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Fresenius Medical Care, the Nation's largest operator of dialysis centers, is under continuing investigation by the FDA for failing to warn customers of potentially deadly heart problems associated with the company's GranuFlo® and NaturaLyte® dialysis products.

Our national dangerous drug lawsuit attorneys at Golomb & Honik, P.C.are currently litigating GranuFlo® and NaturaLyte® claims and are leaders in the multi-district litigation that is venued in Boston, Massachusetts. If you or someone you love has suffered a heart attack, stroke, cardiac arrhythmia or died after using GranuFlo® or NaturaLyte® during the dialysis process, we may be able to help. Call us at (215) 278-4449 or fill out a free case consultation form to learn more.

Health Problems with GranuFlo® & NaturaLyte®

Dialysis is a procedure that replaces the function of the kidneys by filtering toxic waste products out of the blood. GranuFlo® and NaturaLyte® are products used in the dialysis process. Bicarbonate is a chemical that dissolves acid in the blood. The issue with GranuFlo® and NaturaLyte® is that they produce more bicarbonate than the standard, which can lead to excessively high alkaline levels, or metabolic alkalosis. Metabolic alkalosis increases the risk of serious health complications, such as:

• Sudden Cardiac Arrest
• Sudden Heart Attack
• Cardiopulmonary Arrest
• Death
• Arrhythmia

Physicians who were not aware of the extra bicarbonate resulting from GranuFlo® and NaturaLyte® may have prescribed even more bicarbonates, essentially giving patients an overdose. The resulting excessive levels of alkaline can lead to serious heart problems.

GranuFlo® & NaturaLyte® Warnings & Recalls

According to news reports, Fresenius sent an internal email in November 2011, warning doctors at its own dialysis centers that the use of GranuFlo® and NaturaLyte® contributed to an increased risk of death from cardiac arrest during dialysis. This memo reported that more than 900 patients had already suffered heart attacks at their Fresenius clinics and there was worry about the increased bicarbonate. The memo went on to state that patients with excessive bicarbonate in their blood were 6x more likely to suffer a heart attack than those who did not have excess bicarbonate in their blood.

Unfortunately, this warning was only issued to Fresenius clinics and not to the FDA, other doctors, or consumers. Only after the FDA received a copy of this memo did Fresenius issue a warning to all consumers in March 2012. Questions have arisen as to whether the company's conduct put patients at risk and violated FDA regulations and ethical standards.

In March 2012, the FDA decided to issue a Class I recall of GranuFlo® and NaturaLyte® and revised prescribing instructions. According to the recall, use of these two products could result in low blood pressure and abnormal cardiac functions. This could directly result in cardiac arrest and death.

GranuFlo® & NaturaLyte® Lawsuits

Since the recall in 2012, more than 1,500 lawsuits have been filed and consolidated into a multidistrict litigation in the District of Massachusetts. Lawsuits specifically allege that Fresenius knew of the dangers associated with their products, but failed to adequately inform the public of these risks. This directly jeopardized the lives and health of thousands of consumers-even resulting in death. Our attorneys are leaders in that multi-district litigation.

Free Consultations at Golomb & Honik, P.C.

If you suffered harm that you believe may have been caused by GranuFlo® and NaturaLyte® dialysis products, don't wait to contact 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. Contact our legal team at (215) 278-4449 to get started on your case.