Some 430 patients who received the DePuy Articular Surface Replacement (ASR) hip implants in Australia have reportedly experienced device failure and other complications, according to an article
published in the Sydney Morning Herald. The DePuy Orthopaedics Inc., a subsidiary of Johnson & Johnson, in August of 2010 called for a worldwide recall of two of its hip
replacement systems, the ASR XL Acetabular System and the DePuy ASR Hip Resurfacing Platform. However, the first country to have acted on the two DePuy hip implants was Australia in
December 2009 with Europe initiating its own recall a year later. Lawsuits followed in the aftermath of the worldwide recall with at least 300 hip replacement lawsuits filed in Britain.
The 430 patients had required a revision surgery to remove the implants, said the news report. Depuy’s apparently defective ASR hip implant devices were implanted in about 5,500 Australians including the 430. With thousands of Australians using the implant, better and immediate action from the DePuy Orthopaedics and the Australian Department of Health and Ageing have been urged by the Australian Senate committee to help the affected patients.
The country’s health officials should immediately alert doctors, patients, and the general public to the DePuy device recall, the implants’ adverse effects on patients and treatment options, said the Australian committee which investigated the DePuy recall. The committee also urged the health department to find effective ways of monitoring the levels of cobalt and chromium in patients implanted with metal-on-metal hip devices. Some patients would need to undergo a blood test to find out that they already have high levels of cobalt and chromium in their bloodstream.
The Australian market had featured Depuy’s ASR XL Acetabular system and ASR Hip resurfacing System in July of 2003. In July of 2003, the Australian market made available the DePuy’s ASR XL Acetabular System and ASR Hip Resurfacing System. The Australian National Joint Registry was the first medical body to release data showing that the DePuy ASR devices have a premature failure rate between eight and 11 percent. Study conducted by the British Joint Registry confirmed the findings after it also determined that 12 to 13 percent of the DePuy’s ASR devices fail within five years. The worldwide recall of the DePuy hip systems followed the release of the recent study.
According to medical experts interviewed by the New York Times, the design of the hip implant was said to be the culprit why the device fails five years after it has been implanted instead of its average lifespan of 15 to 20 years. With the intention of giving patients a wider range of motion, Depuy had designed a shallower cup and removed the plastic liner from the inside of the implant. Instead, complications arise when the friction of the ball portion of the hip implant against the socket wears away cobalt and chromium particles from the device and into the soft tissue around the area. The Depuy Lawsuit may have been put in place but only after some 93,000 patients have already received the apparently defective device.
In the United States, approximately 250,000 hip replacement procedures are performed every year. Out of that frequency, only about 1-3 percent of recipients require corrective surgery of the original implant. This small population should be manageable for regulators to quickly identify and track defective hip replacements. Unfortunately, the U.S. does not have a national artificial joint registration system.
Without a registration system in place, in addition to the lag in time it takes for a hip replacement to malfunction, companies like DePuy were able to sell 93,000 hip replacements worldwide undetected. DePuy was able to sell 93,000 hip replacements undetected worldwide due to the fact that there is no regulatory system in place and it takes a long time for hip implants to malfunction.Consequently, the DePuy hip recall has caused deleterious effects to thousands of recipients.
Additionally, the company faces more scrutiny over the ‘kickback’ scandal which says that DePuy pays consultants for them to use its products.
Two countries that do have artificial joint registries implemented, Australia and the United Kingdom, were able to quickly and efficiently detect the defective hip implants. Dating back to 2007, the Australian National Join Replacement Registry reported higher than normal failure rates of the DePuy metal-on metal hip replacements.
In 2009, DePuy took subsequent action and voluntarily withdrew its products from the market.Parallel to this, the National Joint Registry of England and Wales quickly detected the defective hip
replacements as well. A study performed by English researchers at Oxford University showed that 3.4 percent of patients out of 660 who received DePuy metal hip implants experienced signs and
symptoms associated with metallosis. In comparison, a group of 155 patients who received a competing manufacturer’s hip devices were examined and found to not have experienced similar side
Coincidentally, the U.S. Food and Drug Administration was busy processing the several hundred complaints due to the metal-on-metal implants, but did nothing in the absence of a regulatory national registry. Testimonies from numerous surgeons have come to light, stating that they had alerted DePuy early on about the complications caused by their hip replacements, but received little to no response.
It wasn’t until the media began reporting the failure rates of these devices in 2010 that the public became aware of the gravity of the situation. With increasing pressure from the public
and the FDA, DePuy finally initiated a recall in August of 2010.
The orthopaedic manufacturer knew of its defective products and avoided initiating a DePuy hip replacement recall. It is apparently clear that it disregarded the health and safety of the consumer in order to avoid having more defective products undergo a public recall.
Johnson and Johnson’s (J&J’s) recall motives is made more suspicious by its new statement that the DePuy hip replacement recall “is not expected to have a material adverse effect on the
company’s financial position.” With complaints continuing to rise for this year alone, a New York Times analysis had estimated the recall to cost J&J about $1 billion. The
British Joint Registry
estimated that nearly one third of DePuy hip replacement fail after six years, thus more complaints are expected to be filed.
Critics have questioned J&J’s motives when it hired BroadSpire to handle the DePuy ASR hip replacement recalls, and by settling claims with patients before they fully understand their legal rights or the likely cost of their hip-related medical costs in the future, they’ve been accused of cutting down on their expenses. To counter the allegation, DePuy said that all it wanted was to provide efficient assistance to patients and healthcare providers. However, J&J’s new statement hints of a different motive, one that is beneficial to the company itself.
It is hard to believe that J&J’s financial position will not be “adversely affected” with DePuy accounting for 75 percent of the 5,000 complaints received by the US Food and Drug Administration (FDA) on hip replacement since January of this year. A study by the National Joint Registry (NJR) of England and Wales which suggested that the five-year failure rate of this product was approximately 13 percent does not bode well for some 93,000 patients worldwide implanted with the DePuy ASR hip replacement systems. One in every eight patients who have had the DePuy hip replacement will have their hip implant failing in five years.
Considering this, the critics are then not far off with their allegations as to J&J’s motive in letting BroadSpire handle the recall. It may seem the right move but by putting them under the care of doctors on J&J’s payroll, not the patient’s own doctor, and requiring those patients to hand over medical records the company would not normally get a look at unless the patient was represented by an attorney, DePuy is actually taking advantage of the victims. According to David Prince, professor of law at William Mitchell College of Law, "You can see how the company wants to make sure they only pay what they consider in their own mind legitimate claims."
DePuy hip replacement recall issues are not expected to die down soon with 700 complaints filed for the last two months alone. Aside from medical studies suggesting that more than 1 in 8 patients would have their implant failing within five years, a growing number of victims also have their implants lasting only a fraction of that time with some experiencing pain within less than a year.
A number doctors and inventors have tried making and improving existing hip prostheses to relieve the pain and discomfort of having orthopaedic conditions such as osteoarthritis and osteoporosis. Several materials have been used to manufacture them. However, an entirely perfect hip implant is yet to be created. More modern devices have emerged improving the condition of those who underwent hip replacement surgery but with them, some cons are still present. The DePuy hip replacement recallof the ASR XL Acetabular and the ASR Hip Resurfacing System indicates that we have still a long way to go until inventors could produce a flawless implant.
Ceramic-on-ceramic: A more durable implant against wear compared to plastic-on-metal devices, this type of prosthesis is prone to breakage. Ceramics are smooth and hard. A loud squeaking may be heard from this implant.
Metal-on-plastic: This device is favored by most. It consists of a metal ball and socket with a plastic liner situated in between. Despite its popularity, this implant produces the most wear. A different type of metal-on-plastic implant that uses metal and highly crosslinked polyethylene material has a kind of plastic designed to be more resistant to wear. The problem is, the same procedure that makes it resistant also reduces its tensile strength.
Metal-on-highly crosslinked polyethelene: This type of configuration is fundamentally the same concept as metal-on-plastic; however, crosslinking of the polyethylene adds stability and durability to the implant. Because of this, the metal-on-crosslinked polyethylene has largely replaced the less durable metal-on-plastic making it an ideal choice for young, active patients
Metal-on-metal: From the name, this device is made up of a metal ball and socket. Recipients of this implant could enjoy an active lifestyle for this prosthesis is strong and durable. Despite its strength, metal-on-metal implants have been known to produce particles that could lead to muscle, nerve and bone damage. They release toxic metal ions that cause pain and swelling in the hip area.
DePuy implants' major issue was in its material and design. The device does not implant the way it should causing it to protrude at an angle and producing a chisel-like effect. In turn, it releases metal debris that accounts for the pain and complications the hip recall victims undergo. Filing a hip replacement lawsuit should be one of the first steps to take if you've received a DePuy implant. To know more about the types of hip replacements especially DePuy's, visit the hip replacement information center today.
The ongoing lawsuits filed against DePuy are not the only ones that are related to hip replacement devices. In the past, there have been several legal proceedings that involved manufacturers of defective hip implants and DePuy Orthopaedics' ASR XL Acetabular System and ASR Hip Resurfacing System are not exceptions. There were other devices that have harmed and injured recipients and victims of the DePuy recall might want to study them.
There was once a case in Suffolk County, New York that had its plaintiff receive a one million dollar settlement because of an unsuccessful hip replacement procedure. Another case, involving Sulzer, transpired in 2000 wherein the company was being sued due to defective hip implants. The defect was attributed to a small amount of oil founf in the device, and oil (even a 15,000thof a drop of mineral oil) would prevent the device from sticking properly to the bone. The Sulzer case has been the basis for most hip replacement lawsuits. One group which filed a class action suit against Sulzer received in settlement, the amount of one billion dollars. For each of the 3,500 included in the class action lawsuit, each have received about $206,000.
This is not to say that DePuy would settle for the same amount as Sulzer had with its lawsuits. But the fact that Johnson & Johnson reserved about $1 billion for the purpose of handling the DePuy lawsuits is a clear indication that the company is willing to grant a settlement to those who filed for compensatory damages against DePuy.
“Every day, I curse and cry because of the pain. I don’t sleep for an hour without having to get up because of the pain,” one Sulzer victim narrates in a New York Post article. That alone would be hard on anyone to go through. Speaking with a product liability lawyer would be a wise choice in the aftermath of the recall. To know more, visit the hip replacement recallinformation website.