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Plaintiff Seeks $25,000 in New GranuFlo Recall Lawsuit

Melvin L. Brown filed a GranuFlo recall lawsuit against Fresenius USA Inc. on May 24, 2013. The plaintiff is seeking $25,000 to cover hospital expenses, lost wages, as well as future medical expenses and compensation. The Granuflo lawsuit is being handled by the superior court of Middlesex County, Massachusetts.

Plaintiff suffered GranuFlo heart problems

Melvin L. Brown of New York City underwent dialysis in September 2012. He suffered a cardiac event during the procedure, which he believes is due to the use of GranuFlo acid concentrates that were negligently manufactured, distributed, marketed and sold by the defendants, Fresenius Medical Care. In March 2013, the plaintiff discovered that there were thousands of similar cases pending in court, as well as an FDA recall on the product, and decided to file suit.

The plaintiff is suing on seven counts:

  • Negligence
  • Negligent Misrepresentation
  • Fraud
  • Strict Liability in Tort
  • Strict Product Liability – Failure to Warn
  • Breach of Implied Warranty
  • Deceptive Trade & Business Practices Act Violations

GranuFlo recall lawsuit alleges long history of negligence

According to the Granuflo recall lawsuit, “[The] plaintiff’s injury, like those suffered by thousands of similarly-situated victims across the country, was an avoidable tragedy. GranuFlo and NaturaLyte have been implicated in a national epidemic of cardiac events and deaths of dialysis patients.”

Use of the product made individuals 6 to 8 times’ more likely to suffer cardiac injury, the suit adds.

GranuFlo heart problems timeline

  • 1990s – Published studies indicate that elevated bicarbonate levels are linked with increased mortality risk. By 2001, the company was aware of problems with protocol and doctors who were not adequately informed on how to use similar products.
  • 2003 – GranuFlo is approved by the FDA.
  • 2004 – A study published in the American Journal of Kidney Diseases found that patients with high pre-dialysis metabolic alkalosis levels were more likely to experience a heart attack or other sudden cardiac event unless the bicarbonate prescription was reduced.
  • January 2010 – The defendants found that 941 patients in 667 facilities had suffered cardiac events using their products. Instead of correcting the problem, the GranuFlo recall lawsuit alleges that “there was collusion involving individuals in several Fresenius departments… to hide, mislead and obscure information about the extreme patient safety hazards.”
  • September 2011 – The FDA issues a warning letter concerning how the company dealt with complaints and citing its failure to create an adequate hazard prevention program.
  • November 2011 – Fresenius conducts internal training and releases an internal memo stating that “alkalosis is a significant risk factor associated with cardiopulmonary arrest in the dialysis unit.”
  • March 2012 –The November 2011 memo leaked and prompted an FDA inquiry.
  • May 2012 – The FDA released a public safety notice on risks associated with the product.
  • June 2012 – The FDA initiates a Class I Recall. “Inappropriate prescription of these products can lead to a high serum bicarbonate level in patients undergoing hemodialysis,” wrote the FDA, “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.

Status of GranuFlo recall lawsuit

GranuFlo litigation is in its earliest stages right now. At least 119 separate filings have been made across the country, which are expected to be consolidated in Multi-District Litigation. This is often mistaken as a “class action lawsuit,” but in reality each case will be treated separately, with no group settlement likely.

Usually several cases are examined in court as bellwether trials to gauge the amount of evidence on each side. From there, the judge may throw the case out or proceed forward with individual hearings. In some cases, the defendant seeks to settle, rather than endure a lengthy and expensive series of trials.

It’s not too late for individuals who have suffered GranuFlo heart problems to contact a qualified products liability lawyer to see if they have a solid case.