The Product Liability Litigation Group at Schlichter Bogard & Denton is currently investigating cases involving defective hip replacements manufactured by DePuy and Zimmer. If you or a loved one had a DePuy ASR or Zimmer Durom Cup implanted and have suffered complications or experienced a failure requiring revision surgery, you may be entitled to recover damages for lost wages, medical costs, pain and suffering. We handle litigation nationwide, with offices in Missouri and Illinois. For your free legal consultation, please contact our experienced attorneys at Schlichter Bogard & Denton by calling toll-free 1-800-873-5297.

DePuy Hip Implant
The DePuy ASR Hip Replacement is a metal-on-metal device manufactured by DePuy, a division of Johnson & Johnson, which is believed to have a design flaw resulting in many patients needing follow-up operations to replace the device within a few years, when such implants should typically be expected to last 15 or more years.

The New York Times reported that DePuy introduced the ASR Hip Replacement without adequately testing and researching this device. Although the implant was approved for use by the FDA in 2005, it was cleared through a regulatory pathway that did not require it to undergo clinical trials. The DePuy implant appears to have a high failure rate compared with other hip replacement devices and the Food and Drug Administration has received about 300 complaints regarding the DePuy ASR since the beginning of 2008, all involving patients in the United States.

In late 2009, DePuy announced its plan to phase out sales of the product worldwide by the end of 2010, but not before the ASR had been implanted in thousands of people. Approximately 250,000 people in the U.S. alone receive hip replacement implants every year and about 1/3 of those receive metal-on-metal implants. On March 10, 2010, DePuy sent a warning letter to doctors indicating that data from Australia revealed a higher-than-expected failure rate than traditional hip replacements on certain types of patients.

In July 2010, DePuy issued a recall of the DePuy ASR Cups and on August 26, 2010, DePuy recalled the ASR XL Acetabular Head System and the ASR Hip Resurfacing System (not approved in the US) due to the large number of patients who experienced pain and other symptoms leading to a second hip replacement surgery, also known as a revision surgery. Data received by DePuy indicated that five years after being implanted with the DePuy ASR hip implant, 13% of patients (1 in 8) needed revision surgery. The ASR system, subject to the voluntary recall, first became available in July 2003 and approximately 93,000 units were affected by the recall.

A number of orthopedic doctors believe the DePuy metal-on-metal implant has a design flaw that makes it difficult to implant properly. In particular, the ASR cup is shallower than other devices and is believed to be the problem. Even the designer of DePuy's ASR system, Dr. Thomas P. Schmalzried, said that DePuy has known for years that DePuy's ASR hip system might be more of a challenge to implant properly than similar hip implants made by other companies. Additionally, other problems associated with the metal-on-metal implant include the potential for generating large amounts of metal debris during normal wear, which can cause severe inflammatory responses in some patients and even damage muscles and soft tissue, thus requiring a follow-up operation to replace the device. The symptoms of a failed ASR hip implant can include:

• Continued Pain or Discomfort for More than 3 Months After the Procedure
• Swelling
• Difficulty Walking
• Loosening of the Implant
• Migration of the Implant
• Dislocation of the Implant
• Additional Hip Replacement/Revision Surgery

The voluntary recall of the hip replacement products has been accompanied by a commitment from DePuy to pay medical costs related to the recall, including the costs for a replacement hip implant. However, such reimbursement is limited to out-of-pocket costs that are not otherwise covered by the patient's insurance. Additionally, DePuy has refused to compensate patients for pain, tissue or bone damage, lost wages and/or disability associated with the implantation of the DePuy ASR, or associated with revision surgery to replace the DePuy ASR.

Zimmer Hip Implant
The Zimmer Durom Hip Replacement Cup, or Zimmer Durom Acetabular Component, is a newer type of artificial hip which was introduced in the United States in 2006. Unlike traditional hip replacement components, the Zimmer Durom Cup is made from a single piece of material. The device is intended to bond to the patient's hip socket as bone grows into the porous shell of the device so that screws, cement, and epoxy are not required to affix the device.

The Zimmer Durom Cup was marketed with the promise that it was different. It was targeted for young, active patients who are likely to outlive a conventional hip prosthesis. However, Zimmer's claim has not held up to scrutiny. After the hip was implanted in patients in 2006, patients started revisiting their doctors with complaints. Although the doctors knew it would take a reasonable amount of time to achieve full recovery, the patients were experiencing pain well after the expected three-month recovery time. Upon examination, doctors determined that a large number of these patients needed revision surgery to correct problems. In one clinic, 12% of patients with the Zimmer hip implant needed to have it replaced within two years.

The issues with the device surfaced in April of 2008 when Dr. Lawrence Dorr, an orthopedic surgeon in Los Angeles and Director of the Dorr Institute for Arthritis Research and Education, publicly warned other orthopedists about cup failures his patients were experiencing. In particular, Dr. Dorr disclosed that a very high rate of Durom hip cups implanted at his clinic needed to be surgically revised within two years of implantation. Zimmer initially dismissed Dr. Dorr's report of problems regarding the Zimmer Durom Cup. However, Zimmer agreed to investigate the Durom Cup problems in May of 2008. After reviewing data from over 3,100 cases, Zimmer concluded that the technology and design parameters of the Durom Cup require a higher degree of precision than was common in hip replacement surgical techniques.

On July 22, 2008, Zimmer announced that it was suspending sales of the Zimmer Durom Hip Cup, or Zimmer Durom Acetabular Component, in the United States. However, a formal recall of the Durom Cup was never issued because Zimmer did not uncover evidence that the failures were caused by defects within the device. Zimmer indicated that it would reintroduce the hip implant after developing better instructions about the surgical techniques that are necessary for surgeons to utilize in order to avoid the risk of Durom Cup problems. Zimmer also indicated that they would implement a new training program for surgeons in the United States. The Durom Cup Replacement component was reintroduced into the United States market in August of 2008, along with new online training programs for physicians doing the implant surgeries.

Approximately 12,000 individuals had the Zimmer Durom Cup system implanted between 2006 and 2008. While Zimmer's own estimates in 2008 suggested that some doctors have experienced failure rates as high as 8%, more recent claims made in lawsuits suggest that the failure rate is between 20% and 30%. Physicians who used the Zimmer Durom Cup in patients reported that the component parts failed to properly bond together and would easily slip out of place causing excruciating pain in patients and forcing patients to undergo painful revision surgeries. The symptoms of a failed hip implant can include:

• Continued Pain or Discomfort for More than 3 Months After the Procedure
• Startup Pain and Stiffness (meaning patients will hurt or limp badly for 10-20 steps when they first arise from a chair or car)
• Sharp Pain in the Groin After Moving from a Bent Position to an Upright Position
• Difficulty in Climbing Stairs
• Inability to Walk with any Endurance
• Loosening of the Implant
• Migration of the Implant
• Additional Hip Replacement/Revision Surgery

Lawsuits have been filed against Zimmer for the damages patients have sustained as a result of the Zimmer Durom Cup. In particular, current lawsuits against Zimmer are based on the fact that Zimmer introduced a new product without providing adequate warnings or instructions about the proper use and surgical techniques required. In October of 2008, Zimmer announced that they had set aside a fund of $47.5 million to pay lawsuit claims. However, they are still adamant that their research showed no defects in the product. Zimmer states that this money is not being reserved for all patients and revisions, but only for "revisions associated with surgeries that predate the company's voluntary suspension and which also occur within two years of the original surgery date."