"DePuy Orthopaedics Hips. Real Life Tested"
Those words still appear on a website maintained by the company (play the videos at the bottom or click on “read transcript”). Of course, these are about the newer Pinnacle hip device, not the ASR that so far has cost the company $8.3 million in a single lawsuit – with approximately 10,000 more cases lined up right behind it.
If history is any indication, current litigation over the Pinnacle implant, which began last summer, will reveal the same issues involving the ASR (“Articular Surface Replacement”). DePuy hip products may be “real life tested” in patients, but according to recent testimony from witnesses, they haven't been tested all that thoroughly under strict, controlled laboratory conditions.
That is the conclusion reached by the jury in the first ASR trial, which took place in the Los Angeles Superior Court earlier this year. The company's own engineering assessment, conducted back in 2010 when the ASR was pulled from the market, found that “inadequate or incorrect standards” were used in testing the device before introducing it in 2003. Company engineer Graham Isaac told the court that DePuy had done its job in this regard – but added that “they could have done it better.” Furthermore, James Smith, a compliance manager, told the court that the company's report indicates “...that company officials had not used appropriate engineering controls to try to anticipate the device’s problems.”
When surgeon implants such a device into a patient, that implant may be placed at any number of angles, depending on factors such as the patient's weight, the surgical method being used, etc. According to Isaac's testimony, DePuy's own tests on the device involved only one angle.
This echoes a statement made by a British bioengineer, Dr. Thom Joyce, who raised questions about tests in the E.U. Although testing of the ASR may have been more thorough in Europe (an expensive piece of equipment known as a “hip simulator” was used), the results were not made available to the public or the medical profession – and it is not known whether or not different sizes at different angles were used in testing.
So...why was DePuy so careless about testing this product before selling it to the public?
There's no way to know for certain...but consider the amount of money that was at stake. With an aging population across the industrialized world, hip and knee replacements are expected to generate some $8.6 billion by 2016. You can draw your own conclusions...
In the meantime, despite the fact that DePuy is facing litigation over its Pinnacle implant, the company is continuing to market the device, assuring customers that its products are “Real Life Tested.”
Heaven help the “Real Life Test Subjects.”
Chan, Lillian. “DePuy ASR Recalled Due to Safety Issues, Company Engineer Testifies.” Public Health Watchdog, 5 February 2013. Available at http://www.publichealthwatchdog.com/depuy-asr-recalled-due-to-safety-issues-company-engineer-testifies/ .
Meier, Barry. “Implant Risk Was Assessed Inadequately, Court Is Told.” New York Times, 31 January 2013.
N/A. “Research and Markets: Hip and Knee Implants - Global Pipeline Analysis, Opportunity Assessment and Market Forecasts to 2016.” Via Businesswire, 11 August 2010. Available at http://www.businesswire.com/news/home/20100811006361/en/Research-Markets-Hip-Knee-Implants---Global
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