DePuy Recall Info

DePuy Orthopedics recalls ASR hip implants

DePuy Hip Replacement Recall
Did You Or a Loved One Suffer From a faulty ASR hip implant?

August 26, 2010

DePuy Orthopedics pulls its ASR XL acetabular hip replacement and resurfacing system off the market due to a high rate of revision surgeries.

DePuy Orthopaedics Inc. is voluntarily recalling its ASR hip replacement system after receiving reports that a higher-than-normal number of patients required surgeries to correct or remove defective implants.

The Warsaw, Ind.-based Johnson & Johnson (NYSE:JNJ) subsidiary is pulling its ASR XL Acetabular and ASR Hip Resurfacing systems from the market "due to the number of patients who required a second hip replacement procedure, called a revision surgery," according to a press release.
"New, unpublished 2010 data from the National Joint Registry (NJR) of England and Wales shows a five-year revision rate of approximately 12 percent for the ASR Hip Resurfacing System and approximately 13 percent for the ASR XL Acetabular System," according to the release. "These revision rates are across the entire size range. The risk for revision was highest with ASR head sizes below 50 mm in diameter and among female patients."

DePuy said prior post-market evaluations showed lower revision rates and that "the ASR hip was performing in line with other devices in its class." President David Floyd said the orthopedics division will pay for doctor visits, tests and procedures associated with the recall," including revision surgeries associated with the recall.

The company is setting up a phone line for patients and healthcare providers to handle inquiries about the recall at (888) 627-2677, starting Aug. 27. The resurfacing system is not cleared in the U.S., but overseas patients treated with the system can call +1-813-287-1651, starting tomorrow.

Lawsuits over the ASR implant are piling up across the country, accusing DePuy of manufacturing a defective product, failing to warn patients and doctors of problems with the implant and negligence in designing, manufacturing and selling the product. DePuy, which introduced the ASR in the U.S. in 2005 after winning 510(k) clearance from the Food & Drug Administration, allegedly knew of design problems with the cup but failed to adequately warn physicians, according to the lawsuits.
DePuy discontinued the cup and had phased it out by March of this year, sending a letter to doctors that month warning that data from the Australian medical device registry showed a "higher-than-expected" failure rate in traditional hip replacements, especially in smaller patients or those with weak bones.

The ASR isn't the only DePuy hip product with problems. The FDA warned the company this week, saying it lacks clearance or approval to market its TruMatch Personalized Solutions System in the U.S. The warning letter also accused DePuy of improperly marketing its Corail hip system.

"Promotion of this device for osseointegration (a.k.a. osteointegration), whether explicitly or implicitly (for example, through fixation claims that imply osseointegration), represent a major change or modification in the intended use of your device that require a new premarket notification," according to the letter.

The federal watchdog agency warned Biomet Inc. last week about its personalized knee implant offering, also saying the Warsaw, Ind.-based firm lacks approval or clearance to sell the device in the U.S.

DePuy Orthopaedics Metal Hip Replacement Recall

DePuy Orthopaedics recently announced it was withdrawing the DePuy ASR hip replacement following approximately 300 complaints from people undergoing hip replacement. The ASR hip replacement is a metal-on-metal device believed to have a design flaw that has resulted in many patients needing follow-up operations to replace the device soon after implant. The ASR is considered by a number of orthopedic experts to be a defective and suits have been filed on behalf of individuals injured as a result of defective DePuy hip prosthetic implants.

If you or a loved one has had a hip replacement and required additional surgery, suffered infection or experienced failure of the hip implant, it may be due to use of the DePuy ASR System hip device. Your orthopedic surgeon can advise what device was used during your surgery. In addition, the hospital will often give you a card with the information regarding the make and model of the device implanted during your surgery.

DePuy Hip Replacement Recalls

DePuy Hip Replacement Recall

The DePuy ASR hip replacement device was recalled from the Australian market in December 2009 and from the US market in March 2010 after several hundred complaints from patients who needed costly and painful hip replacement surgeries within a few years of receiving the ASR implant. Individuals receiving the ASR hip prosthesis reportedly have a high failure rate and have an increased occurrence of requiring redo surgery compared with those whose physicians used other hip replacement devices.

DePuy Orthopedics, a division of Johnson & Johnson, announced in the latter part of 2009 its plan to phase out sales of the product worldwide by the end of 2010. By that time however the ASR had been implanted in thousands of people. Approximately 250,000 people in the US alone receive hip replacement implants every year and about one-third of those receive metal-on-metal implants.

In March, 2010 Depuy sent a letter to doctors saying recently analyzed data from Australia indicated a higher-than-expected failure rate than traditional hip replacement on certain types of patients. As well, the data showed that the risk was highest for patients of small stature, which would indicate women and patients with weak bones.

In May 2010 the London Times reported "The Medicines and Healthcare products Regulatory Agency (MHRA) in Britain announced an official review in April of some 40,000 hip replacements." " Doctors are now warning that metal debris originating from the defective implants can cause non-cancerous tumors, severe swelling and sinew damage."

 

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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