Charleston GranuFlo and NaturaLyte Defective Drug Lawyer
Serious side effects and other problems with medications frequently do not become evident until the drug starts harming consumers. Many drugs out on the market today went out to consumers without thorough testing and checking for side effects. In fact, it is well known that drug companies have been known to push physicians to market their products off label, and use the questionable drug to treat conditions it was never approved to treat. No one should be in a situation where the medical help they need is the very thing that seriously harms them or causes death.
At the Steinberg Law Firm we understand what it is like to discover that a drug you thought was helping is actually harming you. We are here to help you get the compensation you deserve. Our personal injury attorneys know the ins and outs of defective drug cases and work with you one-on-one to get justice.
About GranuFlo/NaturaLyte used in dialysis
Dialysis is supposed to save lives, not put patients at risk for serious heart problems or death. Two dialysis products made and marketed by Fresenius Medical Care (FMC), headquartered in Bad Homburg vor der Hohe, Germany, which produces medical supplies primarily to facilitate or aid renal dialysis, could seriously harm and/or kill patients.
Fresenius Medical Care has over 2,200 dialysis clinics in the United States. Recently the company’s internal memo warning about GranuFlo/NaturaLyte was leaked to the Food and Drug Administration (FDA). According to the information gathered by attorneys suing FMC, GranuFlo/NaturaLyte contain ingredients that can cause the risk of a heart attack to spike.
Dialysis is a process where the patient is hooked up to a machine to filter their blood. GranuFlo, a dry acid concentrate and NaturaLyte, a liquid concentrate are used during the process to help failing kidneys filter waste products from the blood. During the process, the machine also filters out excess water and salt from the blood and controls the patient’s blood acid level. The active ingredient in GranuFlo/NaturaLyte is sodium diacetate. During dialysis using GranuFlo/NaturaLyte, the patient gets more than the usual amount of bicarbonate than they would be received using other brands of dialyses. To neutralize the blood acid levels, an alkaline substance must be added to the blood.
According to FMC’s marketing material and claims, GranuFlo/NaturaLyte, introduced in 2003, are effective and safe. As it turns out, neither product is safe because every dialysis patient has a different blood acid level. This is important to know because most other dialysis concentrates do not contain any or include very little bicarbonate, because physicians add the needed, correct amount themselves.
Fresenius Medical Care markets their products as all-in-one. However, one size does not fit all when it comes to treating patients with differing blood acid levels. Furthermore, doctors were not advised GranuFlo/NaturaLyte already contributed to bicarbonate levels and because they did not know that, more bicarbonate was added to the GranuFlo/NaturaLyte concentrates — a bicarbonate overdose. Many heart conditions and deaths could have been avoided if doctors had been provided the information they needed to help their patients. GranuFlo contains 8.0 mEq/L of acetate and NaturaLyte Liquid contains 4.0 mEq/L, far more than other competing products on the market.
What happens when a patient gets too much bicarbonate?
Too much bicarbonate has been known to cause:
- Metabolic alkalosis
- Heart failure
- Congestive heart failure
- Sudden cardiac death
- Cardiopulmonary arrest
- Various, potentially permanent cardiovascular injuries
- Low blood pressure
- Low oxygen pressure in blood, hypoxemia
- Low potassium levels, hypokalemia
- Dangerously high blood carbon dioxide levels, hypercapnia
- Irregular heartbeat
Fresenius Medical Care leaked memo
Along with not warning doctors about not adding more bicarbonate to the concentrates, FMC knowing about the problem, wrote an internal memo to FMC staff in 2011 outlining the risk of heart complications, stating, “This issue needs to be addressed urgently.” The company did not warn other doctors or its customer clinics. It did however warn doctors at its own dialysis centers. The warning saved FMC’s patients, but did not help or warn over 125,000 patients at other clinics.
The internal memo was leaked to the FDA and FMC finally took action by alerting doctors and changing its product packaging. In 2012 the FDA issued a Class 1 recall, the highest level for products that cause serious adverse health outcomes or death.
Fresenius Medical Care has given the FDA a new dialysis solution to approve, one that does not have sodium diacetate in it.
Talk to a lawyer
Have you or your family members experienced serious complications from dialysis? Seek an experienced dialysis GranuFlo/NaturaLyte attorney from the Steinberg Law Firm. Contact an attorney as soon as you can, as each state has its own statute of limitations and other deadlines that may affect your ability to obtain compensation if you wait.
The Steinberg Law Firm understands what it takes to make a defective product case that results in fair and equitable compensation for you. Call us today for your free consultation and learn about your legal rights. Call the Steinberg Law Firm at 843-720-2800 as soon as possible.
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