Dialysis is an important and often life-saving medical treatment. It seems, however, that the largest single dialysis provider in the nation has been deliberately withholding information from patients about a deadly defect in one of its products.
The FDA has begun an investigation into Fresenius Medical Care. Fresenius is not just the nation’s largest dialysis provider: it treats well over one-third of all dialysis patients nationwide. There are around 400,000 Americans on dialysis at any given time. The company also supplies dialysis machines and disposable dialysis supplies to hospitals, dialysis clinics, and other health care providers.
Dialysis is a process whereby a medical device takes the place of the human kidney in filtering waste from the bloodstream. In one part of dialysis, patients must be given bicarbonate to assist with neutralizing blood-borne acids. GranuFlo, a Fresenius product contains (among other active ingredients) a chemical converted by the body to bicarbonate.
The problem was that many doctors were not properly calculating the bicarbonate created by GranuFlo when determining how much separate bicarbonate to use in dialysis. Patients were thus effectively overdosing on bicarbonate, leading to heart problems and cardiac arrest. In fact, 941 dialysis patients had suffered a cardiac arrest in 2010 in Fresenius clinics alone. After comparing data on these patients to others, Fresenius doctors concluded that higher bicarbonate levels in a patient’s blood increases the risk of cardiac arrest six-fold.
The FDA became aware of the problem in March of 2012, when it received an anonymous tip-off.
Fresenius, however, has known about the problem since at least November of 2011, when it sent a memo to all doctors practicing in company dialysis centers. The memo stated that when the company’s products were not carefully and properly used, there was a sharp increase in patients going into fatal cardiac arrest.
The company did not, however, warn other centers and hospitals which use GranuFlo of the risk – until after the FDA received an anonymous copy of the memo and began to investigate.
Fresenius has defended its actions by stating that the data which prompted the internal memo was too preliminary to justify disclosure outside the company. Unfortunately, this left the approximately 125,000 patients who receive dialysis using GranuFlo in non-Fresenius clinics in great danger.
Now that the information has become public, dialysis centers across the country are monitoring bicarbonate levels in patients and adjusting dosages as necessary. What they have uncovered is shocking: around 30 percent of patients on GranuFlo had dangerously high bicarbonate levels. The risk, however, has now been neutralized, as physicians are aware of the problem and have taken steps to correct it.
This does not change the fact, however, that the company’s failure to inform its clients and patients of the risk, as soon as it became aware, is very likely both medical malpractice (as to the company’s clinic patients) and product liability (as to patients who received GranuFlo elsewhere). If you or a loved one experienced heart problems or cardiac arrest after dialysis treatment, contact an experienced attorney to discuss whether Fresenius’ failure to warn could be the cause of your condition.
For a free consultation with an experienced Chicago medical malpractice lawyer at Passen & Powell, call us at (312) 527-4500.