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Serious Safety Testing Violations Found with DePuy Pinnacle Hip

A British federal agency has discovered serious safety testing flaws on metal hip implants, sparking concern the devices were defective and dangerous as sold.

Most artificial hip joints are made from metal, plastic, and cements or a combination of these materials.  The DePuy Pinnacle and DePuy Pinnacle ASR hips were not designed like ordinary artificial hip implants.  These hips were designed with an all metal construction. This means that both the ball and socket were made entirely of metal.  The idea, as suggested by the company’s marketing department is that a metal-on-metal hip joint would be smoother than a traditionally-designed implant.  This in turn would allow younger hip replacement patients to lead a more active life as the joint would act like the patient’s uninjured natural joint.

Defective Hip lawyerUnfortunately, things did not go as planned by the company.  Like most metal surfaces, when it is subject to extreme amounts of force and rubbed against other metal surfaces, it creates friction and this leads to integral breakdown.  There are many consequences to a hip joint breaking down prematurely.

DePuy Pinnacle Hip Implant Problems

As our Boston DePuy Pinnacle injury lawyers can explain, the metal breakdown can lead to a total device failure.  No artificial hip will last forever, but they are supposed to last at the very least for over ten years.  If you have recently had an artificial hip implanted and are experiencing a great deal of pain, you should go back to your orthopedic surgeon as soon as you can get an appointment. If your surgeon tells you the joint has broken down, and you need to have another artificial hip implant, you should contact an experienced defective medical products attorney in Boston as a soon as possible to see if you have a valid products liability claim.

In addition to an artificial hip implant breakdown, there were also cases where the metal shards would enter the plaintiff’s bloodstream and this can result in a dangerous type of poisoning known as metalosis. While DePuy tries to argue that this is not a real disease, the United States Food and Drug Administration (FDA) clearly lists on its website how a metal-on-metal hip implant can lead to metal ions entering the patient’s system and breaking down the patient’s tissue.

Serious Safety Testing Violations Found

While our injury attorneys are primarily concerned with Pinnacle or Pinnacle ASR hips sold in the U.S., these devices are sold all over the world. According to one recent article from the Telegraph, the high court in Britain has just been presented with evidence that safety tests performed by DePuy involving the metal-on-metal hip implants had serious flaws. The allegations are the hip implant safety testing experiments presented to the British counterpart of the U.S. FDA were not done according to acceptable scientific standards.

Specifically, there were four major safety tests conducted at DePuy’s United Kingdom headquarters between 2000 and 2004.  There was a doctor hired to supervise the testing, but he was not physically present to perform this supervision as revealed in company internal emails that have been discovered.  In one experiment, there were five tests performed on the defective hips and in three of these cases, the ball and socket joint suffered a complete failure. Instead of properly handling the situation, emails showed the company engaged in what they referred to as “brainstorming” sessions to figure out why the devices fell apart.  Brainstorming may be a common practice, but it is not a scientifically accepted way to address critical device failure, according to experts.

In one of the tests, the failure of the hip implant was so loud, engineers could actually hear it break.  Instead of continuing the test and declaring it a failure, they opined the loud sound came from the testing machine and cancelled further tests of that type.  This is another troubling revelation involving the safety testing of the DePuy artificial hip implant.

While these tests were conducted in the United Kingdom in accordance with British laws and regulations, the discovery is relevant to artificial hip implants in Boston as well.  It shows the company knew or should have known of serious design flaws and failed to take appropriate action in response to what they learned. It also shows a potential pattern of negligent conduct on behalf of the company that could be relevant in local defective hip implant cases.

Other Hip Device Safety Concerns

Other tests revealed that there was a substantial protein buildup that could result from the metal-on-metal construction when the implant was placed in human patients. This protein buildup can increase the friction and that can result in joint breakdown. As noted in this article, when the safety problems were first learned, the company did not discontinue selling the device.  When surgeons around the world learned of these defects in design, sales declined and the company eventually pulled it from the market in 2013 and stated that was only done to due low use in the market. There were no recalls or safety advisories put out by the company prior to pulling the device from the market once surgeons had stopped using it on their own.

The problem with a defective hip is that even if the surgeon is well trained and very experienced in implanting these devices, if they have no idea the device was defectively designed, there is nothing that can be done to lessen the risk of a partial or total device failure or a patient becoming sick from the metal ions released due to friction. This is not say a device cannot fail due to medical malpractice committed by the doctors, but the vast majority of these cases had nothing to do with surgical errors and were due to defectively designed artificial hip implants.

In the U.S. alone, there are hundreds of thousands of artificial hip implants placed in patients each year so we are dealing with a lot of victims from these defective hips as they controlled a significant share of the market at one time. In the UK, there were 20,000 DePuy metal-on-metal hips implanted before they were pulled from the market.

If you are the victim of Massachusetts product liability, call the Law Offices of Jeffrey S. Glassman for a free and confidential appointment — 1-888-367-2900.

Additional Resources:

DePuy hip replacement safety tests were seriously flawed, High Court hears, October 25, 2017, By Luke Heighton, The Telegraph

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