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What Did Manufacturer Know About Hip Replacement Defects?

February 27th, 2013

metal hipsLots more information since we last wrote about defective metal-on-metal hip replacements. The first trial is underway, and plenty of details are emerging. From all the reports, this looks to be a particularly heinous story of corporate greed causing injury to many thousands of unsuspecting individuals.

First, a little background:

While all hip replacements pose risks, research has shown that metal-on-metal hip implants carry unique risks. In metal-on-metal hip implants, the metal ball and the metal cup slide against each other during walking or running, causing tiny bits of metal to “shed” from the device. These tiny metal particles may cause damage to bone and/or the soft tissue (e.g., muscle, cartilage) surrounding the implant and joint. Soft tissue damage may lead to pain, implant loosening, device failure and the need for revision surgery (a surgical procedure where the implant is removed and another is put in its place). In addition, some of the metal ions released will enter the bloodstream and travel to other parts of the body, where they may cause symptoms or illnesses elsewhere in the body (systemic reactions). The type and severity of physical symptoms and illness seem to be specific to individuals, with different patients having different reactions to the metal particles.

http://www.youtube.com/watch?v=18BkrJnKf3g

What’s New

Previously, we told you that recalls were issued for some DePuy metal-on-metal hip replacement devices after research revealed that the failure rate of some hip replacement devices was higher than usual. Back in 2010, at the time of the recall, Johnson & Johnson (J&J—manufacturer of DePuy hip replacements), reported a high 12% failure rate after five years.

BUT…new research shows that the failure rate was much, much higher than that. Australian data showed that the DePuy ASR LX hip had a failure rate of 22% after five years and 44% after seven years. The same study revealed that the ASR produced 16 times more potentially toxic chromium and cobalt debris than other DePuy products. At these levels, the ASR should have failed, but DePuy allowed the ASR device to pass.

According to an article in The New York Timesan internal J&J analysis reported a failure rate of nearly 40% within five years from date of surgery, but the company never released those projections. The article also mentions that DePuy officials were aware–as early as 2008–that one of the recalled devices was releasing high levels of metallic ions, particularly in women.

But DePuy didn’t test for the effects of those metals. According to Robert Harrison, a professor of medicine at the University of California, San Francisco:

“I would have advised to do a very thorough and careful analysis of chromium and cobalt toxicity and the potential that this could be a problem from this particular hip design,” Harrison said. He also said DePuy should have done studies “before the product was put on the market.” [from Bloomberg.com]

The California Poison Control System says that cobalt levels above 7 micrograms/liter are harmful. One patient, Loren Kransky, whose lawsuit is currently being heard, had his ASR hip implanted in December 2007. On September 1, 2011, he had blood cobalt levels of 53.6, or almost eight times the acceptable level. After Kransky had the ASR replaced in a revision surgery in February 2012, his level dropped to 5 micrograms/liter. According to Dr. Harrison:

“The higher the dose, the greater the poisonous effect”…. The poisoning can damage tissues near the hip, and it can be systemic as the metal circulates in the bloodstream. The metals can kill cells, he said.

A Pattern of Obfuscation?

As the first lawsuits began, documents relating to the case became public. The more one reads about the DePuy executives and their decisions, the more it sounds as though negative information was deliberately hidden, withheld, or downplayed. Some examples include:

  • In 2008, a surgeon who served as one of DePuy’s top consultants told company officials that he was concerned about one of the ASR components and believed it should be redesigned. That surgeon’s suggestions were ignored.
  • In the face of high failure rates, company officials maintained that the problems were related to how surgeons were implanting the device, not to the device design. But at least one executive wrote to marketing officials in early 2009 that failures were related to the product’s design.
  • Later in 2009, the FDA asked DePuy for more safety data about the ASR. Shortly afterward, DePuy decided to “phase out” the ASR device, and sell existing inventory–not stop selling the unsafe product, but stop manufacturing it.
  • The FDA did not approve one version of the hip implant, the “resurfacing” version, but DePuy didn’t disclose the FDA ruling to regulators in other countries where the device was being sold.

Recommendations for People Who Have Metal-On-Metal Hip Implants

You and your doctor should pay close attention to any signs or symptoms that may be associated with metal-on-metal hip implants. These include:

  • Pain or swelling at or near the hip
  • A change in walking ability
  • A noise from the hip joint
  • Local nerve palsy
  • A palpable mass or lump at the hip
  • Infection
  • Hypersensitivity
  • Skin rash (not just at the hip)
  • Neurological changes, including sensory changes (auditory or visual impairment)
  • Change in psychology (depression)
  • Thyroid dysfunction (neck discomfort)
  • Fatigue
  • Weight gain

The FDA recommends routine long-term follow-up of patients every one to two years, for life. People experiencing symptoms should be seen by a physician every 6 months to monitor the progression of symptoms.

Along with a general physical examination, patients may also receive an x-ray or MRI to look for bone and soft tissue damage. Patients with severe symptoms may also have metal ion testing, although there isn’t necessarily a link between blood ion levels and actual damage–some people may have physical damage without having elevated levels of ions.

When To See an Attorney

HensonFuerst Attorneys has been investigating the legal side of metal-on-metal hip replacement devices for years, ever since DePuy Orthopaedics issued a recall of two of their top-selling hip implants. Since then, other metal-on-metal hip manufacturers have also issued recalls or warnings about their products.

If you know that you have one of the recalled hip replacement devices… OR if you have severe pain around your hip… OR if you have been told that you have a defective hip replacement, call HensonFuerst Attorneys for important information about your rights. You may have a legal case and we will fight to help you collect compensation for the injury caused by the faulty medical device.

What’s most important: DO NOT contact any medical device manufacturer, or SIGN RELEASES OF YOUR MEDICAL RECORDS to any company before you talk with a lawyer. Don’t “register” or attempt to file a claim on your own. Let a lawyer handle everything. Big corporations look out for their own financial interests, not the interests of people who may have been harmed.

If you are worried about your future health, or if you would finally like your questions answered, call us at 1-800-4-LAWMED. Or, visit our website at www.lawmed.com for more information.  At HensonFuerst, your health is at the top of our priority list. We dedicate ourselves to protecting individuals from the greed and callousness of large corporations. Let us work for you.

Life Doesn’t Wait…get help today. Call HensonFuerst.