Have You Or Someone You Love Been Injured By GranuFlo And NaturaLyte®?
The Roberts Law Firm, P.C. Can Help
What Is GranuFlo® And NaturaLyte®?
GranuFlo® Dry Acid Concentrate and NaturaLyte®, also known as NaturaLyte Liquid Acid Concentrate, are manufactured by Fresenius Medical Care and are used in the treatment of acute and chronic renal failure during hemodialysis. Fresenius Medical Care is one of the largest dialysis product manufacturers in the world. Fresenius owns a majority share in the multiple billion dollar dialysis market and operates dozens of dialysis centers across the country, providing dialysis for over 100,000 people in the United States alone. Dialysis is a procedure that clears toxic waste from the blood in patients whose kidneys have failed.
Dangerous Side Effects Of GranuFlo® And NaturaLyte®?
In November, 2011, Fresenius Medical sent an internal memo to doctors practicing in the company- owned dialysis centers, warning them that failure to use GranuFlo® properly appeared to be linked to a sharp increase in sudden cardiac events. Despite this warning Fresenius failed to issue any sort of warning to customer clinics until March, 2012 when the FDA became aware of the apparent link between GranuFlo and increased cardiac events. In response the FDA issued a Safety Communication warning of the dangers of dosing errors for products like GranuFlo® and NaturaLyte®.
In June, 2012 the FDA issued a Class 1 recall of GranuFlo®. While the GranuFlo® recall will not involve removal of the products from the market, this is the most serious class of recall, issued when the FDA deems there to be "a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death". The company was required to issue a stronger warning regarding dosing amounts to the warning label and doctors were cautioned to use extra care when deciding the amounts to administer to their patients.
The New York Times also recently reported that an FDA investigation has begun into whether Fresenius violated federal regulations by failing to disclose risk associated with their product.
During hemodialysis, a machine filters waste, extra salt and water from the patient's blood when their kidneys are no longer healthy enough to do this on their own. A necessary part of this process involves neutralizing acid in the blood by supplying the patient with an alkaline substance known as bicarbonate. GranuFlo and NaturaLyte are alkaline substances administered to dialysis patients to neutralize the acid that builds up in the blood. The products are administered in conjunction with bicarbonate, and contain acetate, an ingredient that the body converts to bicarbonate. However, GranuFlo and NaturaLyte contain far more acetate than rival products, and thus result in more bicarbonate in the body.
It has been reported that doctors were not accounting for the additional bicarbonate contributed by GranuFlo when determining how much bicarbonate to administer separately. As a result, patients could be at risk for the effects of excessive bicarbonate, which has been linked to heart problems.
According to the FDA, high bicarbonate levels can contribute to a metabolic condition which is a significant risk factor for the following:
- Low blood pressure
- Cardiac arrhythmia
- Low blood oxygen pressure
- Low potassium levels in the blood
- High concentration of carbon dioxide in the blood
If these conditions are not properly treated, serious adverse events, including the following can occur:
- Heart attack
- Sudden cardiac death
- Cardiopulmonary arrest
- Cardiovascular death
Litigation Related To GranuFlo® And NaturaLyte®
It was reported in October 2012 that lawsuits have been filed against Fresenius Medical Care, alleging that the company failed to properly warn patients and doctors about the risks associated with GranuFlo® and NaturaLyte® dialysis products.
The lawsuits against Fresenius Medical Care center on a number of allegations, including that the company knew or should have known about the increased risk of death and serious injuries associated with GranuFlo® and NaturaLyte®. Specifically, these suits are claiming that the use of GranuFlo® and NaturaLyte® present an increased risk of serious and potentially fatal cardiovascular injuries - risks that were concealed and misrepresented by Fresenius Medical Care. GranuFlo® and NaturaLyte® were advertised as being safe for dialysis, even though Fresenius knew or had reason to know that the products were not safe and could, in fact, cause serious medical problems, according to the GranuFlo® lawsuits.
The Fresenius GranuFlo® lawsuits further claim that the company failed to adequately warn doctors and other professionals working in the dialysis field about the catastrophic risks associated with GranuFlo® and NaturaLyte®.
How The Roberts Law Firm Can Help You
We believe that if you or someone you love have suffered from a side effect or been injured by GranuFlo® and NaturaLyte® you should be fairly compensated for your damages. Men, women, children and their families have had life-changing experiences as a result of these injuries. Damages can include:
- Medical Bills
- Permanent Injuries
- Emotional Suffering
- Loss in the Quality of Life
- Potential Risk of Future Medical Complications
- Increased Health Insurance Costs
- Lost Wages
Due to both the alleged acts and failure to act on the part of the large drug companies that manufacture GranuFlo® and NaturaLyte® many people who have suffered side effects were unaware that there were these risks. The Roberts Law Firm, P. C. would like to assist you in pursuing compensation for your injury or the injury of a loved one. We are currently evaluating claims on behalf of those who were prescribed GranuFlo® and NaturaLyte® and who may have suffered injury. We are representing injured parties on a contingent fee basis which means that there are no legal fees owed unless you are awarded compensation for your injury. For a free, no obligation case review please call 866-585-3690 toll free or fill out our online contact form and we will contact you to answer any of your questions. If you or a loved one has been injured after using GranuFlo® and NaturaLyte®, The Roberts Law Firm, P.C. may be able to help.