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GranuFlo Warnings

The dialysate concentrates GranuFlo and NaturaLyte are used in thousands of dialysis centers around the United States each day for nearly one-third of kidney dialysis patients.

Unfortunately, these products have now been associated with elevated risks of heart problems, cardiac arrest and death. The FDA and the maker of the products, Fresenius Medical Care (FMC), have both issued Granuflo warnings about these risks.

Although Granuflo itself is not a dangerous product, the Granuflo warnings suggest that improper prescription can lead to high bicarbonate levels, which can result in:

  • Cardiopulmonary arrest
  • Low blood pressure
  • Stroke
  • Metabolic alkalosis
  • Heart attack or
  • Death

After learning of these risks, FMC initially concealed them from the FDA, patients and outside dialysis centers, putting hundreds of thousands at risk. Lawyers are now helping those affected file claims for their loss.

If you or a loved one suffered cardiopulmonary arrest, heart attack or death after dialysis treatment with Granuflo, it is important to speak with a lawyer about your options. You may be entitled to substantial compensation. Contact us today.

In 2010, Fresenius conducted a year-long study at its own clinics which showed that the rate of patients suffering cardiopulmonary arrest associated with Granuflo and elevated bicarbonate levels was six times the normal level.

Although FMC issued an internal memo to its own doctors with Granuflo warnings in November of 2011, they failed to warn the FDA, outside clinics or patients of these risks.

The FDA was alerted to the concealment only after they received an anonymous copy of the FMC internal memo. Afterward, FMC moved quickly to issue a public Granuflo warning on March 29, 2012, which the FDA designated a recall. The FDA followed with its own warning about Granuflo on May 25, 2012.

Due to the failure of Fresenius to warn patients about the dangers of their product and their efforts to conceal the risks, they face liability for the damages caused. Lawyers are currently helping those affected file claims.

Due to the number of patients, a federal judicial panel is consolidating all Granuflo lawsuits to a special Multi-District Litigation court. A lawyer can explain whether your case may qualify and how long you have to take action.

Before choosing a lawyer, make sure they are qualified for this type of lawsuit and have experience fighting large drug companies. The DrugRisk Resource Center only recommends law firms that specialize in medical device injuries and have handled Granuflo claims.

For more information on the warnings, recall and legal action related to Granuflo, or to speak with a lawyer, contact us today. We are available 24 hours a day to provide help.