Granuflo Lawsuit Filed Againts Fresenius Due to Dialysis Side Effects

Granuflo Lawsuit Information

Granuflo, a dry acid concentrate used during dialysis in the treatment of kidney failure may have been linked to heart attack, stroke and death. Granuflo was according to an FDA alert, “manufactured and distributed from January 2008 through June 2012”. However, it may have been used under a different name prior to 2008. The manufacturer of Granuflo is under investigation and is currently facing Granuflo litigation. Free case evaluations are available to potential victims by filling out our contact form or by calling our toll-free number.

What is Meant by a Granuflo Heart Attack?

Granuflo is an acid concentrate used to aid in maintaining a delicate chemical balance in the blood of people suffering from kidney failure (chronic and acute). It is used as part of a chemical mix during hemodialysis and is only one of many chemicals that is available for use during dialysis. In 2010, the possibility of heart attack and death during the use of Granuflo was identified by Fresenius Medical Care. The product was not removed from the market but an internal investigation was started. “Granuflo heart attacks” is a descriptive term used to identify instances of heart attack or death by heart attack potentially linked to the use of Granuflo and Naturalyte acid concentrates. Are you concerned? Do you have questions about the use of Granuflo and heart attacks or stroke and possible legal rights? All case evaluations are free and are offered at your convenience by simply filling out our form or calling our toll-free number.

Why Might You Need a Granuflo Lawyer?

Granuflo litigation like all drug and medical device lawsuits are very complex. Fresenius Medical Care, the manufacturer of Granuflo Dry Acid Concentrate and Naturalyte Acid Concentrate, is the world’s largest manufacturers of dialysis equipment and supplies. In addition, they own dialysis centers all across the United States. Kidney dialysis represents a multibillion dollar market worldwide. Fresenius Medical Care will have lawyers with experience in complex litigation working to defend them. Allegations of wrong doing and failure to warn have been made against Fresenius. If you believe you have suffered harm due to a possible link to the use of Granuflo, you may have legal rights and may be entitled to financial compensation. You and your loved ones may need legal assistance from an experienced Granuflo lawyer. All initial consultations are free. Please call today.

How Was Granuflo Used?

Granuflo was used during kidney dialysis and specifically, during hemodialysis. During kidney dialysis, chemicals are mixed according to a specific prescription to keep certain aspects of blood chemistry within normal limits. The kidneys not only filter the blood of waste products but also control the pH (acid/base balance) of the blood. Normal blood pH is 7.35 – 7.45. Any value outside that range can become a serious even deadly concern if not addressed correctly. Granuflo was mixed with ultrapure water and other chemicals and used to raise blood pH or in other words, make the blood more alkaline. However, it is believed that patients may have been over compensated (possibly overdosed) by the use of Granuflo, causing their blood to become too alkaline which can cause heart attack, stroke, coma or death.

What are the Symptoms I Should Know About?

If a patient has kidney failure, chances are his or her blood will be too acidotic because the kidneys are not able to perform their daily functions. This is a condition called metabolic acidosis and is a potentially deadly condition. Kidney dialysis is used to help correct metabolic acidosis when necessary. Granuflo, it has been learned may have not been used correctly and may have caused the opposite condition, metabolic alkalosis. Symptoms of metabolic acidosis include:

Changes in respiratory rate (slowed breathing)
Complete respiratory arrest (stopped breathing)
Alveolar hypoventilation (see above)
Increase in PaCO2 (caused by alveolar hypoventilation)
Hypoxemia (not enough oxygen in the blood)
Cardiac arrhythmia
Confusion
Seizures
Heart attack
Coma
Death

Has There Been a Granuflo Recall?

Yes. On March 29, 2012 the Food and Drug Administration (FDA) notified healthcare professionals and the public about a Granuflo recall as well as Naturalyte recall. The recall was a class one recall, the most serious recalls by the FDA. As part of the recall, the FDA warns of the possibility of serious complications including heart attack and death. For more information about class one recalls or the Granuflo recall, you can visit the FDA’s website.

Did the FDA provide any additional information? Yes. The FDA included a list of serial numbers for the recalled products. The serial numbers along with the dates of use are important as they may have an impact on any potential Granuflo litigation. The serial numbers listed in the FDA’s safety notification can be found below.

Serial numbers for Naturalyte Liquid Acid Concentrate range from:

08-0231-4, 08-1001-0, 08-1201-8, 08-1231-3, 08-1251-1, 08-1301-4, 08-2201-5, 08-2231-2, 08-2251-0, 08-2301-3,08-2351-8, 08-3201-4, 08-3231-1, 08-3251-9, 08-3301-2, 08-4123-1, 08-4223-7, 08-4225-1, 08-4230- 2, 08-4231-0, 08-4323-5, 08-4325-1, 13-1251-1, 13-2201-5, 13-2231-2, 13-2251-0, 13-3231-1, 13-3251-9, 13-4123-1, 13-4220-1, 13-4225-1, 13-4325-1

Serial numbers for Naturalyte GranuFlo (powder) Acid Concentrate range from:

OFD1201-3B, OFD1251-3B, OFD2123-3B, OFD2201-38, OFD2220-3B, OFD2223-3B, OFD2225-3B, OFD2231-3 B, OFD2251-3B, OFD2301-3B, OFD2323-3 B, OFD2325-3B, OFD3201-3B, OFD3231-3B, OFD3251-3B, OFD3301-3B

What happens when I ask for a free case evaluation? Your questions will be given respectful consideration. You do not have to pay for a consultation. You are under no obligation if you request a free case evaluation. You may be asked a series of questions that will help evaluate your situation. It is beneficial if you have access to medical records but if not, your Granuflo lawyer, if you retain one, may be able to assist in obtaining necessary records.

Did you or a loved one suffer a heart attack during dialysis (or shortly after a treatment)?

The manufacturer of Granuflo and Naturalyte acid concentrates has been accused of failure to warn. Furthermore, it has reportedly been alleged that they withheld information from the FDA and from doctors and clinics using their products. It is true that people on dialysis are ill and may die but if a manufacturer’s failure to warn potentially caused or hastened their deaths they may be held accountable. Know your options. Call our toll-free number or if you prefer, fill out the contact form on this page.