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Insight: DePuy's handling of hip recall sparks questions

Aug 21, 2011, 9:54 a.m.

METAL POISONING

Some 93,000 people have been implanted with DePuy's ASR hip system worldwide.

With wear, the grinding of the hip's ball-and-socket structure causes metal debris to collect in the tissue surrounding the implant, damaging muscle and tendons and complicating replacement surgery. In some cases, metal ions released into the blood causes broader health problems.

Aubie Brennan, a 56-year-old teacher on the Hawaiian island of Oahu, had replacement surgery for each hip in 2007 and 2008 due to bone deterioration.

In 2009, he began to be plagued by flu-like symptoms, rashes, swollen lips and debilitating fatigue. Doctors were unable to locate the cause. They thought he might have allergies, or be depressed, or poisoned by a substance in the ocean surrounding his home.

But last August, Brennan said he received a letter from his health insurance company, Kaiser Permanente, alerting him to the recall and urging him to come in for tests. These showed that his left hip was crooked and that his blood contained significantly elevated levels of chromium and cobalt ions. The surgeon told him he wasn't sure if the elevated metal levels were causing his symptoms, and to return for further testing in six months.

Brennan could not wait. He sought a second opinion, and in February met with a surgeon at The Queen's Medical Center in Honolulu, the leading medical referral center in the Pacific Basin.

"He looked at my results and said, 'I think you need surgery, on both hips, and you need it now,'" Brennan said. He declined to name either surgeon.

The Honolulu surgeon was not part of Kaiser's network, so Kaiser declined to pay, Brennan said. He turned to Broadspire for reimbursement.

Broadspire told Brennan it would not agree in advance to pay. His only option would be to pay for the surgery himself. Then he would have to submit the doctor's report to Broadspire, whose physicians would review the case and make a decision on whether the procedure had been necessary.

Brennan could not afford to pay the $43,467 that the surgery would have cost -- or take the risk that Broadspire would decline coverage. He canceled the scheduled procedure.

"I was really devastated," he said. "Emotionally, and as far as my job went, it really devastated me."

Ultimately, Kaiser reversed itself and agreed to pay for the surgery, which took place in July.

Broadspire would not comment on individual claims, or its payment process in general. DePuy said patients first file for reimbursement through their insurance company, and DePuy later repays the insurance company.

RECALL UPON RECALL

Over the past two years, J&J -- for decades one of the most trusted brands in America -- has recalled more than 50 products, ranging from Children's Tylenol to insulin cartridges to contact lenses. The company's handling of the recalls has in some cases sparked Congressional and federal criminal investigations.

Particularly disturbing to regulators was an older "phantom recall" of painkiller Motrin. J&J hired a contractor to secretly buy the product from stores well before it alerted the general public in 2009 that the pills did not dissolve properly.

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