Hip Replacement Implant Lawsuit News
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The massive failure of metal-and-metal hip implants is one of the biggest medical device failures in history. It is a cautionary tale of our time — of what happens when the safety of patients succumbs to lax oversight, outright negligence and the drive for corporate profits.
It is, in the simplest of terms, about greed.
When metal-on-metal hips were introduced they were designed to last longer and allow for high-impact activity, such as running and jumping.
But within a few years, problems began appearing. Patients complained of acute pain and becoming immobilized by joint dislocations, infections and bone fractures. Metal-on-metal hip implants were found to be problematic because, according to the Food and Drug Administration, their components were shown to grind together and shed metallic debris. This metallic debris can damage tissue and bone and metal ions can enter the bloodstream.
DePuy Orthopedics, a division of Johnson & Johnson, was the largest maker of metal-on-metal hips and over 93,000 of the company’s A.S.R replacement joint were implanted worldwide. Even before the company began marketing the A.S.R in the United States in 2005, they had been receiving complaints for years from doctors in Europe. Consulting surgeons to DePuy in Europe stopped using the device because of its poor record.
In 2007, DePuy conducted internal tests on the A.S.R and the joint failed, and reported, “The current results for A.S.R. do not meet the set acceptance criteria for this test.”
The company considered a redesign but in 2009 the Food and Drug Administration rejected an application to sell a resurfaced version of the A.S.R. in the United States. In 2010 the company was forced to issue a recall of the defective implants. Documents have since shown that DePuy executives then started calculating when the company should stop selling the A.S.R., based on the time it would take to convert surgeons to another company implant.
But DePuy was only the largest maker of metal-on-metal hip replacements. Other companies making metal-on-metal hip implants began receiving eerily similar complaints. Dislocations, infections, and pain were common in recipients.
Stryker, maker of the Rejuvenate and ABGII, recalled both hip replacement systems in July 2012. Worldwide, 30,000 of the Stryker hip systems were installed; 20,000 of them in U.S. patients. Both implants were found to be prone to corrosion, joint dislocation, and the release of metal ions which can cause metallosis, tissue inflammation, necrosis and death.
Other smaller manufacturers have also recalled their metal-on-metal hip joints such as the Smith & Nephew R3 and the Zimmer Durom Cup. However, even in spite of the dangerous health threats metal-on-metal joints are proven to pose, several products remain on the market. The Biomet Magnum, the Encore and the Wright Profemur Converse, Dynasty and Lineage, remain available, but are all failing at unacceptably high rates.
Unlike new drugs, the metal hip replacements didn’t have to undergo clinical trials before receiving approval from the FDA, the government agency with the role of protecting consumers from dangerous products.
Without rigorous independent testing that would have uncovered the dangers of metal-on-metal joints, the responsibility fell on the companies that manufactured them to insure their safety. In almost every case they failed miserably and decisions were made based on profits rather than the health and safety of the patients they served.
By 2008, DePuy was well aware of the design flaws in the A.S.R. but continued to actively market it to surgeons in the United States, who then implanted it into tens of thousands of patients. Knowing full well they had a defective product, a top sales official in the company wrote to a colleague that, “We will ultimately need a cup redesign, but the short-term action is to manage perceptions”
For the Stryker Rejuvenate and ABGII hip replacement systems, some doctors have predicted the failure rate might go as high as 70 percent. That would mean over 20,000 patients with the implant will have to undergo painful revisions on top of the painful complications they’ve already endured.
According to a filing with the Securities and Exchange Commission, since the A.S.R. was recalled more than 10,000 lawsuits have been filed against Johnson & Johnson.. In March, a California jury awarded $8.3 million to a retired prison guard who sued the company over health complications caused by his A.S.R. implant. Analysts predict total damages for the company could eventually reach a billion dollars or more.
The failure of the Stryker Rejuvenate and ABGII has so far led to over 100 lawsuits being filed in Bergen, N.J., where the company’s headquarters are located. With over 20,000 of the defective implants in U.S. patients, analysts expect the number of lawsuits against the company to grow dramatically.
There are many reasons patients elect to have hip-replacements, but in every case, regardless of the medical cause, patients all expect to have a better quality of life. In tens of thousands of patients, the failure of metal-on-metal joints in patients who elected to have them implanted has damaged their health and quality of life in ways that may be irreversible. Revised artificial hips often perform worse than a first prosthetic because of issues with bone loss and fit, and in addition to the pain and suffering, they are likely to never recover the same quality of life they expected.
More oversight and corporate governance that placed patient welfare above the bottom line could have prevented these patients’ suffering. But as the lawsuits continue to mount, it is clear what was at the root of this health disaster – greed.
Hip Replacement Implant Lawsuit News