Articles Posted in Medical Devices

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Bloomberg ran an interesting article yesterday that raises the issue of whether or not 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 the 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 reached a settlement 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 are going to 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 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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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.

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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.

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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 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.

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With all due respect to Ted Frank, the Drug and Device Law Blog is making a mad run at the all time lead for snarky comments about plaintiffs. I’m a traditionalist; I would like to see a playoff.
Here’s the latest open-ended, unexplained jab at plaintiffs made in a comment about a federal judge’s ruling in the Kugel hernia mesh cases:

The court rejected defendants’ motion to strike plaintiffs’ experts, who were an assistant professor of surgery at Harvard Medical School and a long-time professor of bioengineering and orthopedic surgery research at the University of Pennsylvania. We don’t see many plaintiffs’ experts with those kinds of credentials, and their credentials and experience appear to have persuaded the court to overlook an otherwise shaky foundation for their testimony.

Really? Where is the evidence/argument you refer to that this federal judge was overwhelmed by the experts’ credentials? I’m fine with anyone taking this position – who knows, maybe they are right – but how about offering a fact or two to support your position. If you are unabashedly committed to taking the defense position on every issue, it is a little hard to jump all in based on unsupported analysis.

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Stryker’s CEO Stephen MacMillan was on Squawk Box this morning talking about the President’s speech and Stryker’s recent boost in profitability. He looked like a nice guy, he really did. I was on the treadmill so I did not get what prompted the joke but in response to something Joe Kernen said, MacMillan said that next time he would bring with him a really good hip replacement (or words to that effect).
The comment underscored to me how in the world of big business, litigation is just one piece of a very large puzzle. I would think MacMillan would be a little more sensitive about the fact that just a few years ago they had to recall Stryker hip implants to the point where he wouldn’t have thought it a joke. But Stryker has settled most of those cases and clearly moved past it.
I don’t know what my point is, really. I’m not even saying the joke was inappropriate. The whole thing just struck me as odd.

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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.