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O’Connor, Acciani & Levy’s defective drug attorneys are reviewing claims filed by patients who were administered GranuFlo, a dialysis drug that has been linked to hundreds of deaths.
If you or a loved one was administered GranuFlo during a dialysis treatment and suffered a heart attack or other health complications, you may be entitled to compensation through a GranuFlo lawsuit. At O’Connor, Acciani & Levy, we are dedicated to defending the rights of victims of defective drugs and will not hesitate to hold pharmaceutical corporations liable for their negligence.
Our Cincinnati GranuFlo lawyers will provide you with a free, no obligation consultation to review your claim and determine if you have legal options to file a lawsuit. We have a strong history of obtaining millions in verdicts and settlements and provide all of our services at no upfront cost. The only time we will charge you is if we recover compensation for your case.
GranuFlo is an acid concentrate used in dialysis solution, or dialysate, for dialysis treatment for acute and chronic kidney failure.
The drug was first released in the U.S. in 2003 by the German pharmaceutical manufacturer Fresenius Medical Care. GranuFlo is unique because it is a dry powder that contains a chemical substance called sodium diacetate. This substance is commonly found in baked goods and other foods as an agent used to kill or stop the growth of microorganisms.
Additionally, GranuFlo is a type of dialysate called hemodialysis. Typically, this type of dialysis treatment is done about three times a week and is most commonly performed at a dialysis clinic. Hemodialysis extracts blood from the body where it is filtered by an artificial kidney known as a dialyzer. The extracted blood is then returned to the body by a separate tube after it has been rid of waste and excess water.
Dialysis patients who were administered GranuFlo have reported experiencing several adverse side effects and other medical complications, including:
Continuous overexposure to GranuFlo may result in metabolic abnormalities such as high levels of sodium in the blood and increased alkaline levels in the blood or loss of acid in the blood. However, these side effects can have an adverse impact on certain patients’ health and may lead to serious medical complications.
Granuflo has been linked to several complications that can cause serious heart problems and other cardiovascular conditions.
Dialysis treatment is a difficult process that is used when damaged or failed kidneys can no longer naturally cleanse the body of toxic waste. However, because GranuFlo contains sodium acetate, it can cause a patient’s bicarbonate levels to rise to dangerously high levels.
When a dialysis patient is administered an improper mix of Granuflo and experiences an increase in his or her bicarbonate levels. This can lead to several life-threatening medical complications, including:
Heart attacks, cardiac arrest and other cardiovascular conditions can be fatal. It is important that you immediately contact a health care provider it you experience:
If you or someone you love experienced a dangerous heart condition after receiving GranuFlo dialysis, you should contact a skilled defective drug attorney as soon as possible to determine if you can file a GranuFlo lawsuit.
Since GranuFlo was first released in 2003, the dialysis drug has been involved in several controversies regarding its safety for patient use.
In November 2011, Fresenius Medical Care released an internal memo warning medical staff at the company’s dialysis clinics that improperly using GranuFlo increases patients’ risk of suddenly dying from cardiac arrest.
The memo highlighted patient safety data that found 941 patients had suffered cardiac arrest inside Fresenius Medical Care clinics in 2010. The company’s medical staff concluded that patients with high levels of bicarbonate in their blood had approximately six times the risk of suffering cardiac arrest as patients with lower levels.
However, Fresenius Medical Care neglected to immediately warn physicians at other dialysis centers that use GranuFlo until March 2012 when the U.S. Food and Drug Administration (FDA) received an anonymous copy of the internal memo and confronted the company.
In March 2012, Fresenius Medical Care released a product notification warning its customers that GranuFlo can increase patients’ risk of dying from cardiac arrest. The FDA also released a safety warning in May 2012 that applied to all dialysis products similar to GranuFlo.
In May 2012, the FDA issued a Class I recall for GranuFlo after it received reports of numerous dialysis patients with dangerously high levels of bicarbonate in their bloodstream. A Class I recall is the most serious type of recall and is reserved for dangerous and defective products that could cause serious health problems or death.
Furthermore, Fresenius Medical Care’s handling of GranuFlo and its delay in alerting the medical community of the drug’s adverse health effects led the FDA to open an investigation into the company in June 2012, according to a New York Times GranuFlo report.
In January 2013, the FDA issued a Class III recall for more than 5,600 GranuFlo units. The FDA alerted all dialysis clinics carrying GranuFlo to isolate the drug and return it to Fresenius Medical Care North America.
Thousands of GranuFlo lawsuits have been filed by dialysis patients and their family members against Fresenius Medical Care, alleging:
Many GranuFlo lawsuits claim Fresenius Medical Care intentionally hid all evidence that GranuFlo put patients at risk of dying from cardiac arrest and other heart complications. Furthermore, because GranuFlo was widely administered to thousands of dialysis patients in the U.S., GranuFlo lawsuits allege Fresenius Medical Care is responsible for hundreds of deaths and injuries.
In 2016, Fresenius Medical Care agreed to pay a $250 million to settle more than 10,000 GranuFlo lawsuits filed by dialysis patients and their family members. The settlement was made “in principle,” which means Fresenius Medical Care agreed to the settlement without admitting to any fault in marketing a defective drug or that the company was negligent in withholding the risks linked to GranuFlo from the medical community and the general public.
Do not hesitate to contact our defective drug attorneys for a free, no obligation consultation to discuss your claim. We provide all of our services on a contingency fee basis and will not charge you upfront legal fees. The only time you have to pay our defective drug attorneys is if we help you recover compensation.
Pharmaceutical corporations and manufacturers, like Fresenius Medical Care, have an obligation to provide safe and effective drugs that do not cause patients harm. When a pharmaceutical company fails to uphold this standard, it should be held liable for the pain and suffering it causes.
If you believe you may be entitled to compensation through a class action lawsuit, contact a Cincinnati GranuFlo lawyer from O’Connor, Acciani & Levy to schedule a free, no obligation consultation as soon as possible. We have the skills and resources you need to bring a claim against a large pharmaceutical corporation, and we will not charge you unless we recover compensation for your case. There is no risk in finding out if you may be entitled to file a GranuFlo lawsuit.