DePuy ASR Hip Lawsuit Update: Rottenstein Law Group Responds to Hip Implant Expert Testimony On ASR Design Flaws

As the nation’s first DePuy ASR trial progresses into its second week in Los Angeles, a metal-on-metal hip implant expert testified Feb. 6 that the device’s design had several alleged flaws, notes the Rottenstein Law Group, which represents clients in DePuy ASR lawsuits.

According to a Bloomberg article,* Dennis Bobyn, a McGill University professor, testified in court (In re: Loren Kransky and Sheryl Kransky v. DePuy, Inc., et al. BC456086, Los Angeles Superior Court) that the recalled ASR’s shape and function – a less-than-half-circle metal cup in which a metal ball sits – contributed to the alleged flaws, as does its one-piece cup design. (Two-pieces is considered a better approach, Bobyn said.)

The alleged design flaws can cause metallosis (metal poisoning), which is one of the most prominent conditions for which hip implant recipients pursue lawsuits with firms such as the Rottenstein Law Group. Contact between hip components results in metal ions that enter the bloodstream. Alleged side effects include the blackening of and growth of “pseudotumors” in the surrounding tissue and adverse effects in the central nervous system.

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Quick Recap on Lawsuits Against DePuy

Hip replacement surgeries became controversial due to defective hip prostheses like the ones manufactured by DePuy Orthopaedics Inc. DePuy is a subsidiary company of Johnson & Johnson (J&J). DePuy Orthopaedics, Inc. is recently being charged with various lawsuits filed by law firms in UK, US and Australia, in behalf of patients who underwent hip replacement operations.  It is possible that the hip replacement lawsuit statute of limitations will run out. Statutes of limitations are designed to ensure that claims are filed promptly and that parties do not have to litigate issues based on old documents and potentially faulty memories.

There are around 98,000 recipients, including 37,000 in the US alone, of the ASR XL Acetabular System and the ASR Hip Resurfacing System worldwide. After the release of data presenting that these devices fail prematurely in one out of eight patients, the two devices were recalled. The manufacturing and marketing of these two devices started in 2003.

The Australian marketed DePuy devices were pulled off in December 2009. The global recall of these products was announced in August 2010.

On January 26, 2011, U.S. District Judge David A. Katz in Toledo, Ohio, appointed the claimants’ executive committee after dozens of lawyers vied for the positions of leading federal litigation against Johnson & Johnson (J&J) over recalled devices used in hip-replacement surgeries. This was reported by Bloomberg. The claimants were the ones affected by the failures and defects (e.g. fractures, displacements, loosening) of DePuy devices.

As of March 31, 2011, Johnson and Johnson had committed $280 million as a response to the recalls. The company also pledged to “address reasonable and customary costs associated with testing and treatment,” including new hips for those who need them.

The symptoms of a defective hip implant are swelling, pain bearing weight, pain when rising from a seated position, pain while walking, pain on the thigh or groin area, and pain on the hip area.

Even in the absence of any of these hip replacement symptoms, one should see a doctor for a check-up for regular assessment. With DePuy hip replacement lawsuit piling up globally, DePuy should pay attention to these the hip replacement problems experienced by its patients. It should circulate a wide range of information regarding malfunctioning hip replacement symptoms so that clients may be provided with due medical attention. To avoid much adverse effects, hip replacement problems should be dealt with immediately.

References:

• bloomberg.com/news/2010-09-03/johnson-johnson-sued-over-recalled-implanted-hip-replacement-devices.html
• arthritistoday.org/news/asr-depuy-hip-replacement-recall078.php
• nursinghomesabuseblog.com/defective-products/defects-with-depuy-hip-replacement-hardware-may-be-responsible-for-complications-following-hip-surgury/

Johnson & Johnson Hires Own Compensation Recall Company

When DePuy Orthopaedics and its parent company, Johnson & Johnson (J&J), initiated the hip replacement recall, it crafted a compensation program that would reimburse hip recipients for the “reasonable and customary” costs associated with another surgery. Thus, Johnson& Johnson employed Broadspire Services, a subsidiary of insurance agency Crawford & Crawford.

The New York Times, on December 27, 2011, published an article about the reimbursement regulations of DePuy, Johnson & Johnson and Broadspire. The article reports that “things were not going smoothly for everyone who has had accepted DePuy’s payment offer.”

With approximately 93,000 recipients worldwide, the ASR XL Acetabular System and the ASR Hip Resurfacing System were recalled after data revealed that the devices fail prematurely in one out of eight people who have them.

“It is a complete untruth that DePuy did not have reason to withdraw the ASR before now; we have been telling them since 2007, but they allowed it to be used on thousands of people,” says Dr. Stephen Graves, the director of the National Joint Replacement Registry in Australia.

“We believe we made the appropriate decision to recall at the appropriate time given the available information,” states DePuy spokeswoman, Mindy Tinsley.

Johnson & Johnson had pledged a total of $280 million in compensatory claims to the recalls, as of March 31, 2011. The company further guaranteed to “address reasonable and customary costs associated with testing and treatment.” The metal particles shed from metal-on-metal hip replacement implants may increase the amount of some metals in the blood, such as chromium and cobalt. This may cause metallosis (blood poisoning) and genotoxicity (genetic damage). Furthermore, tumors and cancer may also arise because of cobalt and chromium in the patient’s blood.

In May 2011, different engineers and medical experts created a registry tasked to track hip and knee implants, after the issuance of DePuy hip replacement recall.

” The goal is to track the more than 700,000 total hip and knee replacement surgeries that take place in the U.S. each year and, over time, record which implants failed prematurely, requiring revision surgery to fix the original operation,” David Lewallen said. He is the AJRRchairman and a professor of orthopedic surgery at the Mayo Clinic in Rochester, Minnesota.

The hip replacement recall positively urged the manufacturer to take an action on the need of the public for safe medical services and products. With the number of duly filed DePuy lawsuit increasing worldwide, DePuy should properly face the hip replacement problems encountered by its clients. It should circulate a wide range of information regarding malfunctioning hip replacement symptoms so that its patrons would be provided with due medical attention.

References:

• nytimes.com/2011/12/28/business/the-high-cost-of-failing-artificial-hips.html?_r=2&pagewanted=all

• medicinenet.com/total_hip_replacement/article.htm

• nytimes.com/2010/03/04/health/04metalhip.html

An Earlier Recall for DePuy ASR Hip Replacement should have been Done

When the complaints on metal-on-metal hip implants increased, the DePuy Articular Surface Replacement (ASR) hip systems recall should have been done immediately, according to medical experts. It had taken three years after evidence showed that the hip implants had a high failure rate, for a recall to be implemented by DePuy Orthopaedics Inc. and its mother company Johnson & Johnson, said Australian medical experts.   Johnson & Johnson had to reimburse thousands to Australians in recall claims as a result.

Before the United States and Europe recalled the two DePuy hip implants in August of 2010, Australia had done it already in December 2009.  Data from a study conducted by the National Joint Registry (NJR) of England and Wales which indicated that the five-year failure rate of this product was approximately 13 percent prompted the recall. Some medical experts claim that this data have been available since 2006.  

Aside from the data which stated that the ASR hip implants also had a higher than normal failure rate, Johnson & Johnson’s DePuy Orthopaedics also said in March of 2010 that it will phase out the devices because of declining sales.  Pointed as the reason for the hip implant’s failure just five years after it was first used is its design.  By designing a shallower cup and removing the plastic liner from the inside of the implant, DePuy had intended for patients to have a wider range of motion. The design, however, allows cobalt and chromium particles to accumulate in the soft tissue around the implant area, after they wear off from the device resulting from the friction of the ball portion of the hip implant against the socket.

More alarming is the claim that other evidence indicates that the revision rate is now at 25 percent, while some experts predict that within six years, as more of the devices fail, it could reach up to 49 percent. The defective hip implant could only be removed by a revision surgery. Although DePuy promises to compensate patients’ revision surgery, lawyers said it is not willing to fully compensate those affected. Apart from the revision surgery cost, full compensation would include the pain and suffering, emotional suffering and financial loss as a result of having the defective implant.

The DePuy hip replacement recall sparked the filing of thousands of lawsuits and complaints.  All cases filed across the country was transferred to the Northern District of Ohio and, with the consent of that court, assigned Honorable David A. Katz to handle it for coordinated or consolidated pretrial proceedings last December 2010 as based on the ruling filed by the US Judicial Panel on MultiDistrict Litigation (MDL. The DePuy lawsuit alleges that the ASR hip replacement was defectively designed and 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.

References:

m.smh.com.au/national/health/three-years-to-recall-problem-implants-20110927-1kvik.html

world.einnews.com/pr_news/59900568/asymptomatic-metal-on-metal-hip-replacement-patients-may-still-be-experiencing-tissue-damage

forthepeople.com/depuy-metallosis-depuy-hip-implant-recall--12-3189.html

nytimes.com/2010/03/10/business/10device.html

moriarty.com/depuy_hip_recall/Stay_Informed/What_is_Metallosis/

orthosupersite.com/view.aspx?rid=40090

Components Of An Artificial Hip Replacement Device

In an update regarding the DePuy hip replacement recall, the U.S. Food and Drug Administration's statement about the latest surveillance report conducted for DePuy Orthopaedics was published:

    “As part of the post-market surveillance, DePuy is continually evaluating data from a variety of sources including national joint replacement registries, published literature, company sponsored clinical trials, internal complaints data and unpublished clinical research reports. As part of the post-market surveillance activities, the firm recently received and analyzed new data regarding the ASR platform which suggests a higher than expected revision rate for the ASR XL Monoblock Metal-on-Metal (MoM) System linked to usage of monoblock MoM cups with corresponding head sizes below 50mm in diameter. As a result of the findings, DePuy Orthopaedics issued a Field Safety Notice to share the new data with the surgeons and reiterate the importance of correct implant positioning and patient selection in achieving optimal implant performance and survivorship.”

If you are considering to have a hip replacement surgery, you can ask your doctor what type of hip replacement prostheses that is suitable for your condition. The following are the components of a hip replacement prostheses considered by the presiding surgeon:

•  ACETABULAR CUP

    In the procedure, a lining on the concave part of the hip socket is fitted and this part of the hip prostheses is called the acetabular cup. This is secured using friction or through the use of a special kind of cement.

•  FEMORAL COMPONENT

    For those with conditions that reached the femoral bone, a femoral component is also included. Cement and non-cemented femoral components are available which allows it to be secured to its right location.

• ARTICULAR INTERFACE

    The part that is located in the middle of the femoral component and the acetabular cup is called the articular interface. A simple ball and socket joint comprises the articular surface. It can be of different sizes: 28 mm, 32 mm and 36 mm and selecting the appropriate size is determined by the diameter of the femoral head or the diameter of the inside of the hip socket.

It has also been stated in the report that research shows those who experienced premature complications due to the hip replacement device tend to have smaller hip cups. It is important to be that you are knowledgeable what hip replacement product is used and what component was advised to use for your operation. For those who are interested to file their own case against DePuy Orthopaedics, you can consult an efficient lawyer to help you raise your case and you can be updated about the latest news about the DePuy hip replacement recall through available sites.