Fresenius Medical Care: GranuFlo and NaturaLyte Dialysis Products

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Current Cases / Fresenius Medical Care: GranuFlo and NaturaLyte Dialysis Products

The U.S. Food & Drug Administration recently declared a Class I recall of Fresenius Medical Care's GranuFlo and NaturaLyte dialysis products. After an internal Fresenius memo was leaked to the FDA, the company warned its customers that the products have been linked to elevated bicarbonate levels, a contributing factor in cardiac arrest.

According to the FDA website:

"FDA issued a Class I Recall notice for Fresenius Medical Care North America Naturalyte Liquid Acid Concentrate and Naturalyte GranuFlo (powder) Acid Concentrate. Inappropriate prescription of these products can lead to a high serum bicarbonate level in patients undergoing hemodialysis. This may contribute to metabolic alkalosis, which is a significant risk factor associated with low blood pressure, hypokalemia, hypoxemia, hypercapnia and cardiac arrhythmia, which, if not appropriately treated, may culminate in cardiopulmonary arrest. This product may cause serious adverse health consequences, including death."

See: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm305630.htm

The company, Fresenius Medical Care, treats more than a third of the estimated 400,000 Americans receiving dialysis. It also is the leading supplier of dialysis machines and disposable products, which are used by many clinics in addition to its own.

Last November, Fresenius’s medical office sent an internal memo to doctors practicing in the company’s dialysis centers, warning them that failure to properly use one of the company’s products appeared to be contributing to a sharp increase in the risk of patients dying suddenly from cardiac arrest. A copy of that internal "Fresenius Medical Care North America" memorandum to doctors and attending physicians, dated November 4, 2011, is located here: http://audetlaw.com/documents/fresenius-memo.pdf

But Fresenius, which is based in Germany, did not immediately warn other centers that use the product, which is known as GranuFlo. It did so only in late March after the F.D.A. received, anonymously, a copy of the internal memo and questioned the company about it.

[from published reports]

If you, or someone you love, has been injured by Fresenius Medical Care's GranuFlo and NaturaLyte dialysis products, please contact the Law Firm of Audet & Partners today, to protect your legal rights. You may call us in confidence, toll-free, at 800.965.1461, or you may use the confidential and easy form on the right side of this page. Please act now, since your time to recover potential losses, and seek compensation under law, may be limited by various factors, including statutes of limitation.

Frequently Asked Questions (FAQs) about Granuflo® & NaturaLyte® Dialysis Medical Products

Our defective medical product attorneys at Audet & Partners, LLP are currently accepting cases from individuals who have suffered serious injury caused by the NaturaLtye and Granuflo medical products used in Fresenius dialysis centers, which is the largest network of dialysis centers in the U.S. Fresenius uses their own products when providing dialysis including the NaturaLyte and Granuflo products. If you have received dialysis at a Fresenius dialysis center and have suffered serious complications, you may have a right to seek legal compensation. The best way to obtain a free evaluation of your legal claim is to contact our Bay Area defective medical device attorneys, but we have provided answers to some common questions below.

What are the Granuflo and NaturaLyte medical products?

These substances are used in the treatment of kidney failure when patients undergo hemodialysis. These products are produced by Fresenius and until recently used in its dialysis centers, but the manufacturer also marketed the Granuflo and NaturaLyte product to other dialysis centers. These medical care products are designed to be used with three-stream dialysis machines, which are calibrated for proper concentration of bicarbonate and acid.

What types of harm may be caused by these dialysis products?

The FDA has issued a recall because these medical products contain substances that the body converts to bicarbonates that may result in excessive levels of bicarbonate in the blood stream. Because physicians may not be aware of these elevated levels of bicarbonate, the physician may prescribe too much bicarbonate. Abnormally high bicarbonate levels may result in cardiac problems and heart attack.

How serious is the risk of serious cardiac conditions posed by these Fresenius dialysis products?

Reports of adverse cardiac incidents at Fresenius dialysis centers revealed that the risk of heart attack was increased six-fold when patients received dialysis where the Granuflo product was utilized. The FDA has issued a recall of both substances because of the elevated rates of heart attack, serious cardiac issues and deaths related to the substances.

Was the manufacturer aware of the risks associated with the use of Granuflo and NaturaLyte?

Fresenius was so concerned with the potential risks of heart attack that the manufacturer sent letters to its dialysis centers in November 2011 that addressed the issue and indicated that there had been 941 cases of heart attack at its treatment facilities during 2010. Nonetheless, Fresenius did not inform patients of the risk until March 29, 2012. When the letter was sent to Fresenius dialysis clinics, the information was not disclosed to the FDA or to other dialysis centers that use the NaturaLyte and Granuflo dialysis products.

What types of injuries have been reported by those treated with these Fresenius dialysis medical products?

While serious cardiac problems, heart attack and death are the most significant injuries that have been associated with use of NaturaLyte and Granuflo during dialysis, other reported injuries include hypoxemia (poorly oxygenated blood), hypercapnia (abnormally high levels of carbon dioxide in the blood), low blood pressure and cardiac arrhythmia (irregular heart beat).

If you or someone you love has suffered a heart attack or other serious adverse effects that may be related to dialysis treatment with the Granuflo or NaturaLyte medical products, our experienced San Francisco medical products attorneys at Audet and Partners, LLP offer a free consultation so that we can evaluate your legal claim and advise you of your options. We invite you to call us at (800) 965-1461 or email the confidential case inquiry form on the right side of this page.

Serious Cardiac Incidents Prompt FDA Recall of Fresenius NaturaLyte® and GranuFlo® Dialysis Drugs

The FDA is currently investigating reports indicating that Fresenius Medical Care, which is the country’s largest operator of dialysis medical clinics, failed to disclose serious medical complications caused by its NaturaLyte®and GranuFlo®dialysis products. These dialysis medical products have been found to release excessive levels of bicarbonate which can promote unsafe elevated levels of alkaline. This is a medical condition referred to as metabolic alkalosis, which can cause serious cardiovascular-related incidents and sudden death. Cardiac incidents account for almost sixty percent of dialysis-related fatalities.

Granuflo Dialysis Lawsuit

Because warnings were not provided to physicians that the GranuFlo®and NaturaLyte®products caused higher levels of bicarbonate than dialysis medical devices produced by other manufacturers, physicians may have prescribed additional amounts of bicarbonate resulting in overdosing the patient. These unnaturally high levels can cause severe cardiac problems and other symptoms, such as:

> Stroke
> Depressed blood pressure
> Heart arrhythmia
> Impaired mental functioning
> Cardiac arrest
> Hemodialysis cardiopulmonary arrest
> Heart attack
> Hemodialysis cardiac arrest
> Death

The use of these dialysis products have been linked to a six-fold increase in sudden cardiac death and cardiopulmonary arrest. Lawsuits against the manufacturer are eminent because Fresenius was aware of the risk of dangerous cardio incidents and death associated with its product but failed to warn patients or physicians until 2012. Because of the excessive level of cardiac arrest incidents in Fresenius Medical Care facilities in 2010, the company circulated an internal memo to its individual clinic facilities in early November of 2011.

However, the company did not advise the public of the risks until the FDA received an anonymous copy of the November memo. It was only after the FDA became aware of the November 2011 memo that Fresenius warned the public of the risk of elevated bicarbonate levels and the attending risks of sudden cardiopulmonary arrest and sudden cardiac death. The company conducted a study and found that dialysis patients in their clinics were six times more likely to suffer a serious cardiac incident if they had elevated bicarbonate levels.

Because serious cardiac incidents and deaths have been linked to the GranuFlo®and NaturaLyte®dialysis products, the FDA issued a Class 1 recall of the dialysis products on March 29, 2012. Class 1 recalls are the most serious type of FDA recall reserved for situations where a medical product may cause adverse health consequences or death. If you received dialysis treatment at a Fresenius Medical Clinic and have experienced serious cardiac complications or a loved one has died, our experienced defective medical product attorneys at Audet and Partners, LLP offer a free consultation so that we can evaluate your legal claim and advise you of your options. We invite you to call us at (800) 965-1461 or email the confidential case inquiry form on the right side of this page.

Fresenius Medical Failed to Warn Thousands of Dialysis Patients of Heart Attack Risks

As reported by the New York Times earlier this year, Fresenius Medical Care failed to warn thousands of dialysis patients about the increased risk of cardiac arrest associated with the use of its products Granuflo and Naturalyte. Fresenius operates a number of dialysis clinics across the U.S., but it is also the leading supplier of dialysis products and equipment to other dialysis centers.

In November 2011, Fresenius discovered a sharp increase in the number of patients suddenly dying from cardiac arrest when its Granuflo and Naturalyte products were not used properly. After learning of these risks, the company sent an urgent memo warning doctors working in its own clinics of this problem, but did not take any action to warn other dialysis centers that use these products.

The six-page memo from Fresenius to its own clinics detailed the company’s findings that increased levels of bicarbonate found in patients using Granuflo and Naturalyte, as opposed to rival products, posed a significant safety risk to patients. Doctors apparently needed to account for the extra bicarbonate when using Granuflo or Naturalyte in patient prescriptions or else patients were at six times the risk of cardiac arrest and other heart problems.

The Food and Drug Administration (FDA) apparently received an anonymous copy of the internal Fresenius memo and began an investigation into this matter. As a result of the FDA investigation, in late March 2012, months after learning of their findings, Fresenius then warned other centers that use its products of the increased risks. Steven Silverman, the FDA’s Director of Compliance for the Medical Devices Division, was quoted in the NYT article that he was “personally…troubled by the fact that Fresenius on its own initiative didn’t notify its entire customer base of this particular concern” and that he believed it was “…not in the interests of public health to sit on information about risks.”

When Fresenius’ Chief Medical Officer was asked why the company didn’t warn all the users of its product about the risks, he responded that the company’s findings were “too preliminary too warrant publication” for “general consumption.” Dialysis centers that used Granuflo and Naturalyte disagreed – if the data was important enough to warn their Fresenius’ own doctors, then everyone who used Fresenius products should have been warned. Hundreds of thousands of patients were treated with Granuflo in non-Fresenius clinics.

If you’ve experienced heart problems after using Granuflo or Naturalyte, seek immediate medical care. Patients who would like to learn more information about their legal rights are encouraged to call our law firm, Audet and Partners, LLP, at (800) 965-1461 or visit our website at http://www.granuflodialysisrisk.com.

Locations of Fresenius Fresenius Vascular Care Centers

Audet and Partners, LPP, a national class action law firm with expertise in pharmaceuticals and defective medical devices, has published a new website at www.granuflodialysisrisk.com for those who have suffered adverse side effects from GranuFlo and/or Naturalyte used in dialysis. This site also lists all Fresenius Vascular Care Centers in the United States. For more information, please visit http://www.granuflodialysisrisk.com.

Patients Who Used GranuFlo or NaturaLyte Dialysis Products at Increased Risk of Heart Problems

Earlier this year, the Food and Drug Administration (FDA) issued a recall of Fresenius Medical Care's GranuFlo and NaturaLyte dialysis products after it was revealed they caused an increased risk of heart attack and death.

Dialysis Recall: An internal memo circulated at some of the Fresenius Medical Care centers about dangers experienced by patients including heart attacks and excessive rates of cardiac arrest. Patients receiving dialysis treatments with GranuFlo or NaturaLyte were suddenly dying from cardiac arrest if the products were used in an improper fashion. While the company alerted some of the centers and staff of this news, it did not do so regarding risks associated with the use of its products. The FDA issued a Class 1 recall of the products, the most serious classification of FDA recall.

FDA Investigation: It is alleged that Fresenius Medical Care knew of the dangers associated with its products, but nevertheless continued to market the highly profitable drugs to the public . The FDA investigation uncovered company research that its patients were at six to eight times greater risk of cardiac arrest when using the company’s dialysis products, yet the company decided not to warn the public of that risk.

Granuflo Lawsuit: Fresenius Medical Care now faces numerous GranuFlo lawsuits. Any patient who suffered a heart attack after receiving dialysis treatment with GranuFlo or NaturaLyte products may be entitled to compensation. If you've suffered heart problems after receiving dialysis treatment, whether during or after the treatment, you may be eligible to join a GranuFlo lawsuit or NaturaLyte lawsuit.

To find out if you have grounds for a class action lawsuit or personal injury lawsuit for damages, contact the law firm of Audet and Partners LLP today at (800) 965-1461.

Call now at (800) 965-1461 or fill out the Granuflo lawsuit contact form on our website. We offer free consultations.

Leaked Internal Memo From Fresenius Medical Regarding Granuflo and NaturaLyte Heart Attack Risk

Fresenius Medical Care, treats more than a third of the estimated 400,000 Americans receiving dialysis. It also is the leading supplier of dialysis machines and disposable products, which are used by many clinics in addition to its own.

Last November, Fresenius’s medical office sent an internal memo to doctors practicing in the company’s dialysis centers, warning them that failure to properly the company’s "Granuflo" and "NaturaLyte" products appeared to be contributing to a sharp increase in the risk of patients dying suddenly from cardiac arrest. A copy of that internal "Fresenius Medical Care North America" memorandum to doctors and attending physicians, dated November 4, 2011, is located here: http://audetlaw.com/documents/fresenius-memo.pdf

Fresenius on U.S. Regulator's Radar Over Dialysis

FRANKFURT (Reuters) - U.S. health regulators are looking at whether Fresenius Medical Care violated any rules by failing to alert dialysis clinics about risks linked to one of its products.

Last November, the German company sent a memo to dialysis centers that it operates in the United States, warning them about a link between dosing errors with its GranuFlo product and a higher risk of cardiac arrest.

But FMC did not send the memo to other U.S. dialysis centers that may use GranuFlo, but are not operated by the company.

After learning of the memo in March, the U.S. Food and Drug Administration asked Fresenius to broaden its notification to all customers.

Dialysis Company’s Failure to Warn of Product Risk Draws Inquiry

The Food and Drug Administration is investigating whether the nation’s largest operator of dialysis centers violated federal regulations by failing to inform customers of a potentially lethal risk connected to one of its products, an F.D.A. official said.

Fresenius Medical Care treats more than a third of the Americans receiving dialysis. It also is a supplier of dialysis machines.

Dialysate Concentrates Used in Hemodialysis: Safety Communication - Alkali Dosing Errors

[UPDATED 06/27/2012] FDA issued a Class I Recall notice for Fresenius Medical Care North America Naturalyte Liquid Acid Concentrate and Naturalyte GranuFlo (powder) Acid Concentrate. Inappropriate prescription of these products can lead to a high serum bicarbonate level in patients undergoing hemodialysis. This may contribute to metabolic alkalosis, which is a significant risk factor associated with low blood pressure, hypokalemia, hypoxemia, hypercapnia and cardiac arrhythmia, which, if not appropriately treated, may culminate in cardiopulmonary arrest. This product may cause serious adverse health consequences, including death.

For further information and list of Product Serial numbers please see the Class 1 Recall Notice.

Important Notice

Persons seeking to preserve any potential legal claims should contact an attorney promptly, since all states have mandatory time periods in which lawsuits must be filed with the courts; otherwise, they may be forever barred.

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