The FDA was already investigating Fresenius for its handling of the GranuFlo recall. Taken as a whole, these issues are certainly concerning.
New York, New York (PRWEB) August 31, 2013
As GranuFlo lawsuits (http://www.granuflodialysislawsuits.com/) filed in the aftermath of Fresenius Medical Care’s recall of GranuFlo and NaturaLyte dialysis concentrates continue to mount, Bernstein Liebhard LLP notes that another Fresenius entity recently received a Warning Letter from the U.S. Food & Drug Administration (FDA) for problems at a manufacturing plant in Puerto Rico. According to a report from Reuters, the letter cited issues with complaint-handling procedures and labeling at a Fresenius Kabi facility that manufactures blood bags.*
“The FDA was already investigating Fresenius for its handling of the GranuFlo recall. Taken as a whole, these issues are 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 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.
This marks the second FDA Warning Letter received by a Fresenius entity since March 2013. That month, Fresenius Medical Care North America was cited by the agency for issues at a plant in Ogden, Utah. That same entity was also behind the GranuFlo recall, which was issued in March 2013 after GranuFlo and NaturaLyte were linked to a rapid and unsafe elevation of bicarbonate, which creates a substantially increased risk of cardiopulmonary arrest and death. The GranuFlo recall was eventually given the FDA’s most serious recall designation, Class I.**
The New York Times reported last summer 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 records, more than 300 GranuFlo lawsuits alleging personal injury and death due to the use of GranuFlo and NaturaLyte have been filed in a federal multidistrict underway in U.S. District Court, District of Massachusetts. All of the pending claims allege that Fresenius Medical Care failed to provide adequate warnings regarding the use of the products, and assert that the company continued to aggressively market the drugs even after the company became aware of their dangers. The Court is scheduled to hold a conference in the proceeding on September 27, 2013. (In re Fresenius GranuFlo/Naturalyte Dialysate Litigation, MDL No. 2428)
Dialysis patients who suffered serious heart problems, including cardiac arrest, heart attacks, stroke, and sudden cardiac death, within 48 hours of a dialysis treatment with GranuFlo or NaturaLyte may be entitled to compensation for their injury-related damages. Learn More about the GranuFlo recall by visiting Bernstein Liebhard LLP’s website. For additional information, please call 800-511-5092.
*reuters.com/article/2013/08/23/fresenius-fda-idUSWEB00AFY20130823, Reuters, August 23, 2013
**fda.gov/MedicalDevices/Safety/ListofRecalls/ucm309990.htm, FDA March 29, 2012
***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 10 consecutive years.
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Bernstein Liebhard LLP