Manufacturer of GranuFlo – Failure to Warn

Fresenius Medical Care (FMC), makers of the most prescribed dialysis concentrate – GranuFlo – is currently under investigation by the Food and Drug Administration (FDA). The FDA is investigating whether or not FMC failed to warn consumers of the potentially life threatening risks associated with GranuFlo.  Allegedly, FMC knew of an increased risk of cardiac arrest for GranuFlo users as early as 2010, but did not warn doctors or consumers of this risk until late 2011. Even then, FMC only issued a warning to company owned dialysis clinics. Not until March 2012 did FMC issue a GranuFlo warning to non-FMC doctors and clinics.

Manufacturing companies like FMC are required to warn consumers of the potential risk and possible side effects associated with the use of a product. A warning should explain to consumers why a risk exists with the use of a product, what the possible side effects are if the warning is not followed, and how a consumer can avoid danger. Manufacturers who fail to warn consumers may be liable for the damages related to an injury or death caused by the use of a dangerous product.

Victims’ Legal Rights

If you or a loved one suffered a serious complication after using GranuFlo, your legal rights may entitle you to financial compensation from the manufacturer. To learn what your legal rights are, consult a trusted California dangerous product attorney at the law firm of Estey Bomberger. We can explain to you what your rights are and quickly determine if your rights allow you to file a product liability (area of law governing dangerous products) lawsuit. Product liability law is a complex area of law and can be difficult to navigate. We have more than 70 years of experience handling product liability cases and have obtained millions of dollars for clients harmed by a dangerous or defective product. Our case results include a $17 million verdict for a client who suffered a serious spinal cord injury as a result of using a defective loader/back-hoe.

Passionate about Helping Clients 

The California product liability attorneys at Estey Bomberger are passionate about helping clients get maximum compensation for medical expenses, lost wages from missed time at work, loss of quality of life, impaired earning capacity, emotional anguish, and physical pain. Please contact our firm today to arrange a free consultation with one of our attorneys. We do not require a retainer fee and will not ask you for any out-of-pocket expenses. We only collect payment when you collect compensation.


GranuFlo Wrongful Death Lawyers

GranuFlo dialysis concentrate, which is manufactured by Fresenius Medical Care (FMC), is the most prescribed dry acid concentrate used in hemodialysis. FMC treats approximately 400,000 patients at its dialysis clinics and of those; about 260,000 of them are treated with GranuFlo. In non-FMC dialysis clinics, approximately 126,000 patients are treated with GranuFlo. In late 2011, FMC notified doctors practicing in the company’s dialysis clinics that use of GranuFlo significantly increased the risk of a patient dying suddenly from cardiac arrest. According to FMCs findings, patients treated with GranuFlo were approximately six times more likely to suffer cardiac arrest than when treated with other dialysis concentrates.

Unlike rival products, GranuFlo contains more of an ingredient that the body converts to bicarbonate, which is an alkaline substance. When alkaline levels are elevated, the body cannot produce enough acid to neutralize the alkali and patients can develop a condition known as metabolic alkalosis. Metabolic alkalosis can lead to heart problems and worse, death.

Fresenius Medical Care – Failure to Warn

Alarmingly, FMC failed to notify non-FMC clinics of the dangers associated with GranuFlo until March 2012 and is currently being investigated by the Food and Drug Administration as to whether or not they violated federal regulations. Manufacturers like FMC are required to warn consumers of the risks associated with the use of a product and may be liable for the damages related to a tragic death if found to have acted negligently in the marketing of their product.

If your loved one’s death was attributed to the use of GranuFlo, you may be able to file a wrongful death claim against FMC. In a wrongful death claim, you can pursue monetary compensation for the damages associated with your loss, including:

  • Final medical bills
  • Deceased’s future earnings
  • Deceased’s anticipated savings
  • Funeral and burial expenses
  • Lost benefits of the victim (pension, 401K, etc.)
  • Loss of love, companionship, and guidance (if applicable).

Fostering Change 

At Estey Bomberger, our California dangerous product lawyers know that no amount of money could ever replace the life of a loved one. Our goal when helping surviving family members is to simply make sure they have the tools they need to begin putting the pieces of their life back together following a tragic loss. By filing a claim, our clients can also make sure the negligent wrongdoer is held accountable and made to pay for the harm they have caused. We feel strongly that our job is to not only help clients obtain full and fair compensation, but also to foster change in the way large corporations like FMC do business.

Call Estey Bomberger for Free, 24 Hours a Day 

For a free and confidential consultation, please call our office at no charge anytime of the day or night. When you call, your call will be taken by one of our caring wrongful death lawyers and not a case manager or paralegal. You can also reach one of our experienced lawyers by submitting a free online case consultation request form. We understand the physical, emotional and financial effects an unexpected loss can have on victim’s family members and are dedicated to helping families see justice served.