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GranuFlo Lawsuit

Fresenius, the maker of Granuflo and Naturalyte dialysis additives, faces a large number of potential lawsuit cases over the link between Granuflo and heart attacks. May of these cases will unfortunately be wrongful death lawsuits as Granuflo has already been linked to deaths. Contact us on our toll free number if you or a family member was injured by Granuflo to arrange a free consultation with an attorney experienced in Granuflo litigation.

1-800-611-7080

 

Granuflo Lawsuit

Granuflo Lawsuit

Granuflo Lawsuit Lawyer Firms are already investigating and filing cases. The first case that we are aware of being filed was on behalf of the family of an Alabama man who passed away after being administered Granuflo as part of his dialsysis therapy. This lawsuit alleges that the man’s death was a result of the administration of Granuflo during dialysis treatments. The lawyers that filed the Granuflo lawsuit further allege that the Fresenius knew that there was a link between Granuflo and heart attacks and did not properly warn the public as to the side effects and risks related to Granuflo. If you or a member of your family suffered a heart attack during a period of time in which you were being administered Granuflo, please contact us immediately to set up a free legal consultation with a Granuflo Lawsuit Lawyer.

1-800-611-7080

 

What is Granuflo?

Granuflo is an additive used in hemodialysis, which is more commonly referred to as kidney dialysis or just dialysis. Granuflo is a drug accede product that containing Sodium Diacetate. A website published by Fresnius Medical Care claims that Granuflo is the “ most wide prescribed dry acid product in the dialysis industry today. The same website also claims that Granuflo is the “safest dry acid product”.

FDA Granuflo Recall

Granuflo Recall

Granuflo Recall

The United States food and drug administration issued a class one recall in March of 2012 , this FDA recall also included a recall of Naturalyte, which is also produced by the same company that produces Granuflo. The Granuflo recall included lots of Granuflo produced from 2008 through 2012.

The reason for the Granuflo recall as stated by the FDA, was a result of the manufacturer warming medical personnel that administered Granuflo to be aware of the concentration of acetate of sodium acetate contained in the product. The FDA gave further warnings regarding the risks of high bicarbonate levels in patients receiving dialysis treatments.  High Bicarbonate levels can lead to a condition known as metabolic alkalosis, which is linked to heart attacks, low blood pressure as well as other potentially fatal conditions.

Th FDA recall came after a number of adverse event reports received by the FDA from medical practitioners and the public regarding severe medical problems, including heart attacks, which occurred in patients undergoing dialysis treatments which included Granuflo as an treatment  additive.  The issues that led to the Granuflo Recall are some of the primary issues being raised in Granuflo Lawsuit cases.

Is There a Granuflo Class Action Lawsuit?

Granuflo Class Action Lawsuit

Granuflo Class Action Lawsuit

A great deal of speculation exists regarding the possibility that a Granuflo Class Action Lawsuit will be formed. Given that the injuries sustained by individuals who used Granuflo vary significantly in severity, a Granuflo Class Action Lawsuit may not be the type of mass action that occurs in the Granuflo Lawsuit case.

A Granuflo Multidistrict Litigation may be more likely to be formed than a Granflo Class Action Lawsuit. Granuflo Lawsuit cases are already being filed. It is not necessary that a Granuflo Class Action Lawsuit or a granuflo Multidistrict Litigation be formed in order for any individual to file a Granuflo Lawsuit if they were injured by the use of Granuflo.

What are Some Potential Granuflo Side Effects?

The primary side effect caused by a an inappropriate dose of Granuflo is Metablolic Alakalosis. Metabolic Alkalosis creates a significant risk factor for additional Granuflo Side Effects which include

  • Cardia Arrest (Heart Attacks)
  • Cardia Arithmia
  • Low Blood Pressue
  • Hypokalemia
  • Hypoxemia
  • Hypercapnia

These conditions can occur independently or in combination. These side effects can also be the cause of other side effects on this list. Any combination of these side effects could lead to a fatal event, which may often be a heart attack.

Reports of Granuflo Deaths

Granuflo Deaths

Granuflo Deaths

A significant number of Granuflo Deaths have already been reported. Not all reports agree as to how many Granuflo Deaths or deaths linked to Granuflo have occurred. It is unlikely that an accurate figure will be available for some time regarding the number of deaths that have occurred as a result of the use of Granuflo. To date, there has not been a great deal of mass media publicity regarding Granuflo and fatal heart attacks. At this time it is highly likely that many individuals have lost family members that were receiving dialisys treatments which included Granuflo, are completely unaware that their loved one may have died as a result of the use of Granuflo.

As more Granuflo Lawsuit cases are filed and more mass media publicity occurs surrounding it, more individuals will become aware of the link between their family members death and Granuflo.

Link Between Granuflo and Heart Attacks

Not all heart attacks linked to Granuflo result in death. Granuflo Heart Attacks may cause various levels of injury. All heart attacks damage the heart

Granuflo Heart Attacks

Granuflo Heart Attacks

permanently. Some Granuflo Heart Attacks that do not result in death may result in severe and permanent diablity.

Anyone who had a  heart attack during the time period in which they were using Granuflo may be eligible to file a Granuflo Lawsuit. Granuflo Heart Attacks resulting in death may be filed by family members of the individual who experienced a fatal Granuflo heart attack.

Talk to a Granuflo Lawyer

Granuflo Lawyers are available to provide free legal consultations about your Granuflo Lawsuit by simply contacting our toll free number. A Granuflo Lawyer or Granuflo Attorney is a lawyer that is experienced in pharmaceutical litigation and is accepting clients for the Granuflo Lawsuit.

You can arrange a free consultation with a Granuflo Lawyer by contacting our toll free number.

Information on Granuflo Lawsuit Settlements

Granuflo Lawsuit Settlements

Granuflo Lawsuit Settlements

The Granuflo Lawsuit is in its early stages. If the defendant in the Granuflo Lawsuit decides to offer Granuflo Lawsuit Settlements it is likely to be further along in the lawsuit process. If lawsuit settlements are offered by the defendant to avoid trial, the amount of the settlements offered will likely be based on the severity of the injury sustained by the plaintiff in each Granuflo lawsuit case.

Granuflo Lawsuit News

This website will be providing information regarding issues related to the Granuflo Lawsuit over the entire period of time the Granuflo Lawsuit is ongoing. Please refer back to our site often for up to date Granuflo Lawsuit News.

Granuflo Lawsuit News

Granuflo Lawsuit News

Aggrevating Circumstances in the Granuflo Lawsuit

There have been reports that internal memos show that Fresenius Care Medical was aware of the link between Granuflo and an increased risk of heart attacks as early as 2011. From recent documents filed in ongoing litigation regarding Granuflo, it would appear the maker of Granuflo did not share the information regarding the risks of Heart Attack associated with Granuflo at the time they first became aware of them. Drug manufacturers are required to report all known risks associated with their product before receiving FDA approval and additionally drug makers are required to report any new risks they discover to be associated with their product after the product is on the market and being used by patients. What the maker of Granuflo knew and when they knew it will be a major issue in the Granflo Lawsuit.

In addition to reporting all known side effects and risks associated with their product to the FDA, the maker of Granuflo also has a legal obligation to report Granuflo Side Effects and risks to the prescribing community and users and potential users of their product. Failing to provide information regarding all known risks associated with Granuflo has already and is likely to result in “Failure to Warn” claims in Granuflo Lawsuit cases.

Granuflo Lawsuit Effect of Withheld Information

If the allegations that Frenius Medical knew about the side effect risks linked to heart attacks and withheld the information, Granuflo Lawsuits could include claims related to this issue. In any lawsuit involving a pharmaceutical product like the Granuflo Lawsuit where allegations that the manufacturer withheld information that could have saved people’s lives if made public are proven, the results can be very negative for the drug maker.

It is likely that some Granuflo Lawsuits will go to trial before a jury. When dealing with juries, the emotions of the jury or jury sentiment can be every bit as important as the facts of the case in how the jury goes about carrying out its responsibilities. A jury must decide to rule in favor of , the plaintiff or defendant. If the Jury rules in favor of the Plaintiff then the jury must also decide how much compensation to award the plaintiff. In past cases where juries have been successfully shown that a pharmaceutical company withheld information that could have save people’s lives, juries have awarded extremely large amounts of money to Plaintiffs. Typically, the impression that a pharmaceutical company withheld information that could have saved people’s lives or saved them from injury to protect the company’s profit margin does not go over well with juries. Punitive damages are among the type of damages that any Granuflo Lawsuit jury could award. Punitive damages are meant to punish the offending party in addition to compensating the plaintiff for their injuries and other losses. A jury that has developed a very negative “sentiment” towards a defendant is more likely to award large amounts of money in damages than a jury that does not feel negatively towards the defendant.

Excerpts from an actual Granuflo Lawsuit

Below we have included excerpts from an actual Granuflo Lawsuit, we believe this to be the first lawsuit filed over the issue linking Granuflo to heart attacks. We do not claim any rights to the information below, this information was taken from a public document and we have added comments headers and notes that were not part of the Granuflo lawsuit filings. Nothing in this document or on this website should be considered legal advice. We have only included portions of the lawsuit example that are unusual or atypical in most pharmaceutical lawsuits.

Granuflo Lawsuit Excerpt Begins

Granuflo Lawsuit claim of FRAUD, MISREPRESNTATION, AND SUPPRESSION

Plaintiff adopts and incorporates by reference all the allegations above.
Defendants Fresenius fraudulently, intentionally and/or negligently misrepresented to the Plaintiff, the FDA, and general public, the safety of NaturaLyte and GranuFlo and/or fraudulently, intentionally and/or negligently concealed material facts including adverse information regarding the safety of NaturaLyte and GranuFlo.
Defendants Fresenius made misrepresentations and actively concealed adverse information at a time when the Defendants knew, or should have known, that NaturaLyte and GranuFlo had defects, dangers, and characteristics that were other than what the Defendants had represented to the FDA, and the consuming public, including the Plaintiff. Specifically, the Defendants misrepresented to the Plaintiff, the FDA, and the consuming public that:
a. NaturaLyte and GranuFlo, when used as recommended, were safe for use in dialysis treatments.
b. NaturaLyte and GranuFlo were fully and adequately tested.
c. NaturaLyte and GranuFlo had no serious undisclosed adverse effects on blood pressure, the heart, or cardiopulmonary physiology.
d. NaturaLyte and GranuFlo were safe and effective.

Comments on Allegations of Fraud in the Granuflo Lawsuit

Fraud is a very serious allegation to make in a lawsuit. The plaintiffs in this case contend that the actions of the defendant rose to the level to be considered fraud. Fraud can be both a civil tort as well as a criminal action depending on the facts alleged. In this Granuflo Lawsuit ,the Plaintiff is making a claim of fraud in a civil suit.

Granuflo Lawsuit Claims Based on Defendants Knowledge

Defendants Fresenius knew or should have known that these representations were false and that the Plaintiff would rely on them, leading to the use of NaturaLyte and GranuFlo. Defendants Fresenius knew that physicians, dialysis clinicians, and nurses had been told the same false and fraudulent information about NaturaLyte and GranuFlo, and that the Plaintiff and the treating physicians, dialysis clinicians, and nurses would rely on information, advertisements and statements made by Defendants Fresenius about the use, safety and efficacy of NaturaLyte and GranuFlo.

What the Granuflo Lawsuit Knew and When the Knew it

What the Granuflo Lawsuit defendant knew and when they knew it will most likely be a major factor in the outcome of the Granuflo Lawsuit. An Act on Inaction committed unknowingly can still make a defendant liable for damages, however an action or inaction committed with knowledge of the harm that action or inaction may cause can result in an award of punitive damages in a Granuflo Lawsuit or any civil litigation.

Granuflo Lawsuit Acts of Concealment

At the time of Defendants’ fraudulent misrepresentations and active concealment, the Plaintiff was unaware of the falsity of the statements being made and believed them to be true.
Johnny Williams justifiably relied on and/or was induced by the misrepresentations made by Defendant of the safety and use of NaturaLyte and GranuFlo, and in fact, used NaturaLyte and GranuFlo as recommended.
Defendants Fresenius concealed the truth from the Plaintiff and the consuming public about the real safety and risks of NaturaLyte and GranuFlo.
Defendants Fresenius had a post-sale duty to warn Plaintiff and the public about the potential risks and complications associated with NaturaLyte and GranuFlo in a timely manner.
The misrepresentations and active concealment by the Defendants Fresenius constitutes a continuing tort against Johnny Williams.
As a direct and proximate result of the misrepresentations and concealment of the Defendant as set forth above, Johnny Williams sustained injuries and died.
WHEREFORE, THE ABOVE PREMISES CONSIDERED, Plaintiff demands judgment of the Defendants Fresenius for damages in an amount determined by the jury and such other and further relief as allowed in equity or law.

Granuflo Lawsuit effect of mispresentation and concealment

If the Granuflo Lawsuit plaintiff can prevail in proving that the defendants actively concealed information that could have prevented the death of the plaintiffs family member, the repercussions for the defendant could be significant. To have knowledge and not share that knowledge with another party that has the right to that knowledge is actionable on its on merit. To actively conceal knowledge from a party that has the right to the knowledge is a greater offense and could contribute to an award of Punitive damages in a Granuflo Lawsuit.

Granuflo Lawsuit claims of WRONGFUL DEATH

Plaintiff adopts and incorporates by reference all the allegations above.
As a direct and proximate result of Defendants’ negligence and otherwise culpable acts described herein, the Decedent, Johnny Williams, received GranuFlo which caused him to sustain injuries and damages outlined herein and caused his death.
Johnny Williams’ injuries and death as alleged more fully herein directly resulted from Defendants’ negligent and otherwise culpable acts, omissions, and/or misrepresentations.
WHEREFORE, THE ABOVE PREMISES CONSIDERED, Plaintiff demands judgment of the Defendants, Fresenius and DaVita, for damages in an amount determined by the jury and such other and further relief as allowed in equity or law.

Comment on Granuflo Wrongful Death Claim

Granuflo Wrongful death Lawsuits may be common and among some of the first Granuflo Lawsuit cases that Granuflo Lawyers elect to take to trial. Granuflo Lawsuit cases involving wrongful death may receive some of the highest settlement or judgment amounts.

Granuflo Lawsuit Claim of UNJUST ENRICHMENT

Plaintiff incorporates by reference each and every paragraph of this complaint as though set forth in full in this cause of action.
At all times relevant to this action, Defendants designed, advertised, marketed, promoted, manufactured, distributed, supplied, and/or sold NaturaLyte and GranuFlo.
Plaintiff and/or the decedent purchased NaturaLyte and GranuFlo for dialysis.
Defendant has accepted payment from Plaintiff and/or the decedent for the purchase of NaturaLyte and/or GranuFlo.
Plaintiff and the decedent did not receive the safe and effective pharmaceutical product intended.
It is inequitable and unjust for Defendants to retain this money because the neither the Plaintiff nor the decedent receive the product Defendants represented NaturaLyte and GranuFlo to be.
WHEREFORE, THE ABOVE PREMISES CONSIDERED, Plaintiff demands judgment of the Defendants, Fresenius and DaVita, for damages in an amount determined by the jury and such other and further relief as allowed in equity or law.

Comment on Granuflo Lawsuit Claim of Unjust Enrichment

An unjust enrichment claim may appear in many Granuflo Lawsuit case filings. An unjust enrichment claim is a fairly broad claim and can be made in many situations. If the Granuflo Lawsuit defendants did not sell their products at a profit an or gave their products away for free, a claim of unjust enrichment may not prevail.
The above claim in

Granuflo Lawsuit CLAIM FOR DAMAGES

WHEREFORE, the above premises considered, Plaintiff prays for judgment against Defendants, as follows:
a. For punitive damages in an amount to be proven at the time of trial;
b. For costs of this suit and attorneys’ fees; and
c. All other relief that Plaintiff may be entitled to at equity or at law.

Comment on Claim for Damages in the Granuflo Lawsuit

Demanding compensation for the damages raised in a Granuflo Lawsuit or any other lawsuit is common and necessary. When filing a Granuflo Lawsuit you must be asking the court to grant you some form of relief. In most lawsuits the relief being sought is monetary damages.
End of Granuflo Lawsuit Excerpt.

Granuflo Lawsuit FDA Information

Granuflo Lawsuit Educational Information

  • Formation of Granuflo and Naturalyte Multidistrict Litigation From the SEC

    The following is a release from the SEC regarding the formation of a federal multidistrict litigation in the United States district court. The complaints to be consolidated allege inadequate warnings for NaturaLyte® and GranuFlo® caused harm to patients. If you or someone you love suffered a heart attack while receiving dialysis treatments, please contact us for information on filing a Granuflo Lawsuit or Naturalyte Lawsuit. You may contact us on our toll free number or by using the contact form on this page.

    Investor News Oliver Maier
      Head of Investor Relations
       
      Fresenius Medical Care
      Else-Kröner-Straße 1
      61352 Bad Homburg
      Germany
      T +49 6172 609-2601
      F +49 6172 609-2301
      oliver.maier@fmc-ag.com
      www.fmc-ag.com

    December 13, 2012

    Fresenius Medical Care Announces Update on Dialysate Concentrate Products

    Bad Homburg, Germany — Fresenius Medical Care AG & Co. KGaA (“the company” or “Fresenius Medical Care”), the world’s largest provider of dialysis products and services, announced today that on December 12, 2012, a group of plaintiffs’ counsel filed a petition to form a federal multidistrict litigation in the United States District Court for the District of Massachusetts and thereby consolidate wrongful death lawsuits against the company’s North American subsidiary Fresenius Medical Care Holdings, Inc. and subsidiaries (FMCNA). The complaints to be consolidated allege generally that inadequate labeling and warnings for FMCNA’s dialysate concentrate products NaturaLyte® and GranuFlo® caused harm to patients. The company believes that these lawsuits are without merit, and intends to defend them vigorously.

    Ben Lipps, chief executive officer of Fresenius Medical Care, commented: “We have commented many times on our pride in our global team’s commitment to quality. One has to understand the nature of the medical status that influences the acid/base balance in dialysis patients. The company’s actions related to these products were appropriate and responsible. Both products are safe and effective and were reviewed and cleared by the Food and Drug Administration several years ago. I am confident of our position on this medical issue”.

    On December 7, 2012, FMCNA received a subpoena from the United States Attorney for the District of Massachusetts requesting production of a range of documents relating to products manufactured by FMCNA. FMCNA intends to cooperate fully in this matter.

    Fresenius Medical Care is the world’s largest integrated provider of products and services for individuals undergoing dialysis because of chronic kidney failure, a condition that affects more than 2.1 million individuals worldwide. Through its network of 3,135 dialysis clinics in North America, Europe, Latin America, Asia-Pacific and Africa, Fresenius Medical Care provides dialysis treatment to 256,521 patients around the globe. Fresenius Medical Care is also the world’s leading provider of dialysis products such as hemodialysis machines, dialyzers and related disposable products.

    For more information about Fresenius Medical Care, visit the Company’s website at www.fmc-ag.com.

    Disclaimer

    This release contains forward-looking statements that are subject to various risks and uncertainties. Actual results could differ materially from those described in these forward-looking statements due to certain factors, including changes in business, economic and competitive conditions, regulatory reforms, foreign exchange rate fluctuations, uncertainties in litigation or investigative proceedings, and the availability of financing. These and other risks and uncertainties are detailed in Fresenius Medical Care AG & Co. KGaA’s reports filed with the U.S. Securities and Exchange Commission. Fresenius Medical Care AG & Co. KGaA does not undertake any responsibility to update the forward-looking statements in this release.


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  • Granuflo Recall Lawsuit Information
    Granuflo Recall Lawsuit

    Granuflo Recall Lawsuit

    The following is an excerpt from the website of the FDA regarding the recall of Granuflo and Naturalyte dialysis additives resulting from heart attacks and deaths linked to these products. If you or a family member suffered a heart attack while on dialysis treatments, please contact us for information on filing a Granuflo Lawsuit or Naturalyte Lawsuit. You may contact us on our toll free number or by using the contact form on this page.

     

    Fresenius Medical Care North America, Naturalyte and Granuflo Acid Concentrate

    Recall Class: Class I

    Date Recall Initiated: March 29, 2012

    Product: Naturalyte and Granuflo Acid Concentrate

    Serial numbers for Naturalyte Liquid Acid Concentrate range from:

    08-0231-4, 08-1001-0, 08-1201-8, 08-1231-3, 08-1251-1, 08-1301-4, 08-2201-5, 08-2231-2, 08-2251-0, 08-2301-3,08-2351-8, 08-3201-4, 08-3231-1, 08-3251-9, 08-3301-2, 08-4123-1, 08-4223-7, 08-4225-1, 08-4230- 2, 08-4231-0, 08-4323-5, 08-4325-1, 13-1251-1, 13-2201-5, 13-2231-2, 13-2251-0, 13-3231-1, 13-3251-9, 13-4123-1, 13-4220-1, 13-4225-1, 13-4325-1

    Serial numbers for Naturalyte GranuFlo (powder) Acid Concentrate range from:

    OFD1201-3B, OFD1251-3B, OFD2123-3B, OFD2201-38, OFD2220-3B, OFD2223-3B, OFD2225-3B, OFD2231-3 B, OFD2251-3B, OFD2301-3B, OFD2323-3 B, OFD2325-3B, OFD3201-3B, OFD3231-3B, OFD3251-3B, OFD3301-3B

    This concentrate was manufactured and distributed from January 2008 through June 2012.

    Use: The Naturalyte and Granuflo Dry Acid Concentrate are used in the treatment of acute and chronic renal failure during hemodialysis. The concentrate is formulated to be used with a three-stream hemodialysis machine, which is calibrated for acid and bicarbonate concentrates.

    Recalling Firm:

    Fresenius Medical Care North America
    920 Winter Street
    Waltham, MA 02451

    Reason for Recall:

    The manufacturer is cautioning clinicians to be aware of the concentration of acetate or sodium diacetate (acetic acid plus acetate) contained in Fresenius’ Naturalyte Liquid and Granuflo Dry Acid Concentrate. Inappropriate prescription of these products can lead to a high serum bicarbonate level in patients undergoing hemodialysis. This may contribute to metabolic alkalosis, which is a significant risk factor associated with low blood pressure, hypokalemia, hypoxemia, hypercapnia and cardiac arrhythmia, which, if not appropriately treated, may culminate in cardiopulmonary arrest. This product may cause serious adverse health consequences, including death.

    FDA has issued a general safety communication related to inappropriate prescription and resultant alkali dosing errors in the dialysate concentrates used in hemodialysis.

     

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