NaturaLyte & GranuFlo Lawsuits
The number of Naturalyte and GranuFlo lawsuits is growing as plaintiffs claim serious injury and wrongful death due to use of the dialysis products. Patients who have been injured, or the families of those who have died, can receive confidential, no-obligation advice from the product liability attorneys at Edelman, Krasin & Jaye.
Our experienced Granuflo lawyers work with patients and families to help them determine eligibility for compensation through filing a lawsuit against drug maker Fresenius.
GranuFlo and Naturalyte dialysis products
GranuFlo powder and Naturalyte liquid are essentially identical products used in dialysis treatment, which is required when a person’s kidneys cannot clear toxic waste from the blood.
Roughly 400,000 people in the United States require dialysis several times each week. In recent years, standalone facilities dedicated to dialysis are frequently where patients go to receive treatment. Fresenius, the company that manufactures GranuFlo and Naturalyte, also operates a number of such dialysis centers.
One of the kidneys’ critical functions is to neutralize acid that accumulates in the bloodstream. In dialysis patients, bicarbonate, an alkaline substance, is used for this purpose. Although GranuFlo does not contain bicarbonate, the product does contain sodium acetate, which the body converts to bicarbonate after it enters the patient’s bloodstream.
Both GranuFlo and Naturalyte contain higher percentages of sodium acetate than many competitors. Accordingly, unless treatment providers adjust the types and amounts of other products used in dialysis, dangerously high levels of bicarbonate can build up in dialysis patients, causing a dangerous condition known as metabolic alkalosis.
GranuFlo and Naturalyte’s life-threatening complications
Fresenius learned no later than 2010 that many GranuFlo and Naturalyte patients were suffering life-threatening complications. Company staff reviewed records of patients who used its dialysis centers in 2010 and found that 941 dialysis patients had experienced cardiac arrest inside Fresenius clinics in 2010. A November 4, 2011 internal company memo documenting the review concluded that patients with high bicarbonate levels faced a “6 to 8 fold greater risk of CP [cardiopulmonary] arrest and sudden cardiac death in the dialysis facility.”
The drug maker told its own clinics’ staff of these “troubling findings,” but did not share the information with patients, other dialysis treatment providers, or the FDA. Instead, Fresenius allowed thousands of dialysis patients to continue to undergo GranuFlo and/or Naturalyte treatment without knowing that they were risking dangerously high levels of bicarbonate. As a result, thousands of patients faced critical complications, and many suffered heart attacks and died – all because Fresenius failed to warn them of the danger.
Naturalyte and Granuflo lawsuits
Fresenius’s conduct has led many dialysis patients and their families to file personal injury lawsuits against the drug maker, seeking compensation for the financial and other losses that they have suffered. GranuFlo lawsuits charge that the company’s failure to warn of the risks of product use, and the misleading marketing of the products caused lost wages, medical bills, substantial pain and suffering, emotional and psychological distress, and in some instances death.
At Edelman, Krasin & Jaye, our attorneys have many decades of experience handling personal injury and product liability lawsuits against manufacturers of dangerous drugs. Our legal team specializes in representing patients and families who have suffered because companies like Fresenius put profits ahead of patient care.
Our firm works hand in hand with medical specialists, expert investigators, and world-renowned authorities in the field. We work tirelessly to assemble all the evidence required to document patients’ injuries and families’ losses. Our firm offers complimentary case reviews to victims seeking compensation after suffered heart attacks or other life-threatening injuries due to GranuFlo and/or Naturalyte.
FDA recalls GranuFlo and Naturalyte
The FDA ultimately obtained Fresenius’s November 2011 memo showing that GranuFlo/Naturalyte use led to higher risks of heart attack and death. In March 2012, the FDA instituted a Class I recall of GranuFlo and Naturalyte products. The agency warned that there was “a reasonable probability that use of these products will cause serious adverse health consequences or death.”
But Fresenius continued to downplay the risks of GranuFlo and Naturalyte despite the recall. The drug maker sent an “Urgent Product Notification” to non-Fresenius dialysis centers in March 2012 that was silent as to the eight-fold greater risk of cardiac arrest and sudden cardiac death associated with use of GranuFlo and Naturalyte. And Fresenius made no mention of the 941 patients who suffered cardiac arrest inside the drug maker’s own dialysis centers.
Multidistrict litigation established for GranuFlo claims
After the product recall, hundreds of GranuFlo and Naturalyte lawsuits were filed in both federal and state courts across the country. Many plaintiffs brought their cases in Massachusetts, the site of Fresenius’s North American headquarters.
The lawsuits charge that plaintiffs were injured or killed after the use of GranuFlo and/or Naturalyte during dialysis. As a result of complications with metabolic alkalosis, plaintiffs assert that they suffered low blood pressure, hypokalemia, hypoxemia, hypercapnia, cardiac arrhythmia, or cardiopulmonary arrest.
In March 2013, federal GranuFlo lawsuits that had been filed in courts nationwide were centralized in Massachusetts district court for coordinated pretrial proceedings.
Lawsuits pending under GranuFlo multidsistrict litigation charge that:
- GranuFlo and Naturalyte were defectively designed and/or manufactured
- Fresenius knew orshould have known that its dialysis products were likely to cause serious injury or death
- The manufacturer failed to warn the FDA, dialysis patients, and health care providers that using GranuFlo and Naturalyte carried a significant risk of cardiac arrest, stroke, or other serious side effects
- Fresenius failed to provide adequate instructions and warnings with the products, and/or intentionally misled the public, the FDA, patients, and health care providers about the severe complications caused by use of GranuFlo and Naturalyte
According to the federal judicial panel that ordered the cases centralized, utilizing the MDL process before a single federal judge in Boston “will eliminate duplicative discovery; prevent inconsistent pretrial rulings; and conserve the resources of the parties,their counsel, and the judiciary.”
As of March 2014, 650 Naturalyte and GranuFlo claims had been consolidated in the MDL. At least 300 additional cases have been centralized in state court in Massachusetts, where a single judge is handling pretrial processing. And a number of other dialysis injury complaints are pending in state courts around the country, including several that have been coordinated in California Superior Court.
How attorneys at Edelman, Krasin & Jaye can help
Patients and families who have suffered due to Fresenius’s misconduct may not know where to turn. That is why the highly-credentialed personal injury attorneys at Edelman, Krasin and Jaye offer free, no-obligation consultations to victims of GranuFlo and Naturalyte.
We will review your situation, explain your legal options, and provide all the help you need to protect your best interests. If a GranuFlo lawsuit is the right choice, we will do everything in our power to recover the maximum compensation available.
We charge no fees unless you receive compensation – that’s why your success is our success. Call our offices today at 1.800.869.7429.
- U.S. Judicial Panel on Multidistrict Litigation, MDL Statistics Report - Distribution of Pending MDL Dockets, March 13, 2014 http://www.jpml.uscourts.gov/sites/jpml/files/Pending_MDL_Dockets_By_District-March-13-2014.pdf
- U.S. Judicial Panel on Multidistrict Litigation, “IN RE: FRESENIUS GRANUFLO/NATURALYTE DIALYSATE PRODUCTS LIABILITY LITIGATION MDL, No. 2428 TRANSFER ORDER (March 29, 2013),” http://www.jpml.uscourts.gov/sites/jpml/files/MDL-2428-Initial_Transfer-03-13.pdf
- Fresenius Internal Memo re “Dialysate Bicarbonate, Alkalosis and Patient Safety,” November 4, 2011 http://graphics8.nytimes.com/packages/pdf/business/fresenius-memo.pdf
- FDA, “Medical Device Recall Class I, Fresenius Medical Care North America, Naturalyte and Granuflo Acid Concentrate,” March 29, 2012 http://www.fda.gov/medicaldevices/safety/listofrecalls/ucm309990.htm