IVC Filter Safety Concerns: What Patients Need to Know About Medical Devices
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Greg Vigna, JD, MD | Vigna Law Group 8939 S. Sepulveda Blvd. Suite 102 Los Angeles, CA, 90045 817-809-9023 | vignalawgroup.com
Ben C Martin | Ben Martin Law Group 3500 MAPLE AVE. SUITE 400 DALLAS, TEXAS 75219 (214) 761-6614 | bencmartin.com
TRANSCRIPT:
B: I'm Ben C
V: I'm Doctor V
The Medical Legal Guys
B: Let me ask you this. So what now should happen with regard to what company should I gather that they ought to use a better product? Right.
V: That's a good point. This is brutal. Okay. That we have devices on the market. Okay. But the device is not getting studied. 1 to 1 against the inferior catheters, because the manufacturers of these inferior catheters are not going to agree for a study against the better catheters. You see, what I'm saying is that you're not getting the studies.
They're doing studies to show this and that. But the big question is a new technology, old technology study. This shelved the old technology, move forward, improve. From there we're stuck. We're stuck here. And it's sad.
B: You know, maybe here today should be on what leads a company in what leads the public to have knowledge of and what leads the scientist to determine that something is safer than something else. That particular disease or condition is caused by a product or particular pharmaceutical, a particular medical device. These are determinations that they don't just come out of the air.
People can't just guess at it and be accurate unless it's just totally about what doctor V, how do people and how to researchers go about determining what is the cause of a problem and what is a solution to a problem.
V: Ben, you know, you're the co-lead of the IBC litigation and that is to go, this sounds to the Cook Pharmaceutical. I was involved in a lot of that discovery in the select IVC filter was one of the worst devices on the market, because it had a tendency to perforate. And when that device perforated the IVC, then it would fracture and that device had horrible complications.
The company, Cook Pharmaceutical, they knew all the complications. And while they kept the bad device on the market without telling doctors, they devised a safer, alternative design to fix the problem of this device. That is what is supposed to happen. But you're supposed to study this device before it gets on the market so it doesn't get on the market.
Right. And in this situation, cook pharmaceutical. Medical. Cook medical. Sorry. Yeah. Medical out of Indiana. What they did was they had a problem. They fix the problem which they should have. They should have taken this device off the market. You know, they should have said, hey, this device is a bad device. We're sorry. We're going to pay for our sins.
Instead, they kept this device on the market. They introduced the better device. They kept this device on the shelves, didn't tell doctors, and they let doctors continue to use the inventory on the shelf.
B: Knowing that it had the perforation problem that the newer problem didn't have in as great of an incident.
V: Yeah. So, Ben, you know, our work, your work, you were the head lead in this IVC litigation. I was just kind of the guy who was looking at the documents. And this device, the IVC filter, would go in the vena cava of patients. And for a purpose of preventing blood clots that generally start in the legs to travel up into the lungs and cause death by way of pulmonary embolism. So this device was to prevent serious problems, including death. And the problem with this filter, it goes into the IBC and it looks like a wire kind of right. You've described it in trial. You describe.
B: So we don't see the picture. It's like a badminton, a smaller version of a badminton,, about three inches tall, two and a half, three inches tall in height. And it's an upside down badminton in, in it's fed up into the vena cava. The largest vein in the body. And what it's supposed to do is catch blood clots. If they go from the lower extremities to up towards the lungs and heart, which can be dangerous, not a problems with them. And we found out that they actually don't work.
V: It would go sometimes into the spine. It would go sometimes in the pancreas. It would sometimes go into the small bowel heart theorta. And it was a perforating device and it was narrow perforating machines. Pretty good word for it. Yeah. And so the work that Ben did, you know it got published in the Annuals of Internal Medicine about how this company got the device into the market by having data that's supported, it's approval by the FDA.
Right. That's how devices can get on the market because they aren't studied properly. But when they're on the market, in the market and they're safer alternatives, those safer alternatives should always be worked on and advance to the public. And we're not seeing that because of cash cows.
B: You need to tell doctors, you need to tell the patient so that they have a fully informed decision on whether or not to undergo placement, by inferior vena cava, filter and IVC filter or any of the other products. We get back to the PIC lines, we get back to the port catheters. If there's a safer alternative, use it.
And if you're not going to use it, tell that patient, tell that doctor a bad product. And if you're not going to sell the the good product, tell him, tell the doctors, tell the patients, you know, this isn't the best product for you. And let's see then what happens when you tell them.
V: It should come from the company.
B: The company has more knowledge and the ability to have more knowledge than anybody. They're the ones that are developing the product. They're the ones who have the best knowledge, the most knowledge of the studies that go into the determination as to how to manufacture the product, how to make the product the best product, how to use the best materials and put it all together.
Then they they use those studies, the experiments, the research, animal studies, the human studies, all of those things go together to get product on the market. If the product is safe, right, safe and effective and IVC filter, not only are they not safe, they're not effective.
V: You know, there is some litigation that doctors have turned their, their back on. And for example, in the mid urethral sling litigation, the ultimate device that we have a case in Chicago where we are suing a implanting doctor who caused a serious injury, neurological injury. And he failed to remove the device after it caused injury because he believed in the device.
Okay. So we're suing the doctor for failing to remove a device in a timely fashion on a woman who was severely injured. And, we're suing the manufacturer because the device has significant problems. And this doctor, we took his deposition a few weeks ago, and he refused to sign the confidentiality agreement, which would have allowed him to see the information that we gained through discovery, that he has never been told about the dangers of the device.
And he refused to look at the internal data from the company on why this device causes pain, and why this device causes pain and frequencies that are unusual. So, you know, doctors have some responsibility in this mess. What's your thoughts on that case?
B: The fact that a doctor has the opportunity, you know, doctors usually want and doctors always need the most information, the best information, the most detailed information and some broad information. Every bit of information on a product that a doctor is putting in a patient's body is good information. It's good information. And to just think of a doctor who refuses to look at the information basis amazes me.
That's what I think about at that particular case. That's what I think about that particular doctor. And that's what I think about the company, is they don't ensure that that doc gets the information and make certain that they're aware of it, because these are internal documents, right? We can't get into them because of confidentiality orders and all that stuff.But let me just tell you, internal documents will tell the story usually.
V: And in this trial that doctor is going to see some internal documents.
B: It'll be sitting there right there. And he's going to see him at trial whether he likes it or not.
V: And when they become public and we'll be able to show them everywhere, and we're going to be able to show the public what the company knew and what this doctor, what this doctor did not want to see. And just shameful doctors want to know the information on safe. That's how they make an informed decision in terms of risk versus benefits.
I have to believe that had he known that this is the pain generating machine that was implanted, that he implanted, that was causing serious injury, that he would have removed that device in a very timely fashion? Okay, instead of this woman having to go elsewhere. Yeah. And it's sad.
B: What we do is we represent folks who have been injured by medical devices and other products, and then we follow suit and we try cases.