Investigating the Issues That Affect You Most

Despite Recall, Company Says Patients Liable for Revision Surgeries

After a massive recall, is a medical product-maker blaming the victims?

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    NEWSLETTERS

    Johnson and Johnson company acknowledges 12 percent failure rate on hip replacement system, but says many patients liable for revision surgeries.

    Chicagoan Scotty MacGregor can't walk very far these days, she says, without experiencing debilitating pain. In her line of work, that is a huge problem: she is a flight attendant based out of O'Hare International Airport.

    "It is swollen, inflamed, burning and it pops and clicks and moves out of joint," she says, describing the hip pain she endures.

    And she knows the pain well.  Two-and-a-half years ago, she had one surgery to have her right hip replaced.

    "I was told I was walking bone on bone," she said, adding that she didn't at all fear the surgery.  "People have said hip replacement is one of the easiest surgeries, and I had total confidence going in."

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    But now, the surgery that was supposed to give her a new lease on life has come back to haunt her, she says, with pain much worse than the original.

    NBC Chicago has learned Scotty MacGregor is in good company.

    "On a scale of one to 10, with 10 being the worst pain you've ever had in your life, most people say it's an 11," said attorney Brian Devine. He represents MacGregor and 80 others in her same boat; people who received the DePuy ASR implant that has now been recalled for its high failure rate.

    "The bone never grows into the device and the device over time, within a few months usually will start to loosen and cause the patient very severe pain," said Devine.

    That pain, for patients around the world, would be bad enough. But the subsequent problem, according to a growing number of lawsuits filed by patients who have the implants, accuse the device maker of shirking its responsibility.

    "They're telling patients to turn in the bills for this bad product, have Medicare pay it or have private insurance companies pay it," said Devine.

    On its website, DePuy tells patients who need a second, or "revision," surgery that "bills for services should first be submitted to your insurance company or payer (public or private) in the usual manner."

    "It's wrong because the company has admitted that this is a bad product. And Medicare shouldn't have to lay out the money," said Devine.  "Why should somebody's insurance company have to make payments in the hopes of one day being reimbursed?"

    DePuy, a Johnson and Johnson company, voluntarily recalled 93,000 of the implants last August, acknowledging that "a higher than expected number of patients required a second hip procedure" after getting the defective part. The company said it initiated the recall when it received a study that indicated a 12 percent failure rate.

    DePuy declined NBC Chicago's request for an on-camera interview, but in a statement said it is "committed to assisting patients affected by the recall by paying for the cost of doctor's visits, test and procedures associated with the recall."

    But it appears that won't include MacGregor.

    In an answer to the lawsuit she filed, DePuy denied the allegations, and alleged that MacGregor is the one who "was negligent, careless and at fault and conducted herself so as to contribute substantially to her alleged injuries and damages."

    Her injuries, they said, "were not legally caused by the product at issue."

    So what did cause her injuries? The company lays out six possible factors: an allergic reaction, an idiosyncratic reaction, an idiopathic reaction, an unforeseeable illness, an unavoidable accident or a preexisting condition. None of which, the company states, is due to its culpability.

    Devine said that is the exact script playing out in many of his cases. The company's answer is a verbatim replica of five other complaints he has filed.

    "When we ask them to pay it, when we ask them to just stand up and agree to do what they're telling the public they are going to do, they won't do it," he said.

    All of this, MacGregor said, leaves her in a deeper hole than when she started: in more pain, with less mobility, and with no money or sick time left to go back to the operating room. Hip replacement is a surgery that can cost from $50,000 to $100,000  and takes at least two months to recuperate.

    "The big corporation should be held accountable. When they put a product out on the market it better be researched. So myself and thousands of others don't go through these problems," said MacGregor.

    DePuy responded to NBC Chicago's questions with the following statement:  

      Recall Information
      On August 26, 2010, DePuy Orthopaedics, Inc., announced a voluntary recall of the ASR™ XL Acetabular System and the ASR™ Hip Resurfacing System because new data from the UK showed a higher than expected number of patients required a second hip procedure, called a revision surgery.

      We understand that this recall is concerning for patients, their family members and surgeons. We are committed to assisting patients affected by the recall by paying for the cost of doctor’s visits, tests and procedures associated with the recall and by providing information and updates in a timely manner.

      The company has made detailed recall information available on www.depuy.com and has created a help line for patients to have their questions answered.

      By calling the help line, patients can also initiate a claim so that DePuy can provide reimbursement for out-of-pocket expenses.

      We encourage patients to call the ASR Help Line at 888-627-2677. ASR History Since the ASR Hip products were launched, DePuy has carefully and continually evaluated data from a variety of sources including national joint replacement registries, published literature, company sponsored clinical trials, internal complaints data and external clinical research reports.
      It is important to note that the majority of ASR hip surgeries have been successful. However, recent data from the UK National Joint Registry showed that approximately 12% of patients who received an ASR hip required revision surgery within five years of implantation.

      After reviewing this data, DePuy concluded that it was in the best interests of patients to conduct a recall.

      Patient Follow-Up The company is advising patients with an ASR device to visit their surgeons for evaluation of their implant performance. Yearly testing is recommended to ensure the ASR hip replacement is functioning well, even in the absence of symptoms.

      For patients who require revision surgery, DePuy is requesting patient consent to send the explant to an independent lab for visual inspection to provide information about the higher than expected revision rate.

      Upon request to DePuy by a patient or his/her surgeon or representative, the explant will be returned and a copy of the inspection report provided if available. Additional Information For more information about the recall, we recommend you visit www.depuy.com.


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