Denver, CO: A class action lawsuit has been filed in Ohio against DePuy Orthopaedics Inc on behalf of all United States citizens who received an implant of the ASR XL Acetabular System hip replacement.
On August 24, 2010, DePuy Orthopaedics Inc, a subsidiary of Johnson & Johnson, announced a voluntary recall of its ASR XL Acetabular System hip replacement, after a report published in Britain revealed an unacceptable failure rate of the device, resulting in revision surgery for 13 percent of patients within five years.
The plaintiffs are seeking answers to a number of questions including, whether DePuy should have known of the defects in the device prior to its sale and implant in patients, and whether DePuy failed to provide timely and adequate post-market warnings of the health risks associated with the its ASR XL Acetabular System.
Given the large number of devices recalled, it is conceivable that thousands of individuals across the United States may unknowingly need revision surgery, even if they are currently not experiencing any pain or discomfort, a lawyer representing the plaintiffs said. Although the company announced it will reimburse "reasonable medical expenses" to patients who sign releases providing DePuy complete access to their private medical records, the "offer" may be misleading.
Lawyers representing the plaintiffs state that in their opinion, "DePuy's 'offer' may deceive potential claimants into believing that the company has actually agreed to advance or reimburse their costs for medical monitoring or revision surgery. However, no specific offer to pay medical costs has been made and no specific plan for reimbursement has been announced. Moreover, DePuy has stated that before reimbursement of expenses will be provided, it will review the patient's medical records to determine if the patient meets DePuy's criteria for payment. According to DePuy, the medical records must confirm that the revision is related to the ASR recall and 'not some other type of cause, such as a traumatic fall.' Blaming the device failure on a fall, or another cause, such as physician error, patient misuse, pre-existing condition or underlying diseases is a standard litigation defense in these types of cases. Thus a patient who releases medical records to DePuy may do nothing but provide DePuy with a jump start on litigation defenses."