DePuy Hip Replacements - Product Recall
Updated: Aug 10, 2018
On 26th August 2010, DePuy Orthopaedics Inc announced that it was recalling two of its hip replacement implant products from the worldwide market. The Health Service Executive (HSE) estimates that approximately 3,311 patients in Ireland received these hip replacement implants across 16 public and 14 private hospitals since 2003.
The recall involved the DePuy ASR XL Acetabular System and the DePuy ASR Hip Resurfacing System. It transpired that within the first 5 years, almost 13% of patients with these implants required revision surgery (a second hip replacement operation). In England, a failure rate of 44% was recorded after 7 years. In Sweden, the failure rate after 7 years was 48%.
Failure of these ASR products products have caused considerable pain and suffering to many individuals who have received them. In many cases, where the metal components have grinded against each other and fragmented, the release of particles of metal (specifically cobalt and chromium) into the surrounding tissue and bloodstream have resulted in raised cobalt and chromium metal ion levels, weakness of the hip joint, painful swelling, reduced mobility, pseudotumours, metallosis, damage to soft tissue and bone in the hip joint.
Adverse reaction to metallic debris is an umberella term, otherwise known as ALVAL / pseudotumour / metallosis. Failure of these ASR implants may lead to edgeloading / abnormal wear of these devices, generating metal debris which may cause local tissue and / or bone damaged (necrosis) in or around the hip joint area, or in extreme cases, systemic damage (damaging / affecting other organs or the body as a whole).
There are currently in excess of 1000 claims over injuries and damage sustained from DePuy’s ASR hip replacement devices. Peter McDonnell & Associates are representing approximately 250 of these plaintiffs. However only two have gone to a full Hearing. Actions which go before the Irish Court must first obtain Authorisation from the Personal Injuries Assessment Board (PIAB). PIAB is an independent body which handles all cases involving personal injuries in Ireland. Medical negligence cases, however, are excluded. Due to the fact that these proceedings against DePuy International Ltd. are product liability cases, as opposed to medical negligence cases, PIAB Authorisation is essential. Further to a Ruling by Ms. Justice Mary Flaherty in January 2015 in the matter of Randa Murphy -v- DePuy International Ltd., any claim against DePuy International Ltd. cannot proceed unless Authorisation from PIAB has been obtained.
An Alternative Dispute Resolution (ADR) Process was approved by Mr. Justice Cross on 16th December, 2015. This ADR Process allows Claimants who have undergone revision surgery due to complications caused by the failure of DePuy’s ASR hip replacement products to have their case evaluated by one of a panel of 10 Evaluators. The panel of Evaluators consists of retired High Court or Supreme Court Judges, or Senior Counsel with experience in Personal Injuries cases.
While this Alternative Dispute Resolution Process allows Claimants to avoid the costs of going to Court, the evaluations issued by the panel are not binding, and must be accepted by both the Claimant and by DePuy. The option to take a case to Court is still open to the Claimant if a settlement is not reached through ADR.
DePuy employs a set of criteria for potential Claimants wishing to enter the dispute resolution process:
• The index operation implanting the ASR Product in the patient must have taken place in Ireland. • The Claimant must have undergone revision surgery in Ireland within 10 years of the index operation but not earlier than 180 days after the index operation.
DePuy shall not agree under clause 5.5 of the ADR Process to a claim entering the Process if in DePuy’s opinion:
• The claim is Statute Barred. • The Claimant has not obtained Personal Injuries Board Authorisation. • The claim relates exclusively to a revision necessitated by: 1) Dislocation 2) Trauma 3) Infection 4) Fracture of the femoral head; or 5) any issue relating to the femoral stem; • The claim is not sufficiently pleaded, or sufficient medical records or other essential details have not been furnished to the Defendant.
In November 2016, the High Court ordered DePuy International Ltd to pay over €700,000 in damages to Gillian O’Sullivan, a 52-year-old woman whose injuries were described by the Judge, Kevin Cross J, as “undoubtedly severe.” The Court heard that Ms O’Sullivan would require 3 further, unnecessary hip replacements over the course of her life. She experienced severe problems and disability, including regular pain and limitations of movement.
This was the first case involving the DePuy hip replacement recall to be fully heard before the High Court. Here, DePuy did not contest the allegation that the product was defective and the issue before the High Court was only that of damages without an admission of liability.
In December 2017, Joan Dineen, an 81-year-old woman who had undergone two revision surgeries due to complications arising from failure of her DePuy products, was awarded €321,000 by the High Court.
Justice Cross ruled that Ms Dineen could have expected the DePuy hip replacement product, which she received during surgery in 2009, would have provided her with a good degree of comfort for the rest of her life. However, he went on to describe her subsequent injuries as “severe and indeed permanent” and that this had caused “major disruption to her life.”
Although Justice Cross accepted that DePuy did not set out to manufacture a product which was deliberately defective, he stated that DePuy had failed to “robustly” test the ASR product. Had this been done, the Judge stated, “the defects which subsequently came to light would have been noticed prior to production.”
Litigation involving the DePuy ASR hip replacement product recall has been initiated globally, including in the US, the UK and Australia. In 2016, a class action lawsuit in Australia against DePuy was settled with all parties agreeing to share AUS$250 million in compensation, the largest sum ever in an Australian class action.
In November 2017, a US Federal Court jury ordered DePuy International’s parent company, Johnson & Johnson, to pay US$247 million to 6 patients over defective hip replacements.
In the UK, a product liability group action over defective DePuy hip replacement products has been one of the largest such cases ever taken in a UK court, with over 300 claimants suing for damages.