James C. Ferrell, P.C.
A Professional Corporation
Dialysis is a method of medically treating persons who have serious kidney conditions, or, in some situations, that require assistance to the body temporarily. Dialysis is used to aid the kidneys in removing waste and excess water from the bloodstream. In hemodialysis, the “dirty” blood is pumped from the body through a filter outside the body which removes the waste and excess water. The machine then replaces the “cleansed” blood back into the body. The dialysis machine and products act as an external kidney.
FRESENIUS MEDICAL CARE
Granuflo and Naturalyte are both products manufactured by Fresenius for use in the Hemodialysis procedure. Fresenius, a German company, is the largest supplier of dialysis materials in the United States and treats approximately 1/3 of the 400,000 dialysis patients in the U.S. Fresenius produced these products and operated a large number of clinics throughout the United States. Further, Fresenius also marketed their products to other dialysis clinics which is estimated to be another 25-30% of the market. From approximately June 2003 until June, 2012, Granuflo/Naturalyte was used throughout this market.
FDA WARNING AND CLASS I (HIGHEST LEVEL ) RECALL NOTICE
On June 27, 2012, the FDA issued a Class I Recall Notice on the Granuflo and Naturalyte products. A Class I recall means “a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.” A Class I recall is the FDA’s highest level recall. Both Granuflo and Naturalyte were subject of the recall because they were found to cause a condition known as alkalosis in the human body.
The currently known injuries caused by Granuflo/Naturalyte include heart damage, heart attack and death. Some of these conditions occurred in the dialysis clinic and most happened within 24 hours, although it is believed that the conditions may arise within 48 hours of treatment. Other potential injuries may also have occurred, however, this is not known at present.
Fresenius Medical Care was aware of the potential for these types of injuries. (The awareness of this problem may stretch back for years, although that is not confirmed at this time.) On November 4, 2011, Fresenius issued an internal memorandum regarding Granuflo/Naturalyte to the Dialysis treatment facilities it owned and operated. However, Fresenius did not issue the same warnings to clinics and doctors outside of its clinics who were using the Granuflo/Naturalyte products. Approximately four months later, on March 29, 2012, Fresenius issued a warning to the public. However, the product was not recalled or removed from the market at that time. On May 25, 2012, the FDA issued a Safety Communication which referenced Fresenius and the dialysis problems. Finally, on June 27, 2012, the FDA issued a Class 1 Recall. On the same day (apparently), Fresenius published an “update” regarding the recall and referred to the recall as “labeling change” or “labeling update”, indicating that 90% of its customers had been notified.
1/2010 – 12/2010 – 941 patients suffer cardiac arrest inside Fresenius clinics.
11/4/2011 – Fresenius issues internal memorandum warning its own clinics/staff.
Fresenius is undoubtedly aware of the danger of its products.
No warning is issued to “outside” customers or clinics that Fresenius supplies with these products.
3/29/2012 – Fresenius issues a warning to the public. FDA initiates investigation.
5/25/2012 – FDA issues a Safety Communication, which indicates that Fresenius
worked with FDA to issue 3/29/2012 notice.
6/27/2012 – FDA issues a Class I Recall, indicating that Fresenius issued an “urgent
product notification” to their clinics and customers on 3/29/2012.
-Fresenius issues an “update” on its own website indicating that Fresenius’
“voluntary action to change labeling” was classified by FDA as a Class I
recall. The statement further says that the “FDA’s action does not involve
the removal of any FMCNA products from the marketplace.”
Memorandum prepared by the offices of;