New York, New York – August 23, 2011 – The number of complaints regarding failed hip replacements are mounting as researchers attempt to identify the health dangers of the medical devices.

A New York Times study of the Food and Drug Administration’s (FDA) federal data has found that over 5,000 reports since January show that the majority of filings regard patients who had an all-metal hip removed, or will soon have one removed due to the much premature failure of the device (Only lasting about 3 years rather than 15 or longer). The staggering 5,000 reports since January is the most that the FDA has received than the last four years combined.

Although the adverse side effects are not life threatening, some patients are being affected by injuries as a result of small fragments of cobalt and chromium that the metal devices shave off as they rub together.

The DePuy A.S.R., or Articular Surface Replacement, hip replacement model was one of the biggest problem-causers, accounting for 75% of the complaints as studied by the New York Times. As a result, Johnson & Johnson announced a DePuy Hip recall last year.

It has been found that DePuy Hip Replacement devices were not tested on patients, which was not a rule of the FDA. However, the FDA asked producers in May to begin studying how frequently devices are failing and the adverse affects on patients.

The chief scientist of the FDA’s medical devices division, Dr. William Maisel, said that he believed studies by producers would lead to answers, but it may take several years. This is too late for some individuals who have already had a DePuy Hip Replacement and ultimately suffered from the effects of the metallic particle debris being dispersed into the tissue surrounding the hip replacement.

As a result of the adverse side effects caused by the DePuy A.S.R. Hip Replacement system, some patients are seeking retribution from the producers of the medical devices through DePuy Hip lawsuits. Patients suffering from injuries are being assisted by DePuy Hip lawyers that seek to advocate for the rights of the victims of DePuy Hip Replacements.

In 2007, a San Diego man received a metal-on-metal hip replacement manufactured by DePuy. He chose this particular model because of its expected durability – the hip replacement was supposed to last approximately 30 years. After undergoing the procedure and a grueling six-month recovery, the man expected to lead a normal life with no need for additional hip surgery. He was wrong.

DePuy Hip Metal Poisoning Complications

Within three years, he experienced hip swelling and complications such as hair loss, skin rashes and brittle nails. Eventually, a DePuy Hip recall alerted him to the real problem: he was allegedly experiencing DePuy hip metal poisoning caused by the movement of his joint. Each time the joint moved, it shaved flakes of metal off of the hip replacement. These metal flakes damaged his muscles and caused joint inflammation.

DePuy Hip Lawyer Files Suit

This San Diego man is not the only one affected by possible DePuy hip metal poisoning. More than 90,000 people received this particular implant. An attorney representing several patients in a DePuy hip lawsuit contends that the company did not do enough research or act quickly when hip replacement recipients complained. The DePuy hip lawyer further explained that the metal-on-metal hip replacement was never tested in humans because of a Food and Drug Administration process that fast-tracks approval for implants similar to other approved implants.

FDA Demands Additional Data

On May 6, 2011, the Food and Drug Administration sent letters to the manufacturers of these hip replacement systems. The FDA ordered each manufacturer to conduct additional studies on hip replacements approved for marketing in the United States. The FDA explained that it needs more data to understand the complications associated with these systems. The agency also needs more information on metal ion concentrations in the systems.

Company Releases Statement on DePuy Hip Metal Poisoning

DePuy released a statement in response to the alleged complication of DePuy hip metal poisoning. The company is working with affected patients by covering medical costs directly related to the hip system recall. DePuy will also cover out-of-pocket expenses for lost wages, travel costs, co-pays and insurance deductibles.

Voluntary Recall Due to DePuy Hip Metal Poisoning Complaints

The company also reports voluntarily recalling the ASR hip system in 2010 after receiving new data from the UK National Joint Registry. The data showed that 12 percent of patients who received the ASR hip system had to undergo additional surgery within five years of the procedure. Thirteen percent of patients who received the ASR XL Acetabular system had to undergo additional surgery within five years.

Johnson & Johnson DePuy Hip Recall

Johnson & Johnson, a health care products company, has had near 1,000 lawsuits filed against the company for neglecting to acknowledge defects with their DePuy Orthopedics, Inc.’s metal-on-metal hip replacement implants. According to a Wells Fargo analyst, the lawsuit liabilities of Johnson & Johnson may accumulate to a total of $1 billion or more.

The high number of hip-joint lawsuits in Ohio has caused a federal panel of judges to consolidate the cases. As a result, lawyers of plaintiffs are proposing that the courts group the plaintiffs’ cases into a class – allowing the DePuy hip lawsuits to be combined into one.

Mass litigation at this level can bring multi-million dollar settlements and similar jury verdicts for plaintiffs. These long-running trials allow a DePuy hip lawyer to gather large sums of money through billed services.

Last year, Johnson & Johnson recalled their metal-on-metal hip joints after scientific data showed the devices wearing down or failing prematurely at alarmingly high rates. This was the first acknowledgement that DePuy had flaws in their product, as stated by a DePuy spokeswoman.

According to Johnson & Johnson, an estimated 37,000 patients in the U.S. and 93,000 around the world have received the recalled ASR (articular system replacement). A number of patients complained of pain, infections, or inflammation – these being the most common reasons for doctors performing revision surgeries.

The outcome of an ASR DePuy hip lawsuit depends on when Johnson & Johnson and DePuy learned of the defects with the medical device. Many DePuy hip lawyers argue that the company was warned in 2007 by an Australian medical device regulator of the numerous patient complaints.

John Coffee, a Columbia University law professor, said, “If you knew about the problem and didn’t recall the product for a year more, that tends to justify a higher award of punitive damages.”

DePuy stated they recalled the ASR system because of new findings from the database of England and Wales. The British National Joint Registry finished a study that showed the following:

• Between 12% and 13% of patients with the ASR System needed a second hip replacement within 5 years of the original hip replacement surgery.
• 1 out of every 8 hip replacements with this implant system will have a total failure and an even greater number may experience hip replacement problems less than a failure requiring a revision surgery.

The spokeswoman for DePuy reassured that the ASR system was believed to have low amounts of problems or replacements until the British study was released. In August 2010, DePuy Orthopedics, Inc. announced a DePuy hip recall.

DePuy Hip Recall Spurred by High Failure Rate.

Johnson & Johnson subsidiary DePuy Orthopaedics began marketing its metal-on-metal hip replacement system in 2005. The FDA granted a special clearance for the ASR XL Acetabular System before any clinical trials were performed to determine the product’s safety. After receiving several hundred complaints about the unit between 2008 and 2010, DePuy began warning patients and doctors about the abnormally high rate of failure. Nearly one in eight recipients experienced any of a variety of problems requiring what DePuy called “revision surgery.” With such a high percentage of patients having to undergo a second surgery, a DePuy hip recall was likely.

Numerous Maladies Associated with DePuy Hip Recall.

The DePuy hip replacement system has undergone much criticism for failing components. The hip replacement unit has been said to become loosened and improperly aligned, which can cause infected hip joints, metal sensitivity, fractured or dislocated bones, and chronic pain. Other issues which may have contributed to the DePuy hip recall included bone staining, necrosis and increased metal ion blood levels. Damage also may occur to nerves, muscles and tissues. Even the revision surgery to remove the DePuy hip can be dangerous—complications have been cited in patients due to small fragments of the original unit left behind in the joint.

Official DePuy Hip Recall — August, 2010.

After months of adverse DePuy hip replacement reports, DePuy finally announced a recall of their ASR XL hip replacement system on August 24, 2010. The five-year failure rate was determined to be 13 percent, based on data gathered from an implant registry in Australia. Prior to the recall, DePuy claimed to be phasing out the unit due to a lack of sales. Parent-company Johnson & Johnson had endured recall problems earlier in 2010. Three years prior, DePuy was involved in a scandal involving payoffs to doctors.

After the DePuy hip recall, the first DePuy hip lawsuit was filed. With over 93,000 units in use, and a thirteen percent failure rate for such devices, Johnson and Johnson may easily see several thousand lawsuits filed. For these lawsuits, a DePuy hip lawyer will likely claim that DePuy knew the design of its devices was flawed and did not correct it after they became aware of the problem. The lawsuits will likely also claim that DePuy failed to notify or warn doctors or patients of the potential problems.

If you or a loved one has suffered an injury that may be related to the use of the DePuy hip replacement system, you should contact Chaffin Luhana LLP immediately for a free and confidential case review today. You may be entitled to compensation, and the lawyers at Chaffin Luhana can help. Call our toll free number today for a free, no-obligation case evaluation: 1-888-480-1123.

A DePuy hip lawsuit seeks to hold DePuy Orthopedics legally and financially responsible for manufacturing a defective hip replacement product, failing to warn patients and doctors of the defective aspects of the implant as well as negligence in the design, manufacture and selling of the product.

About the ASR DePuy Hip Recall

The ASR Hip Replacement System was approved in 2005, and malfunctions in the system began gaining notoriety in 2007. There were a reported 100 patients experiencing problems with the device in 2007. In 2008, this number doubled, and in 2009, it tripled. DePuy Orthopedics, Inc. issued a recall of its ASR Hip Replacement System on August 26, 2010. The recall occurred because a greater number of patients required a second surgery due to pain and other symptoms caused by the defective product, and is often the subject of DePuy hip lawsuits. Some of the symptoms of the ASR Hip Replacement System include:

• Loosening detachment of the implant
• Dislocation of the implant components
• Fracture of the bone around the implant

DePuy Hip Lawsuit Precursors

The ASR Hip Replacement System is identified as a metal-on-metal bearing joint-replacement system. This type of system can lead to the creation of debris through regular wear and tear. That debris leads to inflammation as well as tissue damage and other complications, the basis of DePuy hip lawsuits.

An agency in the UK in charge of medical device regulation issued a warning about the debris being caused by the DePuy hip replacement system in March 2010. DePuy then began warning physicians of the possibility for a higher than normal rate of implant failures. Statements from prominent orthopedic surgeons appeared in articles stating, “most major medical centers have seen issues with this device.” The National Joint Registry of England and Wales completed a 2010 study that showed the following:

• 12% of ASR Hip Resurfacing System and 13% of the ASR XL Acetabular System needed a second hip replacement within 5 years of the original hip replacement surgery.
• 1 out of every 8 hip replacements with this implant system will have a total failure and an even greater number may experience hip replacement problems less than a failure requiring a revision surgery.

Starting a DePuy Hip Lawsuit

If you or a loved one has suffered an injury that may be related to the use of a DePuy hip, you should contact Chaffin Luhana LLP immediately for a free and confidential DePuy hip lawsuit case review today. You may be entitled to compensation through a lawsuit, and a DePuy Hip lawyer from Chaffin Luhana can help. Call our toll free number today for a free, no-obligation DePuy hip lawsuit case evaluation: 1-888-480-1123.