Compensation is being sought by thousands of claimants who have filed a DePuy Articular Surface Replacement (ASR) lawsuit following various negative effects and injuries suffered after the device had been implanted. The claimants are seeking compensation for medical expenses, pain and suffering, lost income and other significant costs relating to their failed DePuy ASR hip implant. The device was expected to fail in as many as 40% of all patients within just five years, according to documents which were disclosed in the first ASR trial in California.
Hip replacement recall
The 26 August 2010 worldwide recall affects the following products:
- ASR™ XL Acetabular System
- DePuy ASR™ Hip Resurfacing System
Latest court documents
The latest internal documents revealed at the California trial, in the first of over 10,000 ASR-related lawsuits, exposed a top Johnson & Johnson marketing executive, Paul Berman, as having sent multiple e-mails voicing concerns over the safety of the implant to superiors. These e-mails were sent almost a year prior to the global recall of the DePuy ASR metal-on-metal hip implant by Johnson & Johnson. Berman wrote, “As a marketing professional, I do not make product safety decisions, but I do have an obligation as an employee of Johnson & Johnson and DePuy to make it known when I do not feel comfortable”. A further metal hip model, the “Adept” also manufactured by Johnson & Johnson’s DePuy, which was manufactured and sold in 21 countries, has reportedly been recalled. This comes two-and-a-half years after the issuing of a global recall of the ASR metal-on-metal replacement hip.
Evidence regarding the defective implants includes:
The ASR implants “were not adequately tested because of regulatory loopholes the Food and Drug Administration is now moving to close”. The implants “began failing not long after implantation”, as predicted by undisclosed internal company studies. As early as 2008, DePuy executives were told by a number of surgeons, including its own consultants, that the device appeared flawed. Johnson & Johnson executives never disclosed the ASR’s flaws to doctors or patients and instead “continued to market it aggressively”.
Are you ready for revision surgery?
To ensure that the hip is functioning properly, additional testing and treatment may have to be undergone by patients who had a hip replacement using either of the two products recalled in 2010. In selected cases, additional revision hip replacement surgeries may be required. According to new data gathered by DePuy, approximately one out of every eight patients (12% – 13%) who had received the ASR resurfacing device or the ASR total hip replacement, five years after implantation, needed to have a revision surgery done.
But what went wrong?
- Lack of lubrication: When the hip joint is inactive for long periods of time, the fluid that was believed to lubricate the metal components in fact recedes from the metal parts. This results in the joint’s cup and ball component rubbing against each other. Consequently, metal particles wear off and metallic debris is released inside a patient. These microscopic particles can cause fluid to collect in the joint and the muscles around the joint.
- Angle of insertion: The cup should be placed at an angle of between 40 and 45 degrees and the head should be aligned to the centre of the cup during surgery. It is not however possible to always insert the cup at this exact angle. When the angle is too steep, the forces applied upon the area of the cup are intensified.
- Size of component: Smaller sized components are more likely to wear due to a lack of lubrication. Higher metal ion concentrations are found in these cases. Raised metal ion levels can cause problems such as soft tissue damage, pain and pseudotumours, resulting in the need for revision surgery.
- Shallowness of cup: Another design flaw is the shallowness of the cup, which intensifies the risk of metal debris due to the increase of friction.
Do you have any of the following symptoms?
Serious symptoms resulting from the insertion of the faulty hip replacement devices includes:
- Severe pain
- Metallosis due to high levels of cobalt ions in the blood
- Death to surrounding tissue and bone
- Partial or complete lack of mobility
- Need for revision surgery to remove and replace the device giving rise to even more debilitation
- Prolonged recovery time
- Increased risk of complications and death from further surgery.
He said what?
An international product manager for DePuy responded to lax regulation for the marketing of its products in South Africa with an email to colleagues in June 2007 saying, “You could literally implant a tent rod if you wanted!”
Where do I go from here? If you are unsure whether you received an ASR hip implant, contact your orthopaedic surgeon for confirmation. You can also contact your primary care physician or the hospital where you underwent surgery, to review your medical records in the event that you don’t know who performed the surgery.
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