Parker Waichman LLP Notes Transfer Order Centralizing the GranuFlo and NaturaLyte Lawsuits in Massachusetts Federal Court

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According to a Transfer Order filed on March 29, 2013, the Fresenius Granuflo/Naturalyte Dialysate Products Liability Litigation will be centralized in the District of Massachusetts. Parker Waichman LLP supports the centralizing of these cases and feels that the motion was necessary based on common questions of fact.

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We feel that coordination was necessary based on commonality of allegations among the Plaintiffs, said Matthew J. McCauley, Senior Litigation Counsel at Parker Waichman LLP.

Parker Waichman LLP, a national law firm dedicated to protecting the rights of victims injured by defective drugs and medical devices, is noting a Transfer Order filed on March 29, 2013 in which the United States Judicial Panel on Multidistrict Litigation moved to consolidate lawsuits alleging injuries or death from GranuFlo and NaturaLyte into a multidistrict litigation (MDL No. 2428). Parker Waichman LLP supports the centralization of these cases based on common questions of fact.

“We feel that coordination was necessary based on commonality of allegations among the Plaintiffs,” said Matthew J. McCauley, Senior Litigation Counsel at Parker Waichman LLP. “Overall, these cases allege that GranuFlo and/or NaturaLyte caused injury or death in patients who used the products during hemodialysis and alleges that Fresenius failed to warn about the risks.” According to the Transfer Order, lawsuits filed over the acid concentrate products allege that GranuFlo or NaturaLyte can lead to metabolic alkalosis, causing a number of potentially fatal complications, including:

  •     Low blood pressure
  •     Hypokalemia
  •     Hypoxemia
  •     Hypercapnia
  •     Cardiac arrhythmia
  •     Cardiopulmonary arrest

The lawsuits allege that GranuFlu and NaturaLyte were defectively designed and that Fresenius Medical Care failed to warn about the risks of these hemodialysis products. Parker Waichman LLP is investigating cases on behalf of individuals who suffered an injury after being exposed to GranuFlo or NaturaLyte during hemodialysis, and is available to answer any legal questions.

According to a New York Times article published last June, the U.S. Food and Drug Administration (FDA) began investigating Fresenius Medical Care to determine whether or not they violated federal regulations by failing to warn consumers about the potentially deadly risks of GranuFlo and NaturaLyte. NYT reported that the dialysis products raised safety concerns following news about an internal memo dated November 4, 2011. The memo warned that 941 hemodialysis patients suffered from cardiac arrest in Fresenius facilities in 2010. The memo was issued to Fresenius facilities but this information was not made available to the public until prompted by the FDA.

Last June, the FDA issued a Class I recall on GranuFlo and NaturaLyte, warning that the products may lead to high levels of bicarbonate in patients undergoing hemodialysis when inappropriately prescribed. The agency said that this can lead to metabolic alkalosis “which is a significant risk factor associated with low blood pressure, hypokalemia, hypoxemia, hypercapnia and cardiac arrhythmia, which, if not appropriately treated, may culminate in cardiopulmonary arrest. This product may cause serious adverse health consequences, including death.” A Class I recall is the FDA’s most serious recall status.

Parker Waichman LLP offers free lawsuit consultations to victims of Fresenius GranuFlo and NaturaLyte side effects. If you or a loved one experienced sudden cardiac arrest or sudden heart attack following dialysis with GranuFlo or NaturaLyte, please visit the firm's GranuFlo and NaturaLyte injury page at Free case evaluations are also available by calling 1 800 LAW INFO (1-800-529-4636).

Parker Waichman LLP
Gary Falkowitz, Managing Attorney
(800) LAW-INFO
(800) 529-4636

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