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NaturaLyte & GranuFlo Lawsuits

Granuflo LawyerNaturalyte and GranuFlo lawsuits brought against manufacturer Fresenius continue to be filed over the life-threatening injuries that the products exposed dialysis patients to across the country. With our expertise in dangerous drug cases, the Los Angeles-based product liability attorneys at Ellis Law are available to advise dialysis patients and their families about their legal rights to seek compensation for the harm they have suffered, and for Fresenius’ failure to adequately warn them about the risk of heart attack and other cardiac problems.

Ellis Law is the best choice for filing a product liability lawsuit

The personal injury and wrongful death lawyers at Ellis Law have decades of experience securing damages for our clients from companies like Fresenius that put profits ahead of patient safety. Our expert legal team works closely with medical specialists, highly-trained investigators, and authorities in industries regulated by the FDA to assemble all the documentation needed to recover compensation for patients’ injuries. We offer free legal consultations to patients and families whose lives have been turned upside down due to heart attacks or other life-threatening injuries caused by treatment with GranuFlo and Naturalyte.

Use of GranuFlo in dialysis

Dialysis is used when a person’s kidneys can no longer properly clear toxic waste from the blood. Some 400,000 Americans receive dialysis treatments, sometimes several times per week, usually at a special dialysis treatment center.

A critical part of dialysis treatment involves neutralizing the acid that mounts in the bloodstream by using bicarbonate, which is an alkaline substance. Although GranuFlo does not contain bicarbonate, and is not designed to neutralize acid during dialysis, use of the product increases patients’ bicarbonate levels because one ingredient (sodium acetate) is converted to bicarbonate after it enters the patient’s body.

Because GranuFlo and Naturalyte contain higher percentages of sodium acetate than many competitors, their use can lead to dangerously high levels of bicarbonate for dialysis patients unless health care providers carefully adjust the quantity of other products used in dialysis.

Fresenius dialysis injuries

Fresenius Medical Care manufactures GranuFlo and Naturalyte and operates dialysis treatment centers. The company became aware no later than 2010 that many GranuFlo/Naturalyte patients were suffering life-threatening complications. An internal Fresenius memo dated November 4, 2011 found that 941 dialysis patients had experienced cardiac arrest inside Fresenius clinics in 2010.

According to the memo, patients with high bicarbonate levels in their bloodstreams faced a “6 to 8 fold greater risk of CP [cardiopulmonary] arrest and sudden cardiac death in the dialysis facility.”

Fresenius shared these “troubling findings” with staff inside its own clinics but did not inform patients, other dialysis treatment providers, or the FDA. As a result, Fresenius permitted thousands of dialysis patients to continue to suffer dangerously high levels of bicarbonate after treatment with GranuFlo and/or Naturalyte. Many heart attacks and deaths were the result of Fresenius’ failure to warn that GranuFlo and Naturalyte dramatically increased patients’ risks of life-threatening complications.

Many dialysis patients and families have filed lawsuits against Fresenius, charging that GranuFlo/Naturalyte use caused lost wages, higher medical bills, substantial pain and suffering, emotional and psychological distress, and in some instances death.

GranuFlo and Naturalyte recall

Although Fresenius failed to inform the FDA that GranuFlo and Naturalyte use significantly increased the risk of cardiac arrest and death, a copy of the November 2011 internal memo was ultimately leaked to the FDA. In March 2012, a Class I recall of GranuFlo and Naturalyte products was instituted.

The FDA found “a reasonable probability that use of these products will cause serious adverse health consequences or death.”

Even after the recall, however, the company continued to minimize the risks of GranuFlo and Naturalyte. In a March 2012 “Urgent Product Notification” to non-Fresenius dialysis centers, the company did not mention the eight-fold greater risk of cardiac arrest and sudden cardiac death associated with use of GranuFlo and Naturalyte. Fresenius made no reference to the 941 patients who suffered cardiac arrest inside Fresenius clinics.

Multi-district litigation

After the March 2012 recall, over 130 GranuFlo/Naturalyte lawsuits were filed in federal courts across the country, along with at least 40 more in state courts. Many of the state cases are pending in Massachusetts, the site of Fresenius’s North American headquarters.

All of the lawsuits charge that plaintiffs were injured or killed after the use of GranuFlo and/or Naturalyte during hemodialysis caused metabolic alkalosis. As a result, plaintiffs allege, they suffered low blood pressure, hypokalemia, hypoxemia, hypercapnia, cardiac arrhythmia, or cardiopulmonary arrest.

In March 2013, a six-member judicial panel ordered the cases transferred to federal court in Massachusetts for pretrial processing.

Plaintiffs in Granuflo & Naturalyte lawsuits allege that:

  • GranuFlo and Naturalyte were defectively designed and/or manufactured
  • Fresenius knew or should 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 panel, consolidating the lawsuits in Multi-District Litigation (MDL) 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 December 2013, over 400 Naturalyte and GranuFlo lawsuits had been centralized in the MDL. The court has issued scheduling and other procedural orders but no trial date has yet been set.

The product liability lawyers at Ellis Law can help

The personal injury lawyers at Ellis Law stand ready to assist dialysis patients who suffered injuries, or the families of those who have died as a result of GranuFlo and/or Naturalyte use. We specialize in pursuing companies like Fresenius that seek to minimize their corporate liability for the effects of dangerous products, while seeking to maximize profits by concealing the risks from treatment providers.

The patients whose health, livelihood and lives were put at risk by this reckless strategy deserve the maximum in compensation. We encourage you to contact us any time, day or night, to review your available legal options. You may reach us at 1-800-INJURED.

  1. Fresenius Medical Care, “Urgent Product Notification re Naturalyte and Granuflo,” March 29, 2012, http://www.fmcna.com/fmcna/idcplg?IdcService=GET_FILE&allowInterrupt=1&RevisionSelectionMethod=LatestReleased&Rendition=Primary&dDocName=PDF_300045654
  2. U.S. Judicial Panel on Multidistrict Litigation, “IN RE: FRESENIUS GRANUFLO/NATURALYTE DIALYSATE PRODUCTS LIABILITY LITIGATION MDL, No. 2428 TRANSFER ORDER (March 29, 2103),” http://www.jpml.uscourts.gov/sites/jpml/files/MDL-2428-Initial_Transfer-03-13.pdf
  3. Fresenius Internal Memo re “Dialysate Bicarbonate, Alkalosis and Patient Safety,” November 4, 2011, http://graphics8.nytimes.com/packages/pdf/business/fresenius-memo.pdf
  4. FDA, “Medical Device Recall Class I, Fresenius Medical Care North America, Naturalyte and Granuflo Acid Concentrate,” 2016, http://www.fda.gov/medicaldevices/safety/listofrecalls/ucm480134.htm
  5. NY Times, “Dialysis Company’s Failure to Warn of Product Risk Draws Inquiry,” June 14, 2012, http://www.nytimes.com/2012/06/15/health/fda-investigates-fresenius-for-failure-to-warn-of-risk.html?_r=0