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Fresenius Medical Care is under a lot of scrutiny in the public eye because of dangerous complications linked with two drugs they are currently manufacturing: GranuFlo (powder acid concentrate) and NaturaLyte (liquid acid concentrate) carrying the generic name of sodium diacetate. The two products are used on patients undergoing kidney hemodialysis, and are called dialysates.
Patients undergo dialysis because the kidney can no longer filter the blood on its own and depend on dialysis to do the filtering for them. Dialysates are used to remove waste and cleanse the blood. They work by filtering the blood via the dialysis machine before returning the newly cleansed blood back into the patient’s body.
Dialysates work by transforming the acetate into bicarbonate. The two elements work together to balance the excess acid that the kidney ends up gathering. The problem that lies in this drug; however, is that is produces too much bicarbonate, leading to possibly fatal complications related to the cardiovascular system.
Most complaints from the drug center on cardiovascular diseases – with an increased risk of fatality from sudden cardiac arrest due to arrhythmia, and blockage of blood flow to the heart causing heart attacks. Many lawsuits involve heart attacks more than strokes. However, a large number of these heart attacks have been fatal and loved ones and family members have filed lawsuits against the company in behalf of their deceased beloved.
There is a lot of controversy regarding Fresenius ranging from withholding information from the public and the FDA, to disregarding the safety of patients, to failure of disclosing information to healthcare professionals regarding prescription instructions, among many others. As many as 1,800 pending lawsuits are involved in the multidistrict litigation in Massachusetts, with the first trial set for 2016. More lawsuits are expected to be filed. Included in these lawsuits is the case of the state of Louisiana versus Fresenius Medical Care with claims that the company had defrauded the Medicaid program of the state, as well as the company’s negligence to notify the public about the already known but undisclosed side effects of the product due to excessive bicarbonate.
GranuFlo Lawsuits and Litigation
Two months after the recalls of May 2012, harmed patients due to the use of GranuFlo started filing lawsuits against Fresenius Medical Care. Some patients that suffered from fatal heart attacks from the drug had family members that filed lawsuits as well in the deceased’s behalf. Lawsuit claims allege that the drug manufacturer sold and marketed a perilous and deficient product aside from neglecting to warn doctors and patients of its grave side effects.
Lawsuits allege that Fresenius Medical Care misled consumers about the drug safety of GranuFlo, and that the company intentionally withheld pertinent information about heart attack risks from healthcare professionals outside of Fresenius Medical Care. The drug manufacturer is accused of intentionally endangering patients by not informing the public of its life-threatening side effects, as well as improper training of healthcare providers with regard to safe use of the kidney dialysis products. Evidence like the Fresenius Medical Care internal memo point to the company’s awareness of the dangers of the product but still pursued marketing of GranuFlo without warning both healthcare professionals and consumers.
It was in November 4, 2011 when the internal company memo surfaced. It warned medical directors and doctors at the Fresenius Medical Care clinics that the drug GranuFlo was associated with patients’ increased risk of sudden and fatal heart attacks, strokes, among other fatal conditions. More than 900 patients were involved in heart attacks. Unfortunately, Fresenius Medical Care did not issue the same warning for physicians who were not associated with the kidney dialysis center.
In July 2012, Arthurine Williams sued the drug manufacturer in behalf of her late husband in the U.S. District Court in the Northern District of Alabama. The husband in question is claimed to have undergone dialysis with the use of GranuFlo in July 2010. He passed away due to a heart attack the day after he received dialysis with GranuFlo. Williams says that officials from Fresenius Medical Care knew about the products’ high risk of cardiac arrest and death.
After a month, Betty Lemmond also filed a lawsuit in the same court against Fresenius in behalf of her late husband as well. Her husband, on the other hand, died from a heart attack in August 2012 on the same day he underwent dialysis treatment with GranuFlo. Claims against the drug maker include negligence, wantonness, fraud, unjust enrichment and failure to warn patients about the dangers associated with the products.
Wadell Bishop filed a lawsuit in September of 2012 in behalf of his late mother in the U.S. District Court for the Southern District of Georgia. The mother had gotten a dialysis treatment in early of September 2010 but died later that month, also from a heart attack.
The state of Louisiana had also filed a lawsuit against the drug manufacturer. Claims from this lawsuit allege that Fresenius Medical Care knew about the drug’s bicarbonate level increase that can lead to serious and possibly fatal complications and neglected to notify anyone aside from its internal professionals of said risks. The lawsuit also claims that the company defrauded the state’s Medicaid program.
A multidistrict litigation in the District of Massachusetts has been underway, with over 1,800 GranuFlo and NaturaLyte lawsuits. The multidistrict litigation will be presided over by U.S. District Judge Douglas P. Woodlock, with the first trial set for January 2016. The second trial will be the month after. Waltham, Massachusetts-based Fresenius Medical Care had no objection on the creation of the multidistrict litigation in the said state.
Based on the transfer order for the multidistrict litigation, all the lawsuits that were filed have a common ground of plaintiffs or patients that are adversely harmed or went through deaths resulted from the use of GranuFlo and/or NaturaLyte for kidney dialysis. As of February 2014, there were 515 lawsuits ongoing that are also involved in the multidistrict litigation.
Damages vary from case to case but common damages involved with the GranuFlo lawsuits include pain and suffering, mental anguish, medical bills, lost wages, loss of life’s enjoyment, loss of earning capacity and funeral expenses.
What is GranuFlo?
Manufactured by Fresenius Medical Care, GranuFlo is a drug designed to be used in kidney dialysis. Its generic name is sodium diacetate. The drug is a powder acid concentrate, and is a drug called dialysate crucial in the kidney dialysis procedure. Dialysates remove the waste and cleanse the blood. GranuFlo is used by healthcare professionals in kidney dialysis machines to make sure that the accumulated acid in the blood does not go beyond the normal range. Fresenius Medical Care is the biggest kidney dialysis provider in the United States and also uses the drugs in their clinics while distributing it to other kidney dialysis centers as well.
The company also manufactures NaturaLyte, which is essentially the same as GranuFlo, with the only difference being the form it is in. GranuFlo is in powder form and NaturaLyte is in liquid form. NaturaLyte is also another kind of dialysate.
Unlike other acids that use sodium (mono)acetate, GranuFlo’s active ingredient is sodium diacetate. During kidney dialysis, the liver transforms the acetate into bicarbonate. Acetate and bicarbonate both work together to neutralize the excess acid that the kidney accumulates since it can no longer filter them out from the body on its own. Patients that use sodium diacetate obtain twice the volume of bicarbonate as compared to other formulas. However, excessive bicarbonate levels cause several complications; one of which is rapid and fatal heart attacks.
Fresenius Medical Care reports that GranuFlo is the most prescribed dry acid concentrate in the market. Almost half a million patients have used the drug through kidney dialysis treatment since its market launch in 2003. The manufacturer claims that the drug is the safest in the market due to its unique formula of evenly distributed electrolytes in order to retain balance in a patient’s blood.
Symptoms and Side Effects
The most severe side effects of GranuFlo include fatal and non-fatal heart problems with heart attacks as the most common one. Fresenius Medical Care did a study in 2010 where they observed kidney dialysis patients at their own clinics. Researchers found that the drug increased heart attack risks by six times. The company traced the cause of these heart attacks to excessive bicarbonate in the body which was provoked by GranuFlo. Untreated bicarbonate-related conditions may lead to a fatal heart attack. Low potassium complications, on the other hand, include constipation, fatigue, tingling, muscle damage, numbness, and spasms.
Another complication a patient may get from GranuFlo is metabolic alkalosis – due to high levels of bicarbonate, the pH levels of blood become out of balance, thereby losing the right level of acidity. Other side effects include cardiopulmonary arrest, sudden cardiac death, congestive heart failure, catastrophic cardiovascular injuries, irregular heartbeats, low blood pressure, stroke, low potassium levels, low blood oxygen, and high carbon dioxide. Untreated bicarbonate-related conditions may lead to a fatal heart attack. Low potassium complications include constipation, fatigue, tingling, muscle damage, numbness, and spasms.
FDA Warnings, Recalls and Reports
The FDA issued a class I recall for GranuFlo in May 2012. This class of recall is not to be taken lightly as it endangers patients to be at risk of suffering grave complications that can lead to death. The FDA concerns this issue with the product’s ability to increase the volume of serum bicarbonate in the blood to critical levels. While increased volume of bicarbonate can help with better dialysis treatments, an excessive amount can lead to fatal conditions.
Fresenius Medical Care changed the labels on its dialysate products in early 2012. Resulting in the aforementioned FDA class I recall. Unfortunately, this GranuFlo recall did not entail removing the products from being sold in the market. Fresenius also announced that labels on both dialysates will continue to be updated.
These findings were not reported to the FDA, and the institution only got a hold of the copy of the internal memo anonymously in March 2012. After the receipt of the memo, the FDA started investigations, initiated another Class I recall, and issued a safety communication to warn doctors and patients alike on May 2012.
According to the FDA recall notice, the drug can lead to a high serum bicarbonate level in patients going through kidney dialysis. They also noted that it can cause serious injurious consequences like fatality, low blood pressure, cardiac arrhythmia, and cardiopulmonary arrest.
In the September 2012 complaint, injured patients claim that Fresenius Medical Care withheld warnings from doctors, healthcare professionals, patients and even the Food and Drug Administration. They irresponsibly did not warn healthcare providers and patients of the compelling risk of cardiac arrest and death associated with the drug in spite of the company’s awareness about said risks upon introduction of the products to the market.
The company was also accused of withholding risks of detrimental cardiac occurrences and of withholding pertinent information regarding dangerous possible events from physicians, clinics and healthcare professionals that weren’t associated with Fresenius Medical Care. They also failed to warn about increased liabilities for acute dialysis patients, as well as failure to issue proper warnings and instructions linked with the dialysates.
Under the same complaint, Fresenius Medical Care also ultimately misled consumers by actively marketing and distributing the dialysates all while knowing about the serious safety issues in order to continue receiving profits from sales. Fresenius Medical Care is also deemed to have not addressed the known defects of the dialysates before marketing to the public. The company displayed unfavorable conduct by intentionally having disdain for the public’s safety.