Plaintiffs who suffered life-threatening complications after going through kidney dialysis with concentrate products GranuFlo and NaturaLyte have filed a new class action lawsuit in Pennsylvania. Lead plaintiff Carmen Brysten filed the lawsuit on June 14, 2013, in the Philadelphia Court of Common Pleas.
Brysten is seeking class action status to include all patients living in Pennsylvania who suffered similar complications from these two Fresenius Medical Care products. In June 2012, the FDA notified healthcare providers of a Class I recall of GranuFlo and NaturaLyte, stating that the products may cause serious adverse health consequences, including death.
GranuFlo Linked with Sudden Death
Brysten brought claims against Fresenius Medical care after her husband, Filmon Brysten, suffered a sudden heart attack and died after going through kidney dialysis in November 2011. That month, Fresenius released an internal memo warning their own doctors about potential problems with GranuFlo, which at the wrong dose, was found to increase bicarbonate levels in the blood. When bicarbonate levels become too high, the patient suffers from blood that is too alkaline, which can create symptoms like low blood pressure, low blood oxygen, low potassium levels, and heart rhythm problems that can lead to heart attack and death.
In that memo, Fresenius noted that they had examined data from 2010, during which over 900 patients died from cardiac complications. Their analysis showed that a high level of bicarbonate in the blood was an independent risk factor for cardiopulmonary arrest. They noted that GranuFlo and NaturaLyte were more concentrated than previous products, and thus could raise bicarbonate levels more than expected.
Fresenius Failed to Provide Adequate Warnings
Though Fresenius issued a memo to their own doctors in November 2011, they didn’t warn outside medical centers and nursing homes”which were also using GranuFlo and NaturaLyte. Indeed, they issued no such warnings until late March 2012, and then they did so only in response to an FDA investigation. Plaintiffs involved in GranuFlo litigation claim that the company was negligent in providing adequate warnings, and should have done much more to warn doctors of the dangers.
Brysten’s lawsuit states that Fresenius knew or should have known about the increased risks associated with their products. Since both GranuFlo and NaturaLyte are more concentrated than other similar products, doctors must use less of the products to achieve the same results. Because of a lack of communication, however, dosing errors occurred, placing many patients at risk.
Despite this knowledge, the lawsuit states, Fresenius failed to inform physicians that GranuFlo increases the level of bicarbonate in patients, thus preventing physicians and/or clinicians from learning of the need to reduce the bicarbonate prescribed to patients undergoing dialysis with GranuFlo.
Hundreds of GranuFlo Lawsuits Pending
The U.S. Judicial Panel on Multidistrict Litigation recently formed the GranuFlo/NaturaLyte MDL in the District of Massachusetts. Coordinated pre-trial proceedings are expected to help increase efficiency and reduce the risk of inconsistent rulings.
So far, at least 300 GranuFlo and NaturaLyte lawsuits are pending in the U.S.