In June 2012, the U.S. Food & Drug Administration declared a Class I recall of Fresenius Medical Care’s GranuFlo and NaturaLyte dialysis products. According to the manufacturer’s own records, use of these products increases a dialysis patients’ risk of potentially fatal cardiac arrest by 6 to 8 times.  Fresenius Medical Care is the largest maker of dialysis products and treats more than a third of the estimated 400,000 Americans receiving dialysis.

GranuFlo & NaturaLyte Could Cause Potentially Fatal Cardiac Arrest

Compared to other dialysates, GranuFlo and NaturaLyte contain more of an ingredient that could lead to higher levels of bicarbonate in the body. Recent studies have linked elevated bicarbonate levels to an increased risk of cardiac arrest. Elevated bicarbonate levels can also cause:

  • Death
  • Heart attack
  • Stroke
  • Low blood pressure
  • Hypokalemia (low potassium in the blood)
  • Hypoxemia (low oxygen levels in the blood)
  • Hypercapnia (excessive carbon dioxide in the blood)
  • Cardiac arrhythmia (irregular heartbeat)

Company’s Failure to Warn of Risks

In 2011, Fresenius sent an internal memo to doctors in its own clinics, warning them that the elevated bicarbonate levels had caused 941 heart attacks in its clinics in 2010. But, Fresenius hid this information from doctors in other clinics and the FDA. It was not until March 2012 when Fresenius’ internal memo was leaked to the FDA that other dialysis clinics learned about the heart attack risks that GranuFlo and NaturaLyte pose.

Experienced Personal Injury Lawyer

Claimants in several states have filed suits against Fresenius including Alabama, Colorado, Florida, Georgia, Illinois, Louisiana, Massachusetts and New York. So many lawsuits have been filed that on March 29, 2013, the U.S. Judicial Panel on Multi-District Litigation ordered the forming of the MDL. An MDL is different from a class-action, in particular, because class-action plaintiffs share a monetary award, if there is one. With an MDL, each lawsuit, once it is deemed worthwhile, gets its own trial.

This approach results in better individual representation and consequently, can result in larger settlements. If you or someone you love has been injured by Fresenius Medical Care’s GranuFlo or NaturaLyte dialysis products, please contact one of our experienced national dangerous drug lawyers today to protect your rights. To learn more about your rights and legal options, call the Phillips Law Firm today. Our experienced Granuflo lawsuit lawyers have represented families across the country in their quest for justice. You may be entitled to compensation for your injuries. For a free consultation visit the Phillips Law Firm website or call 1-800-708-6000.