Fresenius NaturaLyte, GranuFlo Dialysis Heart Attack Lawsuit Allegations Update: FDA Cites Dialysis Center over Deficiencies as More Cases Filed

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Resource4thePeople’s national team of attorneys continues offering complimentary consultations for consumers who may have suffered alleged life-threatening side effects from dialysis products.

Resource4thePeople reports today on its latest update to consumers who are following the litigation involving allegations that Fresenius NaturaLyte and GranuFlo kidney dialysis products caused life-threatening problems for patients.

The latest news is that as a federal judge moves forward on consolidated federal lawsuits* involving these allegations a search of U.S. Food and Drug Administration records shows that Fresenius was cited** by federal regulators over deficiencies uncovered at one of the company’s facilities.

In a warning letter dated March 13, 2013, FDA officials informed Fresenius Medical Care officials that dialyzers manufactured at the company’s Ogden, Utah plant are not in conformity with current federal good manufacturing requirements.

“The FDA’s warning letter further calls into question the quality of products that Fresenius is producing for kidney patients and comes at a time when the federal court system has consolidated cases from across the country containing allegations that GranuFlo and NaturaLyte allegedly have life-threatening side effects,” said Resource4thePeople.

“We will continue to provide updates for consumers who may have been affected by these dialysis products and will report on the progress of the federal consolidated litigation. We also will continue to offer consumers free consultations about legal rights to which they may be entitled to seek compensation.”

At least 161 federal NaturaLyte and GranuFlo lawsuits alleging serious heart problems and deaths from the use of these products have been consolidated before U.S. District Court Judge Douglas P. Woodlock, according to the court docket.*

The court filings also summarize the specific allegations involved that plaintiffs who used NaturaLyte and GranuFlo claim they should be compensated for:

“These actions share factual issues arising from allegations that Plaintiffs suffered injury or death caused by the use of GranuFlo and/or NaturaLyte products during hemodialysis, which allegedly may cause metabolic alkalosis in patients resulting in low blood pressure, hypokalemia, hypoxemia, hypercapnia, cardiac arrhythmia, or cardiopulmonary arrest.

“All the actions involve factual questions relating to whether GranuFlo and NaturaLyte were defectively designed or manufactured, whether Fresenius, the manufacturer of these dialysate products, knew or should have known of the alleged propensity of these products to cause injury and whether it provided adequate instructions and warnings with these products.”

Resource4thePeople, in response to inquiries from consumers, is informing them that even though this multidistrict litigation has been created new inquiries will still be accepted and additional cases will continue to be filed.

Among several new cases that have been recently filed are those by:

  •     A man who is alleging in his complaint that he suffered a heart attack while driving to work after a dialysis treatment and was involved in a fatal crash. (Case # 3:2013cv0073, U.S. District Court, Southern District of Iowa.
  •     The daughter of a woman who died of a heart attack who is alleging in her complaint that the fatal condition was caused by treatment with GranuFlo and NaturaLyte. (Case # 1:2013cv1215, U.S. District Court, District of Massachusetts.
  •      Two California sisters who alleging that their mother died as a result of her use of GranuFlo in dialysis. (Case # 3:2013cv01403, U.S. District Court, Northern District of California)
  •      An Alabama woman who is claiming that her husband’s death was caused by cardiac problems because of his treatment with GranuFlo. (Case # 5:2013cv00371 U.S. District Court, Northern District of Alabama)

“Based on the number of inquiries being made by consumers there may be a large number of other dialysis patients affected by this litigation who may be coming forth to seek information about their legal rights,” said Resource4thePeople.

In the warning letter to Fresenius Medical Care, the FDA wrote that it had three times previously expressed its concerns and found Fresenius’s responses to be inadequate. FDA officials also warned of possible strict penalties:

“Your firm should take prompt action to correct the violations addressed in this letter. Failure to promptly correct these violations may result in regulatory action being initiated by the FDA without further notice. These actions include, but are not limited to, seizure, injunction, and civil money penalties.

“Also, federal agencies may be advised of the issuance of Warning Letters about devices so that they may take this information into account when considering the award of contracts. Additionally, premarket approval applications for Class III devices to which the Quality System regulation violations are reasonably related will not be approved until the violations have been corrected. Requests for Certificates to Foreign Governments will not be granted until the violations related to the subject devices have been corrected.”

Resource4thePeople began providing complimentary legal consultations to patients after the Food and Drug Administration issued a Class 1 Recall*** March 29, 2012 of the kidney dialysis products.

In announcing the recall the FDA advised health care professionals and patients that the affected GranuFlo and NaturaLyte products when inappropriately prescribed or administered in dosing errors may cause life-threatening cardiac problems.

“This may contribute to metabolic alkalosis, which is a significant risk factor associated with low blood pressure, hypokalemia, hypoxemia, hypercapnia and cardiac arrhythmia, which, if not appropriately treated, may culminate in cardiopulmonary arrest,” the FDA said in the announcement. “This product may cause serious adverse health consequences, including death.”

The FDA describes Class I Recalls as the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.

According to the FDA, the affected NaturaLyte and GranuFlo Dry Acid concentrates were manufactured between January 2008 and June 2012 and are used in the treatment of acute and chronic renal failure during hemodialysis.

*In re Fresenius GranuFlo/NaturaLyte Dialysate Litigation MDL # 2428, U.S. District Court of Massachusetts, Judge Douglas P. Woodlock

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