The Federal Drug Administration (FDA) has issued a Class I recall on the dialysis medication GranuFlo. This medication has been deemed too dangerous for use because of the side effects which include death. A Class I recall is the most serious type of recall that the FDA issues on medical products.
Fresenius Medical Care (FMC) is the largest company in the United States to provide kidney dialysis services. They are also the largest manufacturers of dialysis equipment, supplies and medications. It is estimated that this German based company provides over one-third of all dialysis treatments and supplies in the U.S.
In 2010, FMC realized that there were serious issues concerning GranuFlo. Use of this concentrated medication was leading to cardiac arrest in many patients. In 2010, there were over 900 incidences of cardiac arrest during dialysis treatments.
By November of 2011, FMC issued an urgent memo to all of its clinics warning them of the problems associated with the use of GranuFlo. Many people are very concerned, however, with FMC’s failure to notify patients and other medical facilities that use this product of the dangers until four months later. It is believed that over 125,000 patients received this medication at non-FMC sites.
The initial memo was anonymously leaked to the FDA in March of 2012. At that time, FMC made a public announcement to patients and dialysis clinics that there were problems associated with use of this product. A FDA investigation was immediately conducted and the Class I recall was placed into effect.
It is believed that the failure of FMC to notify users of their product outside of their clinics was motivated by profit. FMC currently generates $80 million a year in revenues off of this product alone in the United States. While this has not yet been proven in a court of law, the assumption that FMC did not work in the best interest of their clients is quite apparent.
Most people who receive dialysis do not know if their dialysis center is managed by FMC or by another company. In addition, if their center is not FMC managed, it may still use their products. If you or a loved one has suffered from a heart attack, complication or death during dialysis treatment, you may be entitled to compensation. It is important to contact a personal injury attorney who specializes in dangerous drug cases to have your case evaluated. Ken Nugent and his team of attorneys can help you with your GranuFlo case.