Hormone Replacement Therapy Litigation

Transcription

1 p.1 Hormone Replacement Therapy Litigation Hormone replacement therapy, also known as HRT, was prescribed to women to treat the symptoms of menopause for years. Then in 2002, a comprehensive women's health study was published. The study connected HRT to increasing incidences of breast cancer. Ringler Radio host Larry Cohen turns to Attorney Ted Meadows from the Beasley Allen Law Firm, for more details on hormone replacement therapy, ongoing litigation and the various plaintiffs involved in these cases. Host: Larry Cohen Guest: Attorney Ted Meadows Release Date: June 25, 2012 Larry: Well, hello everyone, and welcome to Ringler Radio. I'm Larry Cohen, the head of Ringler Associates Northeast Operations, and we're certainly glad you could join us today. Well, hormone replacement therapy, also known as HRT, was prescribed to women to treat the symptoms of menopause for years. Doctors prescribed drugs like Premarin, Prempro and Provera. These drugs were also encouraged for other uses, including the prevention of Alzheimer's disease. But in 2002, a comprehensive women's health study was published which connected HRT to an increasing incidence of breast cancer. Studies have confirmed that over 200,000 women would not have suffered breast cancer but for their use of a combination of this hormonal therapy. And to this day, Wyeth, the manufacturer, claims that its hormone drugs do not cause breast cancer. So, here we have the typical controversy that makes for a good show, and on Ringler Radio today, we're going to talk about hormone replacement therapy and the ongoing litigation between Wyeth and the various plaintiffs involved in these cases. And to do that, our special guest is attorney Ted Meadows from the Beasley Allen Law Firm in Montgomery, Alabama. Ted practices in the firm's mass torts section, has been chosen to help direct litigation related to hormone replacement therapy as part of the Plaintiffs' Steering Committee. Well, Ted, welcome to Ringler Radio. Ted Meadows: Thanks. Good to be here. Larry: Ted, like most of these pharmaceutical cases, the story unfolds over time. Tell us about that. How does hormonal replacement therapy, how was it started and how was it introduced to combat these menopause symptoms many years ago? How did that start?

2 p.2 Ted: Larry, unlike a lot of modern mass torts, this case stretches back over decades. For purposes of our conversation here, when I talk about hormone therapy, we'll talk about the drugs you mentioned earlier, that being Premarin, Prempro and Provera. There are other hormonal therapies that are out there, but these are the cases that are the focus of the litigation. Premarin actually is probably the first hormonal therapy that was used as a mainstream drug. It was introduced to the market in It was intended to address menopausal symptoms that women have as women age and their estrogen levels drop. So the purpose of the pill, and the FDA approval, was to address symptoms that women have when they reach that point in their life, and those symptoms would include things like hot flashes and something called vaginal atrophy. It might be called vaginal dryness, as well. It's just a natural phase that women go through, as they get older. Premarin actually, you might wonder where the name comes from. It comes from its ingredients. And its ingredients are pregnant mares urine. So you get Premarin from those three words, pregnant mares urine. Many women to this day don't realize that the pill they're taking is conjugated equine estrogen, or pregnant mares urine. So that's when it started, 1942, and it kind of had a lackluster beginning. Then, in the mid- 60s, there was a book published called "Feminine Forever" by a doctor by the name of Wilson who was funded by Wyeth. Probably the first ghostwritten book that I know of. It touted the benefits of hormone therapy such as Premarin. Larry: Interesting. Ted: So sales took off and Wyeth enjoyed increasing sales for about 10 years. Premarin was being prescribed to millions of women across this country. And in the mid- 70s, someone noticed that during that time period there was an increasing endometrial cancer epidemic that was going on and some smart epidemiologists put two and two together and suddenly realized one day that with the increasing incidence of endometrial cancer in this country, there was also an increasing number of Premarin prescriptions. So they were able to link that up and the FDA ended up forcing Wyeth to put a black box warning on Premarin. Not to be deterred, Wyeth determined that they could actually add an extra pill to the cocktail called Provera and that would protect the lining of the endometrium. So that became the standard of care in the late '70s and '80s. Women would take Premarin plus Provera to address the symptoms. The Provera was only intended to protect them from the endometrial cancer. And then, in the mid- '90s, Wyeth decided to combine the two pills into one and they started selling a drug called Prempro, which contained the Premarin plus the Provera. And they

3 p.3 enjoyed great sales of Prempro because many women liked the idea of one pill as opposed to two each day. Larry: And it was relieving their symptoms, too. I mean it was obviously working. Ted: It was relieving their symptoms. It does a very good job of doing that. And they only had to pay one co- pay because it was one pill. So once again, we saw increasing sales all the way up to 2002 when there was a study released called the WHI that showed that Prempro was causing breast cancers, among other problems. Larry: Is that when the litigation began? When did the litigation start? Ted: In I distinctly remember in 2002 driving down the road heading into the office and hearing on the radio that this massive government study called the Women's Health Initiative, which was run by the National Institutes of Health, had been halted. It had been going on for a number of years. There were millions of dollars invested in it and it was a big deal that they had to shut down this study. And the reason they shut it down is because they had preset alarms to go off if certain adverse events reached a certain level. And that happened on July 9th, 2002, or actually a few weeks before that. But the study was halted on July 9th, 2002, because they could no longer expose those women unknowingly to the risks of breast cancer and other problems. And so the litigation kicked off then. Many lawsuits were filed and lawyers, like myself, looked at it at that time. At the time, I didn't feel good about being able to prove causation. But, as follow- up studies came out over the next two years, I became more comfortable with my ability to prove that the drug causes cancer and that I could prove it in an individual case. So I got involved with it in Larry: It's interesting that during the course of these trials and the litigation that was going on, a lot of so- called red flags came out of the evidence that was presented at trial, and Wyeth evidently downplayed a lot of the cancer risk in that process. I also understand there were quite a few studies that were written and articles that were done and that it's been contended that Wyeth actually were the ghostwriters of those articles and they weren't really independent doctors that were doing that. Tell us about that. Ted: Two things I'm hearing there. You asked about the red flags and the ghostwriting. With respect to the red flags, that's actually a term that we use at trial in these cases. And it's a term that's used by regulatory experts to say when something comes up as a red flag, it should alert the company to a problem.

4 p.4 We know that Wyeth had red flags regarding the risk of their drugs causing breast cancer really as early as the mid- '60s. There was a study that showed that rats were getting mammary cancers from taking the drug. But certainly by the mid- '70s when the endometrial cancer crisis hit, it was causing hormone positive endometrial cancers, the same types of cancers that we see in the breast now from Prempro. And yet, Wyeth did no studies. They had internal documents. We now know that there were internal documents from 1976 where Wyeth research were recognizing "a valid concern as to whether or not the use of estrogens can lead to breast cancer." And they did nothing. With red flag after red flag after red flag, and literally there are dozens of them that we can show to a jury that happened over the course of decades from the mid- '70s all the way up to WHI in 2001, and Wyeth's response was either to ignore it, which is what they did early on. By the time it got into the late '80s and into the '90s, it's become such a controversial topic for them that they implemented a strategy to counter it. One strategy was what they called the "Dismiss and Distract" strategy so that if a study would come up suggesting there might be a risk of breast cancer from their drug they would dismiss the study as being under populated or not properly done. Ted: And they would attempt to publish some information that would distract the media to look at some other issue that would take the attention off of that. They also had what was called a "Breast Cancer Containment Committee", an internal committee that...their sole purpose was to come up with ways to contain any bad publicity about Prempro and its link to breast cancer. So they were active, not just ignoring the problem but they were actively downplaying the risk of breast cancer and at the same time touting benefits that didn't exist, such as you mentioned earlier, an Alzheimer's benefit or a heart benefit. Ted: Those are the red flags that we're talking about and I can address the ghost writing as well. Larry: Well, you know, before we get to that let's try to put some balance here just so we can get the other side. Wyeth maintains that its hormone drugs do not cause breast cancer. So I guess on balance we should talk about what type of evidence or findings does Wyeth have to support the statement that it doesn't cause breast cancer in contravention to your findings on the plaintiff's side that it does. What do you have to say about that?

5 p.5 Ted: Well, they...from what we see.. What we see in the courtroom is that Wyeth will typically say, they will appeal to an inherent belief that we all have and that is that no one knows what causes cancer. We all have, for some reason, that belief inside of us, that cancer is a big mystery to us. Larry: That sounds like what the tobacco folks were trying to do! Ted: Exactly what they did and of course we know that tobacco causes cancer. So we do know that there are some things out there that are carcinogenic, they cause cancer. But that's the defense that Wyeth will take in the courtroom, is that no one knows what causes cancer and even if you can say that certain things are carcinogenic it's impossible to tell in an individual woman what caused her cancer and therein lies the real battle in the courtroom. Their whole idea that their hormone therapy doesn't cause cancer is really...we can overcome that one pretty easily from my side because there's numerous studies out there that show that the drug causes cancer and indeed the current Prempro label says as much. It lists breast cancer as a side effect today. Larry: OK. Ted: They did not before. The BHI does today. Larry: OK. Ted: So I think outside the courtroom Wyeth will probably admit, and in fact they do on their label, that it causes breast cancer. Inside the courtroom they use it as further battleground but their real focus is on the individual woman and saying that it's impossible to say that she, this particular woman, got breast cancer from their drug. Larry: From their drug? Well, in a Pennsylvania appellate court decision, which affirmed a $1.5 million dollar compensatory and an $8.6 million dollar punitive award against Wyeth on behalf of a woman diagnosed with hormone positive breast cancer, the plaintiff had taken Wyeth's hormone pill Prempro for 18 months. And that was a pretty substantial verdict. Tell us about that case. How did the facts in that case lead to the conclusion of those numbers being awarded? Ted: The interesting thing about that case to me is that the woman took it for 18 months and actually took the pill every other day so you might say she took for nine months. Ted: And that would be what we call a short- term use case and it presents more challenges for lawyers like me. The shorter the term, the less epidemiological evidence. I have to say that the drug can actually cause breast cancer in a woman on short term. But what they were able to show in the Daniel case was that she was what we call estrogen deficient as she went into

6 p.6 menopause. And how did they know that? She had menopausal symptoms like I said earlier, hot flashes, and vaginal dryness. Ted: This suggested she did not have sufficient hormones circulating in her body to fuel a hormone positive breast cancer. How do we know it was hormone positive? Well, when a woman's diagnosed with breast cancer they do a biopsy. They'll stick a needle into the breast, pull out a piece of the tumor and they'll run some tests on it. And they can tell whether or not that tumor was fueled by or fed by hormones. So the question then becomes, from what source of hormones? Was it the woman's own personal indigenous hormones or was it something else? And the fact that she was hormone deficient when she started taking the Prempro pill suggests that the only source of hormones that could feed that tumor was the pill that she was putting in her body, and in this case, every other day. So that's how they went about proving specific causation in that case and indeed that's how we typically do it in most of the cases that had been to trial. Larry: So what's the track record on the HRT litigation against Wyeth? Are we seeing plaintiffs being compensated or is Wyeth winning some of these trials? How is that going? Ted: Wyeth is winning some but there had been 25 plaintiffs who have gone to verdict to date, with trials that started in September 2006 and most recently March of this year. 25 plaintiffs have gone to verdict. Plaintiffs have won 15 times; the defendant has won 10 times. So the track record here is actually pretty good for a mass tort case. Larry: That's interesting. Have you determined what the elements were that caused the wins and the losses? Was it jurisdictional, was it the nature of the individual, was it the quality of the legal representation? What tends to have caused the wins versus the losses? Have you thought about that? Ted: I think it's a combination of all of those things that you just mentioned. They certainly have an impact on any case, not just hormone therapy cases. Ted: But it can be a mixture of those things, it can be things like the length of usage, it can be an issue and that depends on what jurisdiction you're in as to whether or not that's going to be a problem for you. And it can come down to case specific facts, you know, like what did the woman's prescriber think about the risk of breast cancer in the lead up to him prescribing it to the woman? And what kind of testimony is there... Larry:..the credibility of the experts, it's all the same, it's in every case. You're right, all those elements come into play and they're fascinating plays in themselves, they're little dramas. And

7 p.7 most people are used to watching dramas, trial dramas on television and I'm sure that that's a whole other story, about how juries sit there and react to some of this evidence. Well, let me ask you, Ted. Do you think, with the nature and the size of this litigation, do you think we have something like on the order of a Vioxx in HRT or where is this? How big is this pool? Ted: Well, I think that if we compare this to Vioxx, you know, my firm was very active in Vioxx. Larry: Sure. Ted: In fact I think the last time I spoke to you in 2006 it was about Vioxx. Larry: No question, yes. Ted: Vioxx, we did not have a very good record in Vioxx. Plaintiffs did not win very often, certainly not the win record that we have here in hormone therapy. The verdicts were not as big. In hormone therapy when a plaintiff wins she typically gets eight figures, so it's going to be in excess of 10 million dollars. The punitive awards are huge in these cases. I tried one in Philadelphia with three plaintiffs back in December and we got a $72.6 million dollar compensatory award... Larry: Wow! Ted:...before it even went to punitive damages. We settled the case shortly thereafter, but these cases are big and even with a track record where we lose 10 out of 25, I would say this is prime litigation. The odds are in our favor that we're going to win and that we're going to win big. That's different from Vioxx. Another thing that's different from Vioxx is that Vioxx was a large, massive settlement where all claims were resolved at once. Ted: What we've seen in Prempro litigation to date is that cases tend to not settle until the eve of trial or sometimes in the middle of trial. There have been some inventory type settlements but I don't know that plaintiffs get the full value of their case, at least not to date until they actually are on the courthouse steps and show Wyeth that they mean business. Larry: Well, that's true of a lot of those types of cases and that's the nature of the business you're in, I'm sure. Let's take a quick break right now and be back in a minute with Ted Meadows right here on Ringler Radio and talk more about HRT litigation. Welcome back to Ringler Radio, glad you could join us. I'm joined here by attorney Ted Meadows from the Beasley Allen law firm from Montgomery, Alabama and we're talking about Hormone Replacement Therapy litigation.

8 p.8 Hey, Ted, you've been chosen to help direct HRT litigation as part of the Plaintiffs' Steering Committee. And the multi- district Prempro product's liability litigation involves thousands of cases against Wyeth and is currently consolidated under US District Judge Billy Roy Wilson in Arkansas. Talk about that and the size of all this and where you see Wyeth coming down eventually with the resolution of some of these cases. Ted: Yes, Larry, there are actually I would say two centers of the universe here. One is in Philadelphia; there are a number of state court cases filed there. Probably close to a thousand. The cases that were filed in federal courts around the country and, as you say, have been centralized in MDL, in Little Rock, Arkansas. There, Judge Wilson has been entertaining discovery issues and even some trials over the last several years. He started sending cases back to their home filings I guess about two years ago, maybe three years ago. We're seeing some trials now happen. He's also identified a number of cases for what he calls preliminary discovery. I think we're going to be seeing a lot of cases coming out of the MDL, hopefully in the coming months, going back to their home states. We're going to see more trials. Certainly we're anticipating that, and we have a number of lawyers working on it and bringing more lawyers on to handle all the trials that will be coming up out of the MDL. Larry: Well, you're going to be a busy man that's for sure. Ted: Job security. Larry: [laughs] Ted, let me ask you about probably a much more serious issue than people give it thought. That is the role of the Food and Drug Administration, the role of the FDA, in the process of approving these pharmaceuticals and these drugs. We seem to be seeing drugs, not just these drugs but in other instances where there's harm caused or at least alleged harm caused and yet the FDA has approved a lot of these drugs. What's your opinion about the FDA's role here, and how can we make that a little bit better? Ted: The FDA is like any other bureaucratic arm of the government, it can be a good thing, it can be inefficient. One problem with the FDA is you typically see a revolving door where industry people go back and forth from working for the FDA back to industry. Industry has, in my opinion, a sympathetic ear in the FDA. This can create a recipe for disaster, because the FDA might not be otherwise as diligent as certainly it probably was many years ago in making sure that drugs are adequately tested before they're put on the market. My concern is that there are preliminary tests that will approve a drug, or the FDA will use to approve a drug, but we don't see the true risk of a drug until it's exposed to a large population of people. That right now only happens after the drug goes on the market.

9 p.9 In the context of Wyeth and Prempro, they didn't do the adequate studies to determine whether or not it could cause any type of hormone type cancer before it was put on the market. Larry: It's almost, Ted, as if there's no drug that can be so safe that there's no side effect potentially before the FDA approves it. It sounds like what you're saying is that the pharmaceutical industry, in its effort to sell the drug and to market the drug, might color some of the facts? How does the FDA approve some of these drugs that have obvious issues without the kind of long term testing that's required? Ted: Well you know, there's only so much that the FDA can do. I think a lot of people think that they have labs and thousands of people that conduct the tests and the studies, but actually the way it works is they rely on studies that are submitted to them by the drug company. The studies and testing is expensive and time consuming. To put that on the FDA would be very expensive to the taxpayers. They rely on the companies to submit the proper data and accurate data for them to evaluate. Larry: This brings us back to this ghostwriting concept that you touched on earlier. Does the industry provide documentation and reports to the FDA that ostensibly are supposed to be coming from independent medical sources, and yet are ghostwritten by the industry itself? Or is that not where that takes place? Ted: Well, I think the ghostwriting can have an impact on it. What happens is, and this is probably the most insidious part of the way Wyeth promoted its hormone therapy drugs. They would hire a doctor to put his name on an article that Wyeth had written. They had a very well- oiled machine, and they could orchestrate these ghostwritten articles to be published that would downplay the risk of breast cancer and promote off- label benefits, such as a heart benefit and Alzheimer's benefit that didn't exist. These articles are still circulating out there now. It's like taking a feather pillow, cutting it open and fluffing it in the wind. You're never going to collect all those feathers again. The same thing happens when you publish an article like that. It's out there, and we see some of these articles even today that get cited in other studies. It gets hard to reel that stuff back in. I suspect it has polluted the medical literature out there, and it probably has an impact on the way scientists and regulators view the drugs. Larry: Well that's a cautionary tale for everybody, and I think all of our listeners are going to think a little bit harder as to how this process takes place and give some thought before they start ingesting a lot of these drugs.

10 p.10 In your opinion Ted, given the negative impact of HRT on the lives of thousands of women, even though they've obviously helped thousands of women, there's been a negative impact. How could this have been prevented? What do you sense could have been done that would have avoided some of the troubling results that some of these women had with the HRT therapy? Ted: It's really pretty simple, Larry. We know from the WHI that when the study is done, when a proper and adequate study is done, when the results come out, women and doctors change their perceptions of a drug. After the WHI, Prempro sales dropped off dramatically. Women didn't want it take it because of the fear of breast cancer, and doctors didn't want to take the risk of putting their patients at the risk of breast cancer. If those studies would have been done back when, for instance in 1976, when the internal memo came from a Wyeth scientist saying that there's some real concern that their drug could cause breast cancer, they would have known in the late 70s that it could cause breast cancer. If they would have at any point in time in the 80s, rather than over promote their drug, do a simple study to see if it can cause breast cancer, then women would have known much earlier. You alluded to 200,000 breast cancers that could have been avoided if they would have done these studies earlier. Larry: That's fascinating. Ted, one final question for you. For a lot of the women that are listening to this show, is there a hormone replacement therapy, let's say not Pempro or not the Wyeth product, is there a therapy out there that you're aware of that's safe for women to take? Ted: I'm no doctor. I hesitate to give any advice in that arena. But I think that many doctors now will talk to women about natural alternatives. They might even talk to women about taking Premarin alone on a short- term basis and being monitored very closely. I would suggest that a woman go and talk to her doctor. And if she has some concern that what he's saying is inconsistent with what she might read on the Internet or hear from some other friends, or even have heard on this show, she should get a second opinion about it. I think that would be the best course for them to take. We have a lot of information about the litigation and about hormone therapy in general on our firm website, beasleyallen.com. Larry: That's what I was going to ask you. If someone wanted to get in touch with you to discuss or learn more about this, tell us about your website and maybe a way for folks to reach you. Ted: Yeah. Beasleyallen.com is where you can find me. I'm one of the attorneys in that firm. You can find my contact information on there, and you can also find information on there about the hormone therapy story and the litigation in general.

11 p.11 Larry: Ted, that's terrific. Thank you very much for all the information you gave us today. It's a fascinating subject. I just want to remind our listeners that all of the Ringler Radio shows can be heard on ringlerassociates.com or legaltalknetwork.com. You can reach any Ringler Associate also on ringlerassociate.com, and the website has recently been redone and it's really quite snazzy. I recommend you go there. In the meantime, Ted, I want to thank you again for joining us today. Ted: Thank you. Larry: And for our folks out there, who've been listening, go out and have a great day. Thanks.