Granuflo and Naturalyte - Defective Products Lawyers

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For more updates, please visit our Dialysis Lawsuit Center.

If you or a loved one has suffered a major cardiac event while on NaturaLyte® or Granuflo®, contact the Minneapolis defective product lawyers at GoldenbergLaw.

Dialysis products GranuFlo® and NaturaLyte® are manufactured by Fresenius Medical Care (FMC) and have been linked to a six-fold increase in the risk of cardiopulmonary arrest and sudden cardiac death. Fresenius Medical Care is the largest operator of dialysis centers and treats more than one third of the estimated 400,000 Americans receiving dialysis.1

On November 4, 2011, FMC issued an internal memo to company-run dialysis centers communicating a problem with the way bicarbonate levls on the machines were being interpreted by medical staff. They indicated that this matter should receive immediate attention. However, FMC did not warn patients and doctors in other centers that used the products until late March 2012. The March 2012 warning came only after the FDA received a copy of the internal memo from an anonymous source and questioned the company about it. Other internal documents retrieved from FMC show that they were aware of these problems for over a decade.

FMC’s failure to warn all of the doctors and patients has resulted in many deaths around the country and has placed thousands of dialysis patients at risk.

Dialysis:

The human metabolism constantly produces acids, and a functioning kidney would excrete those acids to maintain a healthy pH in the bloodstream. When one’s kidney is not working properly, their blood will likely become acidic (“metabolic acidosis”). Therefore, the pH levels in the blood must be maintained through dialysis.

Bicarbonate, a solute normally found in the bloodstream, is kept at a higher level in dialysis patients. The slightly elevated bicarbonate level acts as a pH buffer, neutralizing the metabolic acidosis that is often present in these patients. The amount of dialysate bicarbonate (the synthetic bicarbonate used in dialysis) is prescribed by the patient’s nephrologist.

Dialysis patients get their bicarbonate from two sources during dialysis. One is the bicarbonate concentrate, and the other is the acetate in the acid concentrate. Acetate is quickly converted to bicarbonate in the liver; therefore, it is counted as part of the bicarbonate that the patient receives. The totalamount of bicarbonate through these two sources is the “total buffer.”

The Problem:

Bicarbonate dialysis became popular in the 1980’s and all labels for levels of bicarbonate were the same. Fresenius’s new machine, which eventually treated the vast majority of hemodialysis patients in the U.S., came out in the 1990’s with a much different design. The FMC 2008E listed the bicarbonate concentrate level as “bic” on the front. Medical staff assumed that was the total buffer to be administered, not just the bicarbonate concentrate portion.

Medical staff were expected to know to individualize the concentrated bicarbonate and total buffer prescriptions, even though doing so required them to understand an unrealistic amount of information about the possible combinations of dialysis machines, different models and software of Fresenius machines, clinician settings, technical settings, and concentrate formulations for every treatment in every different facility.

Almost everything about the machines was counterintuitive based on how things had been done in the past. For example, the physicians’ dialysis order sheets only listed a “bicarb” level, which meant total buffer level. The confusing design of the user interfaces on these machines appears to have contributed to many – if not most – of the miscalculations of bicarbonate levels.

Internal documents dating back over a decade show that Fresenius failed to effectively educate and train doctors and clinic personnel, even while knowing that these dangerous miscalculations were occurring. In addition, the FMC machine-related buffer errors have never been officially reported to the FDA.

The higher dialysate total buffer errors may have compounded a mortality risk for patients. At the American Society of Nephrology (ASN) Annual Meeting, a study showed that high dialysate bicarbonate levels (total buffer >37mEq/L) were associated with higher mortality. The presentation of the study also showed that dialysate total buffer levels were highest in the U.S. and that a large percentage of U.S. patients had total buffer levels above 37mEq/L.

MDL No. 2428 – FeseniusGranuFlo/Natrualyte Dialysate Products Liability Litigation

On March 29, 2013, the United States Judicial Panel on Multidistrict Litigation filed a transfer order to consolidate GranuFlo/Naturalyte cases into a multidistrict litigation (MDL).

The Panel announced that the MDL will take place in the District of Massachusetts and assigned to Honorable Douglas P. Woodlock.

In addition to its proximity to Fesenius headquarters (located in Waltham, MA), the Panel believes Massachusetts provides better access to many relevant witnesses and documentary evidence common to all of the actions.

In addition to being able to file in the MDL, cases may also be filed in state court in California or in state court in Massachusetts. Cases filed in either state court would proceed in a similar manner to those filed in the MDL. As experienced product liability and mass tort attorneys, GoldenbergLaw understands the importance of selecting a jurisdiction carefully. Just because an MDL exists does not always mean that it is the best place for every case to be filed. Individual facts of each case are considered, as are the laws of the jurisdiction, and the assigned judge’s prior rulings.

July 2013 Update: Stuart Goldenberg has been assigned a leadership role in the litigation as member of the plaintiff steering committee (PSC) in the California JCCP. He is one of several attorneys who will have a direct influence on how the litigation proceeds. GoldenbergLaw is very pleased to have been chosen for this role.

What is an MDL?

“MDL” stands for “multi-district litigation.” When a defendant is facing many lawsuits that involve common questions of fact (such as similar injuries from a drug), parties will often move to centralize the cases to one federal districtin the United States to form an MDL. The chosen judge in that district presides over the pre-trial phase of the litigation.

The formation of an MDL is a more efficient way to conduct pretrial proceedings, serves the convenience of the parties and witnesses, and helps avoid conflicting rulings. Furthermore, certain components of a case, like discovery, are necessary for all of the cases involved. By utilizing a consolidated proceeding, whether through the state courts or through an MDL, we are able to keep the cost of bringing our clients’ cases to a minimum. For example, in the discovery process, a defendant may be asked to produce thousands of pages of documents. Rather than making that same document request over and over again for each individual case, a consolidated proceeding allows us to make one request and use those same documents for the benefit of all of our clients.

Though they are often confused, an MDL is not the same thing as class action litigation. Class actions are most often used when the claims are more uniform and when less information about individual cases is necessary for settlement. On the other hand, when cases are consolidated into an MDL, each case is still resolved individually, based on the unique facts of each case.

It is important to us at GoldenbergLaw that our clients understand that they are not statistics. We know each of our clients, and we work with each person individually to ensure that they are happy with the end result.

Source: http://www.jpml.uscourts.gov/sites/jpml/files/MDL-2428-Initial_Transfer-03-13.pdf

If you or a loved one has suffered a major cardiac event while on dialysis or shortly after, contact The St Paul defective product lawyers at GoldenbergLaw for a free consultation.

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Why GoldenbergLaw?

GoldenbergLaw is currently handling GranuFlo/NaturaLyte cases in Minnesota and throughout the nation and has been litigating mass tort drugs and devices for over 29 years. We understand and possess the resources needed to successfully pursue these cases and are working with some of the top experts in the nation.

 

If you are unfamiliar with the way dangerous drug lawsuits work, please visit our FAQ page that explains some terms you may hear, such as “mass tort” or “MDL.” For many injured people seeking an attorney, this is their first time having to look for this type of help. Often, their uncertainty or hesitance comes from not knowing which questions to ask.

 

http://www.nytimes.com/2012/06/15/health/fda-investigates-fresenius-for-failure-to-warn-of-risk.html
http://graphics8.nytimes.com/packages/pdf/business/fresenius-memo.pdf
http://www.renalweb.com/writings/alkalosis/FMC%20Problem%20Misidentified.htm
http://www.fmcna-concentrates.com/pdf/101517-01_Total_Buffer_Presentation_FINAL-Copy.pdf