The attorneys of Bubalo Goode Sales & Cronen are assisting patients or the families of patients who have been injured after having received the Granuflo kidney dialysis product. Granuflo has been the subject of multiple legal complaints alleging that it has caused death and injury to patients treated with it.
Below are several questions about Granuflo to which Bubalo Goode Sales & Cronen attorneys frequently respond. If you have more questions, or want to discuss your case with an experienced personal injury / wrongful death attorney, contact us at 866-870-2489 or through our online form today.
We are representing clients throughout the country and filing these claims in Boston, where FRESENIUS, the maker of Granuflo, is located and where Bubalo Goode Sales & Cronen has an office.
Granuflo Dry Acid Concentrate is an additive that, when combined with purified water, creates a DIALYSATE used in the process of dialysis. A DIALYSATE is used in the process of hemodialysis to help clean the blood of patients with kidney failure. Granuflo was manufactured and distributed from 2003 through June 2012, when it was recalled by the U.S. Food and Drug Administration in June 2012.
Granuflo is made by Fresenius Medical Care North America of Waltham, Massachusetts. Fresenius Medical Care North America is a division of Fresenius Medical Care, the world’s largest manufacturer of dialysis products and equipment, and provider of dialysis services.
Fresenius operates more than 2,100 dialysis clinics in North America.
Granuflo contains sodium diacetate (acetic acid and sodium acetate). Because of its unique formula, Granuflo increases the amount of acetate in DIALYSATE (the fluid and solutes in a dialysis process that flow through the dialyzer machine) compared to more traditional formulations, which are made with acetic acid. The use in Granuflo of sodium diacetate (versus acetic acid) frequently causes an unintended increase in bicarbonate in hemodialysis patients which, in turn, can cause arrhythmias, injuries such as stoke and sudden cardiac death.
Internal memos obtained from the maker of Granuflo, Fresenius Medical Care, reveal that FRESENIUS knew that about this problem for years, yet failed to correct it.
The U.S. Food and Drug Administration (FDA) finally discovered the safety issues relating to Granuflo when someone anonymously provided FDA with an internal memo reporting a potential problem with the product. In response, FDA issued a Class I recall of Granuflo acid concentrates on June 29, 2012. “Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death,” the FDA says.
The drug and device injury attorneys at Bubalo Goode Sales & Cronen are investigating cases and pursuing legal claims on behalf of dialysis patients who have been injured by the administration of Granuflo or the families of patients who died after receiving Granuflo.
Manufacturers like Fresenius Medical Care are obligated legally to ensure their products are safe and effective and further must provide adequate instructions for the appropriate use of such medical products. Manufacturers, like FRESENIUS, must promptly act when informed of a safety problem with their medical products. After a product enters the market, such manufacturers must monitor their products to continue to assure the safety of patients. If the manufacturer learns that a product may pose a danger to its users, the manufacturer is legally obligated to promptly advise the Food and Drug Administration and others.
When manufacturers violate their legal obligations, they are liable for any harm their product causes users. Bubalo Goode Sales & Cronen attorneys are working to hold Fresenius Medical Care accountable for our clients’ injuries and deaths, which we believe are attributable to Granuflo.
If you or a family member of yours has suffered an injury that you believe was caused by the administration of Granuflo during kidney dialysis, Bubalo Goode Sales & Cronen can review the details of your case and advise you of the legal options available to you.
If we think your claim is valid, and you agree to us proceeding, we will vigorously pursue a legal claim on your behalf. Bubalo Goode Sales & Cronen first tries to negotiate fair and proper settlements of lawsuits as a means to conclude cases quickly and allow our clients to get on with their lives. When we cannot reach a settlement that meets our client’s satisfaction, we prepare strong and persuasive cases for trial.
There is no charge for an initial legal consultation with an attorney from Bubalo Goode Sales & Cronen.
If you ask Bubalo Goode Sales & Cronen to pursue a legal claim on your behalf, you still pay nothing unless and until you receive financial recovery. Bubalo Goode Sales & Cronen legal fees are based on an agreed upon percentage of the settlement or court award that we obtain for you.
Call Bubalo Goode Sales & Cronen at 866-870-2489 or complete our online form to set up a meeting. Personal injury and wrongful death lawsuits have strict time deadlines, so we should get started as soon as possible or you could forfeit your right to compensation that you and your family deserve. We accept claims throughout the county, in order to file them in Boston, Massachusetts where our firm has an office and is admitted to practice. We are also admitted to practice in many other states, including Kentucky, Tennessee, Indiana, Missouri and others.
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