Thursday, July 26, 2012

Recent Developments in the DePuy ASR Hip Recall

At present there are some 4000 DePuy ASR lawsuits which have been consolidated into multi-district litigation in the U.S. District Court, Northern District of Ohio. Very recently a Utah resident added her DePuy lawsuit to the Ohio MDL—a system which exists to streamline the litigation process. In cases where similar allegations are made against a defendant, it becomes more expedient to combine the lawsuits into an MDL. As with many of the current plaintiffs, the newest addition to the MDL alleges that she developed metal poisoning after receiving a DePuy ASR hip implant in November of 2006.

There is a smaller “mini-state” consolidation in Chicago with approximately six hundred plaintiffs involved and another in California with an estimated 1500 plaintiffs. Due to the economic crisis in California, it could prove difficult to get a trial setting for those cases. An unpublished source contends a state case filing in Las Vegas is believed to be the first ASR set for trial and was coming up at the end of 2012. It is believed that that case has since settled which would definitely be a positive precedent for all the other ASR lawsuits to follow.

The DePuy ASR hip utilizes a metal-on-metal design which was implemented because of its ability to last significantly longer than the metal-on-ceramic or metal-on-plastic. However, the metal-on-metal design allows the acetabulum cup and the ball to rub against one another causing microscopic metal ions of cobalt and chromium to shear off and enter the surrounding tissue or bloodstream of the recipient. The DePuy ASR hip was approved by the FDA in 2005 through the 510(k) process which is a much less rigorous approval process which allows manufacturers to skip clinical trials which more fully determine safety. A mere five years later the ASR was recalled and very recently the FDA held a two-day panel to discuss the relative safety of the metal-on-metal design.

A survey taken in 2010 showed some 16 percent of surgeons chose metal-on-metal implants for their patients but it is believed that number is down significantly—to less than 10 percent—following FDA warnings and the August 2010 voluntary recall by DePuy. While the final failure rate for the ASR has not been established, it is estimated that as many as 49% of the implants fail within the first six years. This number is at least four times the rate cited by DePuy when the device was recalled. Dr. David Langston, an orthopedist who has studied the implants for years believes that failure rate will rise to a staggering 80 percent at eight years following the initial implant.

Although the numbers vary somewhat depending on the source, an estimated 93,000 individuals worldwide and some 43,000 in the United States were implanted with an ASR device prior to the recall in 2010. It is believed by some that DePuy held back on recalling the ASR for many months in order to sell as many of the allegedly defective products as possible since the units had already been produced. Considering the number of implants in the United States as compared to the approximately 7,000 plaintiffs who have entered into the lawsuits against DePuy there are still some 37,000 ASR recipients out there who have taken no action against DePuy. Many of these people may feel that since they are having no trouble with their ASR right now that it would be wrong to file a lawsuit which alleges damages.

Andrew Sullo, Class Action Lead Counsel & Managing Partner at Sullo & Sullo Attorneys at Law believes it is imperative that those who have received an ASR fully understand the consequences of the upcoming two year statute of limitations. Some twenty-six states operate under the two year Statute of Limitations, meaning that this August 26, 2012, will end that time limit. Then two, three or five years down the road should an ASR patient require a revision and they have neglected to maintain and protect their rights they could find themselves in a very difficult position. The ASR recipient who is forced to undergo revision surgery will endure significant pain and suffering, they will have a minimum of six weeks’ recovery time during which they will likely be unable to work and will either have to pay the full amount of medical expenses should they have no medical insurance or, at the very least, a portion of the those expenses.

Andrew Sullo stresses that even if you currently have no pain or adverse symptoms from the ASR he can place you in a group he calls the “question mark clients”—those who are currently experiencing no pain or adverse symptoms. “What this group of clients needs to know”, Andrew stresses, “is that after the Statute of Limitations expires and they begin to have a problem with their hip they need to be protected. They need financial protection, they need medical protection, they need pain and suffering protection.” The law firm of Sullo & Sullo is both prepared and eminently equipped to offer that critical protection.

Author: Sullo & Sullo Attorneys

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