Lawsuits Allege Dialysis Products Linked to Heart Attacks

Close to 400,000 Americans undergo dialysis treatment every year. Dialysis helps people with failing kidneys in chronic or end stage kidney failure, or who are on a waiting list for a new kidney. Dialysis keeps the body in balance by removing waste, salt and extra water, controlling blood pressure, and keeping a safe level of chemicals in the blood, such as potassium, sodium and bicarbonate. In both hemodialysis and peritoneal dialysis, dialysates like Granuflo are used to maintain the balance of acid and base in the blood.

Because failing kidneys do not remove enough acid from the blood, dialysis patients may experience a condition called acidosis, which can lead to heart problems. To prevent this, dialysis providers use a balanced mixture of water, sodium bicarbonate and an acid, such as Naturalyte (liquid acid) or Granuflo (dry acid powder). Unfortunately, when combined with bicarbonate, Naturalyte and Granuflo can lead to blood becoming not neutral but alkaline or basic (a condition known as alkalosis). Alkalosis is associated with many side effects, including shallow or slow respiration, coma, diarrhea, muscle cramps, irregular heart beat, convulsions, hyper ventilation, seizures, and drop in blood pressure. In addition to the side effects, patients experiencing alkalosis are at increased risk of sudden cardiac arrest.

In November 2011, Fresenius Medical Care, a German company and the manufacturer of Granuflo, sent a memo to its dialysis companies warning that collected data from 2010 indicated a link in Granuflo dialysis products and increased risk of heart attack and sudden cardiac death. The problem with this discovery was that dialysis clinics that were not owned or operated by Fresenius (but that used Fresenius products) were not immediately warned. It was not until March 29, 2012, that Fresenius shared their memo with non-Fresenius owned dialysis clinics. That same day, the US Food and Drug Administration (FDA) issued a Class 1 Recall of Granuflo and Naturalyte.

As a result of Fresenius/ failure to disclose vital information to the FDA and doctors, many people died and suffered devastating health consequences. In one case filed in California, a pair of sisters filed a lawsuit following the alleged wrongful death of their mother due to Granuflo side effects. In Alabama, a widow filed a lawsuit alleging her husband’s death was the result of dialysis treatment with Granuflo. Some settlements have already been reached for seven figure amounts.

Lawsuits continue to mount in state and federal courts across the country. If you or a loved one has suffered a heart attack, sudden cardiac death, stroke, metabolic alkalosis, or another catastrophic side effect within 48 hours of receiving dialysis with Granuflo or Naturalyte, you may be entitled to compensation in a lawsuit. By taking legal action, you can help hold drug manufacturers accountable for their products’ safety. Contact an experienced attorney who can answer your questions and help you protect your legal rights.As a result of Fresenius/ failure to disclose vital information to the FDA and doctors, many people died and suffered devastating health consequences.

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Michael Bomberger

Licensed since 1993

Member at firm Estey & Bomberger, LLP

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