What are the health risks associated with GranuFlo and NaturaLyte?
Nearly 2 million men and women worldwide suffer from chronic kidney failure. Recently the U.S. Food and Drug Administration (FDA) issued a Class 1 recall of two drugs frequently used in the treatment of the disease, GranuFlo and NaturaLyte, because they put patients at significant risk of serious injury or even death.
If you are a dialysis patient and have suffered from any of the following conditions, the injury may be the result of your dialysis center using GranuFlo or NaturaLyte:
- Heart attack or myocardial infarction
- Heart problems
- Hypotension (low blood pressure)
- Metabolic alkalosis
- Cardiopulmonary arrest
- Cardiovascular death
Why the FDA issued a Class 1 recall on these dialysis drugs
Both GranuFlo and NaturaLyte have been shown to cause alkalosis, a condition associated with an increase in cardiovascular death and catastrophic cardiovascular injuries in dialysis patients. As early as November 4, 2011, an internal memo issued by the manufacturer, Fresenius Medical Care AG, reveals that the company knew there was significant risk of cardiac arrest and death during hemodialysis treatments when GranuFlo was used. There are also indications that top company officials have known about potential problems since the product's introduction in 2003. It has been alleged that when the manufacturer's medical services division began acknowledging the problem in 2010, top company executives did not report the problem to the FDA, but instead withheld information putting the public at great peril. In March 2012, the manufacturer issued an 'urgent product notification" with 'important prescribing information" highlighting risk factors associated with GranuFlo and NaturaLyte. According to findings, use of the products puts patients at significant risk for cardiopulmonary arrest.
How will I know if I am at risk?
If you are on dialysis in the United States, you may be at significant risk of injury from the use of GranuFlo and NaturaLyte. Manufacturer Fresenius Medical Care AG is the largest dialysis services and products company in the world, treating more than a third of the estimated 400,000 dialysis patients in the United States as well as many thousands more worldwide. Fresenius itself operates over 1,800 kidney dialysis clinics in the United States and more than 2,700 clinics elsewhere in the world. In addition, it is also a leading supplier of products used in dialysis clinics it does not own.
What to do if you are at risk
If you or a member of your family who is on dialysis has been treated for any of the conditions listed above, you may be entitled to compensation. The best way to assess your risk is to contact us immediately at 303-953-6784.
Bachus & Schanker is one of the largest personal injury law firms in Denver, Colorado Springs, and Fort Collins, Colorado. Our team of experienced attorneys is committed to seeking justice on behalf of those injured or killed through a medical product manufacturer's negligence or deception.
Health problems from use of Granuflo?
If you or any member of your family has experienced negative side effects from the use of Granuflo dialysis product, then please contact us right away at 303-953-6784.
All of our Colorado Granuflo attorneys work on a contigency basis, which means you will pay no up front out-of-pocket money.