Early Trials Moving Forward in GranuFlo MDL

Early Trials Moving Forward in GranuFlo MDL

Posted By Golomb & Honik, P.C. || 11-Jan-2016

Coordinated litigation involving the dialysis products, GranuFlo and NaturaLyte, is moving forward in order for thousands of injured plaintiffs to eventually have their day in court. The judge who is currently overseeing the litigation reviewed the preparation of early trials which may provide important insight into how more than 4,300 cases could potentially be settled in the future. The GranuFlo and NaturaLyte lawsuits, which are currently pending in a Massachusetts U.S. District Court, allege manufacturer Fresenius did not provide necessary warnings regarding the risks of heart attack associated with the two products.

First Two Bellwether Trials Set for Early 2016

As the first state court trial heads toward a verdict, bellwether trials in the Federal Court MDL will begin early next year. In that case, the plaintiff filed a complaint in 2013 following a fatal cardiac event his wife experienced during dialysis at a Mississippi Fresenius clinic. The second bellwether trial will begin in February 2016. In that case, the plaintiff claims her husband died of a cardiovascular event in February 2012 after undergoing dialysis at a North Carolina Fresenius clinic. In both of these cases of wrongful death, NaturaLyte or GranuFlo was used during the dialysis procedures. Some believe these two products may have been the cause of both fatal cardiac events. These bellwether cases will provide valuable information to both sides as far as how future trials may be decided. The bellwether trials could also convince the manufacturer to consider global settlement negotiations with plaintiffs.

What are NaturaLyte and GranuFlo?

Both NaturaLyte and GranuFlo are concentrates manufactured by Fresenius, which remove waste from the blood during hemodialysis. In 2012, several serious cardiac events and deaths were linked to NaturaLyte and GranuFlo, both of which call for extremely specific mixing instructions. When the solutions are not precisely mixed, patients can suffer heart attack, metabolic alkalosis, and even death. Fresenius was cited in 2012 for failure to alert the public and medical community about the potential risks associated with the products.

Fresenius Medical Care neglected to warn physicians that NaturaLyte and GranuFlo contain more of an ingredient that is converted to bicarbonate in comparison to other similar products. Fresenius eventually warned doctors in its own clinics but did not notify other clinics who used the products until a memo was leaked to the FDA nearly a year later. Fresenius’s decision to not inform other clinics of the dangers left more than 100,000 dialysis patient, who received the products at facilities other than Fresenius, at serious risk.

Class I Recall Issued in 2012

Also in 2012, Fresenius Medical Care voluntarily changed the labeling on GranuFlo and NaturaLyte products—a Class I recall. The recall did not involve removal of the products; however, the FDA did indicate there was a reasonable probability that exposure to the product could result in severe health consequences or even death. When a patient undergoes hemodialysis, the machine sifts waste, extra salt, and extra water from the patient’s blood when the kidneys are unable to do so. A part of the process includes neutralizing acids in the blood by administering bicarbonate to the patient.

Apparently, doctors were unaware of the additional bicarbonate in GranuFlo and NaturaLyte, putting patients at risk for ingesting excessive bicarbonate. High bicarbonate levels can create the following symptoms: low blood pressure, a high concentration of CO2 in the blood, low potassium levels, and low blood oxygen pressure. Cardiac arrest and death can occur if these conditions are not promptly and properly treated. If you or someone you love has suffered serious, adverse effects as a result of NaturaLyte or GranuFlo, it could be extremely helpful to speak to an attorney who can determine whether you are entitled to compensation for your injuries.

National Dangerous Drug Attorneys Ready to Fight for You

If you have used NaturaLyte® or GranuFlo® dialysis products and believe you have suffered harm as a result, we encourage you to get in contact with our Philadelphia dangerous medical device lawyers at Golomb & Honik, P.C. today. When you contact our firm, we will provide you with a no-cost evaluation. When you work with us, you can rest easily knowing we have the necessary resources and skills it takes to fight against large pharmaceutical companies. Contact our Philadelphia dangerous medical device attorneys for seasoned legal advocacy or complete our confidential contact form.

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