San Diego, CA (PRWEB) July 23, 2013
Resource4thePeople today announces its latest update to consumers interested in developments involving lawsuits alleging that Fresenius NaturaLyte and GranuFlo kidney dialysis products caused life-threatening problems for patients.
The most recent news is that a federal judge who has been selected to coordinate consolidated federal lawsuits* involving these allegations has made key appointments of lawyers to plaintiffs' executive and steering committees.
"This action is significant in moving these NaturaLyte and GranuFlo dialysis lawsuits forward because it will be these attorneys who will be in charge of important pre-trial evidence gathering and other legal filings involving these allegations," said Resource4thePeople.
"Consumers who may have been affected by dialysis health problems similar to those contained in these allegations should also be aware that our national network of attorneys will continue to accept cases as this litigation progresses."
Resource4thePeople said free consultations will continue to be offered to consumers who may be seeking information about what legal rights they have to seek compensation over allegations that NaturaLyte and GranuFlo products caused life-threatening heart problems.
The docket of the multidistrict litigation in the U.S. District Court of Massachusetts summarizes the specific allegations involved that plaintiffs who used NaturaLyte and GranuFlo claim they should be compensated for:
“These actions share factual issues arising from allegations that Plaintiffs suffered injury or death caused by the use of GranuFlo and/or NaturaLyte products during hemodialysis, which allegedly may cause metabolic alkalosis in patients resulting in low blood pressure, hypokalemia, hypoxemia, hypercapnia, cardiac arrhythmia, or cardiopulmonary arrest.
“All the actions involve factual questions relating to whether GranuFlo and NaturaLyte were defectively designed or manufactured, whether Fresenius, the manufacturer of these dialysate products, knew or should have known of the alleged propensity of these products to cause injury and whether it provided adequate instructions and warnings with these products.”
At least 300 federal NaturaLyte and GranuFlo lawsuits from across the country alleging serious heart problems and deaths from the use of these products have been consolidated before U.S. District Court Judge Douglas P. Woodlock, according to the court docket.
“As the number of cases increases in this litigation we will continue to provide updates for consumers who may have been affected by these dialysis products and will continue report on the progress of the federal consolidated litigation," said Resource4thePeople.
The selection of plaintiffs' attorneys who will lead the litigation came in a July 16, 2013 order from Judge Woodlock, according to the court file. He selected six attorneys from across the country to serve on the executive committee.
"The Plaintiffs' Executive Committee shall serve as Lead Counsel and will be responsible for overall coordination and management of all pretrial proceedings and case preparation on behalf of the PSC and all Plaintiffs, including authority to organize, staff and direct committees to carry out various functions necessary for case preparation and prosecution," the judge wrote in his order.
Resource4thePeople began providing complimentary legal consultations to patients after the Food and Drug Administration issued a Class 1 Recall*** March 29, 2012 of the kidney dialysis products.
In announcing the recall the FDA advised health care professionals and patients that the affected GranuFlo and NaturaLyte products when inappropriately prescribed or administered in dosing errors may cause life-threatening cardiac problems.
“This may contribute 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,” the FDA said in the announcement. “This product may cause serious adverse health consequences, including death.”
The FDA describes Class I Recalls as the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.
According to the FDA, the affected NaturaLyte and GranuFlo Dry Acid concentrates were manufactured between January 2008 and June 2012 and are used in the treatment of acute and chronic renal failure during hemodialysis.
Meanwhile, FDA records show that Fresenius was cited*** by federal regulators over deficiencies uncovered at one of the company’s facilities.
In a warning letter dated March 13, 2013, FDA officials informed Fresenius Medical Care officials that dialyzers manufactured at the company’s Ogden, Utah plant are not in conformity with current federal good manufacturing requirements.
“The FDA’s warning letter further calls into question the quality of products that Fresenius is producing for kidney patients,” said Resource4thePeople.
In the warning letter to Fresenius Medical Care, the FDA wrote that it had three times previously expressed its concerns and found Fresenius’s responses to be inadequate. FDA officials also warned of possible strict penalties:
“Your firm should take prompt action to correct the violations addressed in this letter. Failure to promptly correct these violations may result in regulatory action being initiated by the FDA without further notice. These actions include, but are not limited to, seizure, injunction, and civil money penalties.
“Also, federal agencies may be advised of the issuance of Warning Letters about devices so that they may take this information into account when considering the award of contracts. Additionally, premarket approval applications for Class III devices to which the Quality System regulation violations are reasonably related will not be approved until the violations have been corrected. Requests for Certificates to Foreign Governments will not be granted until the violations related to the subject devices have been corrected.”
*In re Fresenius GranuFlo/NaturaLyte Dialysate Litigation 13-md-02428, U.S. District Court of Massachusetts, Judge Douglas P. Woodlock