Articles Posted in Medical Device Manufacturers

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Last month, a group of plaintiff’s filed a motion requesting that all federal Mirena IUD lawsuits be consolidated into an MDL. The defendant, Bayer, is fighting this motion.

The technical definition of an MDL is a “sort of a class action.” Okay, maybe not so technical.

But the nutshell is that this type of coordination allows the cases to be combined before one federal judge for the purpose of common discovery. In this instance, all product liability lawsuits filed against Bayer over the IUD would be transferred to one U.S. District Judge for coordinated handling during the pretrial proceedings.

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In the past few years, orthopedic surgeries to replace failing body parts have become incredibly common. We live active lives, and damage done to our joints in high school sports, skiing, running, and other outdoor activities is, incredibly, correctable using modern technology and science.

Problems With Zimmer Hip Replacements

Zimmer’s Duron Cup hip replacements are one type of metal-on-metal implant that has been making the news as causing problems for patients. We’ve seen evidence of problems with other metal device manufacturers, including DePuy, Wright and Stryker.

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New Jersey has rejected Zimmer request to consolidate 10 NexGen Flex knee litigation lawsuits in New Jersey.

Typically, the medical device defendant will try to avoid consolidation as Zimmer did in the MDL. Here, they made the opposite argument: centralizing the New Jersey lawsuits would help streamline discovery.

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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 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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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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There have not been any medical device recalls announced by the FDA since early June. This is a good thing. But there are a lot of silent recalls when a product is taken off the market because sales are crashing in response to all of the reasons why there should be a recall in the first place.
From a plaintiffs’ lawyers’ standpoint, the best cases to try are those cases where a bad product was given a soft recall but the product is left on the market until the shelves clear. Defense lawyers are not racing to the courthouse steps to try these cases and they usually settle in the highest value range of a mass tort settlement (or the plaintiff opts out of the settlement and gets a higher offer later).

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I hate spam. A lot of folks had comments about their Zimmer knee replacement but I did not see them in the midst of so much spam. I went back today and found a lot more comments. They are all published now here.

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DePuy’s president resigned yesterday. What does this mean for settlement of the DePuy hip replacement lawsuits?

My question is: who replaces him? If it is someone outside of DePuy, it increases the likelihood the DePuy hip lawsuits settle faster. Why? It is always easier to accept the pain that comes with settling cases when you were not the person on the line making the decisions that caused the problems in the first place. Would a new DePuy president from outside of the company – outside DePuy, not necessarily J&J – be more inclined to pay a reasonable settlement value on the thousands of hip implant cases that are out there? Of course.

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In an article about what the FDA does not tell you, Smart Money tells us that 90% of medical devices approved by the FDA go through what is called a “510(k)” which allows device manufacturers to skip testing a device before putting it on the market if there is already a “similar device available.”
I’m not saying necessarily that every medical device that has the slightest modification should have to jump through the full FDA approval process. I think few people are really saying that. The question is simply where do we draw the line and it seems fairly clear that we are drawing it in a way that makes it far too easy on medical device manufacturers.
The FDA recently took a shot at making the 510(k) device clearance process “more predictable and smarter” but has not made any real progress. Again, I understand their trepidation. We want to get products with slight improvements on the market quickly. I just think we have to (1) better define what qualifies for 510(k) and (2) intensify the requirement – something in the middle of full blown testing and “bring it on through.”

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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.