However, one of the very popular diabetes medications in the marketplace has been found to have some fatal side effects. Ring of Fire’s Farron Cousins and attorney David Haynes discuss those side effects.
Transcription of the aforementioned video:
Farron: David, Invokana, a blockbuster diabetes type two medication, we are finding out now it has a lot of negative side effects, as often happens with some of these blockbuster drugs. Before we get into these, real quick, just give us a summary of what Invokana is specifically employed for so far as the identification and things of that character.
David: This is just another Johnson and Johnson product which has become extremely popular. They have put a lot of money behind it. It is a drug to take care of the control of diabetes, which of course is a condition that millions of people have. Diabetes has a lot to do with the acid levels in a specific individual, and this is an inhibitor of some of those issues and has helped to control the diabetes difficulties, but what we are seeing is again, with real security concerns with Johnson and Johnson being elevated, and very serious concerns and lots of very serious adverse side effects for these patients, where it appears that Johnson and Johnson hasn’t properly tested this blockbuster medication before bringing it to market, and putting millions and millions of dollars behind their advertising rather than more clinical trials before pushing it out nationwide.
Farron: What is really intriguing is that Invokana commercials are very common on tv, obviously because type two diabetes is becoming more and more common these days. In these commercials, as we’ve often seen, they show the joyful men and women. Once they’re about the medication, they are living their own lives. They’re out there having fun. They’re barbecuing. They’re exercising. Then, in the real professional speak, they begin giving all these, ‘Invokana can lead to yadda, yadda, yadda, yadda.’
That’s what they do. There is a difference. The negative effects are spoken at a high school grade level. The benefits of the medications are always spoken at a grade school level. Study after study has shown that this is the way that these medications are marketed.
When we’re discussing a medication like Invokana, we are looking at something that is causing kidney failure, heart attacks, ketoacidosis, and this really is a medication that is supposed to help excrete blood glucose in the bloodstream through the uterus. Those were only the first side effects we understood. Now we are starting to see things where people are shedding limbs as a result of taking this medication?
David: Yeah, that’s right. That’s the latest FDA advisory that has come out, is that there are a number of instances of amputation. Of course, diabetes sufferers can be prone to risk for amputation and reduction of limb, loss of feet. A lot of times that’s where it begins, so if you have a serious diabetes condition, you need to always be cognizant of this, but the information that’s coming out in this recent clinical trial evaluation, which the FDA has issued an advisory about and stated that they are going to be checking into further, is that the Invokana medication is greatly increasing the propensity for these types of amputations.
To begin with, this is the way the routine for a lot of these drugs unfortunately has performed. Info keeps seeping out about some of the concerns here, first starting with heart attacks, stroke, bone fracture, and things like this. This past year, those were the advisories that were coming out, and now more recently the amputation risk. The issue is that using a lot of these medications there are side effects, obviously, but the issue is if the maker, in this case Johnson and Johnson, have correctly warned about the potential side effects so that the doctor and the individual can make a educated decision about whether the medication’s pros outweigh the potential disadvantages and the risk.
Johnson and Johnson hasn’t properly warned of these dangers, which now are coming out after the fact, and that is actually the disconcerting thing. Johnson and Johnson, who we think of it as this kind of family product and the baby to baby shower and talcum powder, which we are learning a lot about cervical cancer there unfortunately, but it’s a family name. Obviously, with the systemic problems at Johnson and Johnson, it surely appears that advertising and profit is a primary motive here, possibly over individual safety.
Farron: You pointed out something really interesting there, and I want to expand on this just a small bit. That’s the fact that it’s not that the medication, or any medication, cause side effects. Even aspirin and Tylenol can cause side effects. A lot of it has to do with the risk benefit analysis, the negative effect of it versus what it really does, but the most significant thing, and that is where lawsuits come from, is what did the firm know, did they hide it, did they correctly provide this information to doctors and patients. It’s when there is a cover-up, or when they didn’t disclose, that they face liability. It’s not just because their product isn’t doing everything it says. It’s because they knew it wouldn’t, and they hid the risks. I believe that’s something that the public needs to understand. People do not only get sued for no reason. It’s because there was a cover-up, since there wasn’t any warning.
David: That’s correct. The warnings, and also we view the fine print and so on, but you wonder how much customers actually know, as you state with the TV commercials, or you look in the weekly periodicals and items, and you’ve got all this fine print which of course goes over everybody’s head. A lot of it is education of the doctors too. Instead, Johnson and Johnson is spending tens of millions of dollars in marketing the products for medical advisors, literally wining and dining a lot of doctors to the tune of a couple of thousand dollars in food and drink expenditures for this specific medication, and thus they are glossing over lots of these difficulties. Either they knew of the problems and they have not given proper warnings they didn’t do sufficient medical and clinical trials to ascertain what the side effects were.
When a black box warning goes on a specific medication, various studies have proven that the prescriptions of that drug may go down by about 40 percent. That’s what these producers do not desire, and thus they are making an oftentimes … Regrettably, they are making calculated decisions about if it’s better to steer clear of the black box warning and take their chances on the liability side, and manage the lawsuits that come as a consequence of the various injuries, amputation, stroke, heart attack, or death, versus having their medication, which they are discussing on their own quarterly Wall Street conference calls, that this is great, ‘We’re getting good market share in this massive patient population for diabetes’
That’s the issue. Is the black box warnings suitable warnings to the sufferers? The patients need that. Johnson and Johnson is a really sophisticated business. They need to be putting out all of the information that they have about such medications so patients can make informed decisions.
Farron: As we’ve seen too frequently, it always comes down to profits over patients, and that’s why folks love you, the trial lawyers, Mike Papantonio, Howard and Michael Burg, all a part of this show, that’s why you guys are out there doing what you do every day, to help protect American customers. We love your job both in the courtroom and on this show, so David, thank you very much for speaking with us today.
David: Thank you, Farron. It’s my pleasure.