Metal on Metal FDA Advisory Committee Hearings

This is the interesting story of a woman who scheduled to speak today to an FDA advisory panel hearing looking into the problems of metal-on-metal hip-replacement systems. The woman’s husband has a hip implant and is one of the thousands of plaintiffs who have filed a lawsuit against Johnson & Johnson’s DePuy Orthopedics division claiming its metal-on-metal ASR hip system was defective.

You can read the article here.

Did Johnson & Johnson Knowingly Sell Defective Hip Replacements?

Though widely hailed as breakthrough medical devices when they first came onto the market, experts are now recommending that patients avoid them. The onslaught of problems (which seems to span all metal hip implants, regardless of manufacturer) is one reason that Johnson & Johnson has been phasing out their DePuy ASR implants. Of course, the phase out allows a manufacturer to retire a device gracefully, despite the fact that a full-blown hip implant recall is warranted in these cases.

What did Johnson & Johnson (DePuy) Do Wrong To Cause Hip Implant Injuries?

As the authors of the British Medical Journal The Lancet said, the problems with metal hip implants that surgeons have discovered, could have been determined with adequate pre-market studies and regulation. If Johnson & Johnson did their homework, there would be a lot fewer people with these hip implant problems. The reality, though, is that a medical device manufacturer always makes more money by sending a defective device to the market than they do by canceling a project.

In 2009, the FDA told Johnson & Johnson that it was rejecting the DePuy ASR hip resurfacing system. That letter went one step further by telling Johnson & Johnson that all of the DePuy metal-on-metal implants were suspect because of metal poisoning problems (See Hip Device Phaseout Followed FDA Data Request, New York Times). Regardless, these implants are still being implanted into patients.

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Problem with Metal Hip Replacements

It is easy to forget what a rarity hip replacement surgery used to be. Today, people with artificial hips are ubiquitous. Direct costs of hip and knee replacements exceed $35 billion in the United States. More than 285,000 hip replacements are performed annually in the United States and it is projected that total joint replacement will increase to 4 million patients annually due to the aging population. Until very recently, hip replacements have been applauded as a wonderful, revolutionary way to get people back on their feet with less or no pain. But with this revolution came medical device makers looking to make as much money, and get as much market share, as possible.

The temptations for hip makers was extraordinary. Hip replacement surgery may be recommended in cases where hip pain limits daily activities, continues while resting (night or day), limits the ability to move or lift the leg, or in cases where pain relief is not provided by physical therapy, walking supports or anti-inflammatory drugs. Hip replacement surgery has a high rate of success, due to improvements in surgical techniques and technology. Total hip arthroplasty (total hip replacement) involves removing the damaged bone and cartilage and replacing it with prosthetic components. These components did not come cheaply but health insurance companies readily admitted that this was the appropriate treatment for people with compromised hips.

Though many hip replacement surgeries are successful, there is risk for infection, failure, and other adverse effects. Concerns have been raised in peer reviewed publications relating to metallosis, the build up of metal debris in soft tissues or blood. Reports are generally restricted to metal-on-metal devices, or those constructed with acetabular polyethylene liner. Metal-on-metal devices often contain cobalt or chromium. Although the occurrence is rare (occurring in approximately 5.3% patients), it is a serious complication associated with these devices. Metallic debris can occur due to malpositioning of the implant, subluxation, or jamming of the femoral head.

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One Year After U.S. and Australian Recalls of Hip Implants, Australia Demands that DePuy Help Victims

DePuy issued a U.S. recall of its metal-on-metal ASR hip implants in August of 2010 (after 93,000 implant procedures) because of an extremely high failure rate requiring patients to have revision surgeries. Evidence so far indicates that the device is exceedingly difficult for orthopaedic surgeons to implant properly. For background on the DePuy saga, see prior DePuy Drug Recall Lawyer Blog entries.

The hip implant was withdrawn from the Australian market in late 2009. DePuy (a subsidiary of Johnson & Johnson) told the public in the U.S. shortly thereafter that it was phasing out the implant because they were “focusing on newer technologies.”
The Australian Senate likened these hip implants to “ticking time bombs.” They want a system put in place to monitor adverse outcomes for hip implant patients, and they want to make sure doctors and patients are aware of the problems they may be facing. Most importantly, they want to make sure implant patients are continually monitored for future problems.

The medical monitoring program would help people to be regularly evaluated for metallosis, blood poisoning caused by metal fragments from the implants. So far, 430 out of 5,500 Australian patients have undergone a second surgery because of the faulty implant—that’s almost a ten percent failure rate. The real number is probably higher—many patients may be in line for that surgery, and experts believe that many more installed devices will fail within about six years of implant.

If you have had a DePuy ASR hip implant, and you are experiencing problems or have had to replace the implant, contact us at 800-553-8082 or get a free online consultation.

Sources: Sydney Morning Herald

Where Are DePuy Hip Implant Cases? New Opinions from MDL Judge in Ohio

The vast majority of DePuy hip replacement lawsuits will – if they go to trial – be tried in the states where the surgeries occurred (excluding bellwether trials and state court cases). But the discovery of these DePuy cases is consolidated in Ohio. That means for now, every federal court case sits in what is called an MDL in Ohio.

Some DePuy plaintiffs’ lawyers, for various reasons, do not want to wait on the slow pace of the MDL in Ohio. A number of cases that were transferred from Alabama have named a sales representative from DePuy/Johnson & Johnson as a defendant. Plaintiffs’ lawyers claim because there is diversity of citizenship – an Alabama resident on both sides of the “v” – that the cases should be remanded to Alabama.

Let’s be honest. Plaintiffs’ lawyers would not have named this sales rep if he was not an Alabama resident. The DePuy lawsuits are clearly not about a sales rep. Still, that is not the litmus test as to whether the joinder is fraudulent. In fact, the burden for the defendants is quite high. To keep these Alabama cases in the MDL, DePuy was required to meet the difficult burden of showing either “(1) there is no possibility the plaintiff can establish a cause of action against the resident defendant; or (2) the plaintiff has fraudulently pled jurisdictional facts to bring the resident defendant into state court; or (3) there is no real connection between the claims against a diverse defendant and those against a non-diverse defendant.

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DePuy Pinnacle Hip Implant Recall MDL

On Monday, a U.S. Judicial Panel on Multidistrict Litigation assigned all DePuy Pinnacle hip implant recall lawsuits pending in federal courts nationwide to Judge James E. Kinkeadein in the U.S. District Court for the Northern District of Texas.

The whole idea of the MDL process confuses victims? Are the DePuy claims a class action lawsuit?

The answer is the DePuy hip claims are “sort of” a class action lawsuit. The federal cases will be consolidated in Texas for what is called core discovery – interrogatories (written questions) to DePuy, depositions of key DePuy witnesses and experts on both sides, and other discovery procedures to determine the facts of these lawsuits. Typically, the MDL judge may preside over a few trials to help both sides better understand the value of the cases. If there is not a global “class action settlement” at that point, the cases are sent back to their home state for specific discovery and trial.

What is the settlement value of these DePuy hip implant cases? Anyone who answers this question definitively is not being entirely honest – at this point, no one really knows. But DePuy/Johnson & Johnson have set aside almost $1 billion to pay these claims and, ultimately, I don’t think is going to cover it. Many of these cases have trial values that are worth millions of dollars. So are high six figure and seven figure DePuy settlements likely? I think so. But only time will tell.

Do you have a DePuy Pinnacle hip implant? Get more information at 800-553-8082 or get a free online consultation here.

Latest Depuy Hip Recall Lawsuit News

Nine plaintiffs filed a motion in the DePuy recall MDL saying that, for all of the legal nuances, “Hey, keep us out of the MDL because we are getting old and don’t want to wait forever for this.” The MDL panel judge said that while she appreciates the concern of plaintiffs of advanced age and their desire for quick resolution of these lawsuits, these argument should be taken up by the transferee judge, who is “invested with wide discretion to structure pretrial proceedings to accommodate the needs of all parties” to the Depuy lawsuits.
You can read the order here.

DePuy Hip Lawsuit Pile On

Everybody wants in. You can’t do a search on Google without finding 20 lawyers looking for recalled DePuy hip replacement cases. It is pathetic. (Oh, now that you mention it, you can find some pandering from us here.)

Anyway, the fund that manages health benefits for a number of towns in New Jersey has filed a class action lawsuit against DePuy Orthopaedics over its ASR hip implant recall. The fund accuses DePuy (Johnson & Johnson) of fraud and unjust enrichment, alleging DePuy knew its hip implants had problems and left them on the market, ostensibly hoping no one would notice (no one did for a while, actually).

In other words, their lawsuit mimics the language of virtually every DePuy hip replacement lawsuit.

DePuy Recall: J&J Sets Money Aside

Johnson & Johnson’s fourth-quarter profit fell 12% and projected lower than expected earnings in 2011. One big reason: J&J recorded a $922 million charge for the cost of defending and paying claims in the DePuy ASR hip recall lawsuits.

I don’t think $922 million is going to be enough to cover the Depuy and Pinnacle hip lawsuits. But it does give an indication that J&J is starting to put money aside to deal with cost of the recall.

If J&J wants to increase profitability, it has to get back to the basics of making great products. It is easy to forget, J&J was once the gold standard in the industry. It has a long way to dig itself out of the hole it created.

DePuy Class Action Lawsuit, Part 2

History tells us that it is not the crime but the cover-up that often causes the most damage. In drug and medical device cases, there is usually a Nixonian leitmotif: what did you know and when did you know it with respect to the potential harm caused by the drug.
Last month, another DePuy class action lawsuit was filed. The claim is an interesting cover-up allegation. The class action claims that after the DePuy ASR recall, the company deceived patients by agreeing to make things right and in exchange, getting access to hip recall victims’ medical records. Of course, making things right is relative. DePuy has essentially promised victims nothing in exchange for something, which is the essence of this class action lawsuit.
This byproduct DePuy hip recall lawsuit is probably a sideshow to the core of these hip implant lawsuits. Rummaging through plaintiffs’ medical records while pretending to promise them something in exchange is awful. It is a clear end run artifice designed to fool plaintiffs into believing they don’t need a lawyer. But the compensation for this inappropriate conduct pales in comparison to the real injuries that stem from the DePuy ASR hip recall. But this class action lawsuit underscores that people are mad and DePuy is not making things any better by not playing it straight with victims.
If you have a potential DePuy hip implant lawsuit, call 800-553-8082 or get a free online consultation.