Colorado Federal Court Judge Throws out Failure to Warn Claims in GranuFlo Lawsuit
A federal judge in Colorado has dismissed certain claims filed in a GranuFlo lawsuit alleging serious cardiovascular injuries caused by the dialysis medication, court documents indicate.
An Order on April 9th indicates the dismissal of failure to warn and breach of warranty claims against a dialysis clinic owner who administered GranuFlo and NaturaLyte, another acid concentrate, in its treatment centers. According to documents in the U.S. District Court, District of Colorado, claims were thrown out after the judge ruled that the company did not manufacture the medications, and should not be held liable for failing to warn about their alleged side effects. According to the Order, negligence and fraudulent concealment claims in the case were allowed to proceed after plaintiffs adequately explained how monitoring systems at the center in which GranuFlo and NaturaLyte were given out would have been able to detect changes in patients’ blood pH levels.
Dialysis Center Failed to Monitor Patient pH Levels, GranuFlo Lawsuit Alleges
This information is relevant to claims filed in this dialysis lawsuit based on an Urgent Product Notification issued on March 29, 2012 by Fresenius Medical Care. Among other things, the manufacturer of GranuFlo and NaturaLyte warned that both acid concentrates contained a high amount of an ingredient the body converts to bicarbonate, which may result in a condition referred to as metabolic alkalosis. This condition may be associated with the risk for sudden cardiac death, heart attacks, strokes and other cardiovascular problems.
Following this public health notice, the U.S. Food and Drug Administration (FDA) issued a Class I recall of NaturaLyte and GranuFlo after determining their alleged risk for heart side effects to be serious and potentially life-threatening. A New York Times report published shortly after the recall on June 25, 2012 indicates that the FDA was investigating whether Fresenius’ handling of the situation with its products violated federal regulations. This announcement was made after the FDA learned of an internal memo sent by the company in November 2011 that warned doctors operating in its facilities of 941 deaths that occurred after use of GranuFlo and/or NaturaLyte. Physicians were advised at this time to adjust dosages of the medication, while doctors in thousands of clinics outside the Fresenius network did not receive an alert.
A Case List updated on April 15th by the U.S. Judicial Panel on Multidistrict Litigation (JPML) shows 1,570 federal GranuFlo recall claims now filed in the District of Massachusetts.
Filing a GranuFlo Lawsuit
Contact our Firm to learn more about GranuFlo lawsuits, and whether you may be eligible to file a claim of your own against Fresenius. Call us today for a free and confidential review of your case at (877) 779-1414.