Granuflo Lawsuits Rising

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 allegations:

  • 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 Legalfor 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.