Current Updates on the DePuy ASR Hip Recall

The DePuy ASR metal-on-metal hip implant was approved in 2005 by the FDA, but soon thereafter both DePuy and the FDA began receiving reports of adverse health events. Some believe that the much less rigorous 510(k) approval process which allows manufacturers to skip clinical trials could be at least partially responsible for the adverse health effects in the thousands of ASR recipients. Following a flurry of complaints, DePuy voluntarily recalled the ASR on August 26, 2010. At present there are approximately 4000 DePuy ASR lawsuits consolidated into an MDL in Ohio as well as a smaller mini-state consolidation in Chicago with approximately 600 plaintiffs and another in California containing 1500 or so plaintiffs. Since California is experiencing so many financial problems, the plaintiffs and their attorneys are expected to face problems in getting a trial setting.

The MDL, or multi-district litigation system is meant to streamline the litigation process, taking advantage of the fact that there are similar allegations from all plaintiffs made against the defendants—in this case DePuy and Johnson and Johnson. The first trial regarding the ASR was scheduled to begin in state court in Las Vegas in mid-December although it has been rumored the case settled prior to trial. Should this be true, it would be a positive precedent for all other ASR lawsuits to follow. The metal-on-metal design came about due to its ability to last significantly longer than the metal-on-ceramic or metal-on-plastic hip implants. Unfortunately, the metal-on-metal design allowed the cobalt and chromium ball and cup to shave off microscopic metal ions into the body, entering the surrounding tissues or even the bloodstream. The FDA recently held a two-day panel to discuss the safety of the metal hip implant. 

 Soon after the metal-on-metal ASR hip implant was FDA approved, as many as 40% of surgeons were using it in their patients who required hip implants. Once the adverse reports began coming in only about 16% of surgeons were implementing the all metal hip implant in 2010 and the recent numbers show that fewer than 10% of surgeons are choosing to use the metal-on-metal hip implant model even though there are many brands out there other than the ASR. While the final failure rate of the ASR has not yet been established, it is believed that half of all the implants will fail within the first six years—a number that is easily four times the rate stated by DePuy at the time of the recall. One well-known orthopedic surgeon puts the numbers even higher—80% failure rate at eight years following the initial hip implant surgery.

There are an estimated 93,000 recipients of the ASR worldwide with 43,000 of those in the United States alone so the problem is a staggering one. Corporate e-mails which came to light during the discovery process strongly suggest that DePuy held off recalling the ASR for several months in order to sell as many of the defective implants as possible. While the ASR hip replacement system was initially discontinued, there were still significant amounts of inventory on medical shelves around the world. A recall is implemented so this unused inventory can be retrieved, barring it from implantation but the prolonged period of time DePuy waited between the discontinuation and the actual recall leads one to wonder whether they were hoping the problem would simply go away quietly.

Of the 43,000 United States recipients of the ASR hip implant approximately 6,000 have come forward to join in the lawsuit against DePuy and Johnson and Johnson. You may wonder about the other 37,000 ASR patients. It is believed that some of these people simply have not heard about the recall while others are elderly and believe their symptoms are related to aging rather than metal toxicity or failure of the implant. Still others may feel they cannot enter into a lawsuit against DePuy unless they are currently having medical issues related to the implant.

Andrew Sullo, Class Action Lead Counsel & Managing Partner at Sullo & Sullo wants to reach out to those 37,000 people and let them know how vitally important it is that they speak to an attorney quickly before the statute of limitations runs out on August 26^th. Those people may find to their dismay that a year from now or even two, three or five years from now when their ASR implant fails or they develop severe metal toxicity they are left with absolutely no legal recourse because they have neglected to maintain and protect their rights. They may be left with astronomical medical bills, lost wages during the six weeks to six months of recovery time, and could also end up partially or totally disabled.

Sullo calls this group “question mark clients” because they are currently experiencing no adverse symptoms from the metal implant. He stresses however that, “What this group of clients does have 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 Sullo & Sullo Law Firm has the expertise and the knowledge to provide that level of protection. Don’t wait—call today.