Yaz On Trial : Yaz Birth Control Lawsuit : Info on Yasmin & Ocella Side Effects

Bob:
Craig, women have reported claims of harmful side effects such as blood clots which have allegedly led to strokes and heart attacks after taking these pills. In some cases there have been reports of women who have had damage to their gall bladder, liver, pancreas, among other conditions.

Craig:
Well, just this week in U.S. District Court in San Francisco, a suit was filed in what the plaintiffs’ lawyers have labeled as one of the more tragic cases. A 39-year-old mother of twins allegedly suffered a stroke and subsequently had a portion of her skull removed, leaving her mentally impaired, allegedly as a result of taking Yaz for only four weeks. We’re going to take a look at that piece of litigation and some others sparking up around the country.

Well, our first guest today is attorney Mike Danko from The Danko Law Firm who has filed a federal lawsuit against the makers of Yaz and Yasmin. Mr. Danko is representing clients seriously injured in explosions, fires, falls and collisions, and represents those injured by such dangerous drugs as they’ve alleged to be Yaz and Yasmin. He also co-writes the legal blog, capersonalinjurycaselawnotes.com and it’s called California Personal Injury Case Law Notes, also written by his colleague, attorney Kristine Meredith. Welcome to Lawyer2Lawyer, Mike Danko.

Mike Danko:
Thanks Craig, glad to be here.

Bob:
Joining us also today is James O’Reilly, a professor of law at The University of Cincinnati, College of Law, where he has taught since 1980. Professor Jim O’Reilly literally wrote the book on FDA regulation of pharmaceuticals and has been quoted by the U.S. Supreme Court on FDA law. He teaches products liability, FDA law and other topics and is a consultant to and expert witness for defense and plaintiff law firms nationally. Within the American Bar Association, Professor O’Reilly chairs the FDA Committee and is co-editor of the products liability newsletter for the ABA litigation section. He counsels large and small drug, biotech, device and food firms and previously worked at the Proctor & Gamble Company as Associate General Counsel for 24 years. Welcome to lawyer Jim O’Reilly.

Jim O’Reilly:
Thank you, Craig.

Craig:
Well, Bob, we should also note that our producers for our show, Lawyer2Lawyer, have reached out to Bayer Corporation to be on today’s show, but we did not hear back from them in time for them to be on the show.

Let’s start off by discussing the lawsuits; some reports so far say that there are somewhere between 70 or 75, maybe even 100 lawsuits so far. Mike, do you have any idea what the numbers are?

Mike Danko:
No, because they’re getting filed every day, but there’s certainly, I think it’s safe to say there’s over 100 lawsuits filed and, frankly, I expect that there’ll be in the near future more than 1,000.

Bob:
You represent Susan Galinis in one of these cases. Tell us her story.

Mike Danko:
Well, what happened was in May of 2008, Susan started taking Yaz, not for birth control, but rather to relieve some of her premenstrual issues, and four weeks later – four weeks and one day, actually – she woke up with a headache and minutes later had a stroke which left her partially paralyzed and caused some brain damage. As you mentioned at the outset, the doctors had to remove part of her skull to let the brain swell. She was in the hospital for about six months and when it was all over, she did suffer brain damage. She now is not the same person she was. She has cognitive problems, her personality is different, her voice is different, she has vision problems, and she’s still weak on one side. So, it’s really been devastating for her. She’s got what are now four-year-old twins, and instead of being able to take care of them, she has to be taken care of.

Craig/Bob:
Well, what is – Jim, you have a lot of experience, having written the FDA regulations on pharmaceuticals, and we understand that FDA has sent some warning letters to Bayer regarding Yasmin and Yasmin advertising. In fact, I think I’ve seen some commercials where they’ve corrected some of the things that they had made some statements about. Can you give us the background for that?

Jim O’Reilly:
Sure. Since 1906, the legislation that today is our Food, Drug and Cosmetic Act has been protecting consumers against false claims, and consumers have had that protection because we’ve had a vigorous Food and Drug Administration that’s been able to examine the science behind each claim and challenge those claims that are made without sufficient support. When the FDA makes a claim challenge, it typically does so in a warning letter. The warning letter says – company, we think you don’t have enough support for what you’re doing and we think that you should demonstrate that support in great detail and convince us that you’ve got the support, and if you don’t, you ought to retract that ad and do corrective advertising.

There were, during the George W. Bush administration, a dramatic decrease in the number of these warning letters because the administration and its political appointees felt strongly that the industry had been pushed too far by the FDA. And as a result, there were fewer and fewer actions in which the FDA became aggressive or enforcing and the like. One of the telling signs of change was at the annual meeting in Chicago in August, the Director of Compliance for the FDA Center for Drugs, who is herself a very experienced lawyer, stood up and said – new game in town, new sheriff; we’re pursuing these very actively, we’re not going to sit down and take it, we’re going to be more aggressive. After her speech, a few weeks later, the new Commissioner, Dr. Peggy Hamburg, said we are going to go now more aggressively against people making these claims; we’re going to be very assertive and we’re going to push toward court cases for those instances in which the companies haven’t done enough to reveal or to disclose or to share the true adverse effects of what they’re doing.

So, the mood has changed; the FDA is much more active today, and as a result of those changes, there’ll be some – probably a major increase in the number of challenges brought by the FDA against pharmaceutical advertising in the near future.

Craig/Bob:
Mike, what are the allegations in your lawsuit against Bayer? Is it that Bayer knew of these potential side effects and did not disclose them, or that the side effects are a result of the drug, but were unknown to Bayer?

Mike Danko:
The side effects were known and then they were understated and the benefits of the drug were exaggerated. Really what we’re talking about, if I can sort of go back a little bit –

Craig/Bob:
Please.

Mike Danko:
– all birth control pills are basically a formulation of different hormones, and what makes this birth control pill – Yaz and Yasmin – different, is that one of the hormones called drospirenone, or DRSP for short, that particular hormone is a synthetic hormone, which means that it doesn’t match up with the hormones that appear naturally in the human body, and that’s the drug, that’s the hormone, that causes all the problems.

Craig/Bob:
So, what is your complaint alleging then? That Bayer is negligent in failing to disclose that, or in failing to disclose the consequences of that?

Mike Danko:
Well, you know, they were – Bayer knew of the risks. Again, to go back a little bit, what Bayer did, and what their predecessors did, back in basically around 2000 and the late 90’s, they said, alright, the birth control market is yet to be exploited. We can promote a birth control pill, for use not just in birth control, but for all sorts of off-label uses – to relieve premenstrual anxiety, to improve complexion, to alleviate weight gain; and basically they wanted to create a lifestyle drug that would get a bigger market share. The problem is that if you do that, if you formulate a drug using what’s called bio-identical hormones, or hormones that look just like the ones that appear in the human body, you can’t get a patent on that. So what they did is they said alright, let’s come up – let’s invent a drug that’s different – or, let’s invent a hormone that’s different from that which appears in the human body and that’s DRSP. So that allowed them to get a patent. The problem is that DRSP is no more effective than the bio-identical hormones, or the old-fashioned hormones, but there are additional risks. And that’s why they put the hormone into the drug, that’s what causes the problems, they know it causes the problems, they minimize those risks and they overstate the benefits. And that’s exactly, by the way, what the FDA told them beginning in 2003. They said, your advertising says that DRSP has benefits that it doesn’t have. And also, as far as we’re concerned – as far as the FDA is concerned – we’re aware of additional risks associated with this drug and you’re not telling people about it. So that was in 2003 they told Bayer to clean up the advertising; in 2008 they actually required Bayer to spend money – about $20 million – on remedial advertising, and then again in 2009 they said you’re still not doing it. So that’s kind of the history in a nutshell of the drug and what the problems are with it.

Craig/Bob:
Jim, is this based more in advertising or are the issues based more in the configuration of the drug?

Jim O’Reilly:
Well, I can’t speak to the particular case, of course, because Mike is the expert on the case. I can speak generally about the FDA process. The FDA’s process looks at the advertising as part of the overall labeling. The labeling is the name used for the stuff that’s on the package that’s in that little flier called the patient package insert and the other notes that are given to prescribers. The FDA is giving prescribers, the people that actually choose, which pill goes to which patient. The FDA is giving the prescriber the opportunity to choose which pill might be appropriate for a particular patient, but the FDA is forcing each of the manufacturers to demonstrate to the FDA that the claims are supportable. Most of the time the claims are, in fact, supportable and most of the time the FDA has looked at the evidence as part of approving a new drug application. Every so often, though, the FDA has to go after a manufacturer and challenges the adequacy of the disclosure or the adequacy of the information provided. In those cases, the FDA will typically start with a warning letter and then progress to a court action. If the action is so egregious that a mere “dear doctor, I’m sorry I over spoke,” – that kind of a preventive or responsive or remedial action may not be enough in all cases, and that’s why the FDA reserves the right to go to court for injunctive relief, if necessary.

Craig/Bob:
Jim, do you know if any of these questions arose during the approval process for this drug?

Jim O’Reilly:
Well, generically I can say, in the approval process, the FDA looks at the particular ingredient, looks at what’s known about the risks of that ingredient, and requires the labeling to include those known risks, including those that might be remote. So many warnings and so many communications about warnings have occurred that people are basically developing an immunity to it. Prescription drug advertising to consumers is a relatively new phenomenon, beginning about 1997 and is now about $8 billion a year. It’s gotten so pervasive that you can’t watch the news in the evening without seeing pharmaceutical ads.

My favorite story is a true one, you can look it up in the Library of Congress website, that a congressmen this year introduced a piece of legislation directing the FDA not to require that male erectile dysfunction drugs include the adverse effect regarding four-hour erections. Now, I don’t know the basis – I don’t know whether Congress is going to pass this law, but the fact that he’s offering that in the House is an indication that these advertising approaches have alienated some of the consumers who previously would have been relatively benign toward the advertising.

Craig/Bob:
Consumers with children watching TV, anyway.

Jim O’Reilly:
Mommy, what’s a four-hour erection?

Craig/Bob:
Yeah, exactly.

Mike Danko:
And, you know, Mr. O’Reilly makes a very good point. Bayer, on its labeling, discloses that there are potential side effects, and in some of their commercials they disclose that there are potential side effects. But that is not what people need to hear with regard to this drug. All they need to hear – what would really affect their decision making – is a warning that says, what you need to know about Yaz is that it’s no more effective than other birth control pills, but it is more dangerous. Period. That’s an effective warning. It tells you forget for a moment what the risks are, but you as a consumer need to know that the risks of this drug are greater than another drug and the benefits aren’t there. This drug is no better than another, safer drug. Of course, you know, they’ll go on and on and list all of the risks – the strokes, clots, gall bladder disease – they list that, but the consumer doesn’t know what to do with that because they assume that all the drugs have those risks. In fact, they do, but what’s important to know is this drug carries a greater risk.

Jim O’Reilly:
And it’s up to the prescriber, it’s up to the physician to choose among the alternative drugs. And so the drug company can say as long as we’re giving enough information to the prescriber, he or she is acting as a screening agent or the expert, the learned intermediary, between the consumer and the pharmaceutical maker.

Craig/Bob:
I was going to ask Jim, or Mike, either one of you, what kind of defenses are available to bear in this lawsuit?

Mike Danko:
Well, Professor O’Reilly just mentioned one, they’ll say, hey, it doesn’t matter what we tell the consumer, it doesn’t matter what our commercials say because it’s up to the doctor to be the screening agent. Unfortunately, the doctors do not read the studies themselves, word for word. They do not do their own research. They largely rely on what the drug manufacturers are telling them, and the drug manufacturers walk into their office with free samples and tell them this is the greatest thing since sliced bread, you ought to give it a try. So then what happens – why, then, do the drug companies market directly to the consumer via television? Because the 25-year-old woman goes to her gynecologist and says, hey, what about this Yaz, it sounds like it’s pretty good? And the doctor essentially, I think, shrugs his shoulders and says yeah, that’s what they’re telling me – give it a try.

Craig/Bob:
Mike, this drug has been on the market for several years now and yet it seems there’s been a surge in the number of lawsuits filed over the last year. Why is that? What’s brought this greater number of lawsuits to be filed?

Mike Danko:
Because as we said at the outset, which I will always say, there is a risk to every type of birth control. I mean, that’s in the nature of the drugs. They can do great things – they can help; they can also harm. So, people who have been victimized by Yaz, that’s one thing. That doesn’t necessarily mean that that entitles them to bring a lawsuit. What entitles them to bring a lawsuit is when it comes to light that the risks associated with this drug are greater than other drugs, and that that hasn’t been disclosed. So, what’s coming to light now is that this drug causes more clotting, more strokes, more pulmonary embolisms, more heart attacks than other birth control pills. And that’s coming to light now as a result of a couple of – a Danish study, a Dutch study – and just generally what people are seeing. So, that’s what the turning point was – when what Bayer has known from the outset became more or less known to the public, and that is that DRSP causes more clotting, more side effects and has no corresponding benefit.

Jim O’Reilly:
There’s an important aspect of the law that most people overlook. When a new drug comes on the market, the FDA does not judge whether it’s going to be more effective than others. It’s going to judge whether it’s deemed to be reasonably safe in light of its efficacy. The FDA does not take off the market other products competing with it on the basis they might be less safe or that a newer product might be more safe. So the market has a lot of products on it, some of which will be more effective than others and the communication of what’s more effective is left to the manufacturer.

Craig/Bob:
Mike, should we be expecting to see any kind of multi-district administration on these kind of cases now that there’s been 100 of them filed? What’s the status of the federal court consolidating some of these claims?

Mike Danko:
In fact, it’s already happened. There is an MDL proceeding pending in the Southern District of Illinois. So, all of the federal cases that are being filed are being sent there. And, in fact, next month there’s a Case Management Conference before Judge Herndon.

Craig/Bob:
What steps has Bayer taken so far in asserting their defenses? In Merck’s situation, Merck took these cases on one by one and started trying them as they got challenged by some pharmaceutical distribution they were doing. What have you seen from Bayer so far?

Mike Danko:
We haven’t really seen any legal strategy. So far, it’s been sort of PR, where they just, you know, kind of the boilerplate, hey we’re concerned about the safety of our drug. And they have some spokesman saying, look, the risks of stroke, pulmonary embolism, blood clots and so forth using this drug are very, very, very small. Let’s say hypothetically that it’s twice that of another competing drug; twice a very, very small number is a very, very small number. So, that’s kind of, right now, it’s been their response. Of course, I don’t think that really cuts it.

Craig/Bob:
Well, it’s time for us to take a short break. When we return, we’ll take a look at the real-life stories of those who have allegedly suffered from the side effects of these birth control pills and a look at some additional law suits.

Craig/Bob:
Welcome back to Lawyer2Lawyer on the Legal Talk Network. We’re back with attorney Mike Danko of The Danko Law Firm and James O’Reilly, who’s a Professor of Law at the University of Cincinnati. Jim, what are the next steps for Bayer? Are they going to try and consolidate this? We’ve got the multi-district litigation pending. How are they seeking to deal with this – are we going to be seeing class actions being filed now?

Jim O’Reilly:
Well, let’s ask Mike that because he’s closer to it. I can say that under Rule 23, there’s very likely to be some form of Class Action. The MDL is a good indicator that there will be a consolidation, at least for a portion of these cases for certain purposes, but I’ll leave it to you Mike.

Mike Danko:
I don’t think we’re going to see Class Actions for a number of reasons. Each one is going to be different because one thing is, for example, each of my clients had been prescribed the drug for a different purpose. Some for on-label use, some for off-label use, that is uses for which the drug has not been approved. And, as a result of the advertising, they each suffered different injuries at different times. So, I don’t know if in this case a Class Action will be appropriate, which is why, I think, so far everyone has filed individual cases.

Craig/Bob:
Jim, you alluded earlier to the comment from an official at the FDA that there’s a new sheriff in town, I guess, on these cases. What does that suggest? You talked about some of the actions the FDA has taken already, but what else might it do with respect to this drug?

Jim O’Reilly:
I don’t know what the FDA’s plans are for Yaz because when you’re outside the negotiation, you don’t know what the FDA is saying to Bayer, you don’t know what Bayer is saying back to the FDA, but on a more generic sense, the FDA regulatory people no longer feel that they are constrained by the political appointees at the top of the FDA. They feel that they can be as aggressive as they need to be to compel the companies – companies in general, not specifically Bayer – to be more adherent to FDA standards and policies for the disclosure of all the effects and all the benefits of the drug.

Craig/Bob:
Not to put words in your mouth, but it sounds like you’re saying that the FDA’s decisions about the enforcement are driven by political concerns as much as by health concerns.

Jim O’Reilly:
I’ve been in the field 35 years. In an article I published in the Cornell Law Review in 2008, I emphasized that the George W. Bush administration did more to control FDA enforcement, to limit it and to assert preemption arguments more than any of the administrations during the previous 30 years and that ultimately that was harmful to the FDA’s receipt of judicial deference for its positions. Again, I’m not speaking directly to Yaz or to a particular company, but I’m saying the FDA is being more aggressive now because they’ve got some ground to make up they recognize that there was a period of time when, for various reasons, the administration was not friendly toward the control of certain companies.

Craig/Bob:
Jim, it seems like that we’ve heard that Bayer has put about $20 million out in some corrective advertising. I mentioned at the beginning of the show that even I’ve seen some of those ads. How do you think that’s going to play with the juries when Bayer comes out and says, look, we told you it was a problem.

Jim O’Reilly:
After the fact, if the company takes an appropriate action, it is communicating sufficiently with its base of prescribers and the like and prescribing customers – customers is the wrong word – the patients – if the company is communicating effectively to patients and the prescribers, it’s going to have a very positive effect relative to jurors. Jurors are becoming more and more jaded with more and more television advertising for prescription drugs because they’re much more aware of risk issues than they’ve ever been before. One of the up sides of this flood of $8 billion of advertising is people are now seeing prescription drugs as a trade off. There will be some risk; there will be some benefit, and the prescriber is acting – they hope – in their best interest in choosing which product will be more effective compared to its risks. But people are no longer believing that any drug that they get from their prescribing physician will be 100% healthy or 100% happy. Consumers are past that point.

Craig/Bob:
Mike, what do you think about the advertising you see from the law firms soliciting people who have been exposed to asbestos, who’ve been exposed to this particular drug or that particular drug? I watch CNN news in the morning, so I see these ads all the time. Is that having an adverse effect on jurors who may be listening to this realizing that there is a risk with pharmaceutical drugs, and they need to pay attention and read the disclosures from the pharmaceutical companies?

Mike Danko:
Well, my problem with the disclosures from the pharmaceutical companies – and to go back maybe to your earlier question – what about the corrective advertising that Bayer has put out? I just don’t think they’re going to get anywhere with that because the corrective advertising is in itself a joke. I mean, if you watch that commercial, which is still available on the internet, you can look at it kind of whenever you want, it was written by Bayer’s lawyers in conjunction with their marketing department. It’s a lot of very clever fast talk, doublespeak and over-warning of risks that people really either know or don’t care about. What’s missing and what they continue to conceal, even in this corrective advertising, is that the drug is more dangerous than other competing drugs but is no more effective. If a consumer has that particular piece of information, that’s the only thing they need. They will say, I will choose another drug. And until that disclosure is made, I think any of the disclosures are ineffective because you want a disclosure that you can act on. You want a disclosure – not, hey, there are risks here – the question is what do I need to know to make an informed decision about whether I’m going to use this drug. In this case what you need to know is that the drug is not any more effective than the competitors, but is more dangerous. That’s what you need to know, and they don’t want to say that, obviously because if they did say that, how many people would be taking Yaz or Yasmin? And right now, you know, last year they sold $1.8 billion of Yaz and Yasmin and Bayer is going to fight all the way, and they’re not going to tell people the truth because they want to hold on to their market share.

Craig/Bob:
Gentlemen, we’re just about at the end of our time for this program and we would like to give you each an opportunity to conclude with your final thoughts on this topic. And, we can also let our listeners know how they can follow up with you. Mike Danko, let’s start with you.

Mike Danko:
Well, you know, I guess you have to ask what is it we’re doing, what is it we’re trying to accomplish? What we’re trying to accomplish, number one, is getting the word out for women. Women are being bombarded by these advertisements, and it’s affecting what they do, and it’s affecting their health. And so what we’re trying to do is get the word out to them so they stop taking this drug. If there’s any way we can, we want to get the drug off the market. And lastly, of course, I want to get compensation for some of the women who have been injured by this drug, whose life has been changed. Some of our clients now, Bayer just kind of leaves them. Susan Galinis – she needs help. She needs cognitive retraining, she needs help around the house. She needs help so that someday, maybe, she can get back to work. Not in her old job, but in another job. And Bayer is doing nothing to help these people.

Craig/Bob:
How can our listeners follow up with you?

Mike Danko:
They can get hold of me through my website which is dankolaw.com, and I have a new blog which is yazontrial.com which will have information about the drug.

Craig/Bob:
Mike, thanks a lot. Jim O’Reilly, how about your final thoughts?

Jim O’Reilly:
My final thoughts are these are very complex, very difficult cases to win. There are many costs involved, including the evidence, the experts, the Daubert, the hearings and the like, and you’ll be in this for a long time if you get into it. So these are for a more sophisticated, more specialized torts lawyer rather than for the average person. This is a very complex deal of litigation. It can do a wonderful job for particular clients, but in general it is more difficult than most lawyers perceive it to be from the outside. Be careful before you take these cases and be very thoughtful as you approach both settlement issues and the issues of going ahead in either group, MDL or class settings.

If people wanted to reach me, my textbook is called Food and Drug Administration. It’s published by, Thomson West. My email is james.oreilly@uc.edu. Thank you.

Craig:
Well, thank you both for being on the program today. That was a great discussion. Bob, that does it for this week’s Lawyer2Lawyer. For our listeners, remember you can check out all of our Lawyer2Lawyer shows at legaltalknetwork.com.

Bob:
Let me add my sincere thanks to our guests for taking the time to be with us today and let me also remind our listeners that they can also find this program and all of our past programs in the podcast library on itunes.