In 2012, the FDA began an investigation into whether the country's largest operator of dialysis centers failed to tell customers of the potentially lethal risks of its dialysis product.
Fresenius Medical Care treats more than one-third of the of the nation's 400,000 dialysis patients. The company is also the leading supplier of dialysis machines and related products, which are used in many of the clinics it does not operate.
In 2011, the company's medical office circulated an internal memo to physicians working in the company's dialysis centers, highlighting risks of the improper use of its GranuFlo product. The memo revealed use of the product seemed to be contributing to a sharp increase in the risk of patient death by sudden cardiac arrest.
However, Fresenius, which is headquartered in Germany, did not immediately tell other centers about the risks of using its GranuFlo product. Only after the FDA received the memo and asked the company, did it ultimately warn outside clinics of the dangers. In July, the FDA issued a Class I recall; the agency's most serious recall, it's issued when there is a reasonable probability a dangerous or defective medical product will cause serious adverse health consequences or death.
RenalWEB, a website voted to dialysis, first reported the controversy. It estimates about 125,000 patients in non-Fresenius clinics were treated with GranuFlo. GranuFlo contains more of an ingredient that converts to bicarbonate in the body than rival products. Bicarbonate is used in the dialysis process, which replaces kidney function in clearing toxic waste from the blood.
It's reportedly that higher concentrate in GranuFlo that is cause for concern, as doctors are not always accounting for the extra bicarbonate when prescribing treatment. The overdose can cause heart problems. Thus, the higher concentrate created the overprescribing risk, which in turn created the risk of serious or fatal hemodialysis induced cardiac injury.
There are two primary types of dialysis: hemodialysis and peritoneal dialysis. These cases involve hemodialysis, which filters blood through a machine to clear away harmful waste, extra salt and excess water.
Defenders of the GranuFlo product say the label provides enough information for doctors to determine the proper dosage. Still, when those instructions weren't followed, cardiac arrest often resulted.
The Fresenius memo reports nearly 1,000 dialysis patients suffered a heart attack inside a Fresenius clinic in 2010. The company concluded that patients with higher levels of bicarbonate in their blood were at six times higher risk of having a heart attack.
The company contends it had no way to notify outside clinics expect through clinical journals. However, it clearly could have done so through the supply chain where it routinely bundles GranuFlo and NaturalLyte with other products for pricing discounts.
Despite the known risks, the product remained in use until the recall. Health officials believe it was used at an estimated 3,300 dialysis clinics, serving approximately 260,000 dialysis patients.
Patients who suffered a heart attack while receiving dialysis should consult an experienced Massachusetts personal injury law firm. The Law Offices of Jeffrey S. Glassman offers free and confidential consultations to victims and families.
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