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Lawsuits against kidney dialysis drug maker Fresenius are going to be much easier now that the Joint Panel on Multidistrict Litigation (JPML) has ordered that all cases be filed in a consolidated proceeding to Judge Douglas P Woodlock, a Reagan nominee, at the Federal Court in Boston, Massachusetts.

The order filed on August 6, 2013 by John G. Heyburn II, the Chairman of the JPML, found that the United States District Court in Massachusetts was the appropriate venue to hear cases on claims of patients who have suffered injury or death caused by the use of GranuFlo Acid Concentrate (GranuFlo) or NaturaLyte Liquid Acid Concentrate (NaturaLyte) during hemodialysis. The first hearing is scheduled for August 30, 2013.

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THE CASE AGAINST FRESENIUS–METABOLIC ALKALOSIS

The allegation against Fresenius is that GranuFlo and NaturaLyte were defectively designed or manufactured as they have been found to cause a medical condition called “metabolic alkalosis.” Metabolic Alkalosis is a relatively frequent clinical problem that is most commonly due to the loss of hydrogen ions from the gastrointestinal tract or in the urine, resulting in the following medical conditions:

  • Low blood pressure
  • Hypokalemia
  • Hypoxemia
  • Hypercapnia
  • Cardiac arrhythmia and
  • Cardiopulmonary arrest

We believe that Fresenius either knew or should have known their products can cause injury, but failed to provide adequate instructions and warnings to both doctors and patients. The lead case, Nunez (LEAD CASE NUMBER 13-md-2428), involves a patient who died after suffering metabolic alkalosis as a result of the use of GranuFlo and/or NaturaLyte.

FDA RECALLS FRESENIUS DIALYSIS PRODUCTS

In March 2012, Fresenius issued a Class 1 Recall and sent an “Urgent Product Notification” to both its dialysis clinics and customers, warning that its products may cause metabolic alkalosis and other serious adverse health consequences that can be fatal–because of the high concentration of acetate or sodium diacetate.

Class 1 Recalls are 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. To learn more about how and why the FDA recalls drugs and medical devices, please read my recent blog for the Huffington Post: When Your Medicine Makes You Sick.

ABOUT FRESENIUS MEDICAL CARE (FMC)

Fresenius Medical Care (FMC)–headquartered in Waltham, Massachusetts–is the world’s largest manufacturer of dialysis products and provides the products used by most by the 400,000 Americans who receive treatment each year in one of the its 2,100 freestanding dialysis facilities across the country.

Interestingly, Fresenius not only manufactures GranuFlo and NaturaLyte, the drugs used for dialysis, but it also operates its own the dialysis clinics, employs its own doctors (such as board certified Interventional radiologists, interventional nephrologists, and vascular surgeons) to administer treatment, and also sells GranuFlo to the competition at non-Fresenius clinics.

Our investigation reveals that Fresenius may have provided information about the risks associated with GranuFlo well before they shared it with the FDA and their competitors, allowing the product to continue to be used.

Be aware of the kidney dialysis medication recall for Fresenius.

Be aware of the kidney dialysis drug maker, Fresenius.

DO I HAVE A DIALYSIS RECALL CASE?

Patients across the country who have been injured by GranuFlo have begun to file lawsuits against Fresenius. In response to the serious medical risks associated with GranuFlo, the dialysis recall attorneys at Aronfeld Trial Lawyers have begun offering a free initial consultation to anyone with a potential claim for having a heart attack after receiving dialysis or while undergoing dialysis.

You can read more about this situation on our website: Read More

If you have a question concerning a potential case for a dialysis-related injury, please email me, Spencer Aronfeld, or call our office today: 305-441-0440 or 866-597-4529. Our offices are in Miami, Florida, but we are representing people across the country, from New York to San Diego, who have been harmed by Fresenius, and we can help you. Call today.