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No alternative, feasible design for the 3DMax used as reason for denying judgement
I don’t want to turn this excellent and informative forum in to a lawsuit site. But I found a fascinating comment in a recent judgment in favor of Bard that, I think, shows that the device makers have very persuasive reasons to avoid developing better products. If they design a better product the better design can be used against them to show that their previous design was defective. It’s mind-boggling, if you sit and ponder it.
I think that change can only be driven by outside new aggressive medical device companies, with no significant past in the industry. The big device makers can’t justify, risk-wise, developing better products. They are financial businesses, not really medical organizations.
The absurdity of the situation almost hurts. The device makers have the means to develop better products but if they do they might destroy themselves. This is a very recent article, March 20, 2018. There is more worth reading in it. Fascinating.
“In the instant case, none of the experts specifically opined that 3DMax is defective and that this defective design caused the medical complications complained of by the plaintiff. Instead, plaintiff’s three experts gave general opinions about the various medical risks of the product that can cause complications. This is not enough to overcome the summary judgement standard,” the three-judge appellate panel wrote. “In addition, no expert presented an alternative, feasible design for the 3DMax. As previously stated, this is one of the determining factors in a defective design case.”
https://www.massdevice.com/bard-wins-3dmax-hernia-mesh-appeal/
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3 Replies
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quote Good intentions:In broad terms, the statement is saying that all mesh products are the same. There are many many alternative designs, but somehow the “expert” witnesses were not able to make that clear.The irony is that Bard markets its “alternative” design, the 3D shape, explicitly. 3D Max is the alternative, feasible design for flat mesh.
It’s one of the barriers to understanding why one out of six people will probably have chronic pain from mesh repair. Bard put a lot of time, money, and effort in to developing 3D Max as a “better”, different, product. Without understanding why these failures occur they just allow them to continue happening. Letting the courts classify all mesh products in to one broad category is not helping anyone, except Bard.
p.s. I don’t mean to seem argumentative. I’m just stating what I see. It’s a missed opportunity. Bard has a financial obligation to their shareholders to win these cases. But if they lose, the obligation turns to making a making a better product to avoid similar losses, which requires understanding the failures. It’s the great strength and weakness of our free market economy. Money drives progress.
I think it’s a little difficult to fully understand the failures given the large, and largely uncontrollable, variable of having different surgeons with different techniques and skill levels.
Whether mesh has a place inside the human body is irrelevant if the pain in question could just as easily be caused by how much mesh the surgeon used, what technique it was inserted with and how it was attached.
And if the pendulum swings back in favor of tissue repairs then perhaps companies like Bard will begin developing “special” Hernia sutures that have new and unique properties to them.
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In broad terms, the statement is saying that all mesh products are the same. There are many many alternative designs, but somehow the “expert” witnesses were not able to make that clear.
The irony is that Bard markets its “alternative” design, the 3D shape, explicitly. 3D Max is the alternative, feasible design for flat mesh.
It’s one of the barriers to understanding why one out of six people will probably have chronic pain from mesh repair. Bard put a lot of time, money, and effort in to developing 3D Max as a “better”, different, product. Without understanding why these failures occur they just allow them to continue happening. Letting the courts classify all mesh products in to one broad category is not helping anyone, except Bard.
p.s. I don’t mean to seem argumentative. I’m just stating what I see. It’s a missed opportunity. Bard has a financial obligation to their shareholders to win these cases. But if they lose, the obligation turns to making a making a better product to avoid similar losses, which requires understanding the failures. It’s the great strength and weakness of our free market economy. Money drives progress.
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I don’t think it’s that simple. Just developing a better design than the one you developed previously is called progress, and “well, we didn’t have that design back then” is a perfectly reasonable defense. I think that you’d have to show that a reasonable alternative design existed at the time of the injury.
The problem would come if a better design existed in theory, but had been scrapped due to cost, for example. Device companies have to continue attempting improvements, though, if for no other reason than patents have a limited shelf life and it’s important to bring out the “next” thing before the current one’s IP protections expire.
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