GranuFlo and NaturaLyte are acid
concentrates used during dialysis to remove toxins from the blood. Dialysis
takes the place of the kidneys in clearing toxic waste from the blood. Part of
this involves providing bicarbonate, an alkaline substance, to neutralize the
acid that builds up in the blood. GranuFlo performs different functions, but it
does contain an ingredient that the body converts to bicarbonate, and it
contains more of this ingredient than rival products.
A company named Fresenius
Medical Care manufactures GranuFlo. Fresenius, based in Germany, treats more
than a third of the estimated 400,000 Americans receiving dialysis treatment.
It is also the leading supplier of dialysis machines and disposable products,
which are used by many clinics in addition to its own.
An internal memo, dated November 4, 2011,
found that 941 patients had suffered cardiac arrest inside Fresenius clinics in
2010. By comparing these patients with others, the company’s medical staff
concluded that patients with high levels of bicarbonate in their blood had
about six times the risk of cardiac arrest as those with lower levels. This
memo was sent to doctors practicing in the company’s dialysis centers, warning
them that failure to properly use one of the company’s products appeared to be
contributing to a sharp increase in the risk of patients dying suddenly from
cardiac arrest.
Fresenius did not immediately warn other
centers that use of GranuFlo could cause serious health effects. It did so only
later when the F.D.A. anonymously received a copy of the internal memo and
questioned the company about it. Thereafter in March 2012, Fresenius issued an
“Urgent Product Notification” to its customer clinics warning of possible heart
risks associated with their products. According to the notice, GranuFlo and
NaturaLyte have the potential to cause a rapid and unsafe elevation of
bicarbonate, which creates a substantially increased risk of cardiopulmonary
arrest and death.
The F.D.A. would later deem Fresenius’
notification a Class I GranuFlo recall, its most urgent type of recall.
The attorneys at Pittman, Dutton &
Hellums, P.C., are currently investigating claims against the manufacturers of
GranuFlo and NaturaLyte. If you or a loved one were a dialysis patient who suffered heart attacks,
sudden cardiac death, and other catastrophic heart side effects within 48 hours
of a dialysis treatment with GranuFlo or NaturaLyte, please contact Booth
Samuels at booths@pittmandutton.com
or toll free at 1-866-515-8880.
