary arrest and sudden cardiac death. Manufacturer of the products, Fresenius Medical Care (FMC) failed to warn patients and doctors of the dangers associated with the drugs until this year, even though there is documented evidence that they were aware of the risks.
Over 30 percent of all dialysis patients across the country are given one of these drugs, leaving them at a six-fold increased risk of cardiopulmonary arrest and sudden cardiac death.
If either of these products has been used in your dialysis treatment, we urge you to speak with an attorney as soon as possible.
To begin exploring your legal options, contact our GranuFlo lawyers by completing the Free Case Review form on this page today.
Fresenius Medical Care was Aware of Risks
On March 29, 2012, the Food and Drug Administration (FDA) issued a Class 1 recall of both GranuFlo and NaturaLyte. A Class 1 recall is the most serious type of recall as it involves situations where there is a reasonable probability of adverse health consequences or death.
Between January 1 and December 31, 2010, Fresenius Medical Care conducted a case-control study that evaluated risk factors in dialysis patients who suffered from cardiopulmonary arrest in FMC facilities compared to other dialysis patients in the same facilities.
This study found that 841 patients in 667 FMC facilities had cardiopulmonary arrests resulting in their death. Data from these 941 patients showed that their risk of cardiopulmonary arrest was up to six times higher if they had an elevated bicarbonate level before undergoing dialysis treatment.
Fresenius Medical Care sent an internal memo to FMC’s doctors and dialysis facilities, recommending action for patients with elevated pre-dialysis bicarbonate levels. They failed to inform those outside of FMC, however. They only shared knowledge of the risk after the internal memo had been leaked to the FDA.
Risks and Side-Effects of GranuFlo and NaturaLyte
GranuFlo and NaturaLyte are both chemical products used in dialysis machines to help clean the blood of patients with impaired kidneys. The ingredients in these products are intended to prevent the buildup of dangerous acids that are naturally removed by properly functioning kidneys.
GranuFlo and NaturaLyte patients have reported suffering from:
- Cardiopulmonary arrest
- Heart attack
- Cardiac arrhythmia
- Low blood pressure
- Cardiovascular death
- Sudden cardiac death
Contact an Experienced Dangerous Drug Attorney
An estimated 400,000 Americans undergo dialysis treatment every year. Over a third of those patients are given GranuFlo and NaturaLyte products, putting them at an unnecessary risk of suffering from serious and deadly side effects.
If you or a loved one has been given GranuFlo or NaturaLyte during your dialysis treatment and suffered a heart attack, you may be eligible to file a lawsuit in order to recover damages.
At Lewis & Keller, we believe that the makers and manufacturers of dangerous drugs should be held responsible when their products cause harm to consumers, especially when they had prior knowledge of the risks involved.
Our team of lawyers is committed to fighting for the rights of dangerous drug victims and their families.
If you are unsure if you have a claim, don’t hesitate to contact our firm to schedule a free initial consultation. With offices in Winston-Salem and Greensboro, we are available to help North Carolina residents who believe they have a claim.
During your consultation, one of our attorneys will assess the merits of your claim and offer guidance on how to best pursue legal recourse for your condition.
For more information on the legal rights which may be available to GranuFlo or NaturaLyte victims and their families or to schedule a confidential, no-obligation consultation with one of our dangerous drug lawyers, please complete the Free Case Review form on this page.
It is likely we will associate another law firm with more experience in this particular practice area to assist us with the prosecution of your claim, all at no additional cost to you.