Hemodialysis treatment can be an efficient way to replace loss of function in the kidneys; however it can also cause a number of side effects, such as low blood pressure, muscle cramps, itching, sleep problems, anemia, bone diseases and high blood pressure. Patients could also suffer from pericarditis, high potassium levels, stiffness and fluid in joints and depression. Many of these side effects are a result of the loss of electrolytes during the dialysis process. One treatment which is effective at reducing the side effects caused by loss of electrolytes is the use of Granulfo, a drug originally seen as a safe treatment option due to its lack of volatile chemicals.
Unfortunately, GranuFlo also has some very dangerous side effects of its own, and was recalled in March of 2012 because it contains more of a substance which converts into bicarbonate in the human body. This additional bicarbonate can lead to heart problems and cause side effects including death, heart attack, low blood pressure, low potassium in the blood, low levels of oxygen in the blood, excessive carbon dioxide in the blood and cardiac arrhythmia (irregular heartbeat).
In the early 2000’s, GranuFlo was seen as the safest dialysate on the market. However, increased use of GranuFlo and its sister product, NaturaLyte, led to a rise in the number of cardiac arrest complaints by patients who were treated with its usage in early 2012. At that time, the drug was deemed unsafe for human consumption due to the increased amounts of bicarbonate in the body. In February of 2013, a widow filed a lawsuit in Alabama Northern District Court alleging her husband suffered severe injuries, including cardiovascular death, after receiving Granulfo. In March of 2012, the FDA published a Class I recall of NaturaLyte and Granulfo due to the high serum bicarbonate levels, causing metabolic alkalosis, associated with cardiac arrhythmia that had the potential to culminate into cardiac arrest. In January of 2013, an additional lawsuit was filed in the Louisiana Eastern District Court alleging the plaintiff suffered heart attack and stroke as well as severe pain and suffering, following hemodialysis treatment with Granulfo and/or NaturaLyte.
Fresenius Medical Care, the manufacturers of Granulfo and NaturaLyte, owes the users of these drugs a duty of care. If you or a family member were exposed to the use of Granulfo or its sister product, NaturaLyte, and suffered a cardiac arrest or developed serious heart complications you may be entitled to compensation. Inserra & Kelley is proud to offer a free initial evaluation of your case. Contact us today to start your claim evaluation.