Hemodialysis is supposed to save lives, not endanger them. Sadly, two popular dialysis concentrates have been recalled after causing fatal episodes of heart failure. The manufacturer, Fresenius Medical Care, recently recalled its GranuFlo and NaturaLyte products.
Medical data found that GranuFlo and NaturaLyte create a sixfold increase in heart attacks for dialysis patients, but what’s more shocking is how Fresenius handled the matter.
Fresenius was the first to see a connection between its two dialysate concentrates and heart failure. Not only does Fresenius manufacture medical products, it also operates the largest for-profit chain of dialysis centers in the U.S. Fresenius noticed that a disproportionate number of patients receiving GranuFlo and NaturaLyte were suffering devastating heart attacks during dialysis.
Fresenius distributed an internal memo to its dialysis centers, warning that the two dialysates may not be appropriate for patients with high bicarbonate levels; however, Fresenius did not share this knowledge with the U.S. Food and Drug Administration (FDA) or independent dialysis centers using its product. This decision unnecessarily put patients’ lives at risk.
Fortunately, a concerned whistleblower anonymously leaked the internal memo to the FDA in an effort to save lives. The FDA has condemned Fresenius’ actions and has been working on remedial measures, but plenty of harm has already been done.
If you or a loved one has suffered a heart attack while undergoing kidney dialysis, contact an experienced Michigan medication recall lawyer to discuss your legal options.
McKeen & Associates is a highly regarded Detroit-based law firm that maintains a national presence in its practice of medical law. If you live in the United States, contact us to discuss your legal rights to money damages.
Source: NorthJersey.com, “Dialysis Product Is Recalled And May Pose Fatal Risks,” Lindy Washburn, July 22, 2012