DePuy ASR Defects

DePuy ASR Defects

A number of orthopedic doctors believe the DePuy metal on metal implant had a design flaw that made it difficult to implant properly, specifically that the component has a narrow window for proper placement. The design of the ASR cup is shallower than some similar devices, and believed to be the implant's problems.

The New York Times reported other problems associated with the DePuy metal on metal implant including the potential for generating large amounts of metal debris during normal wear and tear, which can negatively impact soft tissue and evolve into a health issue for some patients.

The ASR was approved for use by the FDA in 2005. However it was cleared through a regulatory pathway that did not require it to undergo clinical trials.

Some patients who were implanted with the DePuy ASR have developed ALVAL (aseptic lymphocyte dominated vasculitis associated lesion), which is an adverse tissue reaction to metal particles and ions, and pseudotumor (a soft tissue mass that may be the result of a toxic reaction to an excess of particulate metal wear debris).

More Concern about DePuy Metal-on-Metal Implants

London, UK: Much has been written about DePuy Orthopeadics implants and their potential for early failure due to an implied design flaw. Despite the fact that metal-on-metal hip implants are increasing in popularity and designed to last 15 years or so, early failures have prompted a recall of the DePuy hip replacement system known as the ASR cup. Since then there have been troubling allegations the DePuy metal-on-metal implant could be associated with non-cancerous tumors.

That's the situation overseas in the UK at any rate, according a recent report in the Sunday Times of London. The Medicines and Healthcare products Regulatory Agency (MHRA) in Britain announced an official review in April of some 40,000 hip replacements. Following review, it is expected that many implants will be replaced.

The Sunday Times reports that DePuy is one of the manufacturers involved in the potential replacement of hip implants in the UK.

So far, there has been no mention of potential non-cancerous tumor growth associated with defective hip implants in the US, but the UK reports are troubling—especially given the popularity of metal-on-metal implants and their promise of durability. While most implant procedures are carried out on older patients, the Times reports that eight percent of hip replacements involve people under the age of 55.

Doctors are now warning that metal debris originating from the defective implants can cause non-cancerous tumors, severe swelling and sinew damage.

It has been reported that younger women are particularly vulnerable to the effects of metal debris. Those at risk will have blood tests conducted to determine levels of metal compounds in the blood.

Even though it is phasing out the products subject to the safety concerns, DePuy issued an urgent safety notice back in March emphasizing that its products should not be used in "females of childbearing age" and admitting to "higher than expected" rate of implant removals.

The non-cancerous tumor concern goes back to a report released in January 2008—more than two years ago—when a report to the MHRA found "evidence of genetic damage in patients with certain metal hip implants."

A year ago, the Nuffield Orthopaedic Centre in Oxford published a study showing that women under 40 were at the highest risk of developing such tumors, associated with "soft tissue destruction." In a group of more than 1,200 patients who had hip resurfacing over an eight-year period, four percent required a further operation because of the reaction, described as "pseudotumours." The Nuffield study said 13 percent of women under 40 required a new operation.

Justin Cobb, professor of orthopaedic surgery at Imperial College London, suggested that the problem originated with the alignment of the two halves of the metal-on-metal replacements, adding that such procedures are generally effective. The adverse reaction was identified in only a small number of cases." It's like a Formula One car," he said in statement to the Sunday Times. "If you don't get the wheels perfectly aligned, you will shed them on the first lap."

The patients thought to be affected include those who have undergone full hip replacements involving metal-on-metal implants, or a resurfacing procedure where a metal surface is added to the top of the thigh bone and the hip socket is lined with metal. Following tests, those considered at risk will have their implants replaced.

In 2008, the year of the initial report to the MHRA, there were nearly 65,000 hip replacement operations, of which about 4,500 were full replacements with metal-on-metal implants. About 5,000 patients had metal-on-metal resurfacing operations.

DePuy nonetheless has stood by its product, pronouncing it as safe. "This is not a recall, as data about safety were not the basis for this decision," DePuy said in a statement.


Verdicts & Settlements

Scott has been involved in numerous and diverse settlements and verdicts throughout his 18 year legal career.  He prides himself on taking care of the injured people he represents.  Scott has represented individuals from almost every state in the country and can point to settlements involving millions of dollars. Whether it be a faulty medical device, a flawed manufacturing process, a failed prescription drug or some other issue that has caused personal injury, Scott has the experience, determination and the integrity to represent a client’s interests aggressively and see that justice is served. The following examples are but a few of recent notable accomplishments:

  • Hundreds of Scott’s clients from numerous states received monetary awards in the Silicone breast implant litigation. These cases involved defective leaking or ruptured silicone implants which caused significant injury, illness and/or damage to women who relied on the manufactures of the implants.  Scott worked with the women all the way through to verdict or settlement and was responsible for ultimately settling client cases for millions of dollars.

  • Scott represented clients in the Rezulin litigation which involved a drug used by diabetics. The FDA ultimately removed the drug from the market due to liver and cardiac adverse events. Scott was involved in hundreds of hours of document review and depositions in the U.S. and Europe.  He deposed corporate witnesses who designed, manufactured, marketed and sold the drug and his clients received exceptional settlements.

  • Scott and his partner Ed Blizzard were involved in representing hundreds of individuals who suffered as a result of defective Sulzer hip and knee implant replacement joints.  Scott and Ed worked at both the state and federal level and were instrumental in developing documents and deposing corporate witnesses so that ultimately a global settlement of all claims was announced.  Scott and Ed were able to secure millions in settlement for their clients.

  • Scott represented many clients who encountered problems as a result of the diet drugs Pondimin and Redux.  He was involved with discovery committees, reviewed thousands of documents and deposed many corporate witnesses.  He tried many of these cases to verdict receiving large settlements for his clients. In December 2000, Scott tried a case in Philadelphia for two ladies from Utah who developed heart valve damage after taking the diet drug combination known as Fen-Phen. After a two week trial the jury awarded each of his clients $100 million dollars. This $200 million dollar verdict stands today as the largest Fen-Phen valvular heart disease verdict in the country. Because of this verdict, Scott was inducted into the Million Dollar and the Multi-Million Dollar Advocates Forum.

  • Scott’s clients in the Ephedra litigation were compensated well for the damages they suffered.  These cases involved  products such as Herbalife, Dexatrim, Stacker and Hydroxicut that were associated with heart attacks and strokes. He was heavily involved in developing justification documents and taking corporate depositions that ultimately led to large dollar settlements for his clients.  

Most recently, Scott began working on Paxil birth defect cases. Paxil is an antidepressant still used by millions of Americans daily.  In recent years, however, it has been associated with significant heart defects when ingested by women during the first trimester of a pregnancy.  Scott has been actively prosecuting these cases against GSK, maker of the drug. One of his cases was the first to be set for trial.  The case was resolved in favor of Scott’s client.

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