GranuFlo Recall

The U.S. Food and Drug Administration (FDA) has sent warning letters to Fresenius Medical Care Holdings, Inc. (FMCH) and issued a recall notice in 2012 regarding the potential dangers in its acetate or sodium diacetate (acetic acid plus acetate) solutions found in its GranuFlo and NaturaLyte dialysis compounds. Both bicarbonate products are used by dialysis centers around the country.

However, both have been found to be either contributing or underlying causes in the increased cardiac-related deaths of dialysis patients throughout the US and the world since these products were released in 2003.

Inappropriate levels of a vital chemical in these products can produce high serum bicarbonate levels in patients who undergo normal hemodialysis (dialysis) procedures, according to the FDA recall. These high levels often contribute to metabolic alkalosis (MA); a significant risk factor for dangerous side effects such as low blood pressure, hypokalemia, hypoxemia, hypercapnia, and cardiac arrhythmia.

If any of these problems are not quickly and properly treated as dialysis patients undergo treatment the resulting side effects can result in cardiopulmonary arrest and, in some cases, death.

FMCH is one of the largest operators of privately owned dialysis centers in the United States. It provides more than one-third of the 400,000 dialysis treatments that Americans receive annually. Worldwide, it operates one of the largest single shares of privately-owned dialysis centers.

Because of the tragic outcomes arising from the widespread use of NaturaLyte and GranuFlo, several injury lawsuits have been filed against FMCH which allege negligence not only as a manufacturer of this dangerous drug, but also accuse the company of attempting to mask or hide the hazardous – and at times fatal – side effects from healthcare providers and the FDA.

Serious GranuFlo and NaturaLyte Risk Factors

A June 14, 2012 issue, of the New York Times article published shortly before the FDA’s Class I recall of GranuFlo and NaturaLyte explained how FMCH sent an internal memo to doctors throughout the company’s own dialysis centers on November 4, 2011. Click here to view a copy of the memo.

This memo followed several years of internal – and highly secretive – clinical research into these problems. It clearly warned company heads and senior managers that high blood bicarbonate levels “appeared to be contributing to a sharp increase in the risk of patients dying suddenly from cardiac arrest.”

It added that 941 patients had suffered cardiac arrest within Fresenius’ own facilities in the previous year (2010). When compared to other patients, Fresenius’ own research found high levels of bicarbonate in the bloodstream; resulting in up to, “six times the risk of cardiac arrest” than those who had not been administered GranuFlo and NaturaLyte into their dialysis processes.

Fresenius, however, failed to issue the same warning to independent dialysis centers throughout the country which used these products or notify the FDA of its findings.

The FDA launched its investigation after the internal memo was anonymously sent to the government agency. After the investigation as launched, FMCH issued a voluntary nationwide warning in March, 2012, two weeks after the FDA informed the company of the investigation. Shortly thereafter, the FDA concluded its investigation and issued its Class I recalls – the most serious, which warn of possible deaths – of both products.

Experienced Lawyers Take On GranuFLo and NaturaLyte

GranuFlo and NaturaLyte are currently subject to extensive litigation due to the large number of serious side effects to dialysis patients who were administered these drugs. Those side effects include, but are not limited to:

  • sudden cardiac death
  • debilitating heart attack
  • severe, permanent cardiovascular injury
  • cardiopulmonary arrest

Some of the already filed civil complaints accuse FMCH of deliberately failing to notify doctors and the FDA of the dangers associated with GranuFlo and NaturaLyte and in so doing, violated its legal duty to properly identify and publicly communicate its findings.

If you, or someone you love, have been negatively impacted by the use of GranuFlo or NaturaLyte, or you have lost a loved one due to this dangerous drug, you will need to consult with an experienced attorney to determine if your situation merits a personal injury or wrongful death claim. You may have the right to seek fair and full compensation for real – and possibly punitive – damages, particularly considering FMCH’s questionable behavior in keeping the dangers of their product from government and medical experts.