April 8, 2013--Washington, DC--According to a new study published in the Clinical Journal of the American Society of Nephrology, certain lifestyle factors can prolong the lives of individuals who are suffering from chronic kidney disease or CKD. The study points out that while healthy lifestyle choices are associated with longer life in the general population, these factors may have an even more significant impact on those with CKD, especially those undergoing dialysis treatment.

According to the study, 26 million people in the United States suffer from chronic kidney disease. These patients are at higher risk for heart disease than those in the general population, and certain dialysis drugs such as GranuFlo® or NaturaLyte® may increase that risk due to their tendency to cause serious heart conditions.

The study examined the effects on 2,288 participants with CKD of smoking, excess weight and BMI, and lack of physical exercise. Findings included:

• Nonsmokers who exercised regularly and ate a healthy diet with a BMI or body mass index between 22 and 25 were 53 percent less likely to die from all causes.
• Individuals with a low BMI, between 18.5 and 22, had a 30 percent greater chance of dying than those with a BMI between 22 and 25.
• Those who smoked at a 46 percent greater chance of dying than those who never smoked.
• Those who engaged in regular physical activity decreased their death risk by 20 percent.

After adjustments for various factors, researchers concluded that smoking was the single greatest risk factor. However, regular physical activity and a healthy weight were also linked to decreased mortality risk.

The study's findings are subject to review since the patients were observed in "natural" settings rather than controlled ones, giving rise to the possibility of other factors contributing to the mortality rate. However, it seems clear that there may be a link between a healthy lifestyle and continuing survival during dialysis.

The study did not examine heart conditions caused by dangerous dialysis drugs, however. Even with a healthy lifestyle, patients who used the Fresenius drugs GranuFlo® or NaturaLyte® may be at higher risk for heart complications and possible death than those who did not use these drugs.

GranuFlo® and NaturaLyte® have been shown to increase death risks in dialysis patients due to the tendency of these drugs to suddenly spike blood alkaline levels. This can lead to heart arrhythmia, heart attack, stroke or other serious complications.
Victims who have been injured by the use of dialysis drugs may be entitled to compensation as part of new class-action lawsuits filed against Fresenius, the maker of these dialysis drugs.

Source: News Medical Net, "Healthy Lifestyle May Help Prolong Lives of Individuals With Chronic Kidney Disease," March 25, 2013.

Continue reading "Healthy Lifestyle May Help Dialysis Patients Live Longer" »

March 27, 2013--Washington, D.C.--The Centers for Medicare & Medicaid Services published proposed rules for reporting and assessment of dialysis centers each year. These standards outline requirements for those who provide End-Stage Renal Disease or ESRD services. The 2016 Quality Incentive Program, or QIP, will be released this summer, and could mandate a number of changes for ESRD centers, including locations that perform dialysis.

For 2014, a previously-tabled measure from 2013 will be implemented that concerns treatment for hypercalcemia, or high levels of blood calcium. Topics being considered for the 2016 regulations include pediatric peritoneal dialysis as well as adult dialysis adequacy, preventative care, and mineral bone disorders. This year, QIP requirements concern anemia in dialysis patients but failed to include standards for hospital readmission.

Hospital readmission remains a thorny subject for those concerned with quality care for dialysis patients. The high cost of re-admissions concerns Medicare and Medicaid providers, while dialysis clinics lose income when a patient is admitted because dialysis is performed in the hospital. Readmission rates remain high for the first 30 days after dialysis patients are discharged from hospitals. CMS has begun a penalty program for hospitals that will reduce the amount Medicare or Medicaid pays in the event of a readmission.

Kidney Care Partners argues that the proposed re-admission measures are counterproductive and will not cause reductions in the number of dialysis patients readmitted to hospitals. They believe that any measures should consider global causes of hospitalization rather than focusing on dialysis causes.

There can be many reasons for re-admission to a hospital for dialysis patients, including the use of dangerous dialysis drugs. Fresenius, the manufacturer of two such drugs, GranuFlo® and NaturaLyte®, is currently facing class-action lawsuits based on allegations that the company knew that its drugs posed health hazards to dialysis patients. These dangers include:

• Sudden heart arrhythmia
• Heart attack
• Stroke
• Cardiovascular damage

The two drugs have been shown to cause sudden spikes in blood alkaline levels that can lead to heart issues. Currently, class-action lawsuits seek to recover damages for dialysis patients who have suffered complications from these drugs.

Unless the ESRD QIPs take into account all factors that may lead to hospitalization, it is likely that many groups will continue to have issues with the standards. By focusing on all the possible problems that can lead to hospitalizations for dialysis patients, fair standards may be developed that will allow healthcare providers and hospitals to treat dialysis patients with the highest possible quality of care and avoid problems for these patients.

Source: Nephrology News, "What dialysis facilities should expect for the ESRD QIP in 2016," March 27, 2013.

Continue reading "Dialysis Facilities Examine ESRD QIP Requirements for 2016" »

March 23, 2013--Alberta, Canada--A new study published in the American Journal of Kidney Diseases outlines the correlations between proteinuria, or excessive protein in the urine, and mortality among kidney disease patients. The study reviewed more than 810,000 Canadian patients' medical records to determine if there was a link between excess protein levels and life expectancies. The subjects were between 30 and 85 years of age, and the study found that life expectancies for those with proteinuria were between 8.2 and 17.4 years shorter than those without this condition, depending on age and gender.

These figures represent a "striking reduction in life expectancy," according to the study's lead author at the University of Calgary. Severe chronic kidney disease has already been associated with higher mortality, but this study is the first look at one of the specific factors that may be linked to early death.

Doctors can use this information to help them understand the risk of death among patients at high risk for kidney disease, according to the authors of the study. Screening for proteinuria may help lengthen lives by allowing doctors to take early intervention measures to control protein levels. Patients with a family history of kidney disease, high blood pressure and diabetes would be likely candidates for this early screening.

Dialysis Drugs Can Worsen Other Conditions

Certain dialysis drugs have been shown to create serious medical conditions in the patients to whom they are administered. When Fresenius, a world leader in dialysis products, released the drugs GranuFlo® and NaturaLyte®, formulations used to combat blood acidity during hemodialysis, doctors noticed a high rate of heart attacks and other cardiovascular problems in patients. However, it was not until several years after the drugs had been released that evidence came to light that Fresenius knew that the drugs were dangerous.

A memo circulated only to doctors in Fresenius clinics mentions the high rate of heart attack and advises doctors that dosage levels must be carefully controlled. However, this information was not distributed to the general public, leading to the possibility that thousands of dialysis patients became victims of unnecessary cardiovascular injuries.

Lawsuits against the makers of GranuFlo® and NaturaLyte® are being created at the present time. Victims who have suffered dialysis injuries are encouraged to explore their rights under to collect damages for their pain and suffering, physical impairment and other losses, including wrongful death in cases where people lost loved ones as a result of use of GranuFlo® and NaturaLyte®.

Source: Nephrology News Net, "Protein in the urine linked to life expectancy, can be early sign of kidney problems," March 21, 2013.

Continue reading "Study Finds Correlation Between Protein Levels and Kidney Disease Death" »

March 23, 2013--Ottawa, Canada--Patients who take certain drugs for high blood pressure may be at risk for developing acute kidney injury or AKI, according to a recent study. This includes patients who may have suffered injury from dangerous dialysis drugs.

The study showed risk levels as high as 34 percent greater for patients taking high potency statins as opposed to those taking the low potency versions of these drugs, according to observational analyses carried out by researchers who examined data from seven Canadian provinces and two databases in the United Kingdom. These drugs are often prescribed to control high blood pressure and cardiovascular disease. More than 2 million records were examined as part of the study. The mean age of patients was 68 years.

Statins with dosages greater than 10 milligrams were categorized as high potency. These drugs produced a reduction of low density lipoproteins or LDLs, commonly known as "bad" cholesterols. Patients are at the highest risk during the first 120 days of treatment, but risk levels remain elevated for two years. More research is needed to establish the reason for acute kidney injury in these patients.

Kidney Injury Risks Heightened by Dialysis Drugs

Along with the risk posed by high potency stations, the risk of heart attack and kidney injury can be heightened by the use of certain dialysis drugs. The dialysis drugs GranuFlo® and NaturaLyte®, marketed by Fresenius, were found to greatly increase the risk of hemodialysis patients for heart attacks and other cardiovascular symptoms.

Fresenius released these drugs and marketed them as "safer" alternatives to other dialysis formulas for raising blood alkaline levels. However, it was later noted that patients who received this drugs suffered a risk at least six times greater of having cardiovascular problems. Later evidence revealed that Fresenius had known for some time about the results of clinical trials and other tests that confirmed this risk, but had not shared this information with doctors outside its network.

Patients who have suffered heart attacks, strokes, dangerously elevated blood pressure and other symptoms while using GranuFlo® and NaturaLyte® now have a way to recover damages for their medical injuries. Lawsuits are currently being filed against the manufacturer of these dangerous drugs, seeking compensation for victims who had no idea that the drugs were dangerous. The plaintiffs in these lawsuits may be entitled to damages resulting from the use of these dangerous dialysis drugs.

Source: Nephrology News Net, "High potency statins pose higher risk of acute kidney injury than low potency," March 20, 2013.

Continue reading "Studies Show High-Potency Statins Dangerous for Dialysis Patients" »

March 16, 2013--Cincinnati, Ohio--Studies conducted with both animal and human subjects indicate that a significant rise in the level of the protein semaphorine 3A, as detected in urine samples, can be a biomarker of kidney injury. These findings may lead to better treatments and earlier interventions for victims of traumatic kidney damage.

The study, which was reported in the journal PLOS ONE, was conducted by researchers at Cincinnati's Children's Hospital. Researchers found that semaphorine 3A is not usually detectable in urine but appears in large amounts immediately following acute kidney injury. The level of the protein peaks at six hours and has normalized 12 hours after surgery.

On the other hand, creatinine, a byproduct of metabolism, is not elevated until up to 48 hours after an injury. If doctors look only at creatinine levels, they may miss the opportunity to take measures to improve a patient's condition. However, by measuring semaphorine 3A immediately after an injury or surgery, doctors can quickly predict acute kidney damage.

Dialysis Is A Last Resort

Because dialysis poses so many risks to patients, including the risk posed by the use of dangerous drugs such as GranuFlo® and NaturaLyte®, dialysis is always viewed as a last resort to preserve life. Any efforts that can be taken on the part of healthcare professionals to avoid kidney damage that will lead to the need for dialysis are always appropriate.

This new protein marker may give doctors a way to identify kidney injury at a stage when measures can still be taken to reverse the damage and avoid the need for dialysis for the patient. Further research is necessary to determine exactly why the protein level rises so quickly after a kidney injury.

Dialysis Injury Victims Have Options

Victims who have suffered from the use of dialysis drugs may be able to claim compensation from the manufacturer. In the case of dialysis drugs GranuFlo® and NaturaLyte®, the manufacturer, Fresenius Medical, is accused of withholding important information about side effects from doctors and patients. If this is shown to be true, the company may be required to pay significant damages to those patients who have been injured by these drugs. Class-action lawsuits are currently be filed across the country against Fresenius for injuries suffered by the use of these dangerous dialysis drugs.

Source: Nephrology News, "Potential early indicator of acute kidney injury identified," March 14, 2013.

Continue reading "New Study Shows Protein Can Indicate Kidney Damage" »

March 16, 2013--Washington, D. C.--The federal Food and Drug Administration has issued a written warning to Fresenius Medical Care North America regarding its failure to conduct design verification studies of its electron beam sterilized polysulfone dialyzers. These items, which are the heart of a dialysis machine, are manufactured at Fresenius's Ogden, Utah, plant. The company has issued a statement that it intends to address these observations "as soon as possible."

The Problem Facing Fresenius

A dialyzer is a hollow tube filled with thousands of tubes. During hemodialysis, the patient's blood flows through these tubes to be filtered and returned to the body. A dialyzer is, therefore, the most important component of a dialysis machine.

The FDA alleges that Fresenius failed to conduct design verification studies before releasing this particular model of dialyzer on the open market. Design verification studies help to avoid danger to patients by examining the design of a particular product before it is used by consumers. The FDA has strict requirements about these studies and can impose a recall if it finds that the requirements have not been met. So far, no recall has been issued because the FDA is giving Fresenius time to meet its requirements.

Not The First FDA Warning

This is not the first time Fresenius Medical has run afoul of the FDA. In 2010, the agency issued multiple warnings to Fresenius regarding dialysis products including NaturaLyte® and GranuFlo®, dialysis drugs that are now the subjects of lawsuits on behalf of patients who have suffered injuries due to their use.

GranuFlo® and NaturaLyte® have been shown to cause serious side effects in patients who are given these drugs as part of dialysis treatment. Both drugs can cause:

• Heart arrhythmia or irregular heartbeat
• Heart attack
• Stroke
• Sudden, unsafe surges or drops in blood pressure

The lawsuits against Fresenius are based on the theory that the company knew about the dangers of these drugs but failed to inform doctors and patients. This theory is backed up by documentary evidence that suggest that, at the very least, Fresenius hid the truth about GranuFlo® and NaturaLyte® for a year before the facts about these drugs was discovered. The FDA, in its 2010 letter, warned the company about failure to account for dangerous side effects observed in many patients.

If you have suffered injury from dangerous dialysis drugs, it is time to act to protect your interests. You may find that you are eligible to become a part of the ongoing dialysis injury lawsuits against this company.

Source: Nephrology News, "FDA says Fresenius did not properly verify dialyzer designs in Utah plant," March 14, 2013.

Continue reading "FDA Warns Fresenius About Verification of E-beam Equipment" »

March 9, 2013--Reggio Calabria, Italy--A new study has linked the occurrence of asymptomatic lung congestion and an increased risk of premature death in dialysis patients.

The study, published in the Journal of the American Society of Nephrology, suggests the use of lung ultrasounds to identify this condition and prevent risk to patients through proper treatment. The study stresses that many patients suffer from fluid accumulation in the lungs but do not present symptoms that are easily identified, placing these patients at particular risk for premature death or other medical injuries.

Patients who have suffered from the use of dangerous dialysis drugs such as GranuFlo® and NaturaLyte® may also be at risk for heart attack and other cardiac symptoms. This risk may be compounded in patients who also suffer from lung congestion.

What The Study Shows

This study shows that lung congestion, revealed by routine ultrasound screening, is a big problem for dialysis patients. Among the findings of the study:

• Lung ultrasound testing revealed moderate congestion in 45 percent of 392 dialysis patients tested, and severe congestion in 14 percent of these patients. More than half of patients tested for some degree of lung congestion that could lead to heart problems.
• 71 percent of those patients with moderate lung congestion were asymptomatic.
• Severe congestion results in a risk of death that is 4.2 times that of other patients, and a risk of heart attack 3.2 times greater.
• The study found that asymptomatic lung congestion was a better predictor of death or cardiac arrest than symptoms of heart failure.
Clearly, the risks associated with lung congestion are very high for dialysis patients. These risks may be even higher for dialysis patients who are exposed to dangerous drugs that increase the possibility of heart attack or heart arrhythmia, such as GranuFlo® and NaturaLyte®.

What Should I Do If I Am At Risk?

If you have been a victim of injuries resulting from the use of such dialysis drugs as GranuFlo® and NaturaLyte®, you may be entitled to compensation from the manufacturer. Chris Heavens, a dialysis injury lawyer in Charleston, West Virginia, can explain your rights under current class-action lawsuits and how you may be able to recover compensation for your injuries. You may be entitled to compensation for your injuries, including medical bills resulting from illnesses, medication costs, doctor's fees, costs of rehabilitative therapy, and other healthcare related expenses. You may also be able to recover increased living expenses, lost wages and other expenses. Finally, you may also be entitled to payment of compensation for your pain, suffering and mental anguish. Come to Heavens Law Office to find out about your rights under civil law.

Source: Medical News Net, "Lung congestion increases dialysis patients' risks of premature death or heart attacks," March 1, 2013.

March 9, 2013--Boston, Massachusetts--More than 25 million people throughout the world suffer kidney failure and need dialysis treatment in order to survive. Dialysis flushes fluids and waste products from the body, relieving the kidneys of this burden. However, sudden heart failure is a problem for dialysis patients. Recent studies reveal that the sudden heart failure death rate for dialysis patients is 10 to 20 times that of the rest of the population. A dialysis injury lawyer may be able to help the victims of dangerous dialysis drugs that can contribute to this risk.

Heart Failure Risks Associated with Dialysis

A new study undertaken at Massachusetts General Hospital, in cooperation with Beth Israel Deaconess Medical Center, show that protein carbamylation may contribute to the risk of sudden death in dialysis patients. A blood test can measure carbamylated albumin protein and help doctors know when patients are at risk for this type of heart failure. Supplemental amino acids may help patients reduce this risk.
Patients undergoing dialysis may accumulate urea, a chemical made during the processing of waste, in their bloodstreams. Urea is a normal byproduct of metabolism and is usually excreted from the body by the kidneys. However, if it is left in the blood, it can degenerate into cyanate. Cyanate then binds to proteins through carbamylation, modifying them and making them toxic.

These modified proteins can then lead to rapid buildup of arterial plaque. If patients are exposed to dangerous dialysis drugs such as GranuFlo® and NaturaLyte®, the sudden acceleration in heartbeat can lead to dangerous cardiac conditions, heart attack, and even death.

The drugs GranuFlo® and NaturaLyte® have been linked to cardiac arrhythmia, heart attacks, strokes and other complications from dialysis treatment. Currently, dialysis patients who were exposed to these drugs are fighting back through the legal system.

What Should I Do If I Have Suffered Complications from Dialysis?

Not every dialysis injury is the result of dangerous drugs. However, for dialysis patients exposed to these drugs, the risk of injury is much greater than for those who are given other types of treatments. Because Fresenius, the company that manufactures GranuFlo® and NaturaLyte®, was not transparent with the public about the dangers associated with these drugs, the company may be liable for damages for patients who have been injured by their use.

A dialysis injury attorney such as Chris Heavens in Charleston, West Virginia, can discuss your case with you in a free, no-obligation consultation. You can learn of your rights under class-action lawsuits against the makers of these dangerous drugs, and you may be entitled to compensation for your injuries. This compensation may include payment of medical bills, compensation for disabilities and injuries, and sums for your pain and suffering. Talk to Chris Heavens today about your dialysis injury case and learn about how you can hold companies that make dangerous drugs responsible for their actions.

Source: News Medical Net, "Carbamylation contributes to heart disease risk among patients with CKD undergoing dialysis," March 7, 2013.

Ambulance.jpgMarch 1, 2013--Washington, D. C.--Affymax, Inc., along with Takeda Pharmaceutical Co., are removing the anemia drug Omontys, the trade name for peginesatide, due to reports of adverse reactions including death in some patients. At least three people have died as a result of this dangerous dialysis drug so far and several patients required hospitalization and resuscitation by doctors.

About 25,000 dialysis patients were treated with the drug since its approval by the FDA in March of 2012. The FDA has alerted health care professionals to stop using the drug.

Fresenius, the maker of the drugs GranuFlo® and NaturaLyte®, was using Omontys in its clinic in pilot studies, including one with 18,000 patients that began in July of 2012. However, on February 13 the company announced that it would stop expansion of the studies because of the accumulation of experience with the drug. The announcement caused stock in Affymax to plunge 31 percent in a single day of trading. However, many investors chose to treat the announcement as a temporary setback.

What Does Omontys Do?

The drug causes serious reactions within 30 minutes of administration. If patients have no reaction, they generally will not have problems with the drug and can successful complete dialysis. However, in those in whom a reaction is present, the side effects are swift and often severe.

Omontys is a drug designed to treat anemia in dialysis patients. Due to the nature of dialysis, many patients have trouble producing red blood cells. Anemia is defined as a condition in which red blood cells are either underproduced or do not carry iron sufficiently to function well.

Omontys works by mimicking the structure and production of erythropoietin, a substance that promotes red blood cell development. However, in certain patients, this drug causes a hypersensitive reaction and can lead to anaphylaxsis, a deadly allergic reaction that causes the patient to stop breathing.

Dangerous Dialysis Drugs

Dialysis can be a dangerous procedure if the right drugs are not administered at the right time. Fresenius has a history of producing or using drugs that have caused dangerous or life-threatening conditions in patients.

Most recently, Fresenius has been the subject of a class-action lawsuit due to its use of the drugs GranuFlo® and NaturaLyte® in its clinics. However, the lawsuit is not based solely on the negative side effects of these drugs. It is also based on the fact that Fresenius knew for at least one year prior to recalling the drugs that they were dangerous but failed to notify the doctors who were administering them that their patients could suffer heart attacks, strokes, and other cardiovascular side effects.

What Should I Do If I Have Suffered Dialysis Injuries?

If you have been the victim of a dialysis drug's side effects, contact a dialysis injury attorney immediately. There is a short window of time to file your claim. Chris Heavens at Heavens Law Offices offers free, no-obligation and confidential consultation appointments so that you can learn the facts about your dialysis drug claim.

Source: Nephrology News and Issues, "Deaths reported as Affymax pulls anemia drug Omontys from the market," February 25, 2013.

February 24, 2013--Gainesville, Florida--A study published recently in the Journal of the American Society of Nephrology or JASN shows that dialysis injury is more likely to occur in patients using catheters than in those using other types of access to the vascular system. However, researchers have not yet determined if the risk is based on controllable treatment protocols or hereditary or ethnic factors.

Options for Dialysis Patients

Experts are recommending that kidney patients who must undergo dialysis treatment have an arteriovenous fistula created for the dialysis site. This procedure involves connecting a vein and an artery to form a long-lasting site for dialysis implementation. Another possibility is an arteriovenous graft that uses a plastic conduit to create a connection between the artery and vein.

Many patients are currently using catheter treatment options for a variety of reasons. Some patients simply do not have the vascular strength or integrity necessary to maintain a fistula or graft, especially if their cardiovascular system has been weakened by exposure to dangerous dialysis drugs. Others opt for the catheter because of fear of surgery or needles.

The present study should be considered, however, when dialysis patients or their doctors are considering options for treatment. According to the findings of the study, which reviewed 67 other studies involving 586,337 patients:

• Compared to individuals who had fistulas, catheters posed a risk 38 percent higher of heart-related events, 53 percent higher for death, and double the risk of acquiring fatal infections.
• Compared to individuals who had fistulas, grafts posed an 18 percent higher risk of death and a 36 percent higher risk of fatal infection, but had no higher risk of heart-related events.
The findings of the study suggest that catheters had the highest risk of causing heart-related problems, death and infection for hemodialysis patients, while fistulas posed the lowest risk. One factor that must be considered, however, is that patients given fistulas are often in better health to begin with than those using catheters.

Dangerous Dialysis Drugs Increase Risks

While no part of the study measured the use of dialysis drugs and their effect on the health of patients with different types of vascular access, it has been established that drugs such as GranuFlo® and NaturaLyte® have increased the risk for hemodialysis patients to experience heart attacks and other complications. Patients who have been injured by these drugs may be able to collect damages from lawsuits against the manufacturer.

Source: News Medical Net, "Catheters may increase risk of death, infections and cardiovascular events in dialysis patients," February 22, 2013.

Continue reading "Dialysis Injury--Catheter Use Associated With High Risk for Dialysis Patients" »

February 24, 2013--Chicago, Illinois--In the latest of a series of dialysis drug injuries connected to Fresenius products, a study in the Journal of the American Medical Association reveals that the company's fluid hydroxyethyl starch solution is associated with a significant increase in the risk of death and acute kidney injury.

What Is Hydroxyethyl Starch and Why Is It Dangerous?

Clinical trials have been performed on a substance known as hydroxyethyl starch, a compound that is manufactured to be used in acute fluid resuscitation in critically ill kidney patients. However, the trials have led to conflicting data, primarily due to allegations that one key investigator participated in significant scientific misconduct including fabrication of data and failure to acquire ethical approval for the research studies.

This misconduct not only breaches the ethical and legal standards for medical research but also calls into question any data collected by this researcher. Better data has been collected by a meta-study performed at the University of Manitoba, Canada. The meta-study identified 38 trials with hydroxyethyl starch that met good research standards.

From these 38 studies, reviewers found that the use of hydroxyethyl starch in 10,290 patients resulted in increased risk of death, renal failure and increased use of renal replacement therapy.

The researchers strongly suggested that doctors and policymakers revisit the decision to use hydroxyethyl starch in their patient's treatment protocols.

Fresenius Source of Other Dangerous Drugs

As more data and research emerges, it is becoming clear that Fresenius, the company that manufactured GranuFlo® and NaturaLyte® dialysis drugs, is experiencing significant issues with its dialysis products. Current class action litigation seeks damages from the company based on allegations that it hid knowledge about the dangers of the two dialysis drugs, including how they contributed to high rates of heart attacks and other cardiac issues in dialysis patients. While there is no evidence at this time that the company knew that hydroxyethyl starch could cause complications or that it was in any way involved in the tainted research, every Fresenius product that comes into question under these circumstances will lead more people to believe that the company is hiding defective products behind walls of silence or bogus research.

Victims who have been injured by these dialysis drugs may be eligible for compensation under product liability law. Currently, class action lawsuits are being formed across the country to assist victims in collecting compensation for their injuries and losses from Fresenius.

Source: Nephrology News & Issues, "IV fluid used for critically ill patients linked with acute kidney injury," February 20, 2013.

Continue reading "Dialysis Drugs--Fresenius IV Fluids Linked to Higher Death Rates" »

Drug.jpgFebruary 17, 2013--Barcelona, Spain--A new study that will be published in the Journal of the American Society of Nephrology shows that removal of additional toxins during hemodialysis may increase the patient's chances for survival. The three year study looked at survival rates with traditional dialysis as opposed to online hemodiafiltration or OL-HDF. Patients given OL-HDF had higher survival rates and fewer dialysis injuries than those given traditional dialysis,

How The Study Was Constructed

Doctors at the Hospital Clinic in Barcelona, Spain, conducted a randomized controlled trial study of 906 dialysis patients. They assigned patients to two groups: one that would continue with traditional dialysis and one that would be given the new OL-HDF treatments. Patients were observed for three years under these conditions.
The study found some interesting trends. Among the major findings that occurred during the study were:
• Patients using OL-HDF had a 30 percent lower risk of death overall.
• Patients using OL-HDF had a 33 lower risk of dying from cardiovascular causes.
• Patients using OL-HDF had a 55 percent lower risk of dying from infections.
• Patients using OL-HDF had a lower rate of dialysis sessions complicated by low blood pressure. The OL-HDF patients were also hospitalized less frequently for complications.
• The findings of the study show that switching eight patients from traditional dialysis to OL-HDF would prevent one death per year.

What Does This Mean for Dialysis Injury Victims?

The premise of the dialysis injury cases is that GranuFlo® and NaturaLyte®, drugs manufactured by Fresenius Medical, caused the alkaline blood level of patients to rise to dangerous levels. Therefore, any study that bolsters the theory that making the blood cleaner results in less injury and death also supports the legal questions raised in this lawsuit.

If GranuFlo® and NaturaLyte® indeed caused toxic formations in the blood of dialysis injury victims, then OL-HDF technology may have been able to save some of these patients. However, since this technology was not widely used at the time of the injuries by these drugs, the patients who used them continued to suffer.

If you or a loved one has been undergoing dialysis treatments and has endured a heart attack, stroke, heart arrhythmia or other complication, it is important that you talk to a dialysis injury attorney to determine if you have rights under the existing dialysis class action lawsuits.

Source: Nephrology News, "Hemodiafiltration reduces mortality risk for dialysis patients," February 15, 2013.

Continue reading "Study Shows Removal of Toxins Increases Life Span of Dialysis Patients" »

Dialysis 2.jpgFebruary 17, 2013--New York, New York--The world's largest manufacturer of dialysis products, Fresenius Medical Care, has announced that it is introducing a wireless sensor that will determine if patients are suffering from venous needle displacement during dialysis procedures. Ironically, as Fresenius introduces this new product to the market, dialysis injury lawyers are lining up to file suits against the medical giant for claims that it knew in advance that the drugs GranuFlo® and NaturaLyte® were harmful to patients by raising their blood alkaline levels to dangerous heights.

What Does This New Invention Do?

Fresenius's newest technological venture into the marketplace consists of a wireless sensor that detects wetness around an intravenous needle. This wetness detector is designed to prevent blood loss by alerting dialysis care providers when a needle becomes displaced from a vein, leading to leaking of the dialysis fluid into the area surrounding the blood vessels. This can be painful for the patient and may lead to blood loss in those who are already compromised in terms of venous health.

In some cases, needle displacement has resulted in serious complications and even hemorrhages for dialysis patients. Fresenius is billing the wireless device, known as the WetAlert, as a way to prevent potentially dangerous displacement of venous needles or to deal immediately with the effects of needle displacement. It is hoped that this new technology will give dialysis providers a better way to detect needle displacement and deal with the problems associated with this condition.

Ongoing Lawsuits Still Not Settled

As wonderful as this new invention may be, Fresenius as a company is already under pressure due to ongoing class action lawsuits over its drugs GranuFlo® and NaturaLyte®. This new announcement points out one of the ironies of dealing with large companies: a company with enough funds to engage in research and develop a new and potentially life-saving device is also large enough to attempt to deny responsibility for a badly-manufactured or designed drug.

Patients who have been victims of GranuFlo® and NaturaLyte® injuries may be grateful that the company has developed a potentially life saving device but may also still hold the company accountable for its manufacture of potentially deadly drugs. In the eyes of those who have suffered heart attacks, strokes or other dangerous complications from dialysis drug side effects, the company will still have to answer for its silence in alerting doctors of the dangers of these drugs and for taking steps to deny any responsibility for their results. A dialysis injury attorney can explain patients' rights and help them to file a lawsuit for damages.

Source: News Medical Net, "WetAlert wireless wetness detector from Fresenius Medical Care," February 11, 2013.

Continue reading "Fresenius Medical Care Attempts to Introduce New Products" »

February 10, 2013--London, Canada--Patients who undergo frequent dialysis can experience complications that require more repair procedures, according to a study published in the Journal of the American Society of Nephrology. Researchers at Western University and Lawson Health Research Institute in London, Ontario, Canada, conducted two 12-month clinical trials to test the validity of the claim.

The study utilized 245 patients who would receive dialysis in centers six days per week or three days per week and 87 patients who received dialysis at home six nights per week. The researchers observed the level of repair needed as well as loss of patients and hospitalizations. They found that the risk for problems was 76 percent greater with those receiving dialysis on a daily basis than with those on less frequent schedules.

What Does This Study Mean for Dialysis Patients?

This study points to the increased risk of exposure of dialysis patients in terms of complications. Simply put, the more often a patient has dialysis treatments, the more often he or she is exposed to risk and can suffer complications.

This is especially true if the patient has already been put at risk through the use of a dangerous dialysis drug. GranuFlo® and NaturaLyte®, two dialysis drugs manufactured by Fresenius, one of the world's largest producers of dialysis drugs, have been linked to an increased risk of heart attack, heart arrhythmia, and other cardiac problems in dialysis patients. These drugs have been shown to raise the blood alkaline levels to dangerous proportions, causing dialysis patients further weakening of their already-stressed bodies and systems.

Fresenius, the manufacturer of GranuFlo® and NaturaLyte®, is currently being sued by thousands of dialysis patients after it was discovered that the company knew of the dangers of its drugs but failed to inform doctors of potential risks. Many patients have suffered heart attacks and other health problems believed to be related to these dangerous dialysis drugs. These patients are now coming together to file class action lawsuits against the manufacturer.

Studies such as this point to the fact that dialysis is not a simple process and that anything that upsets the delicate balance of the patient's body is to be avoided. It is especially important for dialysis patients to be given drugs that are manageable by physicians and that these drugs act in exactly the way in which they are advertised in order to protect patient safety.

Sources: Journal of American Society of Nephrology, "Increased Risk of Vascular Access Complications with Frequent Hemodialysis," doi: 10.1681/ASN.2012060595.

Nephrology News & Issues, "More frequent dialysis can increase risks for vascular access complications, study shows," February 7, 2013.

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February 10, 2013--Indianapolis, Indiana--While doctors have known for some time that Omega-3 fatty acids benefit heart health, no real studies have addressed the lowering of risk of heart problems for hemodialysis patients who consume large amounts of these beneficial substances. However, a new study published in the journal Kidney International finally addresses the special considerations of this group and finds that dialysis patients can lower their risk of fatal heart attacks with Omega-3s.

The study examined 100 dialysis patients who died from sudden cardiac events and 300 who survived. The researchers found that patients with high levels of Omega-3 fatty acids in their blood had a lower risk of death in the first year than those who had low levels of these important acids. About 25 percent of dialysis patients die from sudden cardiac events in the first year of treatment. In fact, the risk of sudden cardiac death is about six to seven percent for these patients, higher than the rate in patients with heart failure.

Patients Can Increase Omega-3 With Diet

Even better news for dialysis patients is that they do not need additional drugs to raise their Omega-3 levels; they can do this through diet. Foods rich in Omega-3s include:

• Pasture-fed beef and dairy products
• Eggs
• Cheese
• Edamame
• Wild rice
• Walnuts
• Canola oil
• Flax
• Beans
• Sustainable sources of seafood

By including these items in the diet, dialysis patients can raise Omega-3 levels and provide a level of protection for themselves while undergoing treatment.
Other Risks for Dialysis Patients
While this study is good news for those facing hemodialysis, the issue remains that certain drugs, such as Fresenius's GranuFlo® and NaturaLyte® have been linked to sudden cardiac events in patients who were given these treatments. No matter how good your diet is, you cannot combat the risk posed by dangerous drugs that can suddenly raise your blood alkaline levels, leading to heart arrhythmia and heart attacks.

If you have experienced injury as the result of the administration of a dialysis drug, it is important to protect your rights. Class action lawsuits are being filed against the manufacturers of these dangerous drugs, and a dialysis injury lawyer can explain your right to become part of the class act and help you to receive compensation for your injuries.

Source: Medical News Net, "Omega-3 fatty acids can prevent sudden cardiac death in dialysis patients," February 9, 2013.

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