GranuFlo Disaster

GranuFlo and NaturaLyte are acid concentrates used during dialysis to remove toxins from the blood. Dialysis takes the place of the kidneys in clearing toxic waste from the blood. Part of this involves providing bicarbonate, an alkaline substance, to neutralize the acid that builds up in the blood. GranuFlo performs different functions, but it does contain an ingredient that the body converts to bicarbonate, and it contains more of this ingredient than rival products.

A company named Fresenius Medical Care manufactures GranuFlo. Fresenius, based in Germany, treats more than a third of the estimated 400,000 Americans receiving dialysis treatment. It is also the leading supplier of dialysis machines and disposable products, which are used by many clinics in addition to its own.

An internal memo, dated November 4, 2011, found that 941 patients had suffered cardiac arrest inside Fresenius clinics in 2010. By comparing these patients with others, the company’s medical staff concluded that patients with high levels of bicarbonate in their blood had about six times the risk of cardiac arrest as those with lower levels. This memo was sent to doctors practicing in the company’s dialysis centers, warning them that failure to properly use one of the company’s products appeared to be contributing to a sharp increase in the risk of patients dying suddenly from cardiac arrest.

Fresenius did not immediately warn other centers that use of GranuFlo could cause serious health effects. It did so only later when the F.D.A. anonymously received a copy of the internal memo and questioned the company about it. Thereafter in March 2012, Fresenius issued an “Urgent Product Notification” to its customer clinics warning of possible heart risks associated with their products. According to the notice, GranuFlo and NaturaLyte have the potential to cause a rapid and unsafe elevation of bicarbonate, which creates a substantially increased risk of cardiopulmonary arrest and death.

The F.D.A. would later deem Fresenius’ notification a Class I GranuFlo recall, its most urgent type of recall.

The attorneys at Pittman, Dutton & Hellums, P.C., are currently investigating claims against the manufacturers of GranuFlo and NaturaLyte. If you or a loved one were a  dialysis patient who suffered heart attacks, sudden cardiac death, and other catastrophic heart side effects within 48 hours of a dialysis treatment with GranuFlo or NaturaLyte, please contact Booth Samuels at booths@pittmandutton.com or toll free at 1-866-515-8880.

Could Latest NFL Agreement Effect the NCAA O'Bannon Case?

This month, the NFL settled a case with former NFL athletes for $42 Million over use of likeness issues. The outcome of the case could have a direct impact on how to resolve the O'Bannon case.

Below are a few links regarding the settlement and the fund created out of the settlement. Also below is a piece on how the Big 10 of college athletics could possibly respond to an outcome in the former athletes' favor.

http://www.usatoday.com/story/sports/nfl/2013/03/18/nfl-settlement-retired-players-nfl-films/1997539/

http://profootballtalk.nbcsports.com/2013/03/18/nfl-retired-players-settle-lawsuit-over-use-of-players-images/

http://sportsillustrated.cnn.com/college-football/news/20130318/big-ten-jim-delany-ncaa-obannon/

Stryker's Rejuvenate and ABG II May Be Worse Disaster Than DePuy's ASR

Stryker recalled its Rejuvenate and ABG II modular hip implant systems on July 6, 2012, after the implants showed signs of corroding and fretting – wear that occurs from the constant rubbing together of two pieces, causing bits of metal to crack or flake. Stryker aggressively marketed these products as safe and effective and claimed its patented metal mixture of titanium and cobalt chrome resisted corroding and fretting. Instead, after the devices were already implanted, the implant released bits of metal debris causing premature failure, pain, and tissue and bone death.

Metallosis, an injury attributed to metal-on-metal hips, is an adverse tissue reaction to heavy metals in the body. It can cause pain, limited mobility, failure of the hip joint, pseudo-tumors, dissolution of the bone, DNA changes and chromosomal aberrations. Typically, hip implants are expected to last 15 to 20 years. In some cases, the Stryker Rejuvenate hips are failing in less than five years.

Approximately 20,000 Stryker Rejuvenate and ABG II devices were implanted between 2009 and 2012. Before the recall, Stryker acknowledged that it was aware of the problems by sending an Urgent Field Safety notice to doctors in April 2012. Stryker, based in Kalamazoo, Michigan, is a subsidiary of Howmedica Osteonics Corporation of Mahwah, New Jersey.

The Stryker Rejuvenate hip implant is functionally different from other hip replacement devices that are being litigated because it is not a metal-on-metal hip replacement device. Instead, the Rejuvenate hip replacement device, which uses a ceramic component, was meant as an alternative to the metal-on-metal devices. Like the DePuy ASR, it was marketed to younger patients as a modular hip replacement, meaning the components were custom-made to fit patients better. This was supposed to result in longer-lasting hip replacement devices that offered a better range of motion.

Some patients reportedly developed metallosis from the Stryker Rejuvenate hip. It was initially believed that such a condition was not possible because the Stryker Rejuvenate does not have a metal-on-metal ball and socket design, which is basically what the DePuy ASR and Pinnacle models are.  However, it does have a metal neck piece that can, under some conditions, rub against a metal stem, causing metallic debris to come loose.

Stryker has responded to concerns about the Rejuvenate failure rate by alleging patients did not properly undergo rehabilitation following surgery, or by blaming doctors' implantation techniques. In a Product Correction Bulletin posted on April 4, 2012, Stryker representatives noted, "Factors such as diabetes and infection may play a role in potential corrosion of an implant as these conditions may affect the pH of the tissue surrounding the implant." To this writer, this claim is preposterous. How could elevated cobalt levels be attributed to diabetes, much less infection? I doubt this ‘blame the victim’ defense will hold up to a jury.

Lawsuits have already been filed in the United States over these devices. Many have been consolidated in the New Jersey Superior Court, Bergen County, Case 296. A case management conference has been scheduled regarding the Stryker Rejuvenate Hip Stem and the ABG II Modular Hip Stem litigation on March 19, 2013. It is not certain yet if other cases filed nationwide will be consolidated by the JPML into an MDL.

The attorneys at Pittman, Dutton & Hellums, P.C., are investigating claims against Stryker for the Rejuvenate and ABG II hips. If you or a loved one have been implanted with a Stryker Rejuvenate Hip or the ABG II Modular Hip, contact Booth Samuels at booths@pittmandutton.com or toll free at 1-866-515-8880.