Kidney disease is a considered a chronic and serious medical condition. Although it’s true that there are multiple risks associated with dialysis, patients who received GranuFlo during their dialysis treatment were exposed to an unnecessarily high risk of developing serious or even fatal heart problems. Because Fresenius Medical Care, the drug’s manufacturer, had evidence of this complication and did not immediately notify doctors of the problem, these patients may be eligible for compensation.
What Is GranuFlo?
GranuFlo is a medication used to treat people who suffer from kidney failure, and it plays a vital role in the dialysis process. GranuFlo is used in dialysis machines to neutralize the normal buildup of acid in the blood. Fresenius states that GranuFlo is the most commonly prescribed dry acid concentrate, with nearly half a million patients using it since the drug was first introduced to the market in 2003.
The Serious Side Effects of GranuFlo
GranuFlo is a powder acid concentrate, and its active ingredient is sodium diacetate. GranuFlo is used with NaturaLyte, its liquid counterpart. When this combination of medications enters the body during the dialysis process, the liver converts acetate into bicarbonate. Too much bicarbonate in the body can cause a sudden and possibly fatal heart attack.
In addition to a noted increase in heart attacks among GranuFlo users, the medication has also been linked to:
- Irregular heartbeat
- Low blood pressure
- Low potassium levels
- Low blood oxygen
- High carbon dioxide in the blood
Why GranuFlo Users Are Suing
Patients who are suing Fresenius after experiencing complications from GranuFlo say the company was aware of the potential dangers but failed to properly inform consumers and physicians. They allege that Fresenius displayed a "conscious disregard for the safety of the public" by continuing to actively market a medication they knew was not safe.
In 2010, Fresenius conducted a study of people receiving dialysis in its clinics. They found that receiving GranuFlo and NaturaLyte together as part of the dialysis process increased the patient's risk of a sudden heart attack by as much as six times. Despite this data, the company did not notify doctors of the problem until November 2011 and failed to notify the FDA altogether.
The FDA learned of problems with GranuFlo in March 2013 after receiving a copy of the company's memo detailing study results. After investigating, the FDA issued its most serious recall—a Class I recall. The FDA issues this recall when evidence indicates a reasonable probability the drug or product in question will cause serious or potentially fatal health consequences. In addition to the recall, the FDA also released a safety communication warning for doctors and patients regarding the dangers of GranuFlo.
Results of the Lawsuits
In February 2016, Fresenius agreed to an out-of-court settlement with the plaintiffs in several lawsuits related to GranuFlo’s increased heart attack risk. The settlement was funded with $220 million from the company’s insurers and is expected to be approximately $250 million. Other GranuFlo cases are still pending.
The out-of-court GranuFlo settlement was the result of a mass tort action, which is designed to save time and legal expenses for each individual plaintiff. A mass tort action involves multiple plaintiffs with similar cases filing against a corporate defendant.
We Can Help Determine If You’re Eligible for Compensation
Having been given GranuFlo as part of your dialysis treatment isn't enough to make you eligible for compensation. To file for damages, you need to have experienced a heart attack or other heart problem related to GranuFlo use. Alternatively, the spouses, children, or other family members of someone who had a fatal heart attack or stroke while taking GranuFlo can file on behalf of the deceased.
Obtaining legal representation is essential if you believe that you or a loved one suffered injuries caused by GranuFlo. The skilled mass tort attorneys at Neblett, Beard & Arsenault are dedicated to protecting the legal rights of patients who’ve been harmed by the medications they trusted to help keep them safe. To learn more, schedule a free consultation at one of our six convenient office locations.