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.
WHAT IS GRANUFLO?
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:- Eye irritation or soreness
- Skin irritation
- Lung irritation
- Vomiting
- Diarrhea
- Muscle cramps
- Listlessness
- Low blood pressure
- High blood pressure
- Irregular heart beat
GRANUFLO ASSOCIATED WITH FATAL HEART CONDITIONS
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:- Cardiopulmonary arrest: Also known as cardiac arrest, this is a sudden and abrupt loss of heart function, breathing and consciousness.
- Metabolic alkalosis: This condition develops when your body loses too much acid or gains too much base.
- Hypotension: This occurs when blood pressure is so low that is prevents vital organs like the brain and heat from receiving the oxygen and nutrients they need to function properly.
- Stroke: Granuflo may disrupt the blood flow to certain vital organs, including the brain. When this occurs, patients are at risk of suffering a stroke. This may lead to patients’ brain cells dying, causing paralysis and loss of speech.
- Hypoxemia: This occurs when there is an insufficient amount of oxygen in the blood, and it may result in shortness of breath, coma and death.
- Hypercapnia: This occurs when there are toxic levels of carbon dioxide in the blood and may result in rapid breathing, muscle twitches and an inability to think clearly.
- Cardiac arrhythmia: This is a condition that causes disruptive, irregular heartbeats that leaves patients feeling light-headed, dizzy or unable to perform daily tasks.
- Heart attack: This occurs when the dry acid concentrate in GranuFlo dangerously reduces or completely cuts off the flow of blood and oxygen to the heart muscle, resulting in damage or death of part of the heart muscle.
- Chest pain
- Dizziness
- Shortness of breath
- Coughing
- Fainting
- Nausea or vomiting
- Fast or irregular heartbeats (heart palpitations)
CONTROVERSIES SURROUNDING GRANUFLO
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.FDA ISSUES GRANUFLO RECALLS
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.WHY GRANUFLO LAWSUITS ARE BEING FILED
Thousands of GranuFlo lawsuits have been filed by dialysis patients and their family members against Fresenius Medical Care, alleging:- Fresenius Medical Care negligently manufactured and sold an unreasonably dangerous defective product.
- GranuFlo was insufficiently tested and is unsafe as currently designed.
- Fresenius Medical Care provided inadequate warnings about GranuFlo that failed to warn the medical community about the nature and extent of the risk of cardiac arrest, heart attack and death caused by GranuFlo.
- Fresenius Medical Care continued to manufacture and sell GranuFlo after it discovered the drug was dangerous.
- Fresenius Medical Care provided critical information about the risks and dangers of GranuFlo to doctors working at the company’s clinics before alerting other dialysis centers that used their products.
- Fresenius Medical Care withheld important information about GranuFlo to maintain the company’s market share and maximize its own profits at the expense of dialysis patients receiving its products.
