Dialysis Lawsuit – GranuFlo & NaturaLyte
You need to consider filing a GranuFlo lawsuit if you were among those harmed by GranuFlo and Naturalyte, two dialysis concentrates that were recalled by Fresenius Medical Care in 2012. Both products have been associated with the onset of sudden and life-threatening heart problems, including:
- Heart attack
- Cardiac arrest
- Low blood pressure
- Cardiopulmonary arrest
- Sudden cardiac death
You may qualify to file a dialysis lawsuit against Fresenius Medical Care if you experienced a catastrophic heart problem within 72 hours of a dialysis treatment with either GranuFlo or NaturaLyte. If your family member died due to a cardiac ailment that may have been related to the GranuFlo recall, you may also be entitled to file a wrongful death lawsuit on their behalf. Bernstein Liebhard LLP is now evaluating GranuFlo and NaturaLyte lawsuits free-of-charge, and our GranuFlo lawyers can help you determine whether or not you have a valid claim for compensation. To learn more, simply pick up the phone and calltoday to speak with a member of our highly-experienced legal staff today.
GranuFlo and NaturaLyte Lawsuit Allegations
Hundreds of Fresenius lawsuits filed since the GranuFlo and NaturaLyte recall accuse Fresenius Medical Care of concealing knowledge of the products’ risks. Both drugs are used during dialysis to remove toxins from the body. While GranuFlo is a powder, and NaturaLyte is sold in liquid form, each contains the same active ingredient, sodium diacetate. According to GranuFlo lawsuits, Fresenius altered the amount of sodium diacetate in both GranuFlo and NaturaLyte in 2002, but failed to inform either doctors or the U.S. Food & Drug Administration (FDA) of the modification. As such, physicians administering the drugs were not aware that the dosage of GranuFlo and NaturaLyte would need to be adjusted to ensure patient safety.
According to Fresenius lawsuit plaintiffs, inappropriate dosing of GranuFlo or NaturaLyte can raise bicarbonate levels in the blood to dangerously high levels. This can lead to a condition called metabolic alkalosis, which increases the likelihood that a dialysis patient will suffer a heart attack, stroke or other catastrophic heart side effect shortly after a dialysis treatment. The dialysis lawsuits pending against Fresenius Medical Care claim the company knew of these risks long before the GranuFlo recall, but continued to market the products aggressively and without notifying doctors and the public of the danger.
GranuFlo and NaturaLyte Recall
The GranuFlo recall was announced in June 2012 by the U.S. Food & Drug Administration (FDA), which granted it Class I designation. A Class I recall is the FDA’s most serious type of recall, and indicates that a medical product poses a significant threat of serious injury or death. The FDA announced the Class I status after Fresenius Medical Care issued an Urgent Product Notification in March 2012, warning dialysis facilities to adjust dosage of GranuFlo and NaturaLyte in order to avoid elevated levels of bicarbonate in their patients.
GranuFlo lawsuits charge that Fresenius Medical Care knew about the problems associated with GranuFlo and NaturaLyte far earlier than March 2012. Among other things, plaintiffs claim that the company as aware of a study in 2004 that indicated the two products were associated with increased rates of metabolic alkalosis. The dialysis lawsuits also cite a November 2011 memo that Fresenius Medical Care sent to dialysis clinics within its own network that warned that GranuFlo had been associated with a six-fold increase in cardiac arrest among patients treated at those clinics. The same memo also advised doctors to adjust the dosage of the two drugs.
A key question raised by Fresenius lawsuits is why the company did not do anything in November 2011 to warn thousands of dialysis clinics outside of its network about the problems associated with GranuFlo and NaturaLyte. The FDA has asked the same question, and is currently investigating Fresenius Medical Care’s handling of the GranuFlo recall to see if the delay between the November 2011 memo and March 2012 Urgent Product Notification violated any regulations.
GranuFlo and NaturaLyte Lawsuits Mount in Courts Around the U.S.
Prior to the GranuFlo recall, GranuFlo and NaturaLyte were used to treat tens of thousands of dialysis patients at Fresenius-clinics around the country, and at independent facilities supplied by the company. As such, legal experts expect thousands of Granuflo lawsuits to eventually be filed in courts around the U.S. To allow these claims to move more efficiently through the court system, a multidistrict litigation has been established in U.S. District Court, District of Massachusetts for all federally-filed product liability claims involving the GranuFlo and NaturaLyte recall. A separate consolidated proceeding has been established in Middlesex County (Massachusetts) Superior Court for lawsuits filed on the state level in Massachusetts.
Both of the consolidated proceedings will allow the Fresenius lawsuits to proceed in a way that avoids duplicative discovery and inconsistent court rulings, and preserves the resources of the court, parties and witnesses. However, these coordinated litigations should not be confused with a GranuFlo class action lawsuit, as all claims will continue to maintain their own identity and will be evaluated on their own merits.
Learn More About Filing a GranuFlo and NaturaLyte Lawsuit Today
Patients or the families of patients who suffered serious heart side effect within 72 hours of a dialysis treatment with GranuFlo or NaturaLyte may be entitled to compensation for:
- Medical bills
- Lost wages
- Pain and Suffering
- Permanent disability
- Emotional distress
- Wrongful death
Bernstein Liebhard LLP is now offering free, no obligation GranuFlo lawsuit evaluations to any individual harmed by one of these products. To learn more about the legal options available to you, please contact our office today at .
Since 1993, our lawyers have recovered more than $3 billion on behalf of injured victims, including patients harmed by defective drugs and medical devices. Should you choose Bernstein Liebhard LLP to represent you in your lawsuit, you will have a highly experienced team of attorneys, paralegals and investigators on your side, all committed to protecting your legal rights and working to ensure your physical, emotional and financial recovery.