N.J. Man Files GranuFlo Wrongful Death Lawsuit Against Fresenius

A New Jersey man has filed a wrongful death lawsuit against Fresenius USA Inc. alleging that their two kidney dialysis additives GranuFlo and NaturaLyte were responsible for the heart attack that led to his wife’s death.

Leandro Malara filed the GranuFlo/NaturaLyte lawsuit on behalf of his deceased wife Giovanna Malara on Dec. 23, 2013, in the U.S. District Court for the District of Massachusetts.

Mrs. Malara was undergoing kidney dialysis due to renal failure, which means that her kidneys had stopped working when she had to be hospitalized for an unrelated condition. While she was in the hospital at Lourdes Specialty Hospital of Southern New Jersey in Willingboro, she received kidney dialysis treatment and NaturaLyte and/or GranuFlo were used during her kidney dialysis, which took place on Dec. 23, 2011. About 12 hours later on Dec. 24, 2011, Mrs. Malara began displaying symptoms of a heart attack, and ended up suffering from an acute cardiac arrest, and the hospital staff was unable to revive her even though they made a great effort to do so.

Mrs. Malara died as a result of the heart attack.

Dialysis Chemicals Linked to Hundreds of Heart Attacks

Kidney dialysis is necessary for individuals who have suffered from end stage kidney failure. During dialysis a solution goes through an artificial kidney to clean the blood, since the kidneys are no longer able to do the work themselves. The solution is made up of three fluids: ultra-pure water, bicarbonate concentrate and acid concentrate.

Fresenius makes and sells two acid concentrates — GranuFlo and NaturaLyte – that are used to remove impurities from the blood during kidney dialysis treatment.

GranuFlo and NaturaLyte work by neutralizing the acid in the blood by providing bicarbonate. For kidney dialysis treatment to work and do the job of filtering the blood that is normally done by the kidneys, an acid concentrate such as GranuFlo or NaturaLyte need to be used. When the acid concentrates enter the bloodstream they are naturally converted to bicarbonate. Bicarbonate is how more than 90 percent of carbon dioxide takes form in the bloodstream — keeping the blood from becoming too acidic — a job normally done by healthy kidneys.

The problem with GranuFlo and NaturaLyte is that they were not properly dosed and have been linked to a potential rapid increase of bicarbonate, leading to a condition known as alkalosis — meaning that the blood has become too alkaline. If a person develops alkalosis, the risk of a catastrophic heart side effect becomes 6 to 8 times more likely and can lead to sudden death.

“Ms. Malara’s heart attack and death, as with the injuries and deaths suffered by thousands of similarly situated dialysis patients all over the United States, was preventable,” the GranuFlo lawsuit alleges. “These injuries and deaths occurred because the medical providers administering Defendants’ defective products were unaware that these products caused elevated levels of bicarbonate resulting in an increased risk for cardio pulmonary arrest and sudden cardiac death as well as stroke and other serious or even fatal complications.”

2012 GranuFlo Recall Too Late for Many

In November 2011, Fresenius sent a memo to its own clinics stating that GranuFlo was responsible for 941 deaths due to cardiac arrest at clinics in 2010. They didn’t notify all of the clinics where the acid concentrates were used until March 2012, after Fresenius was questioned by the U.S. Food and Drug Administration (FDA) upon receiving an anonymous copy of November 2011 memo.

In June 2012, the FDA issued a Class I recall of NaturaLyte and GranuFlo — the most serious recall they can issue — restricted only for products that may result in severe injury or death.

Mr. Malara is charging Fresenius with failure to warn, breach of implied warranties, breach of express warranty, fraudulent concealment, negligent misrepresentation, fraud, deceit, negligence, strict liability, and deceptive trade and business practices act violations.

He is suing for punitive damages and compensatory damages.

The GranuFlo/NaturaLyte lawsuit is Leandro Malara et al. v. Fresenius USA, Inc., Case No. 1:13-cv-13255-DPW, in the U.S. District Court for the District of Massachusetts. It has been added to the GranuFlo multidistrict litigation currently underway In Re: Fresenius Granuflo/Naturalyste Dialysate Products Liability Litigation, MDL No. 1:13-md-02428-DPW.

If you or someone you know experienced a negative side effect after GranuFlo or NaturaLyte were used during kidney dialysis, legal options are available. Learn more and get a free consultation regarding a claim’s eligibility at the Kidney Dialysis Heart Attack, GranuFlo & NaturaLyte Recall Class Action Lawsuit Settlement Investigation. Experienced legal professionals acid concentrates played a roll in your complications, so act now.