Widow Files for GranuFlo Class Action Lawsuit in Pennsylvania
It’s been a year since the FDA alerted physicians and patients to the recall of kidney dialysis concentrate solutions GranuFlo and NaturaLyte. It was on June 27, 2012 that the agency issued a Class I recall notice for manufacturer Fresenius Medical Care’s products, saying that they could “cause serious adverse health consequences, including death.”
Since then, hundreds of plaintiffs alleging injuries from the use of these products during dialysis procedures have filed lawsuits against the manufacturer seeking damages. Most recently, a new GranuFlo class action lawsuit was filed in the Philadelphia Court of Common Pleas on June 14, 2013.
Plaintiff Carmen Brysten, whose husband passed away from a sudden heart attack after his dialysis treatment, seeks class action status to include all Pennsylvania residents who suffered similar injuries after GranuFlo dialysis treatments.
Facts of GranuFlo class action lawsuit
According to court documents filed in this Fresenius dialysis class action lawsuit, Filmon Brysten received a kidney dialysis treatment at Langhome Health Center in November 2011. This was the same month the company sent out an internal memo to doctors warning them of potential problems with GranuFlo and NaturaLyte, noting an incorrect dosage could increase bicarbonate levels in the blood, potentially leading to cardiovascular complications.
During the treatment, Filmon Brysten allegedly suffered sudden heart complications that led to his death. The plaintiff states in the Fresenius dialysis class action lawsuit that the product is “unreasonably dangerous” and creates high levels of bicarbonate in the blood, causing a condition known as “metabolic alkalosis,” in which the blood is too alkaline. This condition is known to increase the risk of heart rhythm problems and cardiopulmonary arrest.
“Based on the knowledge readily available to the medical community as early as 2004,” the documents state, “Fresenius knew or should have known of the increased risk of metabolic alkalosis attributed to the use of GranuFlo long before the publication of its November 4, 2011 internal memorandum detailing the problem to Fresenius physicians and clinics.”
Company should have done more to warn doctors
Though Fresenius did send out the internal memo in November 2011, medical centers and nursing homes outside of Frenesius’ own dialysis clinics that were also using GranuFlo and NaturaLyte received no such warning until the FDA started asking questions. In response to the FDA’s investigation, the company issued a second, less detailed memo at the end of March 2012, warning about the potential dosing errors with these products.
GranuFlo and NaturaLyte are used to help control acid buildup in the blood during dialysis. They are made to be more concentrated than other similar products, however. Using the same amount of GranuFlo as other concentrate products is actually using too much. Plaintiffs who have been seriously injured have stated that the company should have made dosing requirements more visible on the product, and should have done more to alert doctors and dialysis technicians of the differences.
Fresenius dialysis class action lawsuit
In March 2013, the U.S. Judicial Panel on Multidistrict Litigation (JPML) agreed to consolidate all federal GranuFlo and NaturaLyte lawsuits into one court in the District of Massachusetts. Fresenius currently faces about 160 cases, though the Brysten case appears to be the first potential GranuFlo class action lawsuit.
- FDA, Fresenius Medical Care North America, Naturalyte and Granuflo Acid Concentrate, http://www.fda.gov/medicaldevices/safety/listofrecalls/ucm309990.htm