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.

California Jury Hits J&J with $8.3M Verdict

In the first case to try in the United States, a California jury found Johnson & Johnson liable for $8.3 Million in damages over the DePuy ASR prosthetic hip. DePuy is a subsidiary of Johnson & Johnson. Loren Kransky, the plaintiff in the California case of Kransky v. DePuy Orthopedics, filed suit over injuries from his implantation and revision of the recalled DePuy ASR XL hip implant.

Even though Dr. Trotsky, Mr. Kransky’s surgeon, felt that Mr. Kransky might not live through the revision surgery, Dr. Trotsky felt that removal and replacement of the DePuy ASR XL implant was absolutely necessary due to Mr. Kransky’s highly elevated levels of cobalt and chromium ions in his bloodstream, which were being shed from his recalled hip implant.

Johnson & Johnson and DePuy aggressively marketed and sold over 33,000 of these recalled hip implants to be distributed and implanted in patients across the United States, despite their knowledge that high levels of cobalt and chromium ions posed a serious threat for unaware patients.

In addition to the $ 8.3 million award for for Mr. Kransky’s damages, over 10,000 other lawsuits filed on behalf of patients that have been injured by the DePuy ASR XL are still pending.

If you or a loved one have had hip replacement surgery and have been implanted with a defective DePuy hip, you may be entitled to compensation for medical bills, pain and suffering, lost wages and other injuries. Our firm is currently investigating claims for those people who have been implanted with DePuy hip replacement devices, both ASR and Pinnacle. If you would like a free case evaluation, please contact Booth Samuels at toll free 1-866-515-8880 or at booths@pittmandutton.com.

Jury Hits Johnson & Johnson in Mesh Case with $7.6M in Punitive Damages

A month-long jury trial against Johnson & Johnson’s Ethicon subsidiary ended badly last week for the mega-corporation (Gross v. Gynecare Inc., Superior Court of Atlantic County, New Jersey, Atl-L-6966-10). A New Jersey jury came out with a $3.35 million verdict in favor of the plaintiff and hit the company for $7.76 million in punitive damages.

The case was tried in Atlantic City over J&J’s Gynecare Prolift vaginal mesh implant. J&J is the world’s largest seller of healthcare products. The New Jersey transvaginal mesh lawsuit is one of 1,800 pending against J&J and its Ethicon division in a multicounty litigation underway in Atlantic County Superior Court. There are approximately 2,000 cases nationwide in various US district federal courts, while most are consolidated in West Virginia.

The Plaintiff, Linda Gross, recounted from the stand that her life since receiving Ethicon’s Gynecare Prolift device as being a “living hell.” Despite undergoing 18 corrective surgeries, the 47-year-old former nurse from South Dakota said she is unable to sit or stand for long periods of time without feeling pain. In urging the jury to award punitive damages, the Plaintiffs’ attorneys said Johnson & Johnson was a “big giant” and jurors must send a “loud message” to punish the company for its conduct, according to Bloomberg.

The $3.35 million compensatory damage verdict in favor of Ms. Gross includes economic loss, pain and suffering, and more. Under New Jersey state law, punitive damages are capped at five times the compensatory damages. Her allegations were that J&J knew it sold a defective device despite knowing the risk of scar and pain, organ damage and perforation.

The jury found that J&J failed to warn the plaintiff’s surgeon of the risks of its Gynecare Prolift implant and fraudulently misled her about the risks. This is the first trial involving 2,100 New Jersey lawsuits and about 2,000 cases nationwide in US District federal court, consolidated in West Virginia - all of which are over J&J’s vaginal mesh.

It is believed that J&J is worth $121 billion and has a net worth of about $65 billion. Last year it spent $21 billion on marketing and advertising alone, which translates to $57 million per day. This behemoth medical company spends $3.5 million on advertising every 45 minutes, which is the same sum that the jury awarded Linda Gross.

J&J is also in serious legal hot water over their subsidiary DePuy and their manufacturing of metal-on-metal hips such as the ASR and Pinnacle. Litigation in regards to those products have both been consolidated into MDL’s.

Transvaginal mesh devices are used to treat pelvic organ prolapse and stress urinary incontinence. They have been the subject of growing safety concerns since October 2008, when the U.S. Food & Drug Administration (FDA) issued a Public Heath Notification advising it had received more than 1,000 complaints over a three year period relating to vaginal mesh products. In July 2011, the FDA issued another alert, noting that it had received a total of 2,864 additional reports of complications. The agency concluded that serious injuries associated with surgical mesh for transvaginal repair of pelvic organ prolapse, were “not rare,” and further advised that transvaginal prolapse repair with mesh “does not improve symptomatic results or quality of life over traditional non mesh repair.”

The attorneys at Pittman, Dutton & Hellums are currently investigating claims against the manufacturers of mesh products. If you or a loved one experienced injuries from a mesh product, please contact Booth Samuels at booths@pittmandutton.com or toll free at 1-866-515-8880.