Fresenius Granu Flo Lawsuit
The recalling by the FDA of oral supplement Granuflip and Natura Lyte (often used in hundreds of dialysis practices nationwide) could be responsible for leading to serious, life-threatening side effects suffered by patients receiving these medications. If you or a family member suffered a stroke, cardiac arrest, congestive heart failure and other serious complications after receiving dialysis, contact a consumer injury attorney to learn if you may qualify to sue the company for medical malpractice. It is easy to file a lawsuit when there is negligence on the part of the manufacturer.
Nurtured by their advertising campaign and heavily promoting to seniors as safe diet pills, Fresenius Granuflip and Natura Lyte are dietary supplements that should never have been given to individuals who are at risk for such dangerous side effects.
According to the FDA, the ingredients in both products increased the risk for such adverse events by inducing calcium deficiency, increased blood pressure, increased heart rate and decreased potassium levels in the body. Such effects were likely to result in increased risk for “unstable calcium levels” and “unrestorable shock.” Even though these were the general conclusions of the agency, the company failed to warn consumers of the increased risk or explain how they were designing the products to avoid such dangers. According to the FDA, the company failed to provide any explanation as to why the increased risk was acceptable.
There are many different classes of prescription and over-the-counter drugs that increase the risk of cardiac arrest, especially if taken by older adults with previous cardiac conditions.
Most of the medications are approved by the FDA; however, they are still unregulated and carry a risk of causing life threatening side effects. The same is true for herbal medications that have similar results, but without a medical need to support their claims. The FDA is not required to warn patients and consumers about these potentially dangerous drugs. If they choose not to, they are breaking the law and it is the responsibility of those who take them to seek out professional medical help before taking a supplement that could put them in danger of suffering from life threatening cardiac arrest.
The company was also found to be in violation of HIPPA, the Health Insurance Portability and Accountability Act, which require that health care providers to inform patients of all risks and potential side effects of prescription drug use.
However, the complaint notes that the company failed to warn the public that there was a link between the products and dialysis clinics. The FDA found that the company advertised its Fresenius Granuflip product as safe for patients with kidney disease. The FDA concluded that the item may cause damage to patients by inducing kidney damage.
The plaintiff’s attorney, Michael J. Kornmehl, says that his client suffered a sudden cardiac arrest after using the Fresenius Granuflo oral supplement.
He says that the supplement caused potassium levels in his body to drop dangerously low, which then resulted in his suffering a heart attack. Mr. Kornmehl says that his client is a patient who has kidney dialysis treatment and is suffering from severe side effects from that treatment, which include a decline in his potassium levels and kidney failure. Mr. Kornmehl contends that he notified the company about the danger of the product, but was told that the company did not plan to change its marketing strategy to warn patients about the dangers of taking the item.
The plaintiff’s attorney, Mr. Michael Kornmehl, says that this case is not an ordinary case, as it deals with something as serious as a heart attack and kidney dialysis treatment.
“The reality is that there are dozens of lawsuits like this one that have been brought against dietary supplement companies,” Mr. Kornmehl states. “This case is different because it involves a strong patent issue, a defendant with knowledge about the product and a sophisticated understanding of the medical community.” He says that if the courts find in favor of the defendant, the dietary supplement company could be liable for $1.75 million in damages.
