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Analysis: When implanted medical devices go wrong, who pays?

By Debra Sherman

CHICAGO (Reuters) - Insurance companies, often stuck with the tab for health services when a medical device fails, are ready to share the pain.

As the number of costly, high-profile recalls rises, along with pressure to cut their own spending, insurers are starting to pin more of the responsibility on manufacturers.

If they succeed, medical device makers - already worried about weaker global demand for many of their products and the impact of a new U.S. tax on their profits - will have even more costs in the wake of product recalls, the biggest of which can already lead to billions of dollars in expenses.

"The (insurance) plans are being more aggressive. The reason it gets so much more focus now is because there are so many cases," said Mark Fischer, chairman of Rawlings & Associates, a unit of the Rawlings Group that helps insurance companies recoup payments from the party that was deemed at fault for claims, a legal service known as subrogation.

In recent years, more than a hundred medical devices were recalled out of concern they could cause serious injury or death.

Rawlings is one of the largest firms providing claims recovery services for the healthcare industry, along with Trover Solutions Group, both based in Louisville, Kentucky. Others include HealthCare Subrogation Group and Meridian Resource Company.

Rawlings is currently retained to pursue more than 30 mass tort cases related to healthcare, compared with an average of about three in a given year just a decade ago, Fischer said.

"There has been a drastic increase in the number of cases being pursued," he said. Insurers tend to hire Rawlings when there are enough cases being filed over a product to warrant multi-district litigation status.

Fischer helped recover funds for insurers from claims on Sulzer Medica's defective hip implants in 2000 and Medtronic Inc's faulty Fidelis defibrillator leads in 2007.

In the Fidelis case, Medtronic settled U.S. lawsuits covering more than 9,000 individual personal injury cases for $221 million, according to their regulatory filings.

Fischer then pursued Medtronic to recover money for clients like WellPoint Inc that had paid doctors and hospitals for treatment relating to the defective leads, or wires that connect an implantable defibrillator to the heart.

He expects a settlement - the first collected from a medical device maker - to be signed by year's end, but would not give a dollar amount.

WellPoint spokeswoman Lori McLaughlin said the insurer routinely tries to collect from manufacturers on recall-related health claims.

Aetna Inc, the nation's third largest insurer, said it has managed to wrest reimbursement from drug and device markers, and has negotiated payments to patients for costs from defective or recalled products, without providing details.

Trover Solutions Chief Executive Robert Bader reckons that about 80 percent of health insurers turn to firms like his to pursue manufacturers in recall cases.

"It's the fiduciary responsibility of the insurer to recover members' premiums from the manufacturer. It's a highly specialized process and so a lot of them outsource," Bader said.

The government's Medicare health plan for the elderly recovers part of the money it paid for recall-related medical services once a settlement is reached, said spokeswoman Kathryn Ceja. She would not give details on how it pursues those funds.

FALLOUT OVER THE RIATA RECALL

A 2010 recall of Riata defibrillator leads by St. Jude Medical could become the next tug-of-war between insurers and medical device makers over who picks up the tab.

Some 79,000 U.S. heart patients still have the lead implanted in a blood vessel leading to the heart. Deciding on how to proceed is tricky since removing the leads may be riskier than leaving them in.

The Food and Drug Administration in August said all Riata patients should receive medical imaging tests to see whether the insulation covering the thin wires eroded, exposing the cables and making them more prone to short-circuit, as well as making the surrounding tissue vulnerable to heat damage.

The agency did not say how often imaging tests should be performed. But ordering just one test per patient will add millions of dollars to the cost of their care.

A single fluoroscopy - which shows a real-time, continuous X-ray image on a monitor - for each Riata patient could cost between $7.9 million and $45.3 million overall, based on a Reuters review of the procedure's cost at different hospitals.

Doctors say more than one X-ray would be needed to monitor the leads, which can remain in a patient's body for many years. Dr. Bruce Lindsay, section head of Cardiovascular Medicine at the Cleveland Clinic, said doing an annual imaging study would probably be sufficient.

Even before the FDA guidelines, Medicare covered the extra cost of imaging studies in almost every instance, doctors say. But some private insurers had balked.

"I've had to call (insurers) constantly and justify it," said Dr. Martin Burke, director of the Heart Rhythm Center at the University of Chicago Medicine.

"We're definitely finding more problems (with Riata leads), but surveillance has gone up. We're finding more because we're looking more," he said.

St. Jude spokeswoman Amy Jo Meyer said the company has expanded its regular warranty to include a baseline fluoroscopic or X-ray screening if a patient's insurer does not cover it. Paying for additional imaging would be reviewed on a case-by-case basis.

"It would not be in device makers' best interest to balk at paying these costs. In the end, they do have to stand behind their products and these products do sometimes fail," said Debbie Wang, an analyst with Morningstar.

TALLYING THE COSTS

Burke and colleagues estimate that Medtronic's Fidelis recall cost Medicare some $287 million over five years for monitoring or replacing the leads, according to a study published in the Heart Rhythm Journal.

Medtronic spokesman Chris Garland said the company gave a credit to patients for its recalled Fidelis leads, plus $1,200 for "reasonable unreimbursed medical expenses." He would not say how many people received the replacement and additional funds.

The Fidelis case was just one out of 113 medical device recalls between 2005 and 2009 classified as serious enough to cause significant health problems or death, according to an analysis published in the Archives of Internal Medicine last year. Most involved devices that correct heart problems.

The study found that 24,000 patients underwent procedures in 2005 related to problems with devices from Medtronic or from Guidant, now part of Boston Scientific Corp.

"We expect manufacturers to take reasonable responsibility for costs associated with a recall of their products to prevent the healthcare system from absorbing the impact," said Aetna spokeswoman Tammy Arnold.

(Editing by Michele Gershberg, Bernard Orr)

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