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INSIGHT – DePuy‘s handling of hip recall sparks questions =2

22 Aug 2011 12:21 Source: reuters // Reuters

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.

To critics, DePuy’s handling of its hip implant recall is designed to save money by potentially settling claims with patients before they fully understand their legal rights, or the likely cost of their hip-related medical costs in the future.

DePuy is adamant in its denial.

“To be very clear: the sole purpose of the Broadspire process is to assist patients and health care providers as efficiently as possible,” Gawreluk said.

David Prince, professor of law at William Mitchell College of Law, said that while the hiring of Broadspire may make economic sense for J&J by saving the company the trouble of gearing up and organizing in-house, it also has the effect of distancing the company from patients.

“By pawning this process off on a third party, they don’t have to deal face to face with patients, and may be less sensible to the human cost of what their product has done,” he said.

Prince, who has represented both plaintiffs and defendants in the past and specializes in product liability, said he can see both perspectives.

“In a larger sense, this is a clash between the individual and his or her needs, and the broad corporate interest,” he said. “If I were a patient I’d be very unhappy if someone I trusted, my own doctor, recommended a procedure and someone stood in the way. I would find that intolerable.”

On the other hand, he said, “You can see how the company wants to make sure they only pay what they consider in their own mind legitimate claims.”

J&J has taken special charges of about $400 million associated with the ASR recall through the second quarter of this year. The company’s litigation expense also includes a component for increased product liability reserves related to the recall. Gawreluk declined to quantify that component or say what DePuy has paid out so far in claims.

Some experts say the ultimate cost to J&J could run to the billions of dollars.

In January 2001, Swiss medical device maker Sulzer Medica AG recalled a hip implant after a manufacturing glitch caused it to loosen. The company settled the case in 2002 for $1 billion. Of the 31,000 patients who received the Sulzer Medica implants, more than 2,760 had them replaced.

The DePuy recall is three times larger and much more complex. The revision rate has not yet been established, but data from a study released in March by the British Orthopaedic Association and the British Hip Society showed the ASR system had a failure rate of up to 49 percent after six years — nearly four times the rate cited by DePuy when it recalled the device.

“This is the absolute worst thing that ever happened to my practice,” Barba, the Rockford surgeon, said of the recall. “It keeps me up at night wondering how to treat these patients whose future is so uncertain. It has been difficult for all of us emotionally.” (Additional reporting by Debra Sherman in Chicago; Editing by Michele Gershberg, Matthew Lewis)

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