Amanda Antell  |  April 17, 2014

Category: Legal News

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Fresenius Medical CareNorth Carolina resident Amy Mills has filed a GranuFlo lawsuit against Fresenius Medical Care for the wrongful death of her husband Randolph D. Mills III, alleging that as a direct result of using the company’s kidney dialysis products GranuFlo and NaturaLyte, her husband suffered and died from a heart attack.

Mr. Mills used GranuFlo and NautraLyte routinely before his death, and had not deviated from prescribed instructions or physicians’ advice.  Despite following all instructions, Mr. Mills had suffered a heart attack following a routine kidney dialysis treatment in which GranuFlo and/or NaturaLyte were used.

Doctors state that it was Mr. Mill’s death was in direct correlation with his use of the dialysate products. Mrs. Mills filed this Granuflo lawsuit on behalf of her husband, when it was announced two years ago that these products could cause heart attack, stroke, and sudden cardiac death.  Furthermore, Fresenius had failed to warn the plaintiff’s husband of these possibilities, just as they had failed to warn the other victims or their loved ones.

There were no warnings or indications of cardiac complications on the products’ labels, nor were there any special warnings or instructions for those in charge of administrating the additives.

Up until the 2012 warning, physicians were not aware that their patients could suffer such side effects, and were not aware of the proper precaution.  Mrs. Mills asserts that Fresenius had the responsibility to warn her, her husband, and other patients of these side effects, because they are relying on the accuracy of the given information. Mrs. Mills insists that her husband never would have used the products, if he had known about the potentially dangerous side effects.

So for being directly responsible for manufacturing, selling, distributing, and marketing dangerous products, Mrs. Mills is suing Fresenius Medical Care.  The charges in the GranuFlo lawsuit include negligence, false advertising, concealing information, and misrepresenting a product.

 

Overview of GranuFlo and NaturaLyte Complications

Fresenius Medical Care is the largest dialysis business in the world with 1,800 established clinics in the United States.  It sells dialysates GranuFlo and NaturaLyte, which are solutions that are dissolved and administered for the treatment of kidney failure. GranuFlo and NaturaLyte were approved by the U.S. Food and Drug Administration in 2003 and 2007 respectively, and have since been the most widely used dialysis treatments in the country.  These dialysates are meant to simulate kidney function, so the body’s natural waste and electrolytes are processed.  The products primarily consist of acetate and bicarbonate, which allows for the vital simulation kidney function.

While these products have been proven to work, there are various medical complications that have been reported from using them.  The prime concern has become hyperkalemia, a condition when the potassium levels of the body rise uncontrollably — this causes the body’s blood-flow to slow down, allowing for the formation of blood-clots. This ultimately allows for the potential side effects of cardiac death, stroke, heart attack, and other dangerous side effects.

Allegedly, Fresenius Medical Care had known about these side effects for year, but had taken deliberate actions to conceal them. It was not until March 29, 2012 Fresenius officially admitted that GranuFlo and NaturaLyte were causing severe cardiac events in patients.  A Class I Recall of these products was conducted in response.

The GranuFlo lawsuit is Amy Mills v. Fresenius USA, Inc., Case No. 1:14-cv-10677-DPW. It has been added to the GranuFlo Mass Tort In Re: Fresenius GranuFlo/NaturaLyte Dialysate Product Liability Litigation, MDL No. 2428, in the U.S. District Court of Massachusetts.

 

File a GranuFlo Class Action Lawsuit Claim

If you or someone you know suffered a heart attack or similar complication and were undergoing dialysis treatment, you may be eligible to pursue compensation for your injuries. Obtain a free legal review of your case by submitting your information now:

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