Family Members Accuse Fresenius of Dialysis-Related Death
Following the untimely loss of Clarence Arrington, his surviving family members filed a Granuflo lawsuit against Fresenius Medical Care Holdings, Inc.
Daniel Lemont Arrington, the plaintiff, claims that the decedent lost his life as a result of the allegedly defective dialysis products manufactured by the defendants. The decedent had been receiving dialysis treatment at a Fresenius medical clinic in Mississippi. On September 28, 2012, the decedent was diagnosed with a severe cardiovascular event, which caused his death.
The plaintiff is demanding compensatory damages for the loss of his family member. The wrongful death lawsuit was filed directly into multidistrict litigation (MDL) No. 2428. The MDL is proceeding in the U.S. District Court for the District of Massachusetts under the supervision of Judge Douglas P. Woodlock.
Problems with Granuflo side effects
Fresenius came under fire following numerous reports of complications and deaths that occurred as an alleged result of the defective nature of the dialysis products, Granuflo and Naturalyte. These products are used at thousands of clinics owned and operated by the defendants, and they are also sold to other dialysis providers. The dialysis additives were found to have raised patients’ bicarbonate levels to a dangerous degree. This can cause a serious condition known as metabolic alkalosis.
Initially, the symptoms of metabolic alkalosis can include hand tremors, prolonged muscle spasms, nausea, and numbness.
However, unless the patient receives prompt medical care, metabolic alkalosis can rapidly progressed to difficulty breathing, stupor, confusion, shock, and coma.
The condition has also been linked to an increased risk of adverse cardiovascular events, such as low blood pressure, heart attack, sudden cardiac arrest, stroke, and death. It has not yet been disclosed which of these specific complications Clarence Arrington passed away from.
FDA issues safety communication
The cases currently pending in the Massachusetts MDL typically point to the FDA safety communication that was issued on May 25, 2012. This came following a 2010 internal review conducted by Fresenius, which identified at least 941 cases in which patients at their dialysis clinics suffered from a sudden cardiopulmonary arrest. Fresenius Medical Care issued an internal memo in November 2011, which warned company physicians about the potential problems with Granuflo and Naturalyte. It instructed physicians to regularly monitor bicarbonate buffers and adjust as needed to reduce the risk of life-threatening complications.
In early 2012, the FDA queried Fresenius about the company’s internal memo. Just a few short months later, the FDA issued its own safety communication that urged physicians to exercise caution when using dialysis additives.
Although Fresenius had apparently known about the life-threatening complications as early as 2010, the company failed to issue a voluntary recall of the products. Instead, the FDA announced a Class I recall for both Granuflo and Naturalyte on June 25, 2012.
The lawsuits pending in the Granuflo MDL demand that the defendants be held liable for serious cardiovascular injuries, and in some cases, the deaths of the patients. The plaintiffs further allege that the company knew about the serious risks, yet failed to take appropriate action to warn healthcare providers and patients. The defendants have been accused of intentionally misleading the public and of displaying a conscious disregard for patient safety.
- FDA, Dialysate Concentrates and Alkali Dosing Errors with Hemodialysis: FDA Safety Communication, http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm305477.htm
- U.S. District Court, MDL2428, http://www.mad.uscourts.gov/worcester/MDL2428/MDL2428-5.htm