GranuFlo Kidney Dialysis Heart Attack Lawsuit
UPDATED: June 19, 2018
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In June of 2012, the kidney dialysis medication GranuFlo was recalled by the Food and Drug Administration. GranuFlo, manufactured by Fresenius Medical Care, was found to contain higher levels of bicarbonate than other dialysis drugs, and as a result patients were at an increased risk for heart attack, stroke, or sudden cardiac death. Patients, and families of patients, who have been injured or have died as a result of GranuFlo use may have a legal claim to recover financial damages.
Fresenius Medical Care Failed to Warn
Information has recently come to light that Fresenius Medical Care sent a memo in November of 2011 that warned doctors practicing at the company’s dialysis centers that almost 1000 people had suffered sudden cardiac arrest after use of GranuFlo in dialysis. This warning noted that GranuFlo had higher than normal levels of dialysis bicarbonate, and that this could result in cardiac arrest.
What Fresenius Medical Care failed to do was warn all doctors of the risks associated with the use of GranuFlo. Doctors not associated with FMC did not receive the memo about the higher levels of bicarbonate involved with the use of GranuFlo, and were unable to adjust their dialysis treatment accordingly.
Fresenius Medical Care knew about the risks associated with GranuFlo and warned doctors at its own treatment centers of those risks. However, it failed in its duty to issue a general warning about the higher levels of bicarbonate in GranuFlo. As a result, many patients were exposed to increased risk of heart attack, stroke, cardiac arrest, or death.
Legal Action and GranuFlo
Drug manufacturers have a duty to potential users of the drug to properly test the product and warn people about any potential side effects. Although the FDA must approve any drug before it hits the market, drug manufacturers are responsible for conducting adequate testing and being aware of the potential side effects associated with use of the drug. Drug manufacturers, therefore, have the ultimate burden of legal liability should any patient experience unanticipated negative side effects.
Patients or family members considering a lawsuit needs to provide evidence that Fresenius Medical Care violated its duty by failing to adequately inform doctors and consumers of the effects of GranuFlo. A plaintiff in a lawsuit against GranuFlo must demonstrate that their doctor was unaware of the potential side effects because FMC did not provide adequate testing before releasing the drug or adequate warning after the side effects became apparent. Attorneys representing plaintiffs in a GranuFlo lawsuit will likely point to evidence such as the November, 2011 memo to show that Fresenius failed to issue adequate warning about the effects of GranuFlo.
Once it is clear that Fresenius failed in its duty to protect consumers, a plaintiff must show that the use of GranuFlo caused their injury. This can be done by citing medical studies or using medical experts to demonstrate a connection between the specific injury the patient suffered and the known side effects of GranuFlo.
A lawsuit against Fresenius Medical Care must show that the company was negligent in its duty to keep patients and doctors informed about the potential side effects of GranuFlo, and that negligence caused injury. Any patient, or family of a patient, who suspects GranuFlo caused significant medical problems should contact an attorney immediately to discuss their case.
GranuFlo Wrongful Death Lawsuits
In a wrongful death lawsuit against Fresenius Medical Care, the plaintiff must demonstrate the same elements as any other negligence case. They must show that FMC had a duty to protect patients who used its drug, failed in that duty, and caused the death of the dialysis patient who was given GranuFlo.
Plaintiffs filing a GranuFlo on behalf of a deceased patient can typically collect damages associated with the death , which can be difficult to calculate. Wrongful death attorneys will help family members determine the value of their case based on the circumstances of the case, the potential for future wages, and the medical history of the deceased.
While state law varies, typically the only people who can file a wrongful death lawsuit are immediate family members or legal guardians of the deceased. In a GranuFlo wrongful death suit, any immediate family member of a patient who suffered a fatal cardiac arrest as a result of the drug should contact an attorney immediately.
Getting Legal Help
If you or a family member has suffered a cardiac episode or died as a result of GranuFlo dialysis solution, contact an attorney immediately. Cases against large drug manufacturers are complex, and require the help of a professional in order to be successful. If you are a party to a GranuFlo lawsuit, keep a few important tips in mind:
- Keep excellent records. Whether it is a doctor bill or email conversation, save everything related to your case and give it to the attorney.
- Do not speak with anyone about the case! Anything you say can drastically influence the outcome of a case against a drug manufacturer, so keep quiet and let your attorney handle any communications.
- Along those lines, do not post anything on social media outlets about the case. Keep everything private at all times.
- Stay informed about your case. Do not just give everything to your attorney and ignore the matter. Speak with your lawyer regularly and keep track of everything that is going on.
If you suspect that GranuFlo has caused you or a loved one harm, click here to find an attorney in your area. Lawsuits against Fresenius Medical Care will start popping up around the country, and if you think you have a case speak with an attorney immediately.
For more information about GranuFlo recall, click here.
To keep track of the ongoing legal action against Fresenius Medical Care arising from the use of GranuFlo, click here.