GranuFlo Lawsuits Consolidated in Massachusetts

In early September, the Honorable Judge Maynard M. Kirpalani of Massachusetts State Court issued a consolidation order for all GranuFlo recall cases filed in the Bay State. From now on, the filing of cases arising from claims against Fresenius Medical Care and its Naturalyte Liquid and Granuflo Dry Acid Concentrate will be placed on the docket of Consolidated Fresenius Cases, No. MICV2013-03400-O in Middlesex County.

Fresenius is a leading biomedical enterprise that supplies dialysis systems and supplies across the United States. In a country where about 400,000 people receive dialysis therapy, Fresenius has about a third of the market share. Problems for Fresenius and medical practitioners around the country started in late 2011, when internal memos were distributed among physicians working in the company’s dialysis centers. The memos warned of the possibility of cardiac arrest among patients receiving dialysis if they fail to properly use certain products.

These warning memos were not distributed outside of the Fresenius internal network. Hospitals and clinics not affiliated with the company were not aware of the potential risk of using GranuFlo Dry Acid Concentrate. In March 2012, the U.S. Food and Drug Administration (FDA) issued a recall on GranuFlo and Naturalyte products used to treat renal failure through dialysis. According to the FDA’s recall notice, the improper use of these substances could increase the patients’ risk of cardiopulmonary arrest.

Outside of the clinics operated by Fresenius, more than 100,000 dialysis patients were treated with GranuFlo and Naturalyte, and yet it was not until March 2012 that the company issued an Urgent Product Notification outside of its internal clinical system. The FDA’s eventual recall and notification of these products was deemed worthy of a Class I recall, which is reserved for products that carry a substantial risk of causing injury or even death.

Hundreds of claims against Fresenius related to the recall of GranuFlo and Naturalyte have been filed in Massachusetts and other parts of the country.

The basis for claims against Fresenius include sudden cardiac problems experienced by dialysis patients after undergoing treatment that involved the use of GranuFlo or Naturalyte.