GranuFlo is the trade name of a powdered concentrate used to treat patients who suffer from kidney failure associated with diabetes and must undergo dialysis routinely. It is a drug that is used in the dialysis process. GranuFlo was designed to be diluted in water and delivered through dialysis machines to cleanse a patient’s blood.
GranuFlo is combined with sodium bicarbonate when it is diluted with water, and this results in patients receiving more than normal amounts of bicarbonate compared to other brands of dialysis drugs.
The sodium bicarbonate can cause a change in the patient’s blood pH, a measure of acidity or alkalinity in the blood. This change in the pH can, in turn, increase the risk of sudden, fatal heart attacks. Other side effects and health risks associated with Granuflo include the following:
- Irregular heartbeat;
- Low blood pressure;
- Low potassium levels;
- High blood carbon dioxide levels;
- Low blood oxygen levels;
- Stroke.
In addition, GranuFlo can cause serious eye damage. People who handle it need to wear eye protection.
Fresenius is the company that manufactures GranuFlo. It also owns and operates thousands of U.S. facilities where dialysis is performed. Reportedly in the year 2010, 941 patients whose dialysis treatment included the use of GranuFlo experienced sudden cardiac arrest during dialysis at 667 of Fresenius’s clinics. Use of the substance even resulted in reported deaths.
Was GranuFlo Recalled by the FDA?
In 2011 in a memo, Fresenius management advised the doctors at its dialysis centers about the incidence of sudden cardiac arrest among the patients at its centers in the prior year. The company warned their doctors that GranuFlo appeared to be the problem and advised them to adjust dialysis settings accordingly to prevent injuries and deaths. But Fresenius did not issue any warnings to doctors outside of its own system of clinics.
Someone leaked the internal Fresenius memo to the U.S. Food and Drug Administration (FDA), which investigated Fresenius and GranuFlo. As a result of its investigation in 2012, the FDA required Fresenius to effect a Class I recall of GranuFlo and NaturaLyte, a similar product. A Class I recall is the most significant kind of FDA recall. It is used in situations where there is a reasonable probability that using the recalled product could cause serious injury or even death.
In response to the recall, Fresenius voluntarily changed the labels on GranuFlo and NaturaLyte. However, these products have not been removed from the market. They are still used and still present significant risk factors.
Have There Been Lawsuits for GranuFLo Injuries?
In addition to the recall, many lawsuits were filed by people injured by GranuFlo seeking damages from Fresenius. One hundred and eighty-eight lawsuits had been filed in various federal courts, and in 2013 the Judicial Panel on Multidistrict Litigation (“MDL Panel”) ordered them to be consolidated in the U.S. District Court for the Districts of Massachusetts for the pretrial phase of the lawsuits.
When many product liability lawsuits are filed against the manufacturer of a product because the victims have all been injured by the same product, often the cases are consolidated into multidistrict litigation for their pretrial phase, including discovery.
This results in efficiencies and reduced costs to the parties to the lawsuits. It also reduces the risk that different courts would issue different rulings on the same issues, prolonging and complicating all of the lawsuits. When the MDL cases are ready for trial, they are returned to the respective courts where they were filed.
Who Can Be Held Liable for Injuries Caused by GranuFlo?
Various parties can be liable for GranFlo or NaturaLyte injuries depending on the situation. For instance, the manufacturer of these products, Fresenius, may be held liable for injuries under a strict product liability theory. If a product injures a person, they must only prove that the product was defective and caused their injury.
If they succeed, the product’s manufacturer and distributors can be liable to pay damages to the person. Among the types of defects that can lead to liability are defects in the product’s warning label, for instance, a lack of visible warnings of known dangerous side effects.
Medical professionals such as doctors or pharmacy specialists may also be liable for medical malpractice for GranuFlo injuries caused by a prescription error. A doctor or pharmacist may have made an error in prescribing the medication for a particular patient. Or they may have made a dosage error, medication administration instructions, or other types of errors.
What Are the Legal Remedies for Injuries Caused by GranuFlo?
GranuFlo or other similar products have caused injuries that can be serious and, in some cases, life-threatening. The use of GranuFlo has caused the deaths of some patients.
Lawsuits based on theories of strict product liability or negligence seek an award of compensatory damages for the injured victims. Compensatory damages reimburse victims for their economic losses, such as the expense of their medical treatment and lost wages, if their injuries rendered them unable to work. The damages also compensate a victim for their non-economic losses, such as pain and suffering.
In the GranuFlo lawsuits, people injured by GranuFlo claim that Fresenius knew of the risks associated with the drug but concealed them from healthcare providers and patients. Although no negligence or intention has to be shown to establish defective warning liability, if intentional concealment is proven against a manufacturer, punitive damages may be awarded to the victims.
In some situations, these types of claims may be filed as a class action lawsuit if many people have all been injured by the same product issue.
If the use of GranuFlo caused a person’s death, their close family members would want to file a wrongful death lawsuit. Damages in a wrongful death lawsuit compensate family members for such losses as the following:
- All medical expenses for the medical treatment the deceased received before their death;
- Funeral expenses;
- Loss of the earnings of the deceased;
- Loss of benefits the deceased may have provided to their family members;
- Loss of the care, protection, and companionship of the deceased;
- The pain and suffering of the survivors; and
- On rare occasions, punitive damages where the defendant’s conduct was intentional, malicious, or especially reprehensible.
Do I Need a Lawyer for Help with a Granuflo Lawsuit?
Granuflo legal claims are the type of cases that require the help of a lawyer. If you believe that GranuFlo has injured you, you want to consult a class action lawyer. Your lawyer can review the facts of your case and determine whether the product is responsible for your injuries or whether a doctor or pharmacist may have been negligent in treating you with GranuFlo, thus making them liable for medical malpractice.
You want to consult a lawyer as quickly as possible because each state has its own statutes of limitations for negligence and strict product liability cases. Any delay might affect the outcome of your case.
Also, a lawyer can keep you updated if there are any changes to the laws that might affect your legal rights and options. They can guide you through the legal process from start to finish and answer any questions you might have along the way.
