According to the Centers for Disease Control and Prevention, one in 10 adults in the U.S. has some form of chronic kidney disease which reduces kidney function over a period of time. One of the ways that people treat kidney disease is through the use of a dialysis machine to perform the blood filtering operation that the kidneys usually do. Few people suspect that by treating one disease they may be putting themselves at risk for other potentially fatal conditions. However, the FDA issued a recall of Fresenius Medical Care Naturalyte and GranuFlo dialysis products after reports that people had died after using them. Fresenius knew of the dangers prior to the recall but did not warn patients. As such, Fresenius may be liable for the harm that its products caused to patients.
FDA recall of dialysis products
On March 29, 2012, the U.S. Food and Drug Administration issued a Class I recall of Naturalyte and GranuFlo, the most serious type of recall involving products that have a reasonable certainty of causing serious health problems or death. The reason that the FDA recalled the products was due to reports that patients had developed dangerously high levels of serum bicarbonate after undergoing dialysis. High levels of serum bicarbonate can cause cardiac arrest, cardiopulmonary arrest, stroke, low blood pressure and possibly death.
Manufacturer knew of dangers
An internal memo that Fresenius issued in November 2011 revealed that the company was aware that patients were dying as a result of using their dialysis products. The memo informed doctors working in Fresenius clinics across the country that “only” 941 patients had died from cardiac complications due to elevated levels of serum bicarbonate. The memo also noted that patients using Fresenius dialysis products were six times more likely to suffer cardiac arrest than those who used competitors’ dialysis products.
The company chose not to broadcast this information to doctors outside its own clinics, even though it sold its dialysis products to other health care providers until the FDA obtained a copy of the internal memo and forced a product recall.
Speak with an attorney
When medical product manufacturers discover the products they make cause harm, they have a responsibility to inform people. Medical product manufacturers need to be held responsible for the harm that their products cause, as well. If you or a loved one has suffered injury after undergoing dialysis, speak with an experienced personal injury attorney who can help you recover just and proper compensation.