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GranuFlo and NaturaLyte are chemical products used in dialysis machines to help clean the blood of patients with kidney impairment. These ingredients are intended to prevent the buildup of dangerous acids that are naturally removed in people whose kidneys function normally. Recent information has come to light, however, that these products may also increase patients’ risk of having a heart attack or other serious cardiovascular problems.
Fresenius Medical Care, the maker of GranuFlo and NaturaLyte, is one of the largest dialysis product manufacturers in the world. Fresenius owns a majority share in the multi-billion dollar dialysis market and operates dozens of dialysis centers across the country, providing dialysis for over 100,000 people in the United States alone.
According to a recent New York Times article, the FDA is now investigating whether Fresenius violated federal regulations in failing to inform patients and doctors of a potentially lethal risks connected to its products. The New York Times has discovered that Fresenius’s medical office sent an internal memo to doctors working in its own dialysis centers to warn that the use of their products could potentially be fatal. However, Fresenius failed to warn other dialysis centers using its products of the same risk until after the FDA received an anonymous copy of the internal memo.
On March 29, 2012, the U.S. Food and Drug Administration (FDA) issued a recall of GranuFlo and NaturaLyte, stating that the use of these products can result in dangerously high levels of bicarbonate, which can cause metabolic alkalosis – a condition associated with low blood pressure, cardiac arrhythmia, heart attack, cardiac arrest and other cardiovascular problems.
It is unclear how many dialysis patients have been injured as a result of Fresenius’s failure to warn of the risks associated with their dialysis products. GranuFlo and NaturaLyte are still being used in dialysis clinics to this day and have not been recalled. Fresenius has even applied to the FDA for approval of a new dialysis solution that does not contain the substance linked to cardiovascular injury.
Many patients across the county have suffered serious heart related injuries from using Fresenius’s dialysis products. If you believe you have suffered any of these injuries after receiving dialysis treatment, please give one of our attorneys a call:
Herman Gerel, and it's partner firms, Herman, Herman & Katz and Ashcraft & Gerel, have been involved in numerous drug and medical device lawsuits on behalf of injured victims.
We have also assumed leadership roles in the various plaintiffs' steering committees authorized by court order to manage the litigation involving mass tort. These lawsuits have involved such drugs as Propulsid, Vioxx, Granuflo, Fen Phen, Galdolinium Transvaginal Mesh, hip and knee replacement products and numerous others.