Below are some of our videos explaining the potential link between the use of Elmiron and maculopathy and other serious eye damage. To learn more about the types of injuries that have been linked to this medication, and the legal claims that have been filed, click Elmiron Lawsuits.
Bladder Drug Elmiron Found To Cause Permanent Eye Damage In Patients
Mike Papantonio: A bladder drug called Elmiron is causing serious and irreversible eye problems in patients. And I'm joined by Attorney Tim O'Brien, who is leading the fight against this whole problem. Thank you for doing that. Tim, first of all, tell us who makes Elmiron and what is it used for?
Tim O'Brien: So the drug is made now by Janssen, which is a subsidiary of Johnson & Johnson, and it's used for a condition called cystitis in the bladder. It's this painful bladder syndrome. So it's primarily given to women, not exclusively, but primarily given to perimenopausal women.
Mike Papantonio: Okay. And so the problems that we're seeing that you're identifying ... and again, I want to point this out, but for your efforts, this story may never be told. And so I hope viewers will listen very carefully. What did you find?
Tim O'Brien: Well, I had a former client of mine call me. I had represented her in Georgia. And she said, "I've got a doctor up in Emory who says I'm going blind because of this drug Elmiron. Will you take the case?" And nothing had been discussed about it in the literature at that point in time. And so I took it in, got her records together, and it turns out she was part of a major study that this researcher at Emory was putting together and was revealing that, yes, hey, once you get over about six months or nine months of taking this drug it actually damages your retina damages, damages your macula. And that's the part of the eye PAP that when you're looking out we've got lenses, and then in the back of the eye we've got things that make sense of all the light that's coming in. And so that part of the retina that focuses everything, that makes it all make sense to the brain, that's called the macula, and it was destroying the macula. So what happened to her and it's what's happened to thousands of other women.
Mike Papantonio: Okay. And so this is something that if this is a typical kind of case that you and I have probably handled so many of these cases, pharmaceutical, probably the clinicals gave some indication that there was a problem here.
Tim O'Brien: Yeah. The clinicals gave not only an indication of a problem, we're talking about the clinical trials that the FDA was reviewing, but not only was there a problem, but there was no benefit. These clinical trials that the sponsor of the drug put the patients through, two times the FDA looked at these clinical trials, said, "There's no benefit. There's no benefit at all." And so they let them backdoor some clinical use evidence, some actual not clinical trial evidence, but in the same time, all of these reports were starting to coming in about all kinds of adverse events, many of which were problems with the eyes.
Mike Papantonio: The FDA, again, that's the most dysfunctional government agency, maybe SEC, FDA, EPA, put them in a bag, none of them do their job. Is that the case here with the FDA?
Tim O'Brien: Yeah. It's like, remember the movie Bonfire of the Vanities, a Tom Wolfe novel-
Mike Papantonio: Sure.
Tim O'Brien: ... when instead a grand jury can indict a ham sandwich?
Mike Papantonio: Mm-hmm (affirmative).
Tim O'Brien: Well, the same is true of the FDA. I think the FDA would improve for marketing in the United States as a drug, a ham sandwich. If they approve this without any evidence of efficacy, their own reviewers said, "This is not an approvable drug," and the FDA approved it any way.
Mike Papantonio: Well, people get this notion, don't they, Tim, that the FDA is doing their own testing, that if the FDA approves it, it's going to be okay. That's so far from the truth, isn't.
Tim O'Brien: It is so far from the truth. You look at what has happened now, as hundreds of thousands of patients have been exposed to this, and in the clinical trials, they only studied about 125 patients who were actually taking the drug for a very short period of time. So really what we're seeing, and it's true in other cases, too, is unfortunately the American public is the clinical study patients, which means the American public are the guinea pigs. And now we're seeing what are the effects of taking the drug, and it's not good.
Mike Papantonio: Okay. So you have shown, I followed your career a long time. You have shown time after time that the only solution is to take him to court. And you've done that successfully. You've gotten black boxes put on products. You've had products taken off the market. You've made stories public that nobody else would know. Where does this fit into that?
Tim O'Brien: Well, glad to report after we first started filing our cases, Janssen did put a black box on the warning, warning about these vision loss changes. But it's not enough. Because if you think about the eyeball, it's kind of like the mouth, so much is happening with what you have to rely upon your eyeball for. So when you get this condition, this maculopathy in the back of your eye, I want you to think about looking at your wife, or looking at your car, or looking at your coworkers normally, and then you look at it through a sheet of cellophane. That's the beginning of the process. And then you look at it through a sheet of wax paper, that's the progression of the process. And then you try and look at it through a black piece of construction paper. And that's what's happening with many of these women who've taken this drug is they're having progressive vision loss, and even getting off the drug doesn't stop it.
Mike Papantonio: Wow, irreversible, huh?
Tim O'Brien: Irreversible.
Mike Papantonio: Tim O'Brien, this is a new one for you. I know you always do your job, I know you always get it done, but this is critically important. So many people have no clue, anything about this drug. Thank you for joining me, okay?
Tim O'Brien: Thank you, Pap.