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Fresenius Silent About Fatal Alkali Dosing Errors

By Brian Chase on February 21, 2013 - No comments

Fresenius Medical Care, the manufacturer of dialysis products GranuFlo and NaturaLyte, has no problem communicating about lawsuit claims according to an article in Lawyers and Settlements. However, they were silent about alkali dosing errors that resulted in numerous tragic deaths. The article states that while Fresenius could have communicated this valuable information in a nanosecond with a tweet, they chose not to do so.


GranuFlo and NaturaLyte are two products manufactured by Fresenius, which also happens to be the largest manufacturer of dialysis machines and the largest operator of dialysis clinics in the country. According to The New York Times, an internal memo from Fresenius in November 2011 cautioned its own clinics to watch out for alkali dosing errors as a result of using GranuFlo and NaturaLyte.

In 2010, 941 people died after suffering cardiac arrest in Fresenius clinics during dialysis treatments. Too much bicarbonate in the blood can potentially lead to heart problems. Fresenius did not communicate the danger posed by the products to other clinics and doctors until the internal memo was leaked to the U.S. Food and Drug Administration (FDA).

Fresenius’s Internal Memo

The New York Times report stated that Fresenius’s memo called the findings “troubling.” But apparently, they did not find it concerning enough to send out an alert to all clinics warning them about these dangerous and defective products that had the potential to send patients into a cardiac arrest. In May 2012, NaturaLyte and GranuFlo products were recalled.

Fresenius’s argument that the information was important enough to convey to their doctors, but not for others, is not unacceptable. As soon as they discovered that their products were dangerous, they should have informed their entire customer base. In fact, this is the basis of many of the product liability and wrongful death lawsuits that have been filed against Fresenius with regard to GranuFlo and NaturaLyte.

Justice for Victims’ Families

Fresenius’s defense attorneys continue to argue that plaintiffs cannot show the products were dangerous or that Fresenius failed to provide adequate warnings and instructions to the intermediaries who used GranuFlo and NaturaLyte to treat patients.

Plaintiffs’ attorneys estimate that as many as 125,000 patients in non-Fresenius clinics may have been exposed to these dangerous and defective products. I hope the lawsuits not only help shine the light on Fresenius’s actions or lack of it, but also ensure that families that have lost loved ones and have suffered irreparable losses as a result of these defective medical products get justice and much-needed closure.

Posted in: Defective Medical Device

About the Author: Brian Chase

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