There has been increasing action taken against Fresenius for the effects their GranuFlo and NaturaLyte products have been having on patients undergoing dialysis. What possible effects could two concentrates used in hemodialysis have on patients undergoing treatment? Heart attacks for starters. In 2010 at least 941 patients inside Fresenius clinics suffered from cardiac arrest after undergoing dialysis treatment. For the people who survived and the loved ones of the deceased, there was very little that could be done, until memos surfaced revealing that Fresenius knew of the dangers posed by GranuFlo and NaturaLyte. Now a number of lawsuits have been launched against Fresenius over their practices and many more are expected.
The Problem with GranuFlo and NaturaLyte and How They Were Unsafe For Dialysis Patients
For patients who have kidney failure, it is imperative that they receive proper treatment, with their bodies no longer capable of performing important functions they rely on hemodialysis to remove water, urea, and creatinine from their blood. One of the effects of kidney failure is that when the kidney stops functioning properly it can no longer remove acid or produce bicarbonate.
GranuFlo and NaturaLyte are Fresenius’s answer to these problems. There are several elements needed to complete the mixture required for dialysis. Dialysate is one of those elements and it is a mixture of a bicarbonate concentrate and an acid concentrate with purified water. GranuFlo and NaturaLyte are the most used acid concentrates for dialysis and are widely used and circulated by Fresenius, so other dialysis centers also use these products. Sounds fine, right? Well for the last 5 years both GranuFlo and NaturaLyte had more bicarbonate in them then they were supposed to, resulting in patients receiving a disproportionate amount of bicarbonate which can produce metabolic alkalosis, which in turn increases the patient’s risk of suffering a heart attack, stroke or cardiac arrest.
The Whistleblower Who Leaked the Information Fresenius Doesn’t Want You to Have
This information should have come as a shock, but it turns out Fresenius knew about it for quite a while and tried to fix the problem quietly without disclosing this information to the proper outlets. Employees of Fresenius were warned as early as 2008 to start cutting the dose of acetate to below the prescription levels. They also altered the operator’s manual for their machines, instructing the operators to cut dosages of acetate in half. The one thing they didn’t do was change the mixtures of GranuFlo or NaturaLyte, thereby making sure the defective products would still be circulated.
In November 2011 an internal memo circulated amongst the top directors and physicians of Fresenius’s dialysis clinics. This memo was eventually leaked to the FDA by a whistleblower, an individual who read this information and couldn’t stand by and do nothing while innocent lives were lost. What were the contents of this memo? A Fresenius study showed that the bicarbonate levels of their patients’ serum increased from 2004 to 2011 and that the patients of Fresenius had six times more risk of experiencing ‘sudden cardiac death.’ Also inside the memo was that little tidbit about 941 patients suffering cardiac arrest in 2010.
Once the Food & Drug Administration got the memo in front of them they immediately ordered a complete recall of all GranuFlo and NaturaLyte produced from January 2008 to 2012.
When Should You Be Concerned?
If you were undergoing dialysis treatment, regardless of whether it was by Fresenius or another party, and you suffered from a stroke, cardiac arrest or a heart attack then you have cause for concern. Also, if you had a loved one who passed away while undergoing dialysis treatment then it would also be best to start to investigate the cause of death further and try to find out if they were being treated with GranuFlo or NaturaLyte. There is a good chance the death or injury could have been avoided and was the fault of Fresenius.
The Fallout and the Consolidated Litigation That Followed
The lawsuits that are being launched are interesting to follow. Although they may be referred to as class action suits they are all separate suits that may end up being consolidated by the court. What that means is that all the legwork in the trial is done as if it is one lawsuit so that the actions are coordinated, but each individual is responsible to prove the validity of their own injury and to settle on their own. All the evidence and depositions used will be the same for each case, saving time for the litigators, defendants and the court in general, but each case will have to play out on its own. Each victim is responsible to prove that they were treated with GranuFlo or NaturaLyte and that their injuries were caused by said products.
It is hard to believe the actions of Fresenius were motivated by anything other than greed. They willingly sacrificed the lives of sick human beings in order to stop this information from becoming public knowledge. They knew about the dangers of GranuFlo and NaturaLyte and continued to circulate the medical products while secretly trying to figure out what to do. If you have been affected by this scandal there are options. Seeking out an experienced lawyer with a history of successful medical malpractice cases under their belt will be your best bet at receiving the compensation you deserve for the negligent actions of Fresenius.
At the law offices of Bruce A. Hagen, Attorney at Law, we are dedicated to our clients and do not rest until we feel they are fully satisfied with the settlement we work for. If you or anybody you know has had a heart attack while undergoing dialysis contact us immediately so that we can determine if the injury was caused by one of the faulty products.