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FDA Investigation Leads to Impending Legal Action Against Fresenius

- Ennis & Ennis

09/26/2012 - An FDA investigation against Fresenius, the manufacturer of the recalled dialysis medications GranuFlo and NaturaLyte, led to the Class I recall of GranuFlo and NaturaLyte on June 27, 2012 and lawsuits are currently being prepared for filing against Fresenius for the wrongful deaths of many patients receiving dialysis. [1].

An anonymous informant leaked an internal memo that Fresenius sent ONLY to its privately owned dialysis treatment centers in November 2011, warning of the dangers of cardiac injuries and death related to its GranuFlo and NaturaLyte products, indicating, “this issue needs to be addressed urgently.” Despite this urgency, Fresenius failed to warn the public until March 2012, after the memo had been leaked to the FDA.

The FDA investigation seeks to determine whether Fresenius violated federal regulations by failing to warn customers of the potential dangers associated with their products. This is particularly egregious as Fresenius is the largest operator of hemodialysis treatment centers, serving over 400,000 Americans a year or one-third of all dialysis patients in this country. It is incredulous that Fresenius executives knew about the increased risk of cardiac arrest and death associated with GranuFlo since at least 2010. Even more disturbing is that this information was held at the corporate level for 15 months before it was shared even to Fresenius’ own operating clinics, let alone the unsuspecting Public.

Attorney David Ennis of Ennis & Ennis, P.A. states that Fresenius must be held accountable for its blatant failure to act when it was in a position to prevent the injuries, but instead chose to put company profits ahead of patient safety. In addition to the FDA’s investigation, it is expected that multiple lawsuits will shortly be filed nationwide against Fresenius for the injuries and wrongful deaths caused by the GranuFlo and NaturaLyte products.

Ennis & Ennis, P.A. continues to offer free, nationwide, confidential consultations to anyone who received the GranuFlo or NaturaLyte products and suffered a cardiac event.

Free Nationwide GranuFLo - NaturaLyte Lawsuit Case Evaluations:

If you or a loved one have suffered serious GranuFlo or NaturaLyte side effects, suffered a loss due to GranuFlo or NaturaLyte Cardiac Side Effects or have been injured as a result of a metabolic alkalosis you may be entitled to compensation. Contact the GranuFlo - NaturaLyte Dialysis Injury Lawyers of Ennis & Ennis today for a free confidential case evaluation by filling out the form on this page or call toll-free: 1-800-856-6405.