Defective Implants: Warranty?

Defective Machinery: Should Hip and KneeReplacements Come With Warranties?

By William Heisel  USC Annenberg – Reporting on Health

October 04, 2013  FiDA highlight

During my last eye exam, my doctor persuaded me to start wearing reading glasses. I should keep my regular pair for driving, watching football, and enjoying the films of John Cusack. But I should wear reading glasses for what I’m doing right now – writing this blog post.

When I received them, though, they were so powerful that I felt like I had knocked back half a bottle of vodka. I tried them for a few days but could never shake that shaky feeling. So I called the optometrist and, to my surprise, I was told just to bring them back in. They were under warranty and new lenses would be cut for me in a few days.

Now, imagine if that eye problem I had was a hip problem or a knee problem or just about any other part of my musculoskeletal structure. If a doctor inserted a hip replacement that didn’t end up working and actually made my life worse, I would be out of luck. Warranties – common in so many aspects of our lives – are not common in orthopedic devices.

And there’s a good case to be made that should be. Witness the massive recall of Articular Surface Replacement Hip Systems sold by DuPuy. The New York Times wrote recently:

The implants were recalled in 2010, but the documents show that as early as 2008 DePuy executives were told by a number of surgeons, including its own consultants, that the device appeared flawed. That was never disclosed to doctors who were putting the device into patients, nor were other unfavorable internal studies. By the time of the recall, the device had been implanted in about 93,000 patients around the world.

And no warranty. DuPuy has tried to make up for the problems by offering financial assistance for patients’ recall-related medical costs, according to company president Andrew Ekdahl.

But what about making it explicit up front – as with my glasses – that device failures within a certain timeframe should be automatically replaced or that a refund should be received?

The Consumers Union’s Safe Patient Project is making a push for warranties on hip and knee replacements. I met with their team during their state-hopping campaign this week, and they raise some good arguments, rooted in a Consumers Union review of replacement products. Their main points include:

•                All major manufacturers have recalled a product or a line of products for defects over the last decade.

•                Most hip and knee implants are allowed on the market without being reviewed for safety and effectiveness by the Food and Drug Administration.

•                The cost for additional surgery and a replacement device is now largely paid by patients or their insurance companies, including Medicare.

•                Revision surgery costs more, results in longer hospital stays, and can often lead to additional surgeries.

•                An estimated 18 percent of hip replacements and 8 percent of knee replacements in the U.S. are for revisions, and the cost for these procedures is likely in the hundreds of millions of dollars per year.

The counter argument is also about costs. Were device makers to cover all costs for all device failures, they may be seriously hurt financially. Also, is there a reasonable expectation that a certain percentage of any product made and sold will fail and do consumers necessarily have a right to get a new one as a result? I used my glasses as an example at the beginning, but if the rechargeable battery in my iPhone fails (making my device useless) I’m out of luck.

I will explore warranties in future posts. Let me know your ideas, too. I’m at askantidote [at] gmail.com and on Twitter wheisel.

Explanthis (Joleen Chambers, FiDA) 

Another issue to consider is that currently there is no patient outcome registry.  Consider the thousands implanted with failed metal-on-metal hips and transvaginal surgical mesh.  Proprietary and profitable medical device companies either missed the signal of device failure or chose to ignore it.  The patient harm in the wake of these private businesses becomes a public health cost borne by all of us.  A warranty would be a simple signal to the company to balance patient safety with marketing and sales efforts.

Failed Implanted Medical Device 'phased out'

J.&J. Unit Phasing Out All-Metal Hip Devices

By BARRY MEIER   The New York Times

Published: May 16, 2013  FiDA highlight

The orthopedic unit of Johnson & Johnson said Thursday that it was phasing out production of all-metal replacement hips, a move reflecting an industrywide trend to abandon the once widely used implants because of high early failure rates.

In 2010, the company, DePuy Orthopaedics, recalled an all-metal model known as the Articular Surface Replacement, or A.S.R., because it was failing just a few years after implant. Typically, artificial hips made from materials like plastic and metal last 15 years or more before they wear out and need to be replaced.

But after that recall, the company continued to sell an all-metal version of a popular hip model called the Pinnacle. In doing so, DePuy insisted that the all-metal Pinnacle was safe and performing on par with other hip replacements, a position it reiterated on Thursday.

It is estimated that all-metal replacement hips — in which both the cup and ball of a device are made from metal — once accounted for about one in three hip implants used in the United States. However, the metal components rubbed against each other as a patient moved, creating tiny particles that could damage tissue, muscle and bone.

Johnson & Johnson is facing a wave of lawsuits from patients who say they were injured when all-metal implants sold by the company failed. It faces over 10,000 cases related to the A.S.R. and 3,300 cases related to the all-metal Pinnacle, according to a company filing with the Securities and Exchange Commission

In a statement Thursday, DePuy pointed to two factors behind its decision to drop the all-metal Pinnacle: sharply declining surgeon demand for all-metal devices and a recent ruling by the Food and Drug Administration affecting such products.

In January, the agency told producers of all-metal hips that any models that were cleared for sale through a regulatory route that did not require premarket clinical testing in patients would have to run such studies to continue selling them.

“DePuy has communicated to the F.D.A. its decision not to pursue” such studies for the device, the company said in its statement.

The company said it was also discontinuing sales of a metal component that can be used with a ceramic hip implant called the Complete. Sales of the metal component used in both the Pinnacle and the Complete will end in August, the company said
.

J&J Patient Harm: Too Big To Fail / Jail ?

New York Times FULL ARTICLE and trial video

During Trial, New Details Emerge About Hip Maker

By BARRY MEIER

Published: January 30, 2013

When Johnson & Johnson announced the appointment in 2011 of an executive to head the troubled orthopedics division whose badly flawed artificial hip had been recalled, the company billed the move as a fresh start.

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Andrew Ekdahl Testifies

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But that same executive, it turns out, had supervised the implant’s introduction in the United States and had been told by a top company consultant three years before the device was recalled that it was faulty.

In addition, the executive also held a senior marketing position at a time when Johnson & Johnson decided not to tell officials outside the United States that American regulators had refused to allow sale of a version of the artificial hip in this country.

The details about the involvement of the executive, Andrew Ekdahl, with the all-metal hip implant emerged Wednesday in Los Angeles Superior Court during the trial of a patient lawsuit against the DePuy Orthopaedics division of Johnson & Johnson. More than 10,000 lawsuits have been filed against DePuy in connection with the device — the Articular Surface Replacement, or A.S.R. — and the Los Angeles case is the first to go to trial.

The information about the depth of Mr. Ekdahl’s involvement with the implant may raise questions about DePuy’s ability to put the A.S.R. episode behind it.

Asked in an e-mail why the company had promoted Mr. Ekdahl, a DePuy spokeswoman, Lorie Gawreluk, said the company “seeks the most accomplished and competent people for the job.”

On Wednesday, portions of Mr. Ekdahl’s videotaped testimony were shown to jurors in the Los Angeles case. Other top DePuy marketing executives who played roles in the A.S.R. development are expected to testify in coming days. Mr. Ekdahl, when pressed in the taped questioning on whether DePuy had recalled the A.S.R. because it was unsafe, repeatedly responded that the company had recalled it “because it did not meet the clinical standards we wanted in the marketplace.”

Before the device’s recall in mid-2010, Mr. Ekdahl and those executives all publicly asserted that the device was performing extremely well. But internal documents that have become public as a result of litigation conflict with such statements.

In late 2008, for example, a surgeon who served as one of DePuy’s top consultants told Mr. Ekdahl and two other DePuy marketing officials that he was concerned about the cup component of the A.S.R. and believed it should be “redesigned.” At the time, DePuy was aggressively promoting the device in the United States as a breakthrough and it was being implanted into thousands of patients.

“My thoughts would be that DePuy should at least de-emphasize the A.S.R. cup while the clinical results are studied,” that consultant, Dr. William Griffin, wrote.

A spokesman for Dr. Griffin said he was not available for comment.

The A.S.R., whose cup and ball components were both made of metal, was first sold by DePuy in 2003 outside the United States for use in an alternative hip replacement procedure called resurfacing. Two years later, DePuy started selling another version of the A.S.R. for use here in standard hip replacement that used the same cup component as the resurfacing device. Only the standard A.S.R. was sold in the United States; both versions were sold outside the country.

Before the device recall in mid-2010, about 93,000 patients worldwide received an A.S.R., about a third of them in this country. Internal DePuy projections estimate that it will fail in 40 percent of those patients within five years; a rate eight times higher than for many other hip devices.

Mr. Ekdahl testified via tape Wednesday that he had been placed in charge of the 2005 introduction of the standard version of the A.S.R. in this country. Within three years, he and other DePuy executives were receiving reports that the device was failing prematurely at higher than expected rates, apparently because of problems related to the cup’s design, documents disclosed during the trial indicate.

Along with other DePuy executives, he also participated in a meeting that resulted in a proposal to redesign the A.S.R. cup. But that plan was dropped, apparently because sales of the implant had not justified the expense, DePuy documents indicate.

In the face of growing complaints from surgeons about the A.S.R., DePuy officials maintained that the problems were related to how surgeons were implanting the cup, not from any design flaw. But in early 2009, a DePuy executive wrote to Mr. Ekdahl and other marketing officials that the early failures of the A.S.R. resurfacing device and the A.S.R. traditional implant, known as the XL, were most likely design-related.

“The issue seen with A.S.R. and XL today, over five years post-launch, are most likely linked to the inherent design of the product and that is something we should recognize,” that executive, Raphael Pascaud wrote in March 2009.

Last year, The New York Times reported that DePuy executives decided in 2009 to phase out the A.S.R. and sell existing inventories weeks after the Food and Drug Administration asked the company for more safety data about the implant.

The F.D.A. also told the company at that time that it was rejecting its efforts to sell the resurfacing version of the device in the United States because of concerns about “high concentration of metal ions” in the blood of patients who received it.

DePuy never disclosed the F.D.A. ruling to regulators in other countries where it was still marketing the resurfacing version of the implant.

During a part of that period, Mr. Ekdahl was overseeing sales in Europe and other regions for DePuy. When The Times article appeared last year, he issued a statement, saying that any implication that the F.D.A. had determined there were safety issues with the A.S.R. was “simply untrue.” “This was purely a business decision,” Mr. Ekdahl stated at that time.

This article has been revised to reflect the following correction:

Correction: February 1, 2013

A headline on Thursday about a patient lawsuit against DePuy Orthopaedics, a unit of Johnson & Johnson, misstated the start of the trial in some copies. It began last week, not on Wednesday.

original post - During Trial, New Details Emerge About Hip Make
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By BARRY MEIER

Published: January 30, 2013

When Johnson & Johnson announced the appointment in 2011 of an executive to head the troubled orthopedics division whose badly flawed artificial hip had been recalled, the company billed the move as a fresh start.

But that same executive, it turns out, had supervised the implant’s introduction in the United States and had been told by a top company consultant three years before the device was recalled that it was faulty.