Tipp FM Legal Slot – 19th February 2013
John M. Lynch on MoM Hip Implant Recalls[soundcloud id=’167061955′]
Recently thousands of “Adept” Faulty Hip Implants were recalled by Johnson & Johnson, the same manufacturers as the DePuy Hip implants, tell us about the recent recall?
During the past couple of years we have been keeping listeners updated on MoM (metal-on-metal) hip implant recalls, particularly the DePuy ASR Hip implants recalls.
We have recently learnt that Johnson & Johnson has again recalled thousands of its hip implants, two and a half years after they issued a recall of the DePuy ASR hip implants. The company recalled the “Adept” brand all-metal total hip replacement system due to higher-than-expected replacement rates. Such replacements, called revision surgeries, are usually needed when an artificial joint starts causing pain, difficulty walking or other problems.
Have other types of MoM hip implants caused problems/been recalled?
Last month authorities in Canada, the U.S. and the UK warned that full metal-on-metal hip implants may be more likely to fail and can cause tissue damage around the joint compared with the traditional metal-and-plastic type of implants.
Last year we spoke about research, published in the world’s leading medical journal, The Lancet, was based on the National Joint Registry of England and Wales, which includes information on more than 400,000 hip replacements implanted between 2003 and 2011.
Experts who carried out the research for The Lancet found “unequivocal evidence” of high failure rates and called for metal-on-metal hip implants to be banned.
Concern about metal on metal hips intensified last year as suspicions emerged about the viability of another DePuy device, the Pinnacle. The British Medical Journal and BBC Newsnight investigation in the UK found that DePuy altered the design of the Pinnacle, which experts warned would lead to the release of high levels of toxic metals into the body.
Despite contrary indicators of benefits of this device, the Pinnacle is still on the market.
How many Adept implants have been recalled worldwide and do you know yet how many were implanted in Ireland?
The “Adept” brand all-metal total hip replacements were sold in 21 countries. All 7,500 Adept implants shipped worldwide between 2004 and September 2011 have been recalled by Johnson & Johnson after a registry in the United Kingdom found that 12.1 percent of patients needed their implants replaced within seven years, while a registry in Australia found 7.1 percent of patients needed replacements within three years.
While the Adept hip implants were not used in Ireland other MoM implants, such as the DePuy ASR hip implants were implanted in patients in Ireland.
What advice has been given to people who may have received the Adept hip implants?
Spokeswomen for Johnson & Johnson’s DePuy Orthopaedics unit reported that they do not know how many of the “Adept” recalled implants were implanted in patients and advised anyone who received the implants and are having problems with them to contact their doctor.
What would be the main health concerns for people who have MoM hip implants?
The hip implants have a high failure rate and one of the main concerns is the impact of the toxicity levels of MoM implants. Metallosis is the metal ions from the MoM device entering the bloodstream. We are representing a significant number of DePuy patients, many of whom would have had their surgery five years ago, and we have seen a marked increase in the number of revision surgeries in the past four to six months.
Another indicator of the failure of the devices is the high blood readings for cobalt or chromium.
What symptoms would DePuy patients have if the device is failing?
Our experts have given us a list of symptoms, which show the failure of the device:
- Continuing hip, groin, leg, or low-back pain;
- Audible noises such as crunching, clicking, grinding, or metallic sounds coming from the ASR device;
- The sensation that one`s hip is not “in place,” especially when standing up or starting to walk;
- Loss of ability to perform physical activities, reduction in mobility and noticeable limp;
- Swelling in the affected hip area or generalised hip pain, discomfort, pressure or tenderness and;
- Loosening of the various components in the implant, necrosis or soft tissue damage and elevated cobalt and chromium levels in the blood due to exposure to metal.
We have identified common symptoms in patients with elevated blood ion levels:
- Rashes, skin patches and skin discolouration;
- Memory loss/difficulties;
- Eyesight deterioration;
- Changes in urine.
Who is usually liable when these types of recalls occur?
The area of product recalls is complex litigation as there is usually more than one party liable. On behalf of our DePuy clients we are pursuing the orthopaedic surgeon, the hospital, the Health Service Executive, DePuy International Limited and PEI Surgical (the distributor).
Remind us again how many DePuy ASR Hip implants were recalled in Ireland and what is the current situation with those cases?
Since 2009 Johnson & Johnson has issued more than 30 product recalls. In August 2010, two types of DePuy ASR metal hip implants were recalled after they were linked to high failure rates. In Ireland, 4,746 DePuy ASR Hip implants were distributed, with 3,317 patients receiving one or more of the components. These patients were spread equally across 16 public and 14 private hospital sites.
We represent a large amount of clients who have been affected as a result of the recall of DePuy ASR Hip implants in August 2010. We are now at an advanced stage with many of our cases and have received “Defences” from DePuy. As we expected DePuy have denied all responsibility, this is not unusual and is a standard approach in this type of complex litigation. It is however ironic that they have stated in their Defences that they require us to prove that the DePuy Hip is defective- DePuy voluntarily recalled these Hip implants due to a high failure rate.
Whilst continuing to press on with our cases we are closely monitoring the first of these cases to go trial in the United States, Kransky v. DePuy. The case is currently in its second week before a Jury at Los Angeles Superior Court and seems to be off to a strong start with the Plaintiff arguing that DePuy knew that its ASR hip implant had design defects and concealed them from physicians.
The Plaintiff’s case is currently being argued before the Court and it is important to remember that DePuy have not yet presented their Defence case to the Court. It is expected that DePuy will assert that they acted properly and in a timely fashion to the device’s problems.
Testimony offered to the Court indicates that DePuy knew of the high risks and side effects well before the recall. Emerging evidence suggests that DePuy were told that there were safety concerns related to the design of the DePuy ASR implant three years before it was recalled. We hope that this emerging evidence will help support claims that the company knew about these dangerous defects and failed to warn the public about them. It has also emerged in the course of the trial that DePuy’s orthopedic unit used incorrect standards in trying to assess some of those risks before first selling the implant in 2003.