Son of Patient Who Died After Treatment with GranuFlo Sues Fresenius

On December 11, 2012, a new GranuFlo lawsuit was filed by South Carolina resident Clarence Lee Dubose, Jr., individually and as a representative of the estate of his father, Clarence Lee Dubose. The defendant in the case is Fresenius Medical Care, the manufacturer of GranuFlo and NaturaLyte, substances used in performing dialysis on patients whose kidneys are not functioning properly.

The case was filed in the U.S. District of Massachusetts and the plaintiff brings counts of breach of warranties, strict liability, and negligence.

According to the lawsuit, Dubose alleges that his father suffered from a fatal heart attack following a dialysis procedure in which GranuFlo and NaturaLyte were used. Many other plaintiffs have made similar allegations of side effects from these products.

Fresenius Medical Care, to date, has paid a reported seven figure amount to settle one case. This occurred prior to a recall of the substances which may be a precursor to other settlements in the future.

GranuFlo and NaturaLyte require lower dosages than other acid concentrates

When a patient receives dialysis, a machine delivers a dialysate solution delivering the necessary minerals to the patient and removes waste products that would normally be removed by healthy kidneys.

Acid formulas such as GranuFlo and NaturaLyte assist in maintaining the proper pH balance of the dialysate and to control acid buildup. Bicarbonate functions as a buffer and neutralizes acid buildup in the blood—often present in patients suffering from kidney failure. A certain amount of bicarbonate is prescribed by doctors to be delivered while dialysis is performed.

Too much can lead to not enough acid being present in the blood and result in the blood being too alkaline.

GranuFlo and NaturaLyte are formulated differently from other concentrates. Because GranuFlo adds acetic acid and sodium acetate to the final dialysate solution, it results in an increased amount of bicarbonate in the blood than formulas that use acetic acid alone. In an effort to compensate for this difference, doctors can lower the dose. However, many of the doctors using these substances were unaware of the difference between it and other concentrates and the potential NaturaLyte and GranuFlo side effects.

Plaintiff’s father dies during routine dialysis treatment

Metabolic alkalosis can result from too much bicarbonate in the blood. This can lead to cardiac arrest. The American Journal of Kidney Diseases published a study in 2004 that indicated patients suffering from high pre-dialysis metabolic alkalosis were increasingly likely to suffer from cardiac arrest or heart attack unless the bicarbonate prescription was reduced.

The deceased, Clarence Lee Dubose, underwent dialysis in a routine appointment on September 19, 2009 at the Fresenius Darlington Dialysis Center in Darlington, South Carolina. At that clinic, GranuFlo and NaturaLyte were used.

The plaintiff in the new case states that employees of Fresenius knew of the issue prior to May of 2005. In 2008, some members of the dialysis medical community found that GranuFlo caused dangerously high levels of bicarbonate.

To prove that Fresenius was aware of the risks of the substances, the plaintiff states that sometime in 2009 or 2010, the manual used by operators of certain Fresenius-manufactured dialysis machines were altered. The edits instructed users of the machines to half the listed amount on the label when using GranuFlo.

Fresenius accused of failing to warn non-Fresenius clinics of GranuFlo and NaturaLyte dangers

Fresenius was allegedly aware of the danger of metabolic alkalosis from GranuFlo prior to an internal memo that revealed this risk on November 4, 2011. Only Fresenius doctors and clinics were informed of this potential issue.

Fresenius did not inform all users of the concentrate until the FDA launched an investigation in 2012.

The deceased, Clarence Lee Dubose, went into cardiac arrest during his treatment and was brought to the hospital. He was pronounced dead from cardiopulmonary arrest.