DePuy hip implant recall

Numerous multidistrict lawsuits against DePuy Orthopaedics may be comprised into one federal case, pending a U.S. Judicial Panel on Multidistrict Litigation hearing Nov. 18.

The Multidistrict Litigation panel, comprised of seven federal and circuit judges who are appointed by the Chief Justice of the United States, will determine the commonality among the separate lawsuits to decide if the actions should be transferred to one federal district and select the judge for such proceedings.

Since its establishment in 1968 by Congress, the MDL Panel, has moved forward more than 30,000 cases, involving millions of claims for litigation including airplane crashes, such as train wrecks or hotel fires; mass torts, such as those involving asbestos, drugs and other products liability cases, according to its website.

DePuy recalled its ASR XL hip implant in August, based on early failure rates. An estimated 12,000 people will have to undergo hip replacement surgery to replace the faulty DePuy ASR hip device. All 90,000 patients with the ASR implant face issues of metal toxicity from the device wearing down and debris entering the blood stream.

There have been numerous claims already filed against DePuy, which is a division of global American pharmaceutical giant Johnson & Johnson. If you or a loved one has been injured by a DePuy hip implant, it’s not too late to file a claim. Talk to a South Carolina personal injury attorney.

The Food and Drug Administration approved Menaflex under the 510(k) approval process, claiming the knee device was similar to an already approved shoulder implant, but some FDA scientists still disapproved of the device’s safety.

The whistleblowers complained to the FDA commissioner in May 2008, reporting medical device reviews were being routinely manipulated within the department, but when he failed to proceed with the inquiry, they did something unprecedented. The scientists sent a letter Congress in October 2008 asking for an investigation.

The House Committee on Energy and Commerce agreed. Through the investigation, the Project on Government Oversight and the Government Accountability Office revealed disturbing facts about the FDA. It found 228 medical devices had been fast-tracked during the period.

Menaflex had already entered the market, but by September of 2009, new FDA commissioner Margaret Hamburg and Deputy Commissioner Joshua Scharfstein publicly admitted that the Menaflex review process had been unduly influenced by both members of Congress and the old commissioner. They promised that the approval would be placed under review.

On October 13, 2010, the FDA rescinded its approval of the Menaflex knee device.

As a North Charleston personal injury lawyer, the FDA’s approval of Menaflex makes me wonder what else has been carelessly approved by the FDA. This case reminds me of DePuy Orthopaedic’s hip implant that was approved under the same process, but later recalled because it was a faulty product. If you or a loved one has been injured as a by a hip or knee implant, have your case evaluated by a Charleston hip implant attorney.

A knee implant that was approved by the U.S. Food and Drug Administration in 2008 is opening eyes to possibly corruption in the agency.

Medical devices sold and used in the United States have to be approved by the FDA before being marketable, but some devices don’t have to be fully examined on a trial bases. Such is the case with ReGen Biologics Inc.’s C-shaped, cow collagen implant, the Menaflex, and DePuy Orthopaedic’s ASR hip implant. Devices ruled similar to already approved devices may receive fast-track approval with the FDA’s 510(k) clearance.

But, in the case with Menaflex, FDA whistleblowers say the FDA was lobbied to approve the device when it shouldn’t have.

In 2004, ReGen Biologics Inc. submitted a C-shaped, cow collagen implant, Menaflex, to the FDA for approval. Intended to replace the cushion between human knee bones, the company claimed the device was a similar to a shoulder implant also made by ReGen.  But the FDA rejected the comparison to the shoulder implant, saying knees are weight bearing and subject to vastly different motions and wear patterns than shoulder joints.

After the second rejection, the company then turned to four Congressmen from New Jersey for help. The congressmen worked with then FDA Commissioner who set up an outside panel to review the device. The new review group was comprised of sports doctors recommended by ReGen.

The four members of Congress, all of whom received campaign contributions from ReGen, remained involved in the process, while previous committee were forbidden to interact with them. In December, the Menaflex device was approved, claiming the decision represented a unanimous committee decision.

For more, read Part 2 by a personal injury lawyer.

The DePuy ASR XL device has had more than 400 complaints of early failure rates, leaving 12-13% of its patients facing difficult revision surgery and nearly all of them at risk for metallosis, but how did the device even get approved in the first place?

DePuy Orthopaedics ASR XL Acetabular System hip implant was approved in 2005 by the U.S. Food and Drug Administration without clinical trials. The speedy approval process is legal under the FDA’s 510(k) process, which allowed approval because the device was similar in design to other devices already on the market.

In four years after the device’s approval the FDA had received nearly 400 complaints that DePuy’s hip implant was failing prematurely. The device’s metal-on-metal design was loosening or breaking and corroding, causing metal debris from the device to enter the bloodstream, which could lead to metallosis.

In 2006, more than 6% of total health care expenditures in the United States went to medical devices like the DePuy hip, a $123 billion industry. In 2009, joint implants (including knees) generated $6.7 billion in profits for manufacturers. None of these products carry warranties and all represent some of the highest profit margins in medical manufacturing.

The DePuy case is an example of manufacturers and agencies bypassing safety for the benefit of business. They risked the health of all their patients and now many are suffering. If you or a loved one has been injured as a result of a DePuy hip implant, have your case evaluated by a personal injury lawyer.

For the early failure rates of the DePuy ASR XL hip implants, it’s everyone’s fault but theirs. DePuy Orthopaedics recalled its ASR XL hip implant in August, but the company, which is a division of global American pharmaceutical giant Johnson & Johnson, has yet to take direct responsibility for the failed implant.

Instead, DePuy continues to place blame of the device’s failure on surgeons who did not accurately position the hip and even patients themselves. In 2009, the company sent a letter to surgeons urging them to follow placement instructions more accurately. And DePuy now claims patients are responsible for the failure of the device in their bodies, such as obesity, failure to follow post-surgical recovery guidelines and inappropriate use of the hip.

As a North Charleston personal injury attorney, I do not agree with DePuy’s blame game. In 2009, complaints to the Food and Drug Administration claiming the device was failing reached more than 400. In Britain, patients also reported metal debris shedding from the hip and causing metallosis in the blood stream and non-cancerous tumors in surrounding tissue.

The number of failures and reports of things going wrong in patients shows something the implant is at fault. If you or a loved one has needed revision surgery or have the implant and fear the risk of metallosis, have your case evaluated by a North Charleston personal injury lawyer.

DePuy Orthopaedics ASR XL hip device was supposed to last 15 to 25 years, but faults in the designed caused its failure rate to be 12-13%, leaving nearly 12,000 people facing revision surgery.

On average, hip prostheses have an early failure rate of 5%, much lower than DePuys. The prosthesis’ failure rate of 12-13% is among 90,000 hip implant patients with the device. More than 400 patients have already complained to the Food and Drug Administration about the metal-on-metal device prematurely failing.

The 12,000 who will likely have to undergo revision surgery may face painful, difficult and expensive procedures. A second implant has a much lower success rate than the first, lasting an average of 12 years, and the third only lasts an average of eight years.

As a North Charleston personal injury lawyer I know the complications and hardships accompanying patients who’ve received a DePuy hip implant. Those who are lucky enough to have a functioning DePuy hip aren’t in the clear yet, however. All 90,000 DePuy hip implant patients face issues of metal toxicity from the devise wearing down and debris entering the blood stream. The metallosis could result in serious injuries down the road.

If you or a loved one has needed revision surgery or have the implant and fear the risk of metallosis, have your case evaluated by a North Charleston personal injury lawyer.

DePuy Orthopaedics ASR XL hip device may be more dangerous than patients think. The hip device was recalled in August for reports the implant failed prematurely, but dangers including metallosis, inflammation and detachment have also been linked to the implant.

As a South Carolina personal Injury lawyer I’ve dealt with DePuy cases involving multiple complications and defects.

The most common known danger with the DePuy device is it’s early failure rate. Since 2008, nearly 400 patients have reported early failure of the device. Between 12-13% of DePuy hip implant patients reported device failure within the five years, much higher than the industry standard 5% failure rate. The early failure rate is dangerous because it leaves patients facing revision surgery, which has a higher failure rate and a longer recovery period than the initial implant.

Another danger of the ASR device is the degeneration of the metal-on-metal device. As the implant wears out, the two portions of the joint can detach from the bone, become misaligned or abrade against one another, creating metallic debris. The metallic debris could potentially enter the blood stream, causing metallosis. Some patients have also reported sever inflammation and damage to the surrounding muscles and soft tissue.

As a North Charleston personal injury lawyer, I suggest patients discuss with their physicians and surgeons about any potential dangers from their DePuy hip implant.

DePuy Orthopaedics ASR XL hip device implant is one of the most complicated hip recalls in recent history. The case includes alleged deception, unreleased reports of failure and not one, but two devices. So can you understand the recall? The key is understanding its history.

DePuy Orthopaedics, Inc., the orthopedic branch of Johnson & Johnson, manufactured two hip implant products that were recalled in 2010: the ASR XL Acetabular System, a hip socket and the ASR Hip Resurfacing System, designed for “partial” replacements. (Only the ASR XL Acetabular System was used in the United States.)

In March 2010, DePuy issued an “advisory,” on some of its devises, indicating they were exhibiting early failure. The devices, however, stayed on the market.

In July 2010, a New York Times exposé exposed various reports of early failures with the DePuy device, prompting the implants to be finally recalled. The U.S. Food and Drug Administration also reported they knew about the early failure rates of the DePuy ASR XL hip implants since 2008, two years before the recall. They have received nearly 400 complaints of early failure rates, requiring patients to undergo difficult and dangerous revision surgery.

DePuy acknowledged the hip implant was experiencing decreased sales after its August recall, and later admitted to the higher than average failure rate.

As a North Charleston personal injury lawyer, I sort through the complicated DePuy case to get you the claim you deserve.

Hip replacement surgery is a complicated procedure that involves anesthetics and an incision 8 to 10 inches long, but it comes with a 95% success rate. That high success rate is necessary because of all the complications and dangers that come with each hip replacement revision surgery.

However, while the success rate is high, recalled or faulty devices could still cause an early need for hip revision surgery. DePuy Orthopaedics ASR XL patients experienced an early failure rate of 12-13% within the first five years of having the implant, compared to the industry standard 5%.

As a North Charleston personal injury lawyer, I take hip revision surgery due to a recalled device very seriously because of the potential complications from the surgery.  Some of those complications include, but are not limited to:

• Formation of blood clots from immobility
• Respiratory issues from pieces of fat from the bone marrow get into the bloodstream and move to the lungs where they cause serious breathing problems
• Infection and bleeding
• Numbness due to nerve damage
• Bone breaking or splintering
• Post-surgical dislocation

When an implant fails early, the dangers will continue for a lifetime, as each revision surgery gets more complicated. If you or a loved one have been affected by an early-failing hip implant, contact a North Charleston personal injury lawyer.

Creaking, cracking, inflammation or feeling perfectly fine can all be signs of a normal or failed hip device. Unfortunately the only tell-tale sign of a failed hip implant is immobility, but are there any warning signs?

As a Charleston DePuy hip recall lawyer, I’ve heard patients report a standard “check list” of indications of a failed hip. These include, but are not limited to:

• Pain – Discomfort in the hip, groin, lower back or opposite hip from altered stride
• Perception – The feeling that something is “not quite right” and a uneasy perception of instability
• Flexibility – A decline in physical skills, stiffness or awkwardness
• Inflammation/Swelling – increased metabolic activity at the site of the implant

If you have a hip implant that was recalled, there are other signs you could look for, based on what the recall was for. Such is the case with the DePuy Orthopaedics ASR XL device, which reportedly has been linked to mettalosis from metal particles breaking off and entering the bloodstream. The only way to check if you have been affected by mettalosis is to get tested by your doctor.

However, there are not always physical symptoms of a failed implant. It is important to visit your doctor if you suspect something is wrong. If you have a hip implant that prematurely failed, you should contact a North Charleston personal injury lawyer.