Affymax, Inc. (AFFY)

[Baron von Stocks]

This may be evidence of a problem with Fresenius and not Affymax. Fresenius has had problems in the past with deaths due to dialysis.
Through the years, dialysis has saved countless lives. Kidneys are necessary to keep the body functioning well, but some patients eventually develop renal failure. Dialysis machines partially replace the function of these machines and allow patients to survive until they can receive a transplant. Because the kidneys performs so many functions, a cocktail of drugs are necessary.

One important function of the kidneys is to filter acids, and two products from Fresenius Medical Care have been linked to sudden cardiac arrest in patients. Because of their alleged mishandling of information showing evidence of risk, Fresenius is now under fire and is likely to face a number of lawsuits in the coming years.

The trouble for Fresenius results from the fact that they appeared to be concerned about their products but did not take appropriate steps according to some analysts. An internal memo from Fresenius seemingly shows that members of the company were aware of potential problems but did not alert doctors appropriately. Because of this, many doctors prescribed dangerously high doses of GranuFlo and NaturaLyte that may have put patients at risk.

With sufficiently high doses of GranuFlo and NaturaLyte, patients are likely to experience a buildup of bicarbonate in patients’ blood. These high levels have been linked to heart arrhythmias and sudden cardiac arrest in many cases. Studies have conclusively linked the use of GranuFlo and NaturaLyte to a significantly increase rate of death for patiently undergoing dialysis treatments.

The FDA recalled both of these products in late June of 2012 after releasing a series of advisories upon receiving the Fresenius memo. Their quick action has lead many legal experts to speculate that significant lawsuits will shortly come as patients learn that their doctors were not given the information necessary to make the right decisions for their dialysis treatments.