arthritis, Cobalt poisoning, DePuy, DePuy ASR Hip, DePuy ASR™ Hip Resurfacing System, depuy hip recall, DePuy Hip Recall Litigation, DePuy Lawsuit, DePuy Orthopaedics, Failure rate, Food & Drug Administration, Hip recall, Hip Replacement, hip resurfacing, Jimmy Smith, Johnson, Johnson & Johnson, metal-on-metal hips, metallosis, Orthopedic surgery, Superior Court of Los Angeles County, UNited States
Hip Implant’s Risks Inadequately Assessed, DePuy Report Found in 2010 – NYTimes.com.
Implant Risk Was Assessed Inadequately, Court Is Told
By BARRY MEIER
Published: January 31, 2013
A review conducted internally by Johnson & Johnson soon after it recalled a troubled hip implant found that the company had not adequately assessed the device’s potential risks before it was used in more than 90,000 patients, court testimony on Thursday showed.
The engineering report, which was done in 2010, also found that Johnson & Johnson’s orthopedic unit had used inadequate or incorrect standards in trying to assess some of those risks before first selling the implant in 2003. The device at issue — the Articular Surface Replacement, or A.S.R. — proved to be among the most flawed orthopedic devices sold in recent decades.
The report was introduced on Thursday in Los Angeles Superior Court, in the first A.S.R.-related lawsuit to go to trial against the DePuy Orthopaedics division of Johnson & Johnson. More than 10,000 similar lawsuits have been filed in the United States.
In videotaped testimony shown in court, Jimmy Smith, a compliance manager at DePuy, was asked about the report, and he said it indicated that company officials had not used appropriate engineering controls to try to anticipate the device’s problems.
“They did their job, but they could have done it better,” Mr. Smith said.
Separately, a DePuy engineer, Graham Isaac, testified on Thursday that before selling the A.S.R., the company only tested its performance on laboratory equipment at one angle of implantation.
Depending on the surgical technique and a patient’s build, orthopedic surgeons can implant the cup component of an artificial hip at a variety of angles. And because the A.S.R. had a design flaw, normal variance from the single angle at which DePuy had tested it made it more likely for the joint’s cup and ball components to strike each other, releasing metallic debris inside a patient.
DePuy conducted the post-mortem review of the A.S.R. in November 2010, just three months after it recalled the all-metal implant, but it never released the analysis. It also, apparently, did not conduct a similar review in response to the mounting number of complaints about the device that it received from doctors and others in 2008 and 2009.
Lorie Gawreluk, a spokeswoman for DePuy, said that she could not comment on any details of the lawsuit, but that the company believed that the evidence would show it acted appropriately. The trial’s proceedings were monitored over the Courtroom View Network.
The A.S.R. is projected to fail within five years in about 40 percent of patients who received the implant. That early failure rate, which is expected to grow over time, is many times higher than the failure rate for most hip replacements.
In the post-recall review in 2010, DePuy engineers examined the criteria and “controls,” or standards, that were used nearly a decade earlier when company officials tried to anticipate how the A.S.R. might perform. Because the version of the device that was sold in the United States was never clinically tested in patients, officials used the controls to assess the implant.
Among other things, DePuy officials failed to anticipate that the A.S.R. would have a high rate of wear as a patient moved, even though the control referenced in the device’s records demonstrated “that the product is more likely to experience contact between the head and rim” than competing implants.
In previously recorded testimony presented in court on Wednesday, DePuy’s president, Andrew Ekdahl, was shown an e-mail in which he was warned about the A.S.R.’s problems nearly three years before it was recalled.
Mr. Ekdahl and other DePuy executives have asserted that they acted properly and in a timely fashion to the device’s problems. The company spokeswoman, Ms. Gawreluk, said Mr. Ekdahl would not be made available for an interview.
- DePuy ASR Trial Update: Parker Waichman LLP Comments on Latest Developments Reported by The New York Times (prweb.com)
- DePuy ASR Hip Litigation Update: Records Show Johnson & Johnson Knew About Defects of DePuy ASR Hip Implant Long Before Recall, Parker Waichman LLP Reports (prweb.com)
- DePuy Hid Data About Failed Hip Implant, Documents Show – NYTimes.com (earlsview.com)
- HELLO – Earth to Major Tom – What Planet is this guy on? At trial of Johnson & Johnson recalled hip implants, doctor testifies device wasn’t defective | NJ.com (earlsview.com)
- DePuy ASR Hip Implant Lawsuit and Recall Gets New Push (prweb.com)
- RD Legal Funding Offers Post-Settlement Advances as Johnson & Johnson Makes Settlement Offer to DePuy Litigants Following FDA Warning (prnewswire.com)
- J&J Failed Own Safety Test in Hip Design, Witness Says – Bloomberg (earlsview.com)
- Maker Aware of 40% Failure in Hip Implant – NYTimes.com (earlsview.com)
- J&J executive testifies DePuy ASR recalled because of clinical needs, not failure, the Rottenstein Law Group reports (businesslawdaily.net)
- J&J Failed to Warn of Metal Hip Implant Flaws, Lawyers Argue (earlsview.com)
Lots of DuPuy coverage again in the press, but nothing for S&N.
If only we could get the Press to see the bigger picture, and stop latching on to the one manufacturer.
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Yes – S&N are snakes lying in grass hoping not to be noticed…
If I was the guy who started this all off (McMinn) I would be very worried…
First of all HAPPY BIRTHDAY to EARL STEVENS
I have been following the DePuy trial. The responses to questions asked of
DePuy’s people is shocking. Not only don’t they seem to have a clue as to what was happening or they are down right ignorant. Because of this look at the 10’s of thousands of innocent people that have suffered and will continue to suffer for the rest of their lives.
Smith & Nephew and other manufacturers of metal on metal hip devices are probably all guilty of withholding pertinent information that could have helped people rather than hurt people.
A recent article appeared Smith and Nephew is laying off 100 people and they are blaming the device tax. They say they are off setting loses of ” their rate of return”
or profits by this lay off.
This is total -BULL- SHIT this company employees 1000’s of people, so I am to be gullible enough to believe this lay off will make a dent in their bottom line.
Other manufacturers indicate the same. Yet Smith & Nephew’s profits indicate a substantial profit.
The out come of the DePuy trial could bring about significant changes in the CORRUP MEDICAL DEVICE WORLD. WHEREBY HUMAN BEINGS WILL BE
OF PRIMARY CONCERN AND NOT THE DEVICE MANUFACTURER AS IS PRESENTLY.
Pingback: J&J Failed to Weigh Hip Metal Debris Risk, Witness Says – Bloomberg « Earl's View
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Patients, getting more recognition of the pre-emption laws and how they are a benefit to the manufacturer as the Smith & Nephew ‘s Birmingham Hip Device.
People need to recognize the law could apply to them in the future if a device is pma approved by the FDA unless we change these laws.
The FDA was established to ensure and protect our well being and safety of life.
The BHR may be good for some, however it has become a nightmare for too many people, both in the USA and many OTHER COUNTRIES.
I would like to know how many BHR’s were sold in the United States, The number of reported adverse events reported to all agencies in the USA each year since pma approval in 2006, how many reported by Smith & Nephew, how many reported revision surgeries because the BHR failed.
There are more and more BHR hip problems being reported each month.
The numbers above are in black and white ” SOME WHERE’s. ”
If a device such as the BHR fails at an unacceptable percentage both to the manufacturer and the FDA then according to the FDA’s own rules this pma device can be pulled off the market or an act of Congress can impose actions that would do the same.
So the law created to protect us, protect the manufacturer isn’t this a conflict of interest, or is another sign of CORRUPTION.
Stay strong and get well.
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