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GranuFlo and NaturaLyte: Another FDA Slip Up is Costing American Lives

Fresenius Medical Care is a German company with subsidiaries worldwide that manufactures and distributes the dry acid GranuFlo and its liquid counterpart NaturaLyte. Prior to the March 29 2012 Recall of these two substances, GranuFlo was the most widely prescribed dry acid product in the dialysis industry.

Fresenius described these products safe to medical professionals and consumers as recently as 2011, though internal documents created by the medical giant in November of that same year prove the company knew their product’s acid was causing heart attacks in patients.

An internal memorandum was sent by Fresenius to its own dialysis centers warning that 941 patients had suffered heart attacks shortly after receiving treatments containing Granuflo. The memo outlines the danger of alkalosis (decreased acidity in the blood) and raised bicarbonate levels. It specifically states, “borderline elevated pre-dialysis bicarbonate levels and overt alkalosis are significantly associate with [a] 6 to 8 fold greater risk of [cardiopulmonary] arrest and sudden cardiac death in the dialysis facility.” The memo clearly proves that Fresenius was aware that their product was causing a massive increase in the risk of heart attacks and other deadly cadiovascular problems such as stroke.

It is clear that drug companies make mistakes in discovering dangerous side-effects prior to the substances being used on consumers. That is why the Food and Drug Administration (FDA) has been created and given the task of protecting the public from improperly tested substances. Unfortunately, the FDA dropped the ball on Granuflo and NaturaLyte.

What is most alarming, however, is that the mistake Fresenius made was not remedied fast enough. We have evidence that the company was on notice that GranuFlo carried this risk of cardiopulmonary arrest and death in November of 2011, but we have no idea when they actually became aware of the danger. What we do know is that following the 2011 November Memorandum, Fresenius contained to to allow doctors and dialysis centers to use the products until the FDA recall began in March of 2012. Fresenius never notified any physicians or dialysis centers (besides the ones it owned) that were purchasing and using GranuFlo that the drug was inherently flawed and dangerous.

After the public became aware that Fresenius knowingly exposed thousands of people to the risk of death or cardiac injury, victims of the dangerous drug began suing the company. In most places, a manufacturer can be held strictly liable for injuries caused by a faulty product. In the case of GranuFlo, Fresenius may be exposed to additional liability for its failure to limit the exposure to danger once the inherent flaw was found. It is unclear how many of these lawsuits Fresenius may face, but it is clear that you should consult an attorney if you or a loved one has suffered because of exposure to dialysis treatment involving GranuFlo or NaturaLyte. Call Sibley Dolman Gipe Accident Injury Lawyers, PA today for a free case evaluation.

If you have sustained injuries as a result of a bad drug or defective medication, call the Dangerous Drug Attorneys of the Sibley Dolman Gipe Accident Injury Lawyers, PA for a free consultation and case evaluation. The injury law attorneys of the Sibley Dolman Gipe Accident Injury Lawyers, PA have extensive experience litigating against corporate giants. For more information, call us today at: (833) 606-DRUG [3784] or email: [email protected]