Lawsuit Alleges Fresenius Concealed Dangers of GranuFlo, NaturaLyte

Lawsuit Alleges Fresenius Concealed Dangers of GranuFlo, NaturaLyte

By Robert J. Boumis

Pamela Dawkins has filed a GranuFlo lawsuit against dialysis supply manufacturer Fresenius USA Inc., alleging that their dialysis products caused the death of her mother, Beverly Dawkins.

Fresenius manufactured the dialysis fluid products NaturaLyte and GranuFlo. These products are used to prepare a dialysis solution, a liquid solution with enough of a concentration gradient to draw waste products from a patient’s blood using a dialysis machine. However, these products were recalled in 2012 over concerns that they could alter blood chemistry in such a way as to promote sudden cardiac death and other GranuFlo/NaturaLyte heart problems. 

In September 2006, Beverly Dawkins underwent dialysis at a Fresenius-affiliated dialysis center. Per the GranuFlo lawsuit, the center used NaturaLyte and/or GranuFlo. While at the dialysis center, Dawkins went into cardiac arrest and died on the scene. 

The GranuFlo lawsuit alleges that the Fresenius dialysis products caused Beverly Dawkins’s death, and that Fresenius was aware – or reasonably should have been aware – of the risks associated with their products. The GranuFlo lawsuit cites an internal memorandum from 2011, which references a risk of cardiac arrest during dialysis treatment when GranuFlo or NaturaLyte was used to make dialysis fluid. 

According to the GranuFlo lawsuit, not only was Fresenius aware of the risks, but the company allegedly actively concealed them. The 2011 memo was only distributed to Fresenius-affiliated dialysis centers. When the company came under U.S. Food & Drug Administration (FDA) scrutiny, Fresenius issued a vaguer version of the memo to non-affiliated dialysis centers that used Fresenius dialysis products. The GranuFlo lawsuit further alleges that Fresenius failed to act quickly, having been aware of the issue years before the eventual recall.

The GranuFlo lawsuit is Pamela Dawkins v. Fresenius USA Inc., et al., Case No. 1:13-cv-12409, in the U.S. District Court for the District of Massachusetts. It has joined ongoing multidistrict litigation, In Re: Fresenius GranuFlo/NaturaLyte Dialysate Products Liability Litigation, MDL No. 1:13-md-02428-DPW, in the U.S. District Court for the District of Massachusetts. 

If you or someone you care about underwent dialysis with Fresenius dialysis products, you may have found yourself in a very challenging situation. Sudden cardiac arrest or other serious heart problems are medical emergencies that require urgent, intensive medical attention. Emergency medicine can be emotionally taxing and usually entails financial burdens such as medical bills and lost wages. And unfortunately, serious heart problems are often fatal. Surviving family members may face challenges like coping with the loss of a loved one, as well as the monetary challenges like final expenses and lost income potential. In such a situation, it is normal to feel depressed and overwhelmed. But you need to remember that regardless of the situation you’ve found yourself facing, you still have rights, and there are steps that you can take to regain a measure of control over your situation. You can start by visiting the Kidney Dialysis Heart Attack, GranuFlo & NaturaLyte Recall Class Action Lawsuit Settlement Investigation. Here, you can enter information about your situation for a review by a legal expert with a background in this type of litigation. The initial consultation is completely free of charge and from it, you can receive additional guidance on the best steps to take in your exact situation. 

All medical device, dangerous drug and medical class action and lawsuit news updates are listed in the Drug and Medical Device section of Top Class Actions.