The FDA was already investigating Fresenius for its handling of the GranuFlo recall. That issue, coupled with news of this new FDA warning letter, is certainly concerning.
New York, New York (PRWEB) March 15, 2013
As GranuFlo lawsuits related to Fresenius’ recent recall of GranuFlo and NaturaLyte dialysis concentrates continue to mount, the company is facing more problems with the U.S. Food & Drug Administration (FDA), Bernstein Liebhard LLP reports. According to Dow Jones Newswire, the agency recently issued a warning letter to Fresenius Medical Care North America after finding problems with its design verification and validation procedures at a plant in Ogden, Utah. Specifically, the agency asserts that the company failed to conduct adequate design verification studies of electron beam sterilized polysulfone dialyzers.*
“The FDA was already investigating Fresenius for its handling of the GranuFlo recall. That issue, coupled with news of this new FDA warning letter, is certainly concerning,” says Bernstein Liebhard LLP, a nationwide law firm representing victims of defective drugs and medical devices. The Firm is currently offering free GranuFlo recall 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.
GranuFlo Recall Lawsuits
GranuFlo and NaturaLyte are used during dialysis to reduce the amount of acid in the blood. According to a New York Times report published over the summer, both have the potential to cause a rapid and unsafe elevation of bicarbonate, which creates a substantially increased risk of cardiopulmonary arrest and death. In November 2011, the company warned its dialysis clinics within its own network about this danger, and advised physicians at those clinics to adjust dosage accordingly. However, a similar warning was not sent to the thousands of independent clinics that had purchased GranuFlo and NaturaLyte from Fresenius.* * It wasn’t until March 2012 that Fresenius issued an “Urgent Product Notification” to its customer clinics with a similar warning, which the FDA would later designate as its most serious recall, Class I.*** According to the Times, the agency also launched an investigation to determine if Fresenius Medical Care’s failure to issue an earlier warning to its customer clinics may have violated the law.
Since then, dozens of Granuflo recall lawsuits have been filed on behalf of dialysis patients who suffered heart attacks and other catastrophic heart problems within a short time of undergoing dialysis with GranuFlo and NaturaLyte. Last December, Plaintiffs with GranuFlo and NaturaLyte claims asked the U.S. Judicial Panel on Multidistrict Litigation (JPML) to transfer the federal GranuFlo recall docket to the U.S. District Court, District of Massachusetts. In January, Fresenius filed a response with the JPML supporting the establishment of a multidistrict litigation in Massachusetts, and revealed that it been named as a defendant in 37 federal GranuFlo recall lawsuits. (In re Fresenius GranuFlo/Naturalyte Dialysate Litigation, MDL No. 2428 (JPML))
Dialysis patients who suffered heart attacks, sudden cardiac death, and other catastrophic heart side effects within 48 hours of a dialysis treatment with GranuFlo and NaturaLyte may be entitled to file a Granuflo lawsuit to obtain compensation for medical expenses, lost wages, pain and suffering, and more. Learn more about filing a GranuFlo recall lawsuit by visiting Bernstein Liebhard LLP’s website, http://www.consumerinjurylawyers.com. For additional information, contact a lawyer at Bernstein Liebhard LLP today by calling (877) 779-1414.
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 10 consecutive years.
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ATTORNEY ADVERTISING. © 2013 Bernstein Liebhard LLP. The law firm responsible for this advertisement is Bernstein Liebhard LLP, 10 East 40th Street, New York, New York 10016, (212) 779-1414. Prior results do not guarantee or predict a similar outcome with respect to any future matter.
Felecia L. Stern, Esq.
Bernstein Liebhard LLP