Fresenius Medical Care is currently the subject of a large number of dialysis lawsuit cases stemming from heart attacks and strokes caused by their dialysis additive products Granuflo and Naturalyte. A version of these products gained FDA approval as early as 2003 and was marketed as Granulyte. If you or a loved on suffered a heart attack or stroke within three days of receiving a dialysis treatment, please contact us today about you potential dialysis lawsuit.
Why are Dialysis Lawsuit Cases Being Filed?
Granuflo and Naturalyte are dialysis additives that were intended to reduce the incidence of strokes and heart attacks in hemodialysis patients by helping to maintain proper blood pH Levels. Maintaining proper blood pH levels are necessary in dialysis patients. An imbalance in blood pH in any individual can lead to stroke, heart attack and numerous other medical issues.
Both Granuflo and Naturalyte were more concentrated versions of products previously used to help maintain proper pH levels in dialysis patients. The allegations in dialysis lawsuit cases filed against Fresenius contend that Fresenius Medical Care did not properly instruct and train medical personnel and dialysis clinics on the proper dosing of their more concentrated dialysis additives.
The failure on the part of Fresenius Medical Care to properly instruct clinics and medical personnel is alleged to have resulted in the over dosing of dialysis patients with Granuflo and Naturalyte. The overdosing of patients with Granuflo and Naturalyte is alleged to have caused or contributed to dialysis patients suffering heart attacks, strokes and other medical conditions.
Other Factors Contributing to Dialysis Lawsuits
Other Factors Contributing to dialysis lawsuits result from actions and in some cases failure to act on the part of Fresenius Medical Care. A memorandum was leaked, which was sent to dialysis clinics owned and operated by Fresenius on November 4th 2011. This memo alerted doctors and other medical personnel at Fresenius clinics of the problems with improper dosing of Granuflo and Naturalyte. In 2010 alone over 900 deaths of dialysis patients treated at Fresenius clinics were attributed to Bicarbonate overdose. Bicarbonate overdose would occur as a direct result of overdoing a dialysis patient with Granuflo and Naturalyte.
To the best of our knowledge, Fresenius did not provide a copy of the memo sent to clinics owned by Fresenius to the the FDA. Fresenius also did not send a copy of this memo to clinics using Granuflo and Naturalyte that were not owned by Fresenius. Fresenius manufacturers dialysis delivery systems, dialysis therapy products, as well as operates dialysis clinics. It is estimated that at least half of the dialysis clinics using Granuflo and Naturlyte were not owned by Fresenius.
The fact that Fresenius did not warn dialysis clinics that it did not own about the problem with Granuflo and Naturalyte when they warned their own clinics, left thousands of dialysis patients at risk of being overdosed with Granuflo and Naturalyte.
Dialysis Additive FDA Recall
Once the FDA became fully aware of the issue with Granuflo and Naturalyte, the FDA’s compliance department did instruct Fresenius to notify all clinics that used Granuflo and Naturalyte of the problems with the products. The FDA further instructed Fresenius to properly educate and train all clinics using Granuflo and Naturalyte of the issues with the product and dosing.
It is unclear at this point whether Fresenius has fully complied with the FDA’s instructions to educate all dialysis clinics using Granuflo and Naturalyte as to the problems that existed with dosing. A representative from our office spoke with a representative of the FDA division of compliance on 02/12/2013. The FDA representative could not confirm that FMC had in fact complied with all FDA mandates. The FDA representative further stated that the investigation was ongoing.
A Class 1 FDA Recall on the dialysis additives was issued on March 29th, 2012 covering losts of Granuflo and Naturalyte Dialysis Additives made between January 2008 through June 2012. Normally a Class 1 recall involves the removal of FDA regulated products form the market. It is unclear as to whether or not the Naturalyte and Granuflo FDA recall actually required the removal of the products from the market or simply required Fresenius to Notify all clinics using these products of the issues with overdosing and what corrective action needed to be taken. You can view the FDA recall notice at http://www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm309990.htm
The fact that the FDA is unable to confirm compliance with this recall notice, there is concern that not all clinics using Granuflo and Naturalyte have received the information mandated in the FDA Recall notice. If any clinic using Granuflo or Naturalyte has not received the information in questions, dialysis patients could still be at risk. A request made by our office for a copy of the names of all dialysis clinics that were supposed to receive the warnings mandated in the FDA Recall. That request has yet to be granted which causes us great concern as we believe dialysis patients have the right to know if they were put at risk or if they are still being put at risk of being overdosed with Granuflo or Naturalyte.
Dialysis Heart Attacks Before 2008
Those who received Granulyte, the product that preceded Granuflo and Naturalyte may be eligible to file a dialysis lawsuit. Granulyte has been on the market since 2003. If you or a loved one suffered a heart attack within three days of receiving a dialysis treatment at anytime after 2003, please contact us. The possibility exists that you may have a cause of action to file a dialysis lawsuit.
Who is Eligible to File A Dialysis Lawsuit
Any patient that suffered a heart attack during the time they were receiving dialysis treatments may be eligible to file a dialysis lawsuit. You may not be aware of whether or not you were dosed with Granuflo or Naturalyte.
Our lawyers handling dialysis lawsuit cases will have to investigate to discover whether or not you were dosed with Granuflo or Naturalyte. If you do know for a fact that you were dosed with Granuflo or Naturalyte as part of your dialysis therapy, please let us know when you contact us for a free legal evaluation as this information will be helpful in your dialysis lawsuit process.
Family members of individuals who suffered fatal heart attacks or strokes as a result of the use of Granuflo or Naturalyte may also be eligible to file a dialysis lawsuit on behalf of their family member. If you lost a loved on as a result of the use of Granuflo or Naturalyte, you have our deepest sympathies. We would be happy to discuss your potential dialysis lawsuit with you. This type of dialysis lawsuit is usually referred to as a dialysis wrongful death lawsuit.
Is there A Dialysis Class Action Lawsuit?
At this time we are not aware of a dialysis class action lawsuit being formed. It is important to note that it is not necessary that a dialysis class action lawsuit exist for you to file your dialysis lawsuit claim.
In December of 2012 a motion was filed with the Judicial Panel on Multidistrict Litigation to form a dialysis lawsuit multidistrict litigation. If granted, this motion would allow for the consolidation of the dialysis lawsuits filed against the maker of Granuflo and Naturalyte to be consolidated into a single court. It would not be mandatory that any individual join their case with the multidistrict litigation (MDL)
A dialysis MDL would be similar to a dialysis class action lawsuit. The major difference in a dialysis class action suit and a dialysis MDL is how the plaintiff’s cases are treated that join a class action or an MDL. In a class action all cases are handle as essentially a single case, in a dialysis lawsuit MDL, each dialysis lawsuit case would remain a separate case, those that joined the MDL would simple be consolidated into a single court under a single presiding federal judge.
How do I file a Dialysis Lawsuit?
In order to file a dialysis lawsuit you should first speak with a lawyer experienced with the dialysis lawsuit case. You may call our toll free number or use the contact form on this page to speak with a dialysis lawsuit lawyer today.