Joint replacements are the #1 expenditure of Medicare. The process of approving these medical devices is flawed according to the Institute of Medicine. It is time for patients' voices to be heard as stakeholders and for public support for increased medical device industry accountability and heightened protections for patients. Post-market registry. Product warranty. Patient/consumer stakeholder equity. Rescind industry pre-emptions/entitlements. All clinical trials must report all data.
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Thursday, January 31, 2013

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


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.
Multimedia
Andrew Ekdahl Testifies

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 postDuring Trial, New Details Emerge About Hip Make
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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.


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