2010 DePuy Hip Recall
Encyclopedia
2010 DePuy Hip Replacement Recall was instituted when DePuy Orthopaedics, Inc.
, a division of Johnson and Johnson, recalled its ASR XL Acetabular metal-on-metal hip replacement
system on August 24, 2010.
, fracture of the bone
, dislocation
, metal sensitivity and pain
. Additional complications from the DePuy ASR XL Acetabular hip replacement system may include increased metal ion levels in the blood, bone staining, necrosis
, swelling
, nerve damage
, tissue damage and/or muscle damage.
The DePuy ASR XL Acetabular System first became available in 2005 in the United States
. Johnson & Johnson was given special clearance from the FDA in 2005 to market the ASR devices without first performing clinical trials—tests to determine the safety of the products. But since 2008, the FDA has received approximately 400 complaints from patients who received ASR hip replacements. In March 2010, J&J acknowledged that ASR products had a higher-than-normal failure rate after data revealed that approximately 12% of patients who received an ASR device needed “revision surgery.” In August 2010, DePuy issued a voluntary recall of both ASR devices, more than a year and a half after the first lawsuit was filed. Many experts agree that a recall should have been issued sooner, due to the high volume of complaints about the devices.
At the beginning of 2010 DePuy Orthopaedics said they were phasing out the ASR Hip Implant because of declining sales, but never mentioned the high failure rate data from an Australia
n implant registry. In March 2010 the New York Times reported that DePuy issued its first warning to doctors and patients about the high early failure rate. However at this point they still had not issued a recall of the product
. In fact, they adamantly denied there was a recall and claimed any statements referencing a recall were false.
Johnson and Johnson has experienced other recall issues this year and DePuy Orthopaedics is barely three years removed from a scandal that involved undisclosed payments to doctors.
It remains to be seen how DePuy’s recent recall, which affects the ASR XL Acetabular System and the ASR Hip Resurfacing System, will affect the company financially. Lawsuits are now being filed, since it was determined that the ASR devices fail in 1 out of 8 patients, making a second hip replacement surgery necessary. Recipients are suing the manufacturer for the costs associated with this “revision” surgery, as well as for pain and suffering in some instances. 93,000 persons worldwide received an ASR implant, making it likely that DePuy will face many thousands of lawsuits.
The first lawsuit
in the United States against DePuy Orthopaedics was filed on June 15, 2010. The lawsuit claims that the DePuy ASR hip replacement was defectively designed, that DePuy knew that there were problems with the implant
early on but didn't do anything to let patients or their surgeons know about the possible problems. The United States Judicial Panel on MultiDistrict Litigation filed a ruling on December 7, 2010 that determined the fate of the thousands of lawsuits regarding DePuy Hip Recalls in the United States. Its ruling stated that all cases filed across the country, "are transferred to the Northern District of Ohio and, with the consent of that court, assigned to the Honorable David A. Katz for coordinated or consolidated pretrial proceedings."
On January 26, 2011, Judge Katz entered an order in the MultiDistrict Litigation naming the leadership counsel for both the Plaintiffs and the Defendants. Ben Gordon, Eric Kennedy, Ellen Relkin, Mark Robinson, Christopher Seeger, and Steven Skikos were named on the Plaintiffs' Executive Committee. Robert Tucker and Susan Sharko were named as Defendants' Co-Lead Counsel. Discovery of documents from Johnson & Johnson and DePuy Orthopaedics has commenced.
DePuy
DePuy is a franchise of orthopaedic and neuroscience companies. Acquired by Johnson & Johnson in 1998, its companies form part of the Johnson & Johnson Medical Devices & Diagnostics group...
, a division of Johnson and Johnson, recalled its ASR XL Acetabular metal-on-metal hip replacement
Hip replacement
Hip replacement is a surgical procedure in which the hip joint is replaced by a prosthetic implant. Hip replacement surgery can be performed as a total replacement or a hemi replacement. Such joint replacement orthopaedic surgery generally is conducted to relieve arthritis pain or fix severe...
system on August 24, 2010.
Background
This recall came after data from a recent study indicated that the five year failure rate of this product is approximately 13%, or 1 in 8 patients. The defective and dangerous replacement hips have already been implanted in patients. The recall means that patients who have already undergone one surgical procedure to replace a hip may have to undergo a “revision.” That is: a second surgery. But even if the defective device is replaced, it can leave behind dangerous, possibly deadly fragments that might not be discovered for years. DePuy identified reasons for the failure of the hip replacement system as component loosening, component malalignment, infectionInfection
An infection is the colonization of a host organism by parasite species. Infecting parasites seek to use the host's resources to reproduce, often resulting in disease...
, fracture of the bone
Bone fracture
A bone fracture is a medical condition in which there is a break in the continuity of the bone...
, dislocation
Dislocation
In materials science, a dislocation is a crystallographic defect, or irregularity, within a crystal structure. The presence of dislocations strongly influences many of the properties of materials...
, metal sensitivity and pain
Pain
Pain is an unpleasant sensation often caused by intense or damaging stimuli such as stubbing a toe, burning a finger, putting iodine on a cut, and bumping the "funny bone."...
. Additional complications from the DePuy ASR XL Acetabular hip replacement system may include increased metal ion levels in the blood, bone staining, necrosis
Necrosis
Necrosis is the premature death of cells in living tissue. Necrosis is caused by factors external to the cell or tissue, such as infection, toxins, or trauma. This is in contrast to apoptosis, which is a naturally occurring cause of cellular death...
, swelling
Swelling
Swelling , is the enlargement of tissue.Swelling can also mean:*Die swell, the increase of volume of material due to absorption of a solvent, common for plastic polymers*Neutron-induced swelling caused by neutron radiation....
, nerve damage
Nerve Damage
Nerve Damage is a compilation album by Groove Metal band Skinlab, released in 2004. It is a 2CD collection of rare and unreleased material, including a live set, demos, remixes, alternate mixes, and two new tracks.-Disc 1:# "Losing All" – 4:04...
, tissue damage and/or muscle damage.
The DePuy ASR XL Acetabular System first became available in 2005 in the United States
United States
The United States of America is a federal constitutional republic comprising fifty states and a federal district...
. Johnson & Johnson was given special clearance from the FDA in 2005 to market the ASR devices without first performing clinical trials—tests to determine the safety of the products. But since 2008, the FDA has received approximately 400 complaints from patients who received ASR hip replacements. In March 2010, J&J acknowledged that ASR products had a higher-than-normal failure rate after data revealed that approximately 12% of patients who received an ASR device needed “revision surgery.” In August 2010, DePuy issued a voluntary recall of both ASR devices, more than a year and a half after the first lawsuit was filed. Many experts agree that a recall should have been issued sooner, due to the high volume of complaints about the devices.
At the beginning of 2010 DePuy Orthopaedics said they were phasing out the ASR Hip Implant because of declining sales, but never mentioned the high failure rate data from an Australia
Australia
Australia , officially the Commonwealth of Australia, is a country in the Southern Hemisphere comprising the mainland of the Australian continent, the island of Tasmania, and numerous smaller islands in the Indian and Pacific Oceans. It is the world's sixth-largest country by total area...
n implant registry. In March 2010 the New York Times reported that DePuy issued its first warning to doctors and patients about the high early failure rate. However at this point they still had not issued a recall of the product
Product recall
A product recall is a request to return to the maker a batch or an entire production run of a product, usually due to the discovery of safety issues. The recall is an effort to limit liability for corporate negligence and to improve or avoid damage to publicity...
. In fact, they adamantly denied there was a recall and claimed any statements referencing a recall were false.
Johnson and Johnson has experienced other recall issues this year and DePuy Orthopaedics is barely three years removed from a scandal that involved undisclosed payments to doctors.
It remains to be seen how DePuy’s recent recall, which affects the ASR XL Acetabular System and the ASR Hip Resurfacing System, will affect the company financially. Lawsuits are now being filed, since it was determined that the ASR devices fail in 1 out of 8 patients, making a second hip replacement surgery necessary. Recipients are suing the manufacturer for the costs associated with this “revision” surgery, as well as for pain and suffering in some instances. 93,000 persons worldwide received an ASR implant, making it likely that DePuy will face many thousands of lawsuits.
The first lawsuit
Lawsuit
A lawsuit or "suit in law" is a civil action brought in a court of law in which a plaintiff, a party who claims to have incurred loss as a result of a defendant's actions, demands a legal or equitable remedy. The defendant is required to respond to the plaintiff's complaint...
in the United States against DePuy Orthopaedics was filed on June 15, 2010. The lawsuit claims that the DePuy ASR hip replacement was defectively designed, that DePuy knew that there were problems with the implant
Implant
Implant can refer to:*Implant , or specifically:**Brain implant**Breast implant**Buttock implant**Cochlear implant**Contraceptive implant**Dental implant**Mini dental implant**Extraocular implant**Fetal tissue implant...
early on but didn't do anything to let patients or their surgeons know about the possible problems. The United States Judicial Panel on MultiDistrict Litigation filed a ruling on December 7, 2010 that determined the fate of the thousands of lawsuits regarding DePuy Hip Recalls in the United States. Its ruling stated that all cases filed across the country, "are transferred to the Northern District of Ohio and, with the consent of that court, assigned to the Honorable David A. Katz for coordinated or consolidated pretrial proceedings."
On January 26, 2011, Judge Katz entered an order in the MultiDistrict Litigation naming the leadership counsel for both the Plaintiffs and the Defendants. Ben Gordon, Eric Kennedy, Ellen Relkin, Mark Robinson, Christopher Seeger, and Steven Skikos were named on the Plaintiffs' Executive Committee. Robert Tucker and Susan Sharko were named as Defendants' Co-Lead Counsel. Discovery of documents from Johnson & Johnson and DePuy Orthopaedics has commenced.
Further reading
- Medical Device Alert: All metal-on-metal (MoM) hip replacements. http://www.mhra.gov.uk/Publications/Safetywarnings/MedicalDeviceAlerts/CON079157
- MedicalDeviceAlert: DePuy ASR TM acetabular cups used in hi pre surfacing arthroplasty and total hip replacement. http://www.mhra.gov.uk/Publications/Safetywarnings/MedicalDeviceAlerts/CON082089
- Australian Broadcasting Corporation - 4 Corners Investigate Journalism report into ASR Hip Replacements . http://www.abc.net.au/4corners/content/2011/s3215297.htm