March 28, 2024

The High Cost of Failing Artificial Hips

Medical and legal experts estimate the hip failures may cost taxpayers, insurers, employers and others billions of dollars in coming years, contributing to the soaring cost of health care. The financial fallout is expected to be unusually large and complex because the episode involves a class of products, not a single device or just one company.

The case of Thomas Dougherty represents one particularly costly example. He spent five months this year without a left hip, largely stuck on a recliner watching his medical bills soar.

In August, Mr. Dougherty underwent an operation to replace a failed artificial hip, but his pelvis fractured soon afterward. The replacement hip was abandoned and then a serious infection set in. Some of the bills: $400,776 in charges related to hospitalizations, and $28,081 in doctors’ bills.

“I’m sitting here on a La-Z-Boy meant for someone who is 80 and I’m 55,” said Mr. Dougherty, who lives in Groveland, Ill., and works at Caterpillar, the heavy equipment manufacturer. His bills are “five times as much” as he paid for his home.

The so-called metal-on-metal hips like Mr. Dougherty’s, ones in which a device’s ball and joint are made of metal, are failing at high rates within a few years instead of lasting 15 years or more, as artificial joints normally do. The wear of metal parts against each other is generating debris that is damaging tissue and, in some cases, crippling patients.

The incidents have set off a financial scramble. Recently, lawsuits and complaints against makers of all-metal replacement hips passed the 5,000 mark. Insurers are alerting patients that they plan to recover their expenses from any settlement money that patients receive. Medicare is also expected to try to recover its costs.

While his insurer has covered his bills so far, Mr. Dougherty said he was preparing to sue his surgeon, who may have implanted the device incorrectly, and Johnson Johnson, which produced his artificial hip, to help recoup some of the insurer’s money.

“All these payers want to be paid back,” said Matt Garretson, the founding partner of the Garretson Resolution Group, a firm in Cincinnati that manages product liability cases.

Until a recent sharp decline, all-metal implants accounted for nearly one-third of the estimated 250,000 hip replacements performed each year in the United States. Some 500,000 patients have received an all-metal replacement hip, according to one estimate. A new study found that no new artificial hip or knee introduced during a recent five-year period — implants that included some of the all-metal hips — were more durable than older devices, and 30 percent were worse.

One troubled all-metal model, implanted in 40,000 patients in the United States, was recalled last year by the DePuy division of Johnson Johnson. As of October, some 3,500 patients had filed a lawsuit involving that device.

There is no data on the number of all-metal hips that have failed prematurely in this country because the outcomes of orthopedic procedures are not formally tracked by the government or private companies.

But extrapolating from overseas data and the estimate of metal hip use here, tens of thousands of patients in the United States may have to undergo operations over the next decade to replace the implants, said Dr. Art Sedrakyan, a researcher at Weill Cornell Medical College of Cornell University, who is studying the hip problem.

A decade ago, Sulzer Orthopedics paid a record $1 billion to settle claims by 6,800 patients who received artificial hips and knees that were contaminated with industrial oil during the manufacturing process. “We have been dwarfed by this,” said Teresa Ford, a lawyer who worked at Sulzer at the time and is now in private practice.

Device producers have taken differing stances to covering patient expenses. Zimmer Holdings, which says its all-metal implants are safe, has settled hundreds of patient claims, lawyers involved in those cases say. Also, DePuy is covering costs related to the device it recalled last year, the A.S.R., or Articular Surface Replacement.

DePuy would not comment on how much it had paid in recall-related costs. But a spokeswoman, Mindy Tinsley, said in a statement that DePuy was working with patients and insurers.

Article source: http://feeds.nytimes.com/click.phdo?i=8965486b501ef3c3c5e08b9343d4f4b9

Hip Implant Complaints Surge, Even as the Dangers Are Studied

An analysis of federal data by The New York Times indicates that the Food and Drug Administration has received more than 5,000 reports since January about several widely used devices known as metal-on-metal hips, more than the agency had received about those devices in the previous four years combined.

The vast majority of filings appear to reflect patients who have had an all-metal hip removed, or will soon undergo such a procedure because a device failed after only a few years; typically, replacement hips last 15 years or more.

The mounting complaints confirm what many experts have feared — that all-metal replacement hips are on a trajectory to become the biggest and most costly medical implant problem since Medtronic recalled a widely used heart device component in 2007. About 7,700 complaints have been filed in connection with that recall.

Though immediate problems with the hip implants are not life-threatening, some patients have suffered crippling injuries caused by tiny particles of cobalt and chromium that the metal devices shed as they wear.

Hip replacement is one of the most common procedures in the United States and, until a recent sharp decline, all-metal implants — one in which both the artificial ball and cup are made of metal — accounted for nearly one-third of the estimated 250,000 replacements performed each year. According to one estimate, some 500,000 patients have received an all-metal replacement hip.

One of the most problematic devices, the A.S.R., or Articular Surface Replacement, was recalled last year by Johnson Johnson and accounted for 75 percent of the complaints reviewed by The Times. A precise count of failed implants reported to the F.D.A. is hard to come by because of the agency’s overlapping reporting system, though The Times sought to eliminate duplicate reports about the same incident. Some complaints came from outside the United States.

Under F.D.A. rules, many all-metal devices were sold without testing in patients or without a requirement that producers track their performance. But in an unusual intervention, the F.D.A. in May ordered producers to study how frequently the devices were failing and to examine the threat to patients. Now, researchers say, producers face substantial hurdles in recruiting the hundreds of patients needed to conduct sound studies because of the lack of patient registries.

“They are grasping at how they are going to get this information,” said Dr. Robert S. Namba, an orthopedic surgeon with Kaiser Permanente.

In addition, researchers are struggling to understand the tissue damage caused by the metallic debris. While some patients experience pain, other patients with the same damage have no pain, complicating decisions about whether to remove devices.

As problems and questions grow, most surgeons are abandoning the all-metal hips, saying they are unwilling to expose new patients to potential dangers when safer alternatives — mainly replacements that combine metal and plastic components — are available. Some researchers also fear that many all-metal hips suffer from a generic flaw. Current use of all metal devices has plummeted to about 5 percent of the market, though a few of the models are performing relatively well in select patients.

“It is like playing Russian roulette,” said Dr. Geoffrey H. Westrich, an orthopedic surgeon at the Hospital for Special Surgery in New York, who has stopped using all-metal implants.

Dr. William Maisel, the chief scientist of the F.D.A. division that oversees medical devices, said he believed that producers would mount rigorous studies and find answers. But he acknowledged that it could take several years.

“There is not an existing infrastructure for studying this kind of information,” Dr. Maisel said.

For many patients, it is too late. In 2008, Ann Morrison, a physical therapist from Newark, Del., received all-metal replacements for both of her hips. But Ms. Morrison, 50, soon experienced pain, rashes and inflammation.

Article source: http://feeds.nytimes.com/click.phdo?i=1ea800d47e37f478c586d6662145f3e8