This is the way conservatives think things should work. Don't get in the way of innovation by business, by requiring studies and proof of safety. If things go wrong, they will be taken care of by lawsuits, and the company will mend it's ways. Of course, big companies can outspend individuals, and the supreme court has been limiting the ability of people to use class-action lawsuits.
http://www.nytimes.com/2011/08/23/business/complaints-soar-on-hip-implants-as-dangers-are-studied.html
By BARRY MEIER and JANET ROBERTS
Published: August 22, 2011
The federal government has received a surge in complaints in recent months about failed hip replacements, suggesting that serious problems persist with some types of artificial hips even as researchers scramble to evaluate the health dangers.
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.
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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.
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http://www.reuters.com/article/2011/08/22/depuy-idUSN1E77K03Y20110822
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J&J's DePuy Orthopaedics Inc unit recalled its metal ASR hip system a year ago after it failed at a higher-than-expected rate, with some patients experiencing pain, swelling, joint dislocation and sometimes systemic damage to the central nervous system, thyroid and heart.
The company now faces more than 2,000 lawsuits in state and federal court in the United States.
In a highly unusual move, DePuy has hired a third party -- Broadspire Services Inc, which manages workers compensation and other medical claims on behalf of insurance companies and employers -- to administer patient claims for out-of-pocket medical costs associated with the recall.
The move has prompted debate among industry and legal experts. Some see it as an efficient way to outsource a process that is unrelated to making artificial hips. Others see it as a way for J&J to limit payments while gaining control of medical records and other material that could be used against patients in court.
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