Fresenius Lawyer - d'Oliveira & Associates, P.C.

GranuFlo and NaturaLyte are Fresenius products linked to side effects such as heart attacks. Our law firm is working with some of the leading Fresenius attorneys in the country. A claim and/or Fresenius lawsuit can be filed on your behalf and there is no fee until you receive an award or a Fresenius settlement. Contact us for a free consultation online or toll free at 1-800-992-6878.

Fresenius Kidney Dialysis Products Linked with Life-Threatening Cardiovascular Injuries

Fresenius Medical Care, which according to their website is the “largest dialysis services provider in the world,” has been linked to serious and sometimes deadly heart complications. Two of Fresenius’s products, GranuFlo and NaturaLyte, have been linked to increased risk of cardiac arrest and death. According to reports, Fresenius was aware that improperly using these two products could lead to serious injury, heart attack, or death as early as November 2011. Fresenius did not notify the FDA or other dialysis clinics of the risk until March 29, 2012.

Fresenius Accused of Hiding Important Kidney Dialysis Heart Attack Risks

The internal Fresenius memo of November 2011 stated that there was a very real risk of patients suffering a heart attack during kidney dialysis while using GranuFlo and NaturaLyte. Studies showed that this risk was independent of the risk normally associated with low pre-dialysis potassium.

Risk Factors for Heart Attacks Related to Fresenius Kidney Dialysis

There were two important risk factors associated with increased risk of heart attack with Fresenius GranuFlo and NaturaLyte products. Among these were:

• Low Potassium (Hypokalemia) – Low potassium can lead to heart attacks very quickly in healthy individuals, and the risk is even more dangerous in patients on kidney dialysis. If serum potassium is low before dialysis, using GranuFlo and NaturaLyte can lead to potentially fatally low potassium levels.
• High Bicarbonate Levels – Bicarbonate is a key component of blood chemistry and is included in the GranuFlo and NaturaLyte products in different concentrations. If this bicarbonate level is too high before dialysis, there can be too much bicarbonate in the blood, which causes an imbalance in the body and can lead to heart attacks.

GranuFlo and NaturaLyte are kidney dialysis products manufactured by Fresenius Medical Care. GranuFlo is a dry acid concentrate used in dialysis. NaturaLyte is the liquid form of Granuflo. Both products are used to evenly distribute electrolytes in the blood during kidney dialysis. Additionally, these products are also supposed to stabilize blood bicarbonate, which neutralizes acid buildup. However, Granuflo and NaturaLyte have in many cases raised bicarbonate to dangerous levels.

GranuFlo and NaturaLyte Side Effect: High Bicarbonate Levels

High bicarbonate levels caused by GranuFlo and NaturaLyte can lead to serious heart problems including low blood pressure, heart attack, stroke, cardiac arrest, and death. Heart problems are the number one cause of death among kidney dialysis patients. GranuFlo and NaturaLyte pose an especially serious risk to kidney dialysis patients because patients who have used these products are six times more likely to experience heart problems than patients who did not.

Side effects of low blood pressure include shortness of breath, dizziness, and chest pain. Additionally, heart attack, stroke, and cardiac arrest are serious side effects of high bicarbonate levels caused by GranuFlo and NaturaLyte. Heart attack and stroke survivors suffer permanent damage after experiencing one of these heart problems. This permanent damage coupled with the human body’s response to a heart attack or stroke make the recurrence of a heart attack or stroke more likely. Finally, in 2011, Fresenius Medical Care issued an internal memo that linked GranuFlo and NaturaLyte to 941 deaths caused by heart attack, stroke, and cardiac arrest.

GranuFlo and NaturaLyte Side Effect: Low Potassium Levels

GranuFlo and NaturaLyte can also cause dangerously low potassium levels. Low potassium levels can cause a condition known as Hypokalemia. The side effects of Hypokalemia include muscle cramps, irregular heartbeat, damage to kidneys, and paralysis causing organ failure. The most serious consequence of low potassium is death.

Fresenius's GranuFlo and NaturaLyte Medical Studies

Fresenius Medical Care's GranuFlo and NaturaLyte were removed from the market June 2012 in response to the U.S. Food and Drug Administration's decision to impose it's strictest class of recalls.  The Class 1 recall came after the FDA was leaked an internal Fresenius memo that discussed the increased threat of heart attack posed by both GranuFlo and NaturaLyte.

According to the November 2011 memo, an internal study was conducted at Fresenius Medical Care, which showed that the products presented increased risk of cardiac arrest, and additionally, that that the increase in risk was as a result of the independent factors relating to the products themselves, rather than the common risks associated with common low pre-dialysis potassium. Titled "Dialysate Bicarbonate, Alkalosis, and Patient Safety," the memo detailed that during the year-long control study, of the 941 patients that suffered cardiopulmonary arrests, there was an average six-fold increase in risk of heart attack.  This memo, including the related study's results, were sent to varying department heads, but was purposefully kept from outside doctors using GranuFlo and NaturaLyte.

Since the release of the internal memo and it's conclusions about the increased risk of cardiac arrests and FDA's strong response, Fresenius Medical Care has attempted to defend itself by arguing that it has properly included the warnings on it's labels.  However, with the prospect of new medical studies aimed at investigating the conclusions of the internal Fresenius study and it's mere response that they have adequately warned about the risks, there is now increased pressure on the medical device manufacturer.

Fresenius's GranuFlo and NaturaLyte Lawsuits

Fresenius Medical Care's dialysis products GranuFlo and NaturaLyte have been the target of intense governmental scrutiny and have become targets for many large lawsuits.  At the heart of the impending claims will be how the manufacturer, Fresenius Medical Care, knowingly failed to disclose to the public information that it's kidney dialysis products posed a significant risk of causing heart attacks. The potential lawsuits will be as a response to The U.S. Food and Drug Administration's harsh punishment of ordering a Class 1 Recall (the strongest type the FDA can administer), after discovering that Fresenius Medical Care internally circulated and purposefully withheld from the public a memo that reported the results of a controlled self-study that found over 900 cases of heart attacks and significantly increased risks associated with its products.

With the harsh recall and abrupt end to GranuFlo and NaturaLyte's presence on the market, and the recent publication by the New York Times detailing Fresenious Medical Care's deceptive practices, claims and lawsuits by those injured are beginning to mount.

About Fresenius Manufacturer

GranuFlo and NaturaLyte are kidney dialysis products manufactured by Fresenius Medical Care. Fresenius Medical Care originated in Germany in 1912 but now provides kidney dialysis products and services worldwide. The company’s North American corporate headquarters are located in Waltham, Massachusetts. Currently, the company has over 2,700 clinics across the globe that provide about 32 million dialysis treatments to over 216,000 people every year. In 2003, the Food and Drug Administration (FDA) approved the kidney dialysis concentrates, GranuFlo and NaturaLyte, for sale on the market by Fresenius Medical Care. The company still advertises on its website that GranuFlo is the “safest dry acid product” even though the FDA has issued a recall on the product.

Fresenius Medical Care Internal Memo and FDA Recall

On November 4, 2011, Fresenius Medical Care issued an internal memo warning its doctors and dialysis service providers that its products, GranuFlo and NaturaLyte, had been reported to cause cardiac arrest and death. Specifically, the memo stated that in the past years the two products had caused 941 deaths. However, Fresenius Medical Care did not warn all doctors and dialysis service providers of the risks created by GranuFlo and NaturaLyte. The FDA received a copy of this internal memo and quickly issued a recall for GranuFlo and NaturaLyte. The FDA issued a “Class I recall,” its most serious recall.

GranuFlo and NaturaLyte Lawsuits Against Fresenius Medical Care

The release of the internal memo and the recall issued by the FDA have led many GranuFlo and NaturaLyte victims to file lawsuits against Fresenius Medical Care. Primarily, these lawsuits allege that the company breached its duty to provide adequate warnings regarding the increased risk of serious heart problems. Initially, Fresenius Medical Care failed to adequately warn consumers of the risks of GranuFlo and NaturaLyte. Subsequently, it failed to take reasonable steps to inform consumers that its products had been a major factor in 941 deaths. In one lawsuit, an Ohio woman’s husband went into cardiac arrest just minutes into undergoing dialysis. In another lawsuit, a Georgia man’s father died from a heart attack shortly after receiving dialysis. The decedent had been receiving dialysis three times a week. Dialysis patients need treatment on such a regular basis that each new treatment with GranuFlo and NaturaLyte amplified the risk of serious heart problems posed by the products. The GranuFlo lawsuits and NaturaLyte lawsuits pose a major risk of liability to Fresenius Medical Care because the company both manufactures dialysis products provides dialysis services. Therefore, the company will have greater difficulty claiming contributory negligence or supervening acts that would lessen or remove liability.

PLEASE SPEAK WITH YOUR DOCTOR BEFORE REFUSING OR WITHDRAWING KIDNEY DIALYSIS.

Have You or a Loved One Had a Heart Attack After Kidney Dialysis at a Fresenius Clinic or Using a Fresenius product?

If you or a loved one have had a heart attack or died after kidney dialysis using the Fresenius kidney dialysis products GranuFlo or NaturaLyte, you may want to speak with a personal injury attorney regarding a potential claim. d’Oliveira & Associates, P.C, Rhode Island personal injury lawyers, are working with some of the leading lawyers in the country who may be able to file a kidney dialysis heart attack lawsuit or claim on your behalf.

Please contact the law offices of d’Oliveira & Associates, P.C. at 1-800-992-6878 or fill out a contact form for a free legal consultation.