Articles Posted in Medical Devices

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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 this will increase to 4 million patients because of 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 were 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 a 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% of patients), it is a serious complication associated with these devices. Metallic debris can occur because of malpositioning of the implant, subluxation, or jamming of the femoral head.

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DePuy issued a U.S. recall of its metal-on-metal ASR hip implants in August 2010 (after 93,000 implant procedures) because of an extremely high failure rate requiring patients to have revision surgeries. The evidence so far shows that the device is exceedingly difficult for orthopedic 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.

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Brain stents, which are used by cardiac surgeons to open up a blocked artery and are designed to prevent strokes in high-risk individuals, may paradoxically and tragically actually increase the risk of stroke and death. How much more? According to a recent New England Journal of Medicine article, patients receiving brain stents were found to have twice the rate of strokes and death compared to those without brain stents. The risks became so apparent that the National Institute of Neurological Disorders and Stroke called off enrollment in a clinical trial.

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Bloomberg ran an interesting article yesterday that raises the issue of whether there should be a vaginal mesh recall. There is a lot of data coming out now that supports the idea of a recall. At some point, these pharmaceutical companies need to cut their losses and not only stop making these vaginal mesh products but also recall the ones that are already on the market.

New information continues to underscore what is becoming increasingly obvious: these surgical implants are unsafe. The FDA is starting to get wind of this fact, and last month expressed more concerns about the risks of transvaginal surgical mesh used to treat pelvic organ prolapse.

This article also talks about the issue moving forward: how these defective mesh implants came on the market in the first place. As it should, it takes a long time to get approval to put new drugs and medical devices on the market. But the FDA has a loophole called the 510(k). This process is a backdoor through the approval process companies usually have to go through to get a medical device on the market. It allowed vaginal mesh manufacturers a free pass on proving their product was safe and effective since it is “substantially equivalent” to others already for sale. One problem with this loophole: the definition of “substantially equivalent” is ever-expanding. The FDA is finally catching on to this. Later this week, the FDA will gather more opinions from doctors and researchers as to whether we need to rewrite 510(k) to make it harder to get untested products on the market.

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The Accident Injury Lawyer Blog has a post on the latest chapter in the alcohol swab recall debacle.

Alcohol swabs are probably the last thing you expected to cause a risk to your family. People using over-the-counter alcohol swabs are often dealing with something serious like to clean off their vial of insulin to treat diabetes. There have been at least 7 deaths linked to this alcohol swab recall that never would have happened if the manufacturer was following just basic principles of safety. Just tragic.

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The C.R. Bard Avaulta vaginal mesh lawsuits allege that mesh surgically implanted to treat pelvic organ prolapse may be defective. As a result, an unbelievable number of women are at risk for internal injuries and urinary problems.

The FDA recently expressed an even graver concern that the placement of surgical mesh through the vagina to repair pelvic organ prolapse may expose women to greater risks than other available options.

Bard Avaulta mesh lawsuits allege that the defective design of the mesh implant may increase the risk of infection, erosion, and other painful complications. Plaintiffs’ lawyers are bringing lawsuits against C. R. Bard, Inc., which makes and sells Avaulta Plus and Avaulta Solo synthetic surgical mesh tissue supports, and a host of other manufacturers.

These lawsuits are multiplying quickly. But there are a lot of women who are not going to bring a vaginal mesh lawsuit because they perceive a privacy invasion. This is understandable, but it underscores a general misconception about what a claim will entail.

These are national mass tort cases. Frankly, mass torts are rather impersonal and are handled by national lawyers – attorneys you likely will ever meet. Many vaginal mesh lawsuits have already settled for pretty decent sums of money – life-changing for many people. In many ways, it is about filling out some paperwork and waiting and you always have the option of just dropping your case if you don’t like where it is going in terms of your privacy or your need to be involved in the case.

Ultimately, some women will read the preceding paragraph and say “I don’t care, I’m not putting myself out there in any way.” I can’t really argue with this. I’m just trying to provide the full context to potential clients.

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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 the diversity of citizenship – an Alabama resident on both sides of the “v” – that the cases should be remanded to Alabama.

Let’s be honest. The 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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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. Kinkeade 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.

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Nine plaintiffs filed a motion in the DePuy recall MDL saying that, for all 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 arguments 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.

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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 several 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.