Granuflo Lawsuit : Are GranuFlo and NaturaLyte Defective Drugs?

On March 29, 2012, the U.S. Food and Drug Administration (FDA) issued a Class I recall of the dialysis drugs, GranuFlo and NaturaLyte. The recall was based on clinical evidence that the drugs increased the risks of heart attack, cardiopulmonary arrest and death during hemodialysis when compared to other similar drugs. While the drugs remain on the market, the maker, Fresenius Medical Care (FMC), was required to provide new labeling with adequate warnings and dosage instructions on all products manufactured after January 1, 2008. Many victims have decided to file a Granuflo lawsuit in order to get compensated for their health complications.

There are indications that FMC may have known about the increased risks shortly after the drugs were released in 2003, but that they failed to notify the FDA, healthcare professionals or the public of the dangers. The company performed a review of 667 FMC owned dialysis clinics and found that at least 941 patients died of heart attacks during dialysis in those clinics. Since FMC owns more than 1800 clinics and sold the drugs to non-owned clinics, it is probable that the actual number of deaths was substantially higher.

Following the review, the company sent a 6 page internal memo to FMC clinics on November 4, 2011, warning of the risks and providing new medical protocols and dosages for dialysis with GranuFlo and NaturaLyte. No attempt was made to notify doctors of non-owned clinics of the increased risks caused by the drugs or the proper treatment protocols to minimize risks. FMC also failed to notify the FDA of their findings.

The memo stated that medical professionals employed by FMC had determined that patients with elevated pre-dialysis serum bicarbonate levels were at 6 times greater risk for an adverse health event during dialysis than patients with normal bicarbonate levels. GranuFlo and NaturaLyte contain acetate and acetic acid which are converted to bicarbonate at an accelerated rate and FMC doctors felt that this was the likely cause of elevated bicarbonate levels in patients undergoing treatment with the drugs. Elevated bicarbonate levels can cause heart attacks or other life threatening complications.

The indications that Fresenius deliberately withheld vital information from consumers, healthcare professionals and the FDA have resulted in a number of Granuflo lawsuits being filed against the drug manufacturer. The lawsuits state that the plaintiffs experienced permanent injuries and suffered damages that included medical expenses and lost income as a result of the company's defective products. A number of wrongful death lawsuits were filed by family members of patients who died of heart attacks after using GranuFlo and/or NaturaLyte.



One of the most damaging allegations contained in the Granuflo lawsuits is that FMC knew of the defects in their products and did not notify consumers. Other serious accusations include that FMC put patients at unnecessary risk by failing to notify healthcare providers of the dangers of the products and train them in correct medical protocols for administering the drugs.

Additional allegations include:

·      Inadequate warnings and dosage instructions when the drugs were released on the market even though Fresenius should have known of the potential for increased risks from GranuFlo and NaturaLyte.

·      Failure to notify the FDA, as required by U.S.regulations, of adverse health events related to the use of the drugs. This allegation is also the subject of an FDA investigation into possible legal violations by FMC.

·      After learning of the increased risk of heart attack and cardiopulmonary arrest associated with their products, the company withheld that information from non-FMC clinics who bought the drugs from Fresenius.

·      Fresenius continued to market GranuFlo and NaturaLyte in spite of their knowledge of the increased risks of cardiac arrhythmia, heart attack and sudden death.

·      FMC did not advise medical professionals of the significantly higher risks for acute dialysis patients, the elderly and patients with certain chronic medical conditions.

·      Drug labels did not provide adequate dosage instructions, medical treatment protocols or warnings about side effects.

·      Fresenius willfully failed to inform the public about the defects of the drugs in pursuance of profit from sales of the defective products.

A wrongful death lawsuit filed in the U.S. District of Northern Alabama alleges that Johnny Williams died one day after undergoing hemodialysis with GranuFlo and/or NaturaLyte in July of 2010. The suit alleges his death was due to a heart attack that resulted from excessive serum bicarbonate levels caused by the drugs.

A second action for wrongful death was filed in the Northern Alabama federal court for the death of Dizzy Dean Lemmond, who died in August 2010 shortly after undergoing dialysis with GranuFlo. In the lawsuit, his widow accuses Fresenius of “negligence, wantonness and unjust enrichment”.

A Granuflo lawsuit filed in the U.S. District Court for the Southern District of Georgia is for the wrongful death of Frances Carol Bishop, filed by her son Waddell. Mrs. Bishop suffered a fatal heart attack on September 16, 2010 after a dialysis treatment with GranuFlo.

Granuflo and NaturaLyte Increase Heart Attack Risks in Dialysis Patients

Fresenius Medical Care, the largest supplier of dialysis equipment, products and services in the world, released the dialysates, GranuFlo and NaturaLyte in 2003. They used the products in the more than 1800 Fresenius clinics in the U.S. and actively marketed the drugs to non-owned clinics. There is mounting evidence that these drugs increase the risk of Granuflo heart attack or cardiopulmonary arrest during dialysis 6 to 7 times compared to other dialysates.

Hemodialysis is a medical treatment for patients with acute renal (kidney) failure. A dialysis machine removes the blood from the body which is cleansed of waste with the aid of dialysates and returned to the body. The treatment typically takes three to four hours and is performed three times per week. The incidence of renal failure in the United States is approximately 2 in 1000 people. A total of about 400,000 patients undergo hemodialysis each year.

Dialysates are mixed with a bicarbonate buffer to reduce acid levels in the blood and maintain a normal pH balance in the body. NaturaLyte and GranuFlo, unlike other dialysates, contain active ingredients that include acetate and sodium acetate. Acetate and sodium acetate are converted to bicarbonate in the liver at a more rapid rate than the compounds used in other dialysates and when combined with the bicarbonate buffers, these drugs can cause a bicarbonate overdose.

When too much bicarbonate accumulates in the blood, a condition called metabolic alkalosis occurs. Metabolic alkalosis is a serious medical condition that can have life threatening complications including low blood pressure cardiac arrhythmia, cardiopulmonary arrest, hypokalemia (low serum potassium), hypoxia (low oxygen), hypercapnia (elevated carbon dioxide levels) and death. Patients suffering from metabolic alkalosis must have urgent medical intervention to avoid these serious problems.

Symptoms of metabolic alkalosis include:

·      Tingling or numbness of the hands, feet and face

·      Cyanosis (bluish tint to skin)

·      Light-headedness and mental confusion

·      Nausea, vomiting and diarrhea

·      Muscle twitching

High serum bicarbonate levels significantly increase the risk of heart attack and cardiopulmonary arrest.

Internal Fresenius Internal Memo Disregards Safety of Thousands of Patients

In 2011, Fresenius conducted a review of 667 of their clinics and discovered that at least 941 patients had died of Granuflo heart attacks or cardiopulmonary arrest during dialysis treatments with GranuFlo and NaturaLyte. In November of 2011, they sent a notification to medical professionals in their clinics that warned of the risks of bicarbonate overdose and outlined proper protocols and dosage recommendations for the drugs.

Although FMC supplied hundreds of outside clinics with the dialysates, they took no action to notify healthcare professionals in these clinics of the risks or new protocols and dosage recommendations. At least half of all dialysis patients in the U.S. were treated with GranuFlo or NaturaLyte including about 125,000 treated at clinics not owned by FMC. The failure of Fresenius to notify the FDA, medical professionals and consumers of the dangers placed these patients’ lives at serious risk.

FMC and the FDA

Some evidence indicates that FMC may have been aware of at least some of the increased risk caused by their dialysates at the time the drugs were released. A 2010 FDA warning noted that they did not have a proper system to handle patient and physician complaints about the drugs, a violation of FDA regulations.

IN March of 2012, an unnamed source provided the FDA with a copy of the 6 page internal memo sent to Fresenius clinics in November 2011. The FDA sent an inquiry to FMC on March 27, 2012. The company responded by sending out a 2 page Urgent Product Notification to non-owned clinics using GranuFlo and NaturaLyte.

The FDA issued a Class I recall for NaturaLyte and GranuFlo manufactured after January of 2008 on March 29, 2012. A Class I recall is one of the strongest actions the FDA can take and it is only issued for products that present the possibility of serious adverse health reactions including death. Although the products were allowed to remain on the market, Fresenius was required to change the drugs' labeling to include proper warnings, medical protocols and dosage recommendations.

A Safety Communication was issued by the FDA on May 25, 2012 that advised healthcare professionals of the risks of GranuFlo and NaturaLyte, the need for monitoring bicarbonate levels in dialysis patients receiving the drugs and the importance of adjusting dosages regularly. Doctors were also advised that the bicarbonate levels in dialysates vary by both product and manufacturer.

The NY Times reported that FDA officials are investigating to determine if Fresenius broke federal laws by their failure to notify the FDA as soon as they knew of the potential problems with GranuFlo and NaturaLyte. The company could be forced to pay fines or other penalties if the FDA investigation finds they broke federal food and drug regulations.

GranuFlo and NaturaLyte Lawsuits

There are over 150 lawsuits against Fresenius pending in U.S. Federal District Courts for injuries suffered by patients who were administered GranuFlo and NaturaLyte during dialysis treatments. The lawsuits allege that the company aggressively marketed the drugs after they were aware of the risks and failed to provide adequate warnings to medical professionals and consumers.

GranuFlo lawsuits have been consolidated in a multidistrict litigation (MDL) to streamline the legal process and expedite trial dates. Fresenius continues to claim that the lawsuits are without merit and has not entered into settlement negotiations at this time.

A wrongful death lawsuit was filed in Alabama by Betty Lemmond whose husband, Dizzy Dean Lemmond died of a Granuflo heart attack after receiving dialysis treatments with the drug for about 2 months. Another wrongful death suit was filed by Waddell Bishop whose mother died of a heart attack after dialysis treatments. Many of the pending GranuFlo lawsuits are for wrongful death or serious disabilities and additional lawsuits are expected to be filed in the coming months.

A Brief History of GranuFlo and NaturaLyte Problems

There are indications that Fresenius Medical Care (FMC) may have been aware of the increased risk of heart attack and cardiopulmonary arrest posed by the drugs GranuFlo and NaturaLyte when the drugs were released in 2003. It is clear that the company deliberately delayed notifying the FDA and the public for at least several months after evidence of the dangers became undeniable.

The world's largest supplier of hemodialysis equipment and supplies, FMC also operates over 1800 dialysis clinics in the U.S. GranuFlo and NaturaLyte are dialysates which are used to cleanse the blood during dialysis treatment. Granuflo is an acid concentrate powder and NaturaLyte is a liquid form of the same drug. The drugs differ from earlier dialysates because they contain acetate and acetic acid which are rapidly converted into bicarbonate by the liver.

During dialysis, the blood is removed from the body, cleansed with dialysates and bicarbonate buffers and returned to the body. Because GranuFlo and NaturaLyte are converted to bicarbonate much more rapidly than other dialysates, they can cause a bicarbonate overdose if the dosage of bicarbonate buffers is not adjusted regularly. A bicarbonate overdose can lead to a number of serious complications including heart attack, cardiopulmonary arrest and sudden death.

While there were clear early signs of problems with GranuFlo and NaturaLyte, Fresenius conducted an aggressive marketing campaign focused on non-owned clinics. By 2010, nearly half of the approximately 400,000 dialysis patients in the U.S. were receiving their treatments with GranuFlo and/or NaturaLyte. When the increased risk of heart attack caused by the drugs became clear, the company failed to notify the non-owned clinics they supplied of the risk.

Warnings Signs Ignored by FMC

Between 2004 and 2010, Fresenius apparently ignored evidence from their own clinics that their dialysates caused increased serum bicarbonate levels in patients that could be seen in pre-dialysis blood screenings. They should have known that these increased bicarbonate levels could lead to serious adverse health conditions including metabolic alkalosis, heart attack and death.

In 2010, Fresenius received a warning letter at their Waltham, MA manufacturing plant. Part of the complaint stated that FMC did not have standard protocols for dealing with complaints or adverse event reports about their products and they did not properly report the complaints or adverse events to the FDA.

In 2011, the company ordered an internal review of 667 FMC owned clinics and found that at least 941 patients had died during treatment with GranuFlo and NaturaLyte in 2010. A six page memo was sent to healthcare professionals in FMC clinics in November 2010 warning of the dangers and advising doctors that bicarbonate dosages needed to be adjusted monthly. The memo included information on patients in the highest risk groups for heart attacks during dialysis and contraindications for use of the drugs. No information was sent to doctors at non-owned clinics that purchased the drugs from Fresenius.

Medical professionals within Fresenius estimated that GranuFlo and NaturaLyte increased heart attack risks in patients with high pre-dialysis serum bicarbonate levels by as much as 6 times and significantly increased risks for patients with only slightly elevated levels.

In March 2012, the FDA received a copy of the FMC internal memo from an unknown source and instituted an inquiry. In response, Fresenius sent out a 2 page “Urgent Product Notification” on March 29 to non FMC clinics using the drugs. The memo advised doctors of the importance of pre-dialysis monitoring of serum bicarbonate levels when using GranuFlo and NaturaLyte.

The FDA issued a Class I recall on March 29, 2012 for GranuFlo and NaturaLyte manufactured after January 1, 2008. A Class I recall is the strongest action the FDA can take and is only issued if there is “a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death.” Although the dialysates remained on the market, the company was required to provide new labeling with adequate warnings and complete information on drug protocols and dosages.

Additionally, the Federal Food and Drug Administration issued a safety communication on May 25, 2012 warning doctors that they should know that the levels of citrates, acetic acid and acetate in dialysis solutions vary between products and manufacturers and should be considered when administering dialysis treatments.

An article published in the NY Times indicated that FDA was investigating the events leading up to the recall of Granuflo and NaturaLyte to determine if Fresenius, a German based company, had violated U.S. regulations in marketing the drugs and reporting adverse events.

GranuFlo and NaturaLyte Increase Heart Attack Risk during Dialysis

The dialysates GranuFlo and NaturaLyte are used with bicarbonate buffers to filter blood during hemodialysis treatments. These drugs contain acetate and acetic acid that is converted into bicarbonate in the liver at a more rapid rate than the compounds found in other dialysates. This rapid rate of conversion can lead to a bicarbonate overdose and serious complications including heart attack and cardiopulmonary arrest.

Elevated serum bicarbonate levels can cause metabolic alkalosis, an imbalance in the body's pH. Symptoms of this condition include cardiac arrhythmia (irregular heart beat), cardiac tachycardia (extremely rapid heartbeat), low blood pressure, muscle twitching, mental confusion, cyanosis ( a blue tint to the skin caused by lack of oxygen), slowed respirations, nausea, vomiting, diarrhea and numbness or tingling of the face, hands and feet.

Metabolic alkalosis has serious medical consequences if not treated immediately. Elevated serum bicarbonate levels can cause cardiopulmonary arrest, heart attack, hypoxia (oxygen deprivation to the brain), stroke, heart attack and sudden death.

Fresenius Medical Care and the FDA

Fresenius Medical Care (FMC), makers of GranuFlo and NaturaLyte, are the largest suppliers of dialysis equipment and products in the world. With more than 1800 company owned dialysis clinics in the United States, they are the largest single provider of dialysis treatments.

Recently filed lawsuits allege that the company was aware or should have been aware of the dangers inherent in their drugs when GranuFlo and NaturaLyte were introduced to the market in 2003. They further accuse Fresenius of failing to provide proper instructions and dosages for administering the drugs and of providing inadequate warnings about possible serious side effects.

A company review of 667 FMC clinics in 2011 disclosed that more than 900 patients died of heart attacks during dialysis in 2010. Following the review, the company issued an internal memo to FMC clinics warning of the need to monitor serum bicarbonate levels before and during dialysis when using GranuFlo or NaturaLyte and gave additional information for adjusting dosage levels monthly to minimize the risk of heart attack.

Although FMC supplied hundreds of non-owned clinics with the dialysates, medical professionals at these clinics were not notified of the changed treatment protocols or dosages for the drugs. The company also may have violated federal drug regulations by failing to report adverse events to the FDA.

After receiving a copy of the Fresenius internal memo from an anonymous source, the FDA sent an inquiry to Fresenius about the problems with GranuFlo in March 2012. The company responded by sending an “Urgent Product Safety Notification” to non-owned clinics with information about treatment protocols and dosages to be used with the products.

On March 29, 2012, the FDA did issue a Class I recall of Granuflo and NaturaLyte. A Class I recall is only issued if use or exposure to a product could result in serious adverse health consequences or death. The drugs remain on the market, but the recall forced FMC to provide new labeling with adequate warnings and instructions for using the drugs.

GranuFlo and NaturaLyte are contraindicated for use in patients with Cushing's Syndrome and Conn's Syndrome since overproduction of certain hormones caused by these diseases place the patients at greater risk of alkalosis. Individuals with COPD (chronic obstructive pulmonary disease) and other lung diseases and those with known hormone imbalances or serious cardiovascular disease should not use these dialysates.