San Diego, CA (PRWEB) August 30, 2013
Resource4thePeople today announced that it is encouraging consumers who may have undergone dialysis treatments to seek expanded legal consultations being offered in connection with an important Food and Drug Administration recall notice* for Fresenius NaturaLyte and GranuFlo kidney dialysis products.
The consultations are being expanded with additional staff in response to the FDA’s Class 1 Recall issued on March 29, 2012 federal officials spelled out details of why the recall was made over concerns about life-threatening heart problems for patients:
“The manufacturer is cautioning clinicians to be aware of the concentration of acetate or sodium diacetate (acetic acid plus acetate) contained in Fresenius' NaturaLyte Liquid and GranuFlo Dry Acid Concentrate. Inappropriate prescription of these products can lead to a high serum bicarbonate level in patients undergoing hemodialysis,” the FDA said.
“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. This product may cause serious adverse health consequences, including death.”
Resource4thePeople said that the expanded consultations services have been established to address questions from consumers who have sought help over dialysis problems about this important notice in connection with free consultations that are being offered over GranuFlo and NaturaLyte claims.
“It is vitally important that consumers familiarize themselves with potential side effects of any medication or medical devices that they may be treated with,” said Resource4thePeople.
“The reality is many consumers may not be taking advantage of the important information that is out there about these dangers and the legal options that they may be entitled to for compensation for any dangerous side effects that they may have suffered.
“Consumers also may regularly check our website at Resource4thePeople.com in order to receive regular updates about the progress of litigation involving NaturaLyte and GranuFlo lawsuits alleging serious heart irregularities,” said Resource4thePeople.
The updates will include information about GranuFlo and NaturaLyte lawsuits** from across the country that have been consolidated before a federal judge in the U.S. District Court for Massachusetts.
Judge Douglas P. Woodlock was scheduled to hold an important hearing this week in which he was to meet with lawyers for plaintiffs and defendants, according to the court file.
Resource4thePeople also is informing consumers that as this litigation advances more lawsuits continue to be filed against Fresenius over similar allegations involving GranuFlo and NaturaLyte products.
One of the most recent was filed by the husband of a woman who, according to the allegations in the court file,*** died as a result of her dialysis treatment with NaturaLyte and/or GranuFlo.
His lawyers are claiming that Fresenius officials knew that serious heart problems might be a side effect of the treatment but failed to adequately warn consumers and health care providers, according to the court file.
The docket of the multidistrict litigation in the U.S. District Court of Massachusetts summarizes the specific allegations involved:
“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 have been consolidated before Judge Woodlock, according to the court docket.
Resource4thePeople began providing complimentary legal consultations to patients after the FDA issued what it called a Class 1 Recall* of the kidney dialysis products.
In the recall the FDA advised health care professionals and patients that the affected GranuFlo and NaturaLyte products may cause life-threatening cardiac problems.
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."
**In re Fresenius GranuFlo/NaturaLyte Dialysate Litigation 13-md-02428, U.S. District Court of Massachusetts, Judge Douglas P. Woodlock
***Case # 2:13cv20858, Harris v. Fresenius, U.S. District Court for the Southern District of Virginia, Judge Paul Zakaib Jr.