This notice comes less than two years after the FDA granted Class I status to the GranuFlo recall, and launched an investigation of Fresenius Medical Care.
New York, New York (PRWEB) January 18, 2014
As GranuFlo lawsuits (http://www.thegranuflolawsuit.com/) filed in the wake of the 2012 recall of GranuFlo and NaturaLyte dialysis drugs continue to move forward in courts around the country, Bernstein Liebhard LLP notes that Fresenius Medical Care has recalled another of its products. According to a notice posted on the U.S. Food & Drug Administration (FDA) website, 111,500 Fresenius 2008 Series Hemodialysis Machines have been recalled due to a saline bag that is inappropriately filling.*
While the machines involved in this latest Fresenius recall are not being pulled from the market, dialysis clinics have been instructed to remove the devices from service until they can be checked by a qualified service technician. The FDA has given Class II status to the recall, which indicates a product could cause temporary health problems, or a slight threat of serious health problems.
“This notice comes less than two years after the FDA granted Class I status to the GranuFlo recall, and launched an investigation of Fresenius Medical Care. Taken together, these events are concerning,” says Bernstein Liebhard LLP, a nationwide law firm representing victims of defective drugs and medical devices. The Firm is currently offering free GranuFlo lawsuit evaluations to dialysis patients who suffered cardiac arrest, heart attacks, stroke, sudden cardiac death or other side effects allegedly related to the administration of GranuFlo and NaturaLyte during dialysis treatments.
In March 2012, Fresenius Medical Care issued an Urgent Product Notification for GranuFlo and NaturaLyte, after the products were linked to a rapid and unsafe elevation of bicarbonate, which creates a substantially increased risk of cardiopulmonary arrest and death. The FDA designated the notification a Class I recall, its most serious type, the following June. A Class I recall is reserved for products that pose a risk of serious injury or death.
In June 2012, The New York Times reported that the FDA had launched an investigation of Fresenius Medical Care’s handling of the GranuFlo recall, after learning that the company had issued a memo in November 2011 to its own clinics that warned of the heart risks associated with GranuFlo and NaturaLyte. However, nothing was done at that time to notify thousands of dialysis centers outside the Fresenius network about the potential dangers associated with the products.**
According to court documents, more than 400 GranuFlo lawsuits have been filed since the recall was issued in a federal multidistrict litigation now underway in U.S. District Court, Northern District of Massachusetts. (In re Fresenius GranuFlo/Naturalyte Dialysate Litigation, MDL No. 2428) Additional dialysis lawsuits against Fresenius Medical Care have been consolidated at the state level in Massachusetts’ Middlesex County Superior Court. (In re Consolidated Fresenius Cases, No. MICV2013-03400-O) All of the claims similarly allege that Fresenius Medical Care failed to provide adequate warnings regarding the use of GranuFlo and NaturaLyte, and continued to aggressively market both products after their risks became apparent in order to protect their market share.
Victims of heart injuries allegedly associated with the use of GranuFlo and NaturaLyte may be entitled to file their own dialysis lawsuit against Fresenius. To learn more about the GranuFlo recall, please visit Bernstein Liebhard LLP’s website, or the Firm’s Facebook page: https://www.facebook.com/granuflolawsuit. For more information, and to arrange for a free case review, please call 800-511-5092.
**nytimes.com/2012/06/15/health/fda-investigates-fresenius-for-failure-to-warn-of-risk.html; New York Times, June 14, 2012
About Bernstein Liebhard LLP
Bernstein Liebhard LLP is a New York-based law firm exclusively representing injured persons in complex individual and class action lawsuits nationwide since 1993, including those who have been harmed by dangerous drugs, defective medical devices and consumer products. The firm has been named by The National Law Journal to the “Plaintiffs’ Hot List,” recognizing the top plaintiffs’ firms in the country, for the past 11 consecutive years.
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Felecia L. Stern, Esq.
Bernstein Liebhard LLP