As of February 2015, more than 2,575 lawsuits are pending against Fresenius
in the District of Massachusetts federally-filed GranuFlo MDL. The lawsuits
claim Fresenius knew-or should have known-about the increased risk of
death and serious injury associated with GranuFlo, and that those risks
were concealed and misrepresented by Fresenius Medical Care. Lawsuits
seek punitive damages in addition to medical expenses and pain and suffering,
claiming Fresenius knowingly exhibited a deliberate disregard for the
value of human life.
Dialysis concentrate GranuFlo was recalled by the FDA after it was determined
the product could place patients at risk for cardiac arrest when administered
or prescribed improperly. The manufacturer of GranuFlo, Fresenius Medical
Care, has been charged with failing to adequately warn doctors or their
patients that the product contains more of an ingredient which the body
converts to bicarbonate than other brands. Overdoses of bicarbonate have
been linked to heart problems, and while Fresenius warned its own clinic
doctors about GranuFlo's potential to cause cardiac arrest, they failed
to warn outside clinics.
In fact, these outside clinics continued to use GranuFlo until an internal
memo from the company was leaked. In early 2012, Fresenius voluntarily
changed GranuFlo's labeling, however they continued to market the
product. The Class I recall for GranuFlo mandated by the FDA is the most
serious type of recall available. A Class I recall indicates a reasonable
probability that the use of the product could cause serious adverse health
issues or even death.
Understanding the GranuFlo Recall
During hemodialysis, a medical machine filters waste and extra salt and
water from the blood of the patient. This process involves neutralizing
acid in the blood by supplying the patient with bicarbonate, an alkaline
substance. Granuflo is a powder concentrate and NaturaLyte is its liquid
counterpart. These two drugs are in a class known as dialysates, and are
used during the dialysis process to neutralize the buildup of acids in
the blood. The active ingredient in NaturaLyte and Granuflo is sodium
dialysate, which is comprised of acetate and bicarbonate.
Reportedly, doctors failed to account for the additional bicarbonate contributed
by GranuFlo when making the decision on how much bicarbonate to administer
separately. High bicarbonate levels in the body can cause low blood pressure,
cardiac arrhythmia, low potassium levels, and higher concentrations of
carbon dioxide in the blood. According to a company memo, 941 patients
treated at Fresenius Clinics experienced cardiac arrest during 2010 because
of using GranuFlo.
Granuflo and NaturaLyte Lawsuits
The 2,575 lawsuits have been consolidated into an MDL in the District of
Massachusetts. As the statutes of limitations grow near for those in some
states, attorneys across the U.S. believe many more lawsuits will be filed.
The first trial is scheduled for January 2016, with a second trial scheduled
in February 2016. The currently filed lawsuits have in common the following
- Fresenius knew of the dangers associated with Granuflo and NaturaLyte yet
failed to warn consumers.
- Fresenius intentionally placed patients in harm's way through their
refusal to warn health care providers of the risks of Granuflo and NaturaLyte.
- Fresenius failed to warn consumers and health care providers of the significant
risk of cardiac arrest and death associated with NaturaLyte and Granuflo.
- Fresenius intentionally withheld risks of adverse cardiac events associated
with NaturaLyte and Granuflo and did not report the risks to the FDA.
- Fresenius failed to release adequate product-related warnings and instructions
to health-care providers.
If you or a loved one has suffered injury or harm from the use of Granuflo
or NaturaLyte, it can be beneficial to speak to a knowledgeable product
liability attorney who can ensure you receive just compensation for your injuries.
Contact Our National Dangerous Drug Attorneys
If you suffered harm that you believe may have been caused by GranuFlo®
and NaturaLyte® dialysis products, please contact the national
dangerous medical device attorneys at Golomb & Honik, P.C. for a no-cost evaluation. Our lawyers
have the resources to take on large pharmaceutical companies-and win.
We believe in holding negligent drug companies responsible for their dangerous
drugs and products and fight aggressively for justice.