The law firm of Feazell & Tighe is offering free case evaluations to patients who believe they were injured by dialysis concentrates GranuFlo and NaturaLyte, as well as loved ones acting on their behalf. The firm has launched an investigation into problems associated with the two drugs after their manufacturer, Fresenius Medical Care North America, reportedly failed to warn certain clinics about a safety problem that could have caused hundreds of cardiac arrests. *
“No company should hide a problem that can lead to the patient’s death,” said attorney Austin Tighe of Feazell & Tighe. “Our law firm believes patients who were hurt because they were misled have every right to seek justice and fair financial compensation.”
Dialysis is a procedure that cleans the blood when the patient’s kidneys no longer work well enough to do so. Dialysis is often administered at outpatient clinics. In addition to making GranuFlo and NaturaLyte, Fresenius also owns a chain of dialysis centers where these drugs are administered.
The New York Times** reported last year that in 2011, Fresenius realized that doctors at its own dialysis clinics could be improperly administering GranuFlo, which could potentially put patients at an increased risk for sudden cardiac arrest. GranuFlo contains more of an ingredient known as bicarbonate than competing drugs, and doctors need to account for this extra bicarbonate when deciding how much of the ingredient to prescribe separately, the Times reported. According to an internal memo distributed by Fresenius, patients who exhibited high levels of bicarbonate in their bloodstreams after their doctors failed to make this adjustment had six times the risk of cardiac arrest when compared to patients with lower levels of bicarbonate. In 2010 alone, the company found that GranuFlo could have contributed to 941 cases of cardiac arrest in Fresenius clinics.
Fresenius sent the memo to its own dialysis centers in November of 2011, reminding doctors to be careful about the dosage and saying the problem “needs to be addressed urgently.” Despite that urgency, the New York Times reported, Fresenius did not warn other dialysis centers which use GranuFlo. The newspaper said those clinics were not informed until an anonymous whistleblower sent a copy of the memo to the U.S. Food and Drug Administration in March of 2012. When the FDA contacted Fresenius about this memo, the New York Times reported, Fresenius finally warned the other dialysis centers—four months later. The same month, the FDA issued a Class I recall of the drugs, indicating that they posed a reasonable chance of death or serious injury.***
Fresenius already faces multiple lawsuits filed by people who allegedly suffered injury as a result of GranuFlo and NaturaLyte. In combination with partner law firm Nix Patterson & Roach, Feazell & Tighe represents more than 1300 people alleging that they suffered cardiac arrest, stroke or the sudden cardiac death of a loved one.**** A panel of the federal judiciary will consider later this month whether to consolidate at least 11 GranuFlo and NaturaLyte lawsuits in Boston federal court.***** (In re Fresenius GranuFlo/NaturaLyte Dialysate Litigation MDL no. 2428)
Feazell & Tighe is currently offering free case reviews to patients and families who believe they suffered serious cardiovascular problems as a result of NaturaLyte or GranuFlo.
* nytimes.com/2012/06/15/health/fda-investigates-fresenius-for-failure-to-warn-of-risk.html?_r=0
** graphics8.nytimes.com/packages/pdf/business/fresenius-memo.pdf
*** fda.gov/MedicalDevices/Safety/ListofRecalls/ucm309990.htm
**** prnewswire.com/news-releases/fresenius-sued-again-in-cardiac-death-lawsuit-193866881.html
***** jpml.uscourts.gov/sites/jpml/files/Hearing%20Order-3-21-13.pdf
