NEW YORK — A recent comprehensive assessment of available data, authored by, among others, the director of epidemiology at the United States Food and Drug Administration, and the director of the Australian National Joint Registry, concluded that the data do not indicate any advantage for metal-on-metal hip implants compared with traditional metal on polyethylene bearings.

The study, Sedrakyan A., et al., Comparative Assessment of Implantable Hip Devices with Different Bearing Surfaces: Systematic Appraisal of Evidence. BMJ 2011;343:d7434, is thought to be the first systematic appraisal of clinical outcomes after hip replacement with various bearing surfaces.

The authors also found that metal-on-metal hip implants were associated with higher occurrence of revision compared with traditional metal-on-polyethylene hip replacements in the adjusted analyses of three national joint registries: Australian, New Zealand, and England and Wales National Registries (including over 720,000 patients). The authors further noted that their findings related to clinical outcomes of metal-on-metal implants were augmented by reports that show severe metallosis associated with such implants.

In the view of the authors, “[A] large and high quality randomized controlled trial of bearing surfaces in total hip replacements need to be conducted before any claims of benefit are made.” This view is in contrast to the marketing campaigns of some of the manufacturers of metal-on-metal hip replacements that suggest that the metal-on-metal system offers benefits such as greater durability and longer useful life, less wear and lesser probability of dislocation than traditional hip replacements.

In one recent study published in The Journal of Bone & Joint Surgery, researchers found evidence that patients with large diameter head metal-on-metal hip replacement systems made by DePuy (ASR™), Zimmer (Durom®), Biomet (M2a-Magnum™) and Smith & Nephew (BHR) had significantly higher blood levels of cobalt metal ions than did patients with smaller diameter metal femoral heads. The authors also found evidence of wear and corrosion in one of the tapers retrieved from a patient. The researchers concluded that use of large diameter metal bearings in total hip replacements may be inappropriate.

A second study also published in The Journal of Bone & Joint Surgery studied 185 patients with large-diameter metal-on-metal hip replacements with a mean implant time of approximately five years. The authors, Bolland and others, found that these metal-on-metal hip replacements showed an unacceptably high rate of failure (including those awaiting surgery, a 15% failure rate), evidence of high wear at the trunnion-head interface, evidence of metallosis (adverse reaction to metal debris), and passive corrosion of the stem surface, raising more concerns about these types of metal on metal hip replacements.

These studies suggest that the metal wear, metallosis and tissue damage and higher failure rates associated with the DePuy ASR™ hip replacement (recalled) may be a problem in other similar large-diameter head metal-on-metal hip replacement systems with modular tapers such as the DePuy Pinnacle® hip replacement system, the Zimmer Durom® hip replacement system (recalled), and the Biomet M2a-Magnum™ hip replacement system.

Despite the popularity of MoM devices in the past decade, research has shown that the implants are prone to early failure with the metal components rubbing against each other and releasing metal particles into the body. In the recalled DePuy hip replacement, the ball rides out towards the edge of the cup (called “edge loading”), shedding cobalt and chromium particles. The more loose metal ions found in the body, the more likely it is that the hip replacement has failed and needs to be removed.

The area surrounding the artificial hip joint is the first affected by metal particles. In some cases, damage to surrounding tissue and bone may contribute to the loosening of a hip device. The metal ions may also make their way into a patient’s blood stream. Studies have shown that, when large quantities of metal ions are flowing through the body, deafness, blindness, neurological problems, headaches, weakness, and heart problems may result. Initial studies of the effects of certain quantities of metal ions in the body, while not conclusive, suggest that high levels of metal ions in the blood are a cause for alarm.

Hip replacement recipients with MoM and especially MoM DePuy hip replacements should regularly have their blood tested by a doctor or lab center for concentrations of metal ions. The results will indicate whether the hip device is failing and allow doctors to take steps to prevent further damage.

Patients should seek the advice of their orthopaedic surgeon if blood tests reveal high levels of metal ions. If the orthopaedic surgeon confirms that the MoM hip device is failing, the patient should seek legal advice.

For more information about metal toxicity resulting from MoM hip replacements click here.

Now that all DePuy ASR™ hip implant cases pending in the New Jersey State courts have been assigned to Judge Brian R. Martinotti in Bergen County Superior Court, and plaintiffs’ attorneys have organized, more cases are expected to be filed in New Jersey. Mr. Borri, who has filed cases in New Jersey, California, Missouri, Florida and Ohio, said that New Jersey judges have substantial experience handling mass tort cases and that some plaintiffs may decide it will be advantageous to file their cases in New Jersey where they might get a faster trial date than the cases filed in the federal DePuy ASR™ hip implant MDL proceedings being coordinated in Toledo, Ohio or the California State court DePuy ASR™ proceedings being coordinated in San Francisco, California.

Attorneys for the parties will meet with Judge Martinotti again on June 1, 2011, when Judge David Katz, who is coordinating the federal DePuy ASR™ MDL, will also be present.

Additionally, two company manufacturing plants operated by its McNeil Consumer Healthcare unit are being supervised by the U.S. Food and Drug Administration for a five-year period after the agency became aware of numerous problems with its manufacturing processes.

In August 2010, Johnson & Johnson announced a recall of its DePuy hip replacement products, even though more than 90,000 had already been implanted worldwide. Some doctors have asserted that the type and amount of metal used in these artificial hips can contaminate the bloodstream of recipients and cause infection.

British medical authorities have put the failure rate of these hips at 49%, roughly four times higher than the company’s own given failure rate. Worse yet, lawsuits against the company allege that DePuy knew by 2007 of the potentially high failure rate of its products. DePuy also reached a $311 million settlement with federal attorneys in New Jersey after being accused of paying off doctors to promote and install their DePuy hip replacement products.

Some observers attribute Johnson & Johnson’s apparently ongoing quality issues to a confluence of its traditional culture of decentralization and a new emphasis on profitability. The fact that the company recalls appear to be spread across several of the company’s subsidiaries may indicate that problems at Johnson & Johnson extend to its highest executives, who have been accused of taking a “hands off” approach as long as their subsidiaries remain profitable. If this is the case, this would be directly at odds with the company mission statement penned in 1943 by then-CEO Robert Wood Johnson II, who urged that “everything we do must be of high quality.”

Ironically, the Johnson & Johnson name was once synonymous with corporate damage control. In response to a 1982 incident when a still-unknown person laced bottles of Tylenol in the Chicago area with cyanide, the company recalled Tylenol, introduced industry-standard tamper-proof packaging, and then basked in the glow of years of widespread accolades for the public relations acumen with which it handled the crisis. Only time will tell if Johnson & Johnson can regain the goodwill it once held among customers, or if the actions and attitude of its corporate leadership have irreparably damaged the company brand.

The legal claims against DePuy Orthopaedics (many of which also name parent company Johnson & Johnson) involve patients implanted with the defective DePuy ASR hip replacement. The failure rate of this metal-on-metal type hip replacement, at five years post-implant, has been found to be much higher than anticipated. Many of those implanted with the faulty hip replacement have experienced painful symptoms associated with excessive wear of the metal from their hip implants. Some victims of the recall are forced to undergo a second, more complex surgery, called revision surgery, to replace the defective device.

The hearing included testimony from patient-safety advocates, industry representatives, and a ASR hip implant recipient. The patient disclosed that her doctor had received $600,000 in consulting fees from DePuy Orthopaedics. The amount, unfortunately, is consistent with the bribery complaint Johnson & Johnson, DePuy’s parent company, recently settled for $70 million. The company admitted to bribing European doctors and health-care providers in order to sell their products, including the DePuy hip replacement device.

Mass Device website, which published an article regarding the hearing, quoted DePuy’s Director of Communications as stating that the company supports efforts to improve patient safety, the establishment of a national joint registry in the U.S., and that DePuy would work “…with the FDA to strengthen an already-robust process that has worked well for three decades and evolved, when appropriate, to better serve patients.” Considering the amount of recalls of 501(k) approved products, it is troubling that DePuy would call the process ‘robust,’ especially because the company had its own product recalled. Although there is pressure from the medical device industry to lighten the approval burden, patient safety should not be neglected in order to make money, only to have the device recalled later. DePuy not only designed a faulty device, but also failed to timely warn surgeons and patients of the health risks of the device. The hip replacement recall of the ASR, which was implanted in over 30,000 patients in the U.S., helped shed a light on the importance of clinical trials and tougher FDA approval process to ensure patient safety.

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The building, to have been demolished in 2011, was infested with asbestos. Many who frequented the place have already contracted serious illnesses prior to the blaze. The residents further affected by the building’s smoldering debris are now in the process of filing a legal case against the city itself. The Chief Administrative Officer of Laurel, Dennis Keveryn, made no comment about the issue.

The concern of the residents is justified as asbestos is a deadly mineral that can cause serious illnesses. Mesothelioma, arguably the most serious disease caused by inhaling asbestos, has a long latency period, taking years to come to the fore. A person who contracts this disease is left with little chance of survival and this is the major concern of the residents of Laurel.