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Granuflo Class Action Lawsuit Filed in California

On August 27, 2013, Tina Nunn, both individually and on behalf of the estate of her deceased husband Earin Blossom, filed a complaint against Fresenius Medical Care – manufacturers of the now recalled Granuflo and Naturalyte dialysis products. Dockets in the U.S. District Court, Northern District of California identify the complaint as a Granuflo class action lawsuit, but at present only Nunn is listed as plaintiff.  Nunn claims the defendant and their subsidiaries “failed to exercise reasonable care in manufacturing and selling defective dialysis products known as Granuflo and and Naturalyte.”  The dialysates, used by the plaintiff’s spouse and other class members, caused fatal complications and sudden death, states the complaint.

Fresenius dialysis class action lawsuit facts and allegations

Court documents show that the decedent Earin Blossom began hemodialysis treatments in November 2010. He received both Granuflo and Naturalyte additives during his dialysis treatments, which took place three times a week at a Fresenius dialysis clinic in Fremont. On April 6, 2011, just a few hours after his dialysis at the clinic, Blossom suffered a massive heart attack and died. Allegations state that the decedent’s metabolic alkalosis, cardiac arrest and subsequent demise were a direct and proximate result of his use of Granuflo and/or Naturalyte. The complaint further argues that the defendant knew its products resulted in excess bicarbonate levels in patients, often leading to metabolic alkalosis – a dangerous condition associated with heightened risks for heart attack, cardiac arrhythmia and sudden death.

As early as March 2001, Fresenius purportedly knew health care providers using their dialysates were confused about Granuflo dosing levels and how much bicarbonate is actually introduced to a patient’s bloodstream during dialysis treatment. The Granuflo class action lawsuit cited an April 2002 memo, in which Fresenius noted an increase in bicarbonate levels for its proprietary clinics and acknowledged concern for “patients who fall in the upper limits of the distribution curve and who may have significant post-dialysis alkalosis.”

A 2004 study published in the American Journal of Kidney Diseases showed that patients with pre-dialysis alkalosis (bicarbonate level greater than 27.0 mEq/L) had a greater relative risk of death. However despite knowledge of potential Granuflo side effects and risks, Fresenius negligently failed to inform all physicians and treatment facilities prescribing and/or using NaturaLyte and GranuFlo before its 2012 recall, says the complaint.

Widow demands damages for her husband’s wrongful death

The plaintiff claims that as a result of the actions and inactions of Fresenius Medical Care, the decedent suffered cardiac arrest and died, and incurred substantial medical expenses before his death.

Fresenius faces eight separate causes of action in the complaint, including:

  • Strict Products Liability Due to Inadequate Warning
  • Strict Products Liability Due to Defect in Design or Formulation
  • Negligence
  • Breach of Implied Warranty
  • Breach of Express Warranty
  • Negligent Misrepresentation and/or Fraud
  • Wrongful Death
  • Survival Action

Granuflo and Naturalyte litigation

In addition to this Granuflo lawsuit, Fresenius is defending its controversial acid concentrates in the Granuflo/Naturalyte MDL (No. 2428), which is proceeding in the U.S. District Court for the District of Massachusetts. All of the complaints consolidated in the multidistrict litigation involve similar issues of fact and allegations of injury and death caused by Fresenius’ Granuflo and Naturalyte. Unlike a class action suit, which is filed on behalf of all plaintiffs in a group, MDL centralizes individual lawsuits before one judge for the purpose of more efficient pre-trial proceedings. Each plaintiff’s case is tried individually, and is entitled to its own verdict or pre-trial settlement.