Breast Implants on Trial

TV Hub

An examination of the medical and legal issues surrounding silicone breast implants.

Transcript

00:00:00Tonight, on Frontline.

00:00:08We're going to win this fight.

00:00:11We're going to beat the Dow machine.

00:00:13400,000 women say they've been poisoned.

00:00:17But medical science says there's no proof.

00:00:19Dow is engaged at the present moment of buying science.

00:00:23Scientific evidence is simply not there.

00:00:27Tonight, get the real story.

00:00:29Frontline puts breast implants on trial.

00:00:36Funding for Frontline is provided by the Corporation for Public Broadcasting.

00:00:43And by annual financial support from viewers like you.

00:00:49This is Frontline.

00:00:57The operation you are seeing is rare and controversial.

00:01:12A few years ago, it was one of the most common operations, performed on more than a million women.

00:01:19Today in America, only a handful of surgeons still offer it as part of a clinical study.

00:01:24The silicone breast implant, a bag filled with silicone implanted to augment or reconstruct breasts,

00:01:33has become the center of a bitter controversy involving nearly half a million American women.

00:01:38Is this a valuable medical device or one of the greatest health disasters in history?

00:01:52Thirty-three years ago, when this woman, Timmy Jean Lindsay, had the first ever silicone breast implants,

00:02:05it seemed like a good idea.

00:02:07In March 1962, Timmy Jean, then 28 years old, went into a Texas hospital to have some tattoos removed

00:02:14when two plastic surgeons came to her with a question.

00:02:17And they asked me, would I like to have breast implants?

00:02:22Mom, look at her!

00:02:23What they were going to do would be enlarge my breast.

00:02:27And, you know, after having six kids, it wasn't as flat, it was just they sag.

00:02:35Hold on, Mary!

00:02:36Of course I said yes.

00:02:38Almost immediately, she noticed an effect.

00:02:40Well, it was about six weeks after surgery, and we were going to go out to a club.

00:02:46So we walked into this bar, and all the men just went, wow, you know, and whistle and whoop calls and everything.

00:02:55So I thought, kind of went to my head, you know.

00:02:58I thought, wow.

00:02:59But the breast standing out and enlarged made me, my waist looked smaller and everything, accentuated the waist.

00:03:09It kind of built my self-esteem or my confidence or something like that,

00:03:14because really I thought, after having six children, that no one,

00:03:18I just probably never would attract any men or anything.

00:03:22But it really did the trick.

00:03:25In the next three decades, many thousands of women followed in Timmy Jean's footsteps.

00:03:33For a few thousand dollars, women could change their shape from the way they were to the way they wanted to be.

00:03:39In Sunbelt states like Texas, as many as one woman in 50 had silicone breast implant surgery.

00:03:45But there was another group of women, for whom the new prosthesis offered a lifeline.

00:03:58In 1977, when Gladys Lass discovered she had lumps in her breast and would have to undergo a radical mastectomy,

00:04:06she was devastated.

00:04:08Then doctors proposed reconstructing her breasts with silicone,

00:04:12offering her a possibility of being whole again.

00:04:15I had to wait a month after the mastectomies to have reconstruction.

00:04:18So I knew what I looked like without breasts.

00:04:22And so then a month later, once again, I have beautiful breasts.

00:04:27They were soft.

00:04:28They were supple.

00:04:30It was just impossible to tell that they were not real breasts.

00:04:33The surgeon, he told me that they were absolutely harmless and that they would last me a lifetime.

00:04:41He said, matter of fact, Gladys, he said, if you live to be 80 and die, all your friends are going to be very envious

00:04:48because when you're in the casket, you may be an old woman, but you'll have beautiful breasts.

00:04:51Gladys was one of many thousands of women with breast cancer or fibrocystic disease

00:05:03who, following radical mastectomies, had their breasts reconstructed with silicone implants in the 70s and 80s.

00:05:09For 13 years, Gladys was happy with her implants.

00:05:18But then she began to experience a litany of bizarre health problems.

00:05:21I started having problems probably around 1990.

00:05:28My shoulders would freeze up.

00:05:30I had to have my shoulders injected and then I had to take physical therapy.

00:05:35And then I would go three or four months and the first thing you know, they would start freezing up again.

00:05:39And so this kept happening.

00:05:42And then I would have a stinging sensation in my face that would come like someone just drew a line right here.

00:05:48Just exact nowhere else.

00:05:50And it would sting, sting, sting, like bees were stinging me.

00:05:54And that would come and go.

00:05:56Just say, hey, take everybody's aim off and we're going to start off.

00:05:58I had double vision.

00:06:00The tip of my tongue would go numb like I'd been to a dentist.

00:06:03I could not remember things.

00:06:06And I would drop things or I'd knock things over.

00:06:09I would have terrible spasms in my legs.

00:06:11They would just drop under me.

00:06:13And my arches would curl up and my husband would have to hold my feet on the floor.

00:06:19In the evenings a lot.

00:06:20I saw a lot of these things before she would realize them.

00:06:24I didn't know what was causing them.

00:06:26And I knew that there was something wrong.

00:06:29And when she would go to sleep on the couch right after supper and sleep at the time to go to bed,

00:06:35that was not my wife.

00:06:38That was this person that had a big problem.

00:06:42Gladys wasn't the only woman with breast implants having health problems.

00:06:45As Connie Chung told millions of viewers later that year.

00:06:49Most of us know little about breast implants.

00:06:52We've seen the ads.

00:06:52We've heard the rumors about which celebrities have them and which don't.

00:06:56But we don't know anything about the dangers.

00:06:59Since the early...

00:06:59The program told viewers that many women with silicone implants were reporting patterns of illness.

00:07:05From breast cancer to autoimmune diseases like rheumatoid arthritis.

00:07:08Since roughly one million women had implants, a huge public health crisis might be looming.

00:07:20Many celebrities had silicone breast implants.

00:07:23And some of them, like Jenny Jones, had also experienced health problems.

00:07:27They used their television shows to warn other women of the dangers.

00:07:30I've got fibromyalgia, chronic fatigue syndrome.

00:07:34I've been tested for scleroderma, lupus, rheumatoid arthritis.

00:07:39And 25, I taught aerobics, and I can hardly get around.

00:07:42I had my first heart attack at 44.

00:07:46I'm on heart medication.

00:07:48I have undifferentiated lupus, Sjogren's, arthritic condition.

00:07:55I'm too young.

00:07:56What kind of implants?

00:07:57I had the silicone breast implant.

00:08:00Raise your hands if you've had problems.

00:08:04That's just about everybody.

00:08:05As the media devoured the story, fear spread among American women with implants.

00:08:10A lot of women have had them removed.

00:08:12When, they wondered, would they get ill?

00:08:18Dow Corning, the largest manufacturer of breast implants, had heard some of these complaints before.

00:08:23In the 1980s, a few women had claimed that the silicone contained in the bags had leaked out, damaging the immune system and causing it to attack their own tissues, which led in turn to autoimmune diseases like rheumatoid arthritis.

00:08:38Some, like Marion Hopkins, had even taken the company to court.

00:08:46In 1991, she sued Dow Corning, arguing that silicone leaking from a ruptured implant caused her autoimmune disease.

00:08:53Her case was based on hundreds of pages of internal memos and reports that her lawyers obtained from Dow Corning, suggesting that the company had been aware of problems with the devices, but had continued to market them anyway.

00:09:07Dow Corning memo.

00:09:09We are hearing complaints from the field.

00:09:11The general claim is that the units bleed profusely after they've been flexed vigorously.

00:09:15Dow Corning memo.

00:09:16I have proposed again and again that we must begin an in-depth study of our gel, envelope, and bleed phenomenon.

00:09:23Time is going to run out on us if we do not get underway.

00:09:25Memo to Salesforce.

00:09:27The new implants have a tendency to appear oily after being manipulated.

00:09:31Wash with soap and water in nearest washroom.

00:09:33Dry with hand towels.

00:09:34Dow Corning memo.

00:09:35To put a questionable lot of implants on the market is inexcusable.

00:09:39I don't know who's responsible for this decision, but it has to rank right up there with the Pinto gas tank.

00:09:44I will tell you, during my trial, I was just absolutely appalled by the information that I heard.

00:09:53I felt that the manufacturer had a social, moral, and ethical responsibility to the consumers, and that this product should not be on the market.

00:10:04The jury agreed.

00:10:07In December 1991, they awarded Marion Hopkins a stunning $7.3 million, claiming Dow Corning was guilty of negligence and fraud.

00:10:19Hopkins' victory served as an inspiration for other women.

00:10:22All this activity had caught the attention of the FDA, which, after years of doing little, had finally gotten around to asking breast implant manufacturers for comprehensive safety data.

00:10:36Commissioner David Kessler, who was appointed in 1990, felt that the FDA had let women down.

00:10:44Kessler was concerned by a series of case reports by physicians suggesting a possible association between breast implants and autoimmune diseases.

00:10:54Then he received the package of Dow Corning documents from Marion Hopkins' lawyer, and he was disturbed by what he read.

00:11:00There were a whole set of internal Dow documents that raised concerns.

00:11:08They were reporting areas of thinness and thickness to the outer envelope.

00:11:14They were talking about increasing bleed rates.

00:11:18They were saying that there were problems when the devices were flexed, that they would bleed profusely or that they would rupture.

00:11:24And when I saw those quality assurance problems, and I saw that those devices had been implanted, my first concern was basically to say, time out.

00:11:36We need to get a handle on this.

00:11:38We need to get certain questions answered.

00:11:41And I can't continue to allow this device to be implanted in women until we have the answers to those questions.

00:11:48On January 6th, 1992, Kessler made a dramatic announcement that caught the attention of the nation.

00:11:56I am asking that physicians cease using silicone gel implants.

00:12:02As physicians, our first obligation is to do no harm.

00:12:07We do not know exactly what material...

00:12:09I don't think Kessler could possibly have foreseen the consequences of his action.

00:12:14Walk in my shoes.

00:12:15You want to study?

00:12:16Study me!

00:12:17He said, look, I'm going to remove breast implants from the market.

00:12:22I know that one to two million of you already have them.

00:12:27Not to worry.

00:12:28Don't get them taken out.

00:12:31Nevertheless, I'm removing them from the market so that other women can't get them.

00:12:35And I think women who had breast implants, quite rightly, were terrified by this.

00:12:40And there were women who were so frightened that they did desperate things.

00:12:45There were a few women who tried to carve out their own implants with razor blades because they couldn't afford the surgeon's fee to have them removed.

00:12:54This is the measure of the fear, the alarm, the desperation that his action caused.

00:13:00Dow Corning, the largest implant manufacturer, found itself under attack from an outraged media.

00:13:09Let me read a couple of the particularly disturbing quotes.

00:13:13One salesman said putting these implants on the market was, quote, inexcusable and had to rank right up there with the Pinto gas tank.

00:13:20An internal document instructed salesmen to wash off the oily film off the outside of the implants, ostensibly, I'm assuming, so doctors wouldn't realize that they, in fact, could leak.

00:13:34You said that this is a PR nightmare, but isn't it much more than that?

00:13:38Doesn't this show some sort of unethical behavior by your company?

00:13:42Not at all.

00:13:43Both those documents are very interesting.

00:13:45Both of them related to the complaint of a salesman back to his sales manager, and they had to do with the appearance of the product.

00:13:53Okay?

00:13:53It was not an issue that involved the safety of the product.

00:13:57It had to do with the appearance.

00:13:59Stop the lies and get the facts.

00:14:01Stop the lies.

00:14:02Kessler's moratorium had turned the concerns of individual women into a political movement.

00:14:06I am appalled that the American public has not called for criminal charges against these many doctors.

00:14:18Thousands of women were frightened, angry, and looking for help.

00:14:25And there was no shortage of people ready to help them, like the legendary Texas attorneys John O'Quinn and Rick Laminack, who some called the kings of tort.

00:14:33There were thousands and thousands, tens of thousands of women who reported being ill.

00:14:42And so only common sense tells you with that many women that are ill, something's wrong with this product.

00:14:47And those women, O'Quinn argued, needed expert help.

00:14:51These women cannot possibly get justice without highly experienced, capable lawyers who are actually willing to put up the money to fight these companies.

00:15:01To do one of these cases, you've got to spend probably a million dollars to get knowledgeable enough to present it.

00:15:09Most lawyers cannot afford to spend a million dollars to take a case to court.

00:15:13He opened her up.

00:15:14He found...

00:15:16O'Quinn could.

00:15:18Later that year, he convinced a jury to find for his client, Pamela Johnson, against implant manufacturer Bristol Myers Squibb, awarding her $25 million.

00:15:27With such huge sums, a flood of women came forward asking O'Quinn and Laminack to sue manufacturers on their behalf.

00:15:38As the number of clients grew, O'Quinn and Laminack began holding regular meetings to brief clients and boost morale in what, for most of them, was going to be a long and bitter fight with corporate America.

00:15:49They are so scared of Rick Laminack and John O'Quinn that they put us on the front cover of their most famous magazine.

00:16:00Fortune.

00:16:01This is what all the executives of Fortune 500 read.

00:16:05And, of course, the point of the article is to demonize us.

00:16:09So they call us the lawyers for hell.

00:16:11We're the lawyers that give them hell.

00:16:14Make no mistake, we are engaged in a holy war.

00:16:31We're going to win this fight.

00:16:34We're going to win it because we're right.

00:16:37And we're going to win it because, like no case, I've ever worked on.

00:16:41This is the champion of all of them.

00:16:45I've got the greatest clients who ever lived.

00:16:50And if we're going to beat the Dow machine, and they've got a lot of help, 3M is not a small squirt itself.

00:16:58Nor is Bristol and Baxter.

00:16:59Together, these companies are worth in excess of $50 billion.

00:17:02It will be only because of a united effort.

00:17:08And your voice, your voice saying, no, we're not going to take this.

00:17:14All over the country, cases were filed.

00:17:28Fueled by lawyers' advertisements, media publicity, and reports of enormous verdicts,

00:17:34women came forward first dozens, then hundreds, then thousands,

00:17:38all wishing to pursue cases against Dow Corning and the other manufacturers.

00:17:44Soon, it was clear that this would become the largest mass tort in history,

00:17:48eclipsing litigation for asbestos, Dow Con Shield, and Agent Orange.

00:17:53There were so many cases that they threatened to choke the legal system.

00:17:57The growing litigation crisis quickly attracted the attention of specialists in mass tort litigation

00:18:03like the Cincinnati lawyer, Stan Chesley.

00:18:06Where's Ginny Ellsberg?

00:18:08When's he coming back?

00:18:10Chesley realized that something had to be done, and quickly.

00:18:13Otherwise, there would be total chaos, and women might not get anything.

00:18:17The average federal judge, or the average state judge,

00:18:21is not going to spend the rest of their judicial career trying only breast implant cases.

00:18:28Oh, hi, I'm Judge Smith, and from now on, I'm 40 years old,

00:18:32and from now on, until I retire, I will try nothing but breast implant cases.

00:18:39Chesley saw the opportunity to create a massive class action

00:18:42by amalgamating thousands of women into a class and representing them all at once.

00:18:48Their chances of getting compensation were much better.

00:18:51The class action was a means to put some order in this,

00:18:56because the key was to build a united front and go after the defendants.

00:19:01And if everybody was going off on their own,

00:19:04one might sue Dow Corning, one might sue 3M,

00:19:07somebody may have wanted to go after the raw manufacturer, the raw product manufacturer.

00:19:11There were certain defendants that we already knew were bankrupt or almost bankrupt.

00:19:17And so my view about the class action was more a procedural case management tool.

00:19:24It was a means to put some order in this.

00:19:28But lawyers like O'Quinn and Laminack thought Chesley was trying to take control

00:19:32of perhaps the most lucrative litigation of the century.

00:19:35They urged their clients not to join Chesley, who had a reputation for settling quick,

00:19:41but stick with them and perhaps get multi-million dollar settlements.

00:19:46A lot of lawyers thought I wanted to take over the litigation.

00:19:50My view was this litigation was big enough

00:19:52that we needed all the help we can get.

00:19:56And the other rap that I get is, oh, Chesley settles quick.

00:20:01Well, I don't settle quick.

00:20:04Dow Corning found themselves under attack on two fronts,

00:20:07Chesley's class action on the one hand

00:20:09and thousands of individual cases brought by trial lawyers like O'Quinn on the other.

00:20:13Located in Midland, Michigan, Dow Corning had built its wealth

00:20:21on mass-producing a single, very versatile and useful product.

00:20:27They took silicon, the second most abundant element on Earth,

00:20:31and transformed it into a polymer, silicone,

00:20:34which they found possessed an incredible set of properties.

00:20:37It could form a liquid, a rubber, a putty, and a solid.

00:20:47It could act as a defoaming agent and as a water repellent.

00:20:52Today, silicones are found everywhere,

00:20:54from glues to shampoos, deodorants to gel tabs.

00:21:03Today, everything from automobile parts to hose pipes

00:21:06are made from silicone.

00:21:09It has become a crucial raw material for American industry.

00:21:14Founded in the 1940s, Dow Corning had prospered

00:21:17as a traditional manufacturing industry,

00:21:19producing one basic product.

00:21:22Now they found their future threatened by an industry of the 1990s,

00:21:26mass tort litigation.

00:21:31At Laminak and O'Quinn's Houston offices,

00:21:34armies of paralegals toil away managing the cases

00:21:36of thousands of women.

00:21:38Success depends on winning lawsuits,

00:21:41a service for which they reportedly charge 40%.

00:21:44The deluge of paper that comes in every day

00:21:48is so extensive that we have half a dozen people

00:21:53that do nothing but file all day, every day.

00:21:57Laminak and O'Quinn have mechanized litigation

00:21:59every bit as much as Dow Corning mechanized production of silicons.

00:22:03Their team of staff, that even includes a full-time nurse,

00:22:08prepares all the groundwork for the ultimate courtroom battle.

00:22:13They even have their own courtroom to rehearse expert witnesses

00:22:16and their own video studio to record performances.

00:22:20The aim is to prepare a formidable case,

00:22:26so formidable that a corporation is willing to make a settlement

00:22:29to avoid fighting them in court.

00:22:31These files contain the deposition testimony of about a million pages.

00:22:39Every corporate executive, every technician,

00:22:43every internal employee of Baxter, Bristol-Myers,

00:22:48Dow Corning, 3M, that had anything to do with breast implants,

00:22:52have been deposed thoroughly,

00:22:53and this is probably the most complete library in the world

00:22:58of the sworn testimony of the bad guys.

00:23:01Now, the explanted implants themselves.

00:23:06But the most unusual archive they have

00:23:08is this room full of hundreds of silicone implants

00:23:11removed from their clients' bodies.

00:23:13It's probably the most complete collection

00:23:17of used implants anywhere in the United States,

00:23:21and that is of great scientific significance.

00:23:26But they weren't the only game in town.

00:23:31Back in Cincinnati, Stan Chesley

00:23:33had not only established the class action,

00:23:36but had also succeeded in having Cincinnati chosen

00:23:38as the main depository for the nationwide litigation,

00:23:41which now involved hundreds of lawyers

00:23:44and tens of thousands of women plaintiffs in every state.

00:23:50Depositions and documents relating to litigation

00:23:52against all the companies

00:23:53were stored in a huge Cincinnati warehouse.

00:24:03Litigation on this scale, in Chesley's view,

00:24:06needed organizing, so that other lawyers,

00:24:08perhaps not as experienced as O'Quinn,

00:24:10could participate.

00:24:12His law firm prepared and sold

00:24:14a do-it-yourself guide

00:24:16to suing breast implant manufacturers.

00:24:20We can have an army of trial lawyers

00:24:23all over the country,

00:24:25and we can arm

00:24:27each one of those lawyers

00:24:30with a briefcase of ROM discs

00:24:35and be prepared to go try their case.

00:24:39CD holds roughly 20,000 to 25,000 pieces of paper.

00:24:42So we have a total of 3 million pieces of paper on CD right now.

00:24:46When we put together these trial notebooks,

00:24:48this is one of the notebooks that's involved with the Baxter Company.

00:24:52And if you look at it,

00:24:53you open it up,

00:24:54you can see by the tabs,

00:24:55you can literally take this notebook

00:24:58and prepare for a case starting from the beginning of a case to the end.

00:25:02You can see jury selection,

00:25:04followed by opening statement,

00:25:05witness list,

00:25:06deposition designations,

00:25:08motions that you can file

00:25:09or respond to,

00:25:11the exhibit list,

00:25:13jury instructions,

00:25:13and then all the way

00:25:14to verdict forms

00:25:15and post-trial briefs.

00:25:19By the end of 1994,

00:25:21some 20,000 individual lawsuits

00:25:23had been filed against Dow Corning

00:25:25and countless other women

00:25:26were considering legal action.

00:25:29In desperation,

00:25:30Dick Hazleton,

00:25:31the third CEO since Kessler's moratorium,

00:25:34began negotiations

00:25:35toward a global settlement plan

00:25:37masterminded by Stan Chesley

00:25:39to pay a fixed one-time amount

00:25:42into a fund

00:25:43against which the women could claim.

00:25:45But if they were innocent,

00:25:47why did they want to settle?

00:25:50For a company in a position like ours,

00:25:52faced with 20,000 lawsuits,

00:25:54the only feasible way

00:25:55for us to move out of that situation

00:25:57is to try to seek

00:25:59some sort of an overall resolution

00:26:00of the case.

00:26:02A settlement.

00:26:03A settlement of some sort.

00:26:05And that presents a problem

00:26:06because when we start to talk about that,

00:26:09the perception that's created immediately

00:26:12is that we're admitting guilt.

00:26:13Why would we spend money

00:26:14to participate in a settlement

00:26:15if, in fact,

00:26:16we believe our products are safe?

00:26:19Why don't we stand and fight?

00:26:20But it comes back

00:26:21to that fundamental economic calculation.

00:26:26Breast implants formed a tiny part

00:26:28of Dow Corning's business,

00:26:30but the ramifications of the mass litigation

00:26:32affected workers in all parts of the company,

00:26:35like Linda McAnally,

00:26:36who now faced an uncertain future.

00:26:39I think that what's happening to Dow Corning

00:26:41could happen to any company in this country.

00:26:44I mean, there's a product at every company

00:26:46that some lawyers are going to decide

00:26:47is the target,

00:26:49and they're going to go after it

00:26:50with their mass torts.

00:26:51I don't think that what's happening

00:26:52is because of Dow Corning

00:26:53and any unique did anything differently

00:26:56than any other company.

00:26:57I just think it's a decision

00:26:58that this lawyer's made

00:26:59to go after this product.

00:27:01Workers rallied around management,

00:27:07giving them their full support.

00:27:09I've never worked with a group of individuals,

00:27:12people, management or otherwise,

00:27:14that are so together on this thing,

00:27:16and I think that by continuing to work hard

00:27:18and keep focused

00:27:19and let the decisions be made in the courts,

00:27:23I think we will come through it.

00:27:25I don't know what the end results will be,

00:27:29but I think we will come through it.

00:27:31Back at the Food and Drug Administration,

00:27:36Kessler had watched in horror

00:27:37at the effects of his announcement.

00:27:39He had never said breast implants were unsafe.

00:27:42He had simply called a timeout

00:27:43to examine the evidence

00:27:44that had emerged in court cases.

00:27:48A few weeks after his moratorium,

00:27:50he had called the FDA

00:27:51Scientific Advisory Panel together

00:27:53to consider all the data.

00:27:56One of the special consultants to the panel

00:27:58was John Surgent.

00:28:00Hello, Tammy.

00:28:00Former President of the American College of Rheumatology.

00:28:04How's your energy level?

00:28:05Surgent is an expert on autoimmune diseases

00:28:07which affect tissues like the muscles and joints,

00:28:10so-called connective tissues.

00:28:12Tammy, who does not have breast implants,

00:28:15has scleroderma,

00:28:16a very serious and sometimes fatal disease.

00:28:21Other of Surgent's patients have rheumatoid arthritis

00:28:24and systemic lupus.

00:28:26If such serious conditions were being triggered

00:28:29by silicone leaking from the implants,

00:28:31then with one million women exposed,

00:28:33rheumatologists might soon be facing an epidemic.

00:28:37So Surgent was deeply interested.

00:28:38I went to the panel with the bias

00:28:43that there probably was something to it.

00:28:44First of all, I believed that Dr. Kessler

00:28:46probably would not have asked for the moratorium

00:28:48if he didn't have real data, meaningful data.

00:28:51And secondly, I hadn't at that point

00:28:53seen any rebuttal to what people had been saying.

00:28:57So I went to the panel expecting

00:28:59that there was something to it.

00:29:01I came back from the panel very disappointed.

00:29:04There was no attempt to do any kind of scientific look

00:29:07at the population, and as a matter of fact,

00:29:09there was almost no attempt to filter this material.

00:29:12It was a series of anecdotal reports

00:29:14from two or three rheumatologists,

00:29:16from a neurologist, from others.

00:29:19You have to understand that these diseases are not rare

00:29:21that we're talking about,

00:29:23and we had a million women walking around

00:29:25with breast implants.

00:29:27Therefore, we would expect to see

00:29:2940,000 or 50,000 cases of these various diseases

00:29:32occurring over a period of time.

00:29:34Please be brief, concise, to the point...

00:29:37Chairperson of the panel was Elizabeth Connell,

00:29:39a veteran women's health researcher.

00:29:41She was also disappointed

00:29:43at the lack of hard scientific evidence.

00:29:45Although there were data on autoimmune disease,

00:29:48they were certainly not scientifically valid,

00:29:50and it's always been very, very clear.

00:29:53You cannot make good value judgments

00:29:56based on anecdotal types of information.

00:30:01But that, you see, was our problem.

00:30:05So the FDA panel settled on a compromise,

00:30:08recommending that use of silicone implants

00:30:10could continue, but only for patients

00:30:13undergoing breast reconstruction,

00:30:15not augmentation,

00:30:16and only as a part of a scientific trial

00:30:20where the women would be followed.

00:30:24Women wanting breast augmentation

00:30:27could still get saline implants.

00:30:28These did not feel as natural

00:30:32and had a tendency to wrinkle,

00:30:34but if they ruptured,

00:30:35all that would leak out was harmless salt water.

00:30:40By the end of 1992,

00:30:42there were several scientific studies underway

00:30:44involving researchers

00:30:46from some of the world's top medical centers

00:30:48aimed at determining whether or not

00:30:50silicone breast implants

00:30:51caused systemic disease.

00:30:53But these studies would take time.

00:30:57Scientific research moves slowly and methodically.

00:31:01Doing the research is just the beginning.

00:31:03Before it is taken seriously,

00:31:05a research report must be submitted

00:31:06to one of hundreds of medical journals

00:31:09and reviewed by other scientists.

00:31:11If it is acceptable, it gets published,

00:31:14where other scientists can read

00:31:15and criticize it further.

00:31:16Only if it survives this process

00:31:19and the results are replicated

00:31:21does the information become accepted

00:31:23into the canon of scientific knowledge.

00:31:25We have to wait for the science.

00:31:29What was so startling to me

00:31:31in this case

00:31:33was the disconnect

00:31:34between the science,

00:31:36which largely wasn't there in 1992,

00:31:39and what was happening in the courts,

00:31:42and what was happening at the FDA,

00:31:44and what was happening in public opinion.

00:31:46The disconnect was amazing.

00:31:49Marsha Angel,

00:31:51the executive editor

00:31:52of the New England Journal of Medicine,

00:31:54had been troubled by Kessler's moratorium

00:31:56and the ensuing panic.

00:31:58She felt that the trial lawyers

00:31:59and the media

00:32:00had proclaimed the dangers of breast implants

00:32:02without waiting for scientific proof.

00:32:05She urged women

00:32:06not to jump to conclusions

00:32:08until the scientific evidence was in.

00:32:11I think a reasonable person

00:32:13has to be skeptical.

00:32:14I think a reasonable person

00:32:16always has to be skeptical.

00:32:18History is replete

00:32:20with instances

00:32:21of health scares

00:32:24based on claims,

00:32:26testimonials,

00:32:28anecdotes,

00:32:29and we have to wait for the science.

00:32:32Being skeptical,

00:32:34according to Angel,

00:32:35did not mean doubting

00:32:36that women like Gladys Lass

00:32:38and Marion Hopkins were ill.

00:32:40The issue concerned

00:32:41whether their illnesses

00:32:42were caused by silicone breast implants

00:32:44or would have happened anyway.

00:32:46You have to look at coincidence.

00:32:50About 1% of the population

00:32:52of women

00:32:53have breast implants,

00:32:55and about 1%

00:32:57of American women

00:32:58have connective tissue diseases,

00:33:00the most common being

00:33:01rheumatoid arthritis.

00:33:03So if you do the arithmetic,

00:33:05you find that in this country

00:33:06you can expect

00:33:07about 10,000 women

00:33:10will have both

00:33:11just by coincidence.

00:33:14Since connective tissue disease

00:33:16can occur in women

00:33:17with or without breast implants,

00:33:19the trick here

00:33:20is to rule out coincidence.

00:33:22And the only way you can do that

00:33:24is by an epidemiologic study

00:33:26which tries to see

00:33:29whether connective tissue disease

00:33:31is more common

00:33:33in women with breast implants

00:33:35than it is in women

00:33:36without breast implants.

00:33:38Only when you have done

00:33:40such studies

00:33:41and found the answer

00:33:42to that question

00:33:43can you rule out coincidence.

00:33:46It was little comfort

00:33:48to women like Gladys Lass

00:33:49that controlled epidemiologic studies

00:33:51were underway.

00:33:53Gladys had spent

00:33:53most of 1992 and 3

00:33:55seeing doctors

00:33:56and racking up

00:33:57huge medical bills.

00:33:58Both of her implants

00:33:59had ruptured

00:34:00and she worried

00:34:01that leaking silicone

00:34:02might have caused her illness.

00:34:05This was the view

00:34:06of the physician

00:34:07who took major responsibility

00:34:08for her diagnosis and care,

00:34:10a Houston neurologist

00:34:11named Dr. Bernard Patton.

00:34:13I heard of Dr. Patton

00:34:15and I was able

00:34:16to get an appointment

00:34:17and have a physical

00:34:18and then have a nerve biopsy done.

00:34:20and when he saw the nerve

00:34:23he immediately told

00:34:25the operating nurse

00:34:26to go get my husband

00:34:27because he wanted

00:34:28to tell us both

00:34:29at the same time

00:34:30that I was extremely ill.

00:34:35After telling Gladys

00:34:36her life was in danger

00:34:38and that her implants

00:34:38needed to come out,

00:34:40Patton ordered a series

00:34:41of tests

00:34:41followed by aggressive therapy

00:34:43including a blood cleansing

00:34:44treatment called

00:34:45plasmapheresis.

00:34:47I had six of those.

00:34:49About six weeks

00:34:50after that then

00:34:51I had three months

00:34:53of chemotherapy

00:34:53every day

00:34:54just like a cancer patient.

00:34:57And before that

00:34:57I had any of that done

00:34:59I had 12 weeks

00:35:01of IVs of GammaMune.

00:35:03Gladys was hit

00:35:03with a mass

00:35:04of medical bills.

00:35:06You get a hospital bill

00:35:07for $30,000,

00:35:08$65,000.

00:35:10You get these lab tests

00:35:11that are $1,500

00:35:12and $3,000 a throw.

00:35:14The GammaMune

00:35:15the GammaMune

00:35:17is $1,500 a dose.

00:35:21I said no, uh-uh.

00:35:23This is not right.

00:35:25We were told

00:35:26that these would last me forever

00:35:27and even if they didn't

00:35:29we were told

00:35:30that they were harmless.

00:35:32Take all of that

00:35:33and set all that aside

00:35:35how would you like

00:35:36to have to have

00:35:36your breast removed again?

00:35:38Even if everything else

00:35:40wasn't so.

00:35:41So it's like

00:35:42no, no.

00:35:44We need to be compensated

00:35:45for this.

00:35:46And I told them

00:35:48you know

00:35:48Mr. O'Quinn

00:35:49and Laminak

00:35:50those people

00:35:50owe us some money.

00:35:57Gladys joined

00:35:57thousands of other

00:35:58Texas women

00:35:59and put her faith

00:36:00in the skills

00:36:00of John O'Quinn

00:36:01and Rick Laminak.

00:36:03Only with their help

00:36:05could she hope

00:36:05to get compensation.

00:36:08How many of you women

00:36:09were told

00:36:10that they would last

00:36:11a lifetime?

00:36:13Raise your hand.

00:36:15That was a life.

00:36:18At Dow Corning

00:36:19shocked by this anger

00:36:21executives

00:36:22were waiting anxiously

00:36:23for the results

00:36:23of scientific studies.

00:36:25They believed passionately

00:36:26that silicone

00:36:27was not dangerous

00:36:28and that in time

00:36:29they would be vindicated.

00:36:30medical products

00:36:33formed only 3%

00:36:34of Dow Corning's business.

00:36:37They had begun

00:36:37using silicone

00:36:38in medical devices

00:36:39in the 1950s

00:36:40with hydrocephalus shunts.

00:36:43Then silicone

00:36:43found its way

00:36:44into cardiac pacemaker

00:36:45leads and catheters

00:36:47even as a lubricant

00:36:51for syringes.

00:36:53Quickly silicone

00:36:54became a mainstay

00:36:55of the medical device

00:36:56industry.

00:36:58Silicone was a natural

00:36:59choice for breast implants

00:37:00because it could simulate

00:37:01the consistency

00:37:02of breast tissue

00:37:03and because it was

00:37:04widely believed

00:37:05to be inert.

00:37:08Dow Corning accepted

00:37:09that implants

00:37:10could cause

00:37:10local problems.

00:37:12Like any foreign body,

00:37:13the implant

00:37:14caused inflammation

00:37:15and a capsule

00:37:16of scar tissue

00:37:17formed around it.

00:37:18This fibrous capsule

00:37:20frequently became

00:37:21hard and contracted,

00:37:22deforming the breast

00:37:23and surgeons

00:37:24often would have

00:37:25to break the capsule

00:37:26to restore the shape.

00:37:27Dow Corning also

00:37:29accepted that

00:37:30occasionally implants

00:37:31could rupture

00:37:32inside the capsule

00:37:33but claimed it was

00:37:34a very rare event.

00:37:36Others disagreed.

00:37:39Since Kessler's

00:37:39moratorium,

00:37:40plastic surgeons

00:37:41had been besieged

00:37:42with women

00:37:42demanding to have

00:37:43their implants removed.

00:37:46Some surgeons

00:37:47did hundreds

00:37:48of explantations.

00:37:49They removed the

00:37:53encapsulated implant

00:37:54from the breast,

00:37:55cracked open

00:37:56the fibrous capsule

00:37:57and looked inside.

00:38:00This implant,

00:38:01surprisingly,

00:38:02is intact.

00:38:03Some implants

00:38:04emerged looking

00:38:04like new.

00:38:07Others seemed

00:38:08to have disintegrated.

00:38:10No one was quite

00:38:11sure of the reason.

00:38:12Trauma,

00:38:13age,

00:38:14weaknesses,

00:38:14surgical nicks,

00:38:16but a number

00:38:16of scientists

00:38:17argued that the

00:38:18true rupture rate

00:38:18might be much higher

00:38:19than previously thought.

00:38:21Some put it

00:38:21as high as 50%

00:38:23or more.

00:38:25While most of the

00:38:25silicone stayed

00:38:26inside the fibrous

00:38:27capsule,

00:38:28there was a possibility

00:38:29that some could escape

00:38:30into the body.

00:38:32The crucial issue,

00:38:33therefore,

00:38:33was not rupture,

00:38:35but whether silicone

00:38:36was truly

00:38:36biologically inert

00:38:38or whether it caused

00:38:39systemic disease.

00:38:43Dow Corning

00:38:44had carried out

00:38:44a series of animal

00:38:45experiments which

00:38:46they claimed proved

00:38:47silicone was neither

00:38:48toxic nor caused

00:38:50cancer.

00:38:51But the FDA had

00:38:52found these studies

00:38:53inadequate,

00:38:54claiming that they

00:38:54did not predict

00:38:55how implants would

00:38:56fare in the human

00:38:57body over a lifetime

00:38:58of use.

00:39:02Since the moratorium,

00:39:04a number of centers

00:39:05had begun controlled

00:39:06epidemiologic studies

00:39:07on humans.

00:39:08The Mayo Clinic

00:39:09in Rochester,

00:39:10Minnesota,

00:39:10had complete records

00:39:12on women going back

00:39:13many decades.

00:39:13They looked at

00:39:15every woman in the

00:39:16county who had

00:39:16gotten breast implants

00:39:18between 1964 and 1991

00:39:20and compared them

00:39:22with a control group

00:39:23of their neighbors

00:39:23without implants

00:39:25matched for age.

00:39:27They tried to

00:39:27determine whether

00:39:28the women with

00:39:29breast implants

00:39:30were more or less

00:39:31likely to contract

00:39:32connective tissue

00:39:33disease than the

00:39:34controls.

00:39:35The article was sent

00:39:38into the New England

00:39:38Journal of Medicine

00:39:39in November 1993

00:39:40where it entered

00:39:42a long peer review

00:39:43process to check

00:39:44if the science

00:39:45was sound.

00:39:47So they're

00:39:48confounding issues?

00:39:49They're confounding

00:39:49issues.

00:39:50These are extra copies

00:39:51that I can give them?

00:39:52Right.

00:39:53Meanwhile,

00:39:53in Cincinnati,

00:39:54Stan Chesley

00:39:55was putting the

00:39:56finishing touches

00:39:57on a global

00:39:57settlement deal.

00:40:00After intense

00:40:02negotiations,

00:40:03Dow Corning

00:40:03agreed to put up

00:40:04more than $2 billion

00:40:05into a breast implant

00:40:06victims fund.

00:40:07Other manufacturers

00:40:09brought the total

00:40:09to over $4 billion.

00:40:13Women with implants

00:40:14were encouraged

00:40:15to register,

00:40:16not only those

00:40:16who were currently

00:40:17sick,

00:40:18but also those

00:40:19who felt fine

00:40:20in case they

00:40:21developed symptoms

00:40:22in the future.

00:40:23The Alabama

00:40:24federal court

00:40:25administering

00:40:26the global settlement

00:40:27announced a deadline

00:40:28for women to join

00:40:29in with Chesley's plan

00:40:30or rocked out

00:40:32and go it alone

00:40:32with trial lawyers

00:40:33like John O'Quinn.

00:40:35If you have ever

00:40:37had breast implants,

00:40:38this is an official

00:40:38legal notice

00:40:39from the U.S. District

00:40:40Court,

00:40:40Northern District

00:40:41of Alabama.

00:40:42Women must decide

00:40:43by June 17th

00:40:44if they do not

00:40:45want to participate

00:40:46in this settlement.

00:40:47To help you make

00:40:48this personal legal

00:40:49decision,

00:40:50the court has prepared

00:40:51this information package.

00:40:52All women with implants

00:40:53should call a right

00:40:54for this information.

00:40:56It's free

00:40:56and all names

00:40:57will be kept confidential.

00:41:01By chance,

00:41:02the same week

00:41:02as the deadline,

00:41:03the results

00:41:04of the Mayo Clinic

00:41:05study made it

00:41:05into print.

00:41:07They had looked

00:41:08to see if women

00:41:09with breast implants

00:41:10got more connective

00:41:11tissue disease

00:41:12than women

00:41:12without breast implants.

00:41:14They found

00:41:15absolutely no difference.

00:41:18Investigator

00:41:18Shireen Gabriel

00:41:19announced the news.

00:41:21It's my hope

00:41:21that these results

00:41:22can reduce

00:41:23some of the anxiety

00:41:24that many women

00:41:25with breast implants

00:41:26feel regarding

00:41:26their future.

00:41:28But far from

00:41:29reducing anxiety,

00:41:30Shireen Gabriel

00:41:31and her colleagues

00:41:32were roundly attacked.

00:41:33question,

00:41:35who paid for it?

00:41:35Mayo didn't pay for it.

00:41:37And second study,

00:41:39I'm very suspect

00:41:40about any studies

00:41:42that are funded

00:41:42by the plastic surgeons.

00:41:44We took away

00:41:44their pet industry.

00:41:46I mean,

00:41:46their industry

00:41:47is in shambles.

00:41:50The Mayo study

00:41:50had received

00:41:51some funding

00:41:51from an educational arm

00:41:53of the Plastic Surgeons

00:41:54Association,

00:41:55which in turn

00:41:56had received money

00:41:57from Dow Corning.

00:41:58But was Chesley saying

00:42:00that the Mayo Clinic

00:42:00had been bought off?

00:42:01I don't like the word buy,

00:42:03but they love

00:42:04research grants.

00:42:05I mean,

00:42:05I was on the board of,

00:42:06chairman of the board

00:42:07of trustees

00:42:08of a university

00:42:09and I know

00:42:10how diligently

00:42:11they fight

00:42:12for research grants.

00:42:14Some lawyers

00:42:15even suspected

00:42:15that the New England

00:42:16Journal of Medicine

00:42:17was implicated

00:42:18along with the Mayo Clinic.

00:42:22Undaunted by the fact

00:42:23that the journal

00:42:24is the most prestigious

00:42:25medical journal

00:42:26in the world,

00:42:27operating independently

00:42:28since 1812,

00:42:29they fired a warning shot

00:42:31across Marcia Angel's desk.

00:42:34I received a subpoena

00:42:36in the fall of 1994,

00:42:39growing out of

00:42:40the Mayo Clinic study,

00:42:42and then another one

00:42:43from the same people

00:42:44the following spring,

00:42:46asking me to produce

00:42:49all documents

00:42:51that indicated

00:42:53that the breast implant

00:42:55manufacturers

00:42:56had paid me.

00:42:58and they implied

00:43:00that the New England

00:43:01Journal of Medicine

00:43:02had been paid

00:43:03by the breast implant

00:43:05manufacturers.

00:43:06An outrageous suggestion.

00:43:08So what?

00:43:09I got news for you.

00:43:10Let them be offended.

00:43:12Let me tell you something.

00:43:13I have seen doctors

00:43:14involved in research

00:43:15at my institution

00:43:16when I was chairman

00:43:17of the board

00:43:17and I asked questions.

00:43:18Why did you take

00:43:19this study?

00:43:21What were the ground rules?

00:43:23And they got offended

00:43:25when I asked those questions

00:43:27because they want to hide

00:43:28behind their white coat.

00:43:29I got news for you.

00:43:30Anybody who gets offended

00:43:31or easily intimidated

00:43:33by these kind of questions

00:43:36shouldn't be in that business

00:43:37because guess what?

00:43:39They are not sacrosanct.

00:43:41The science,

00:43:43the devil with the science,

00:43:44it doesn't matter anymore.

00:43:47Sybil Knighton-Goldrich

00:43:49is a former breast cancer patient

00:43:50who once had silicone implants.

00:43:53Today she spends much of her time

00:43:54as co-chairperson

00:43:55of Command Trust Network,

00:43:57one of a series

00:43:58of well-organized support groups

00:43:59that puts out newsletters

00:44:01and holds seminars.

00:44:03The thrust of such activist groups

00:44:05is that women should take charge

00:44:06of their own health.

00:44:08They are deeply suspicious

00:44:09of the medical establishment

00:44:10and don't hesitate

00:44:11to criticize them.

00:44:13Women get autoimmune disease

00:44:15with or without breast implants.

00:44:17Agree or disagree?

00:44:19I agree.

00:44:20To prove causality

00:44:21is a complex process

00:44:23involving epidemiology,

00:44:26good controls and so forth.

00:44:27Agree or disagree?

00:44:29Disagree.

00:44:31Disagree because

00:44:32to prove causation

00:44:34they should have done it before.

00:44:36If they wanted to really know

00:44:38whether this was going

00:44:39to be a problem

00:44:40and obviously

00:44:41they had a hint of it

00:44:42because they mentioned it,

00:44:44they should have established

00:44:45the studies beforehand.

00:44:47Why now?

00:44:48Why now all of a sudden

00:44:49the hallowed institutions

00:44:50are coming forward

00:44:51and saying,

00:44:52we must tell you

00:44:53you're crazy?

00:44:55Now, shame on them.

00:44:57They can't get away with that.

00:44:59That's wrong.

00:45:00Accountability now!

00:45:02The scientific community

00:45:03abdicated its responsibility

00:45:05when it did not do

00:45:06the science up front.

00:45:10How many times

00:45:11has a woman gone to a doctor

00:45:12who said,

00:45:13oh, your aches and pains?

00:45:14My goodness, you're 40.

00:45:17It's to be expected.

00:45:19Now, now.

00:45:21Now you take this little tranquilizer

00:45:23and go home

00:45:23and be a good girl.

00:45:24One of the things

00:45:25that has hurt me personally

00:45:27is the suggestion

00:45:29that this is a woman's issue

00:45:31and if you don't believe

00:45:33that breast implants

00:45:35cause connective tissue disease,

00:45:37you are therefore

00:45:39anti-feminist or anti-women.

00:45:42I'm a feminist.

00:45:43I think I've earned my badge

00:45:45as a feminist.

00:45:46I believe very strongly

00:45:48in women's rights

00:45:49in all ways.

00:45:53But this is a scientific matter.

00:45:55It is not a matter of opinion.

00:45:57It's not a matter of legal argument.

00:46:00It's not a matter of debate.

00:46:01It's a scientific argument

00:46:02and it will only be decided

00:46:05by good science.

00:46:08Late in 1994,

00:46:10Gladys Loss made it to trial.

00:46:12For 11 weeks,

00:46:13O'Quinn argued her case

00:46:14before a Texas jury.

00:46:18Dow Corning's lawyer,

00:46:20David Bernick,

00:46:20tried to sway the jury

00:46:22and the press

00:46:22with a Mayo Clinic study.

00:46:24That scientific evidence

00:46:25shows no connection

00:46:26between breast implants

00:46:28and the kinds of rheumatic diseases

00:46:30that had been complained about

00:46:31and had been the subject

00:46:32of case reports.

00:46:36Laminack and O'Quinn

00:46:37waited anxiously

00:46:38while the jury deliberated.

00:46:41The jury had a lot

00:46:42of information to consider.

00:46:44Experts had discussed

00:46:45thousands of pages

00:46:46of internal memos,

00:46:48documents,

00:46:48and scientific studies.

00:46:50Doctors had discussed

00:46:51Gladys' medical history.

00:46:53The jurors deliberated

00:46:56for 11 days

00:46:56before handing down

00:46:57their verdict.

00:46:59They awarded Gladys

00:47:00$5.2 million

00:47:01compensation

00:47:02for her suffering.

00:47:04We are extremely pleased.

00:47:07Tell us how you're feeling

00:47:08right now.

00:47:09This has been a long...

00:47:09Oh, I'm very relieved

00:47:12it's over with.

00:47:13That's for sure.

00:47:15I'm also...

00:47:16I'm so thankful

00:47:17that 12 people

00:47:19that I never saw

00:47:20in my life

00:47:21could come together

00:47:24and realize

00:47:26that we're all not crazy,

00:47:28that we really are sick,

00:47:30and these implants

00:47:32did this to us,

00:47:33and that they could try

00:47:34to make these corporate

00:47:36people responsible

00:47:37for what they've done

00:47:39to us.

00:47:41And my husband and I

00:47:43both are very...

00:47:44just very glad

00:47:45that it's over with me.

00:47:47How did the jury

00:47:48reach its verdict?

00:47:50Two jurors

00:47:51agreed to talk to us.

00:47:53We asked if they were

00:47:54satisfied that silicone

00:47:55caused Gladys' disease.

00:47:57No, I don't think so.

00:47:58Mm-mm.

00:48:00Couldn't help.

00:48:03Why not?

00:48:05Evidence.

00:48:06I don't think

00:48:07there's enough studies.

00:48:09I think they're probably

00:48:09still studying them

00:48:10right now

00:48:11to figure out

00:48:13if they really do

00:48:14cause disease.

00:48:15Was there any evidence

00:48:19that the implants

00:48:20hurt Gladys?

00:48:21Did the evidence

00:48:22prove that the implants

00:48:23were actually harmful?

00:48:24No, there isn't

00:48:25enough evidence

00:48:26for that.

00:48:27Was there enough evidence

00:48:29to prove the implants

00:48:30were safe?

00:48:31No.

00:48:32That either.

00:48:33Nope.

00:48:34But what about

00:48:35the prestigious

00:48:36Mayo Clinic study

00:48:37that Dow Corning

00:48:38had pinned their hopes on?

00:48:39Did that figure much

00:48:40in the deliberations?

00:48:42No.

00:48:43They didn't really

00:48:44impress me that much.

00:48:46Mm-mm.

00:48:47I don't think

00:48:47we went over that

00:48:48during the deliberations,

00:48:49either.

00:48:51Mm-mm.

00:48:53So why then

00:48:54did they award Gladys

00:48:55such a large sum of money?

00:48:57She had a couple

00:48:58of years to retire.

00:49:00We had a dad up.

00:49:01That went into

00:49:02the five million.

00:49:04She's having to have

00:49:06help with her housework.

00:49:09She can no longer cook.

00:49:10Her husband's having

00:49:11to do a lot

00:49:12of the cooking.

00:49:14They used to travel a lot

00:49:16and go on vacations

00:49:17and they can't do

00:49:18that anymore.

00:49:19The future medical

00:49:20bill.

00:49:20I mean, it's just,

00:49:21you know.

00:49:22Oh, that was added up

00:49:23together.

00:49:23The whole life

00:49:23has been changed,

00:49:24both of them.

00:49:25Can you hold the door

00:49:27over there, will you?

00:49:28Can you hold the door

00:49:28for her?

00:49:30Dow Corning declared

00:49:31the verdict illogical

00:49:33and promised to appeal.

00:49:35Despite Gladys'

00:49:36impressive victory,

00:49:38the Mayo Clinic study

00:49:39had been a portent

00:49:40of what was to come.

00:49:41By the summer of 1995,

00:49:43many more scientific

00:49:44studies had made

00:49:45it into print.

00:49:48This study failed

00:49:49to demonstrate

00:49:49an association

00:49:50between silicone

00:49:51breast implantation

00:49:52and the subsequent

00:49:53development of scleroderma.

00:49:54These data failed

00:49:55to support the hypothesis

00:49:56that augmentation

00:49:57mammoplasty

00:49:58with silicone gel-filled

00:49:59prostheses

00:50:00is a risk factor

00:50:01for the development

00:50:02of scleroderma.

00:50:03No cases of scleroderma

00:50:04or lupus were found

00:50:05and the incidence

00:50:06of arthritis

00:50:06was not significantly

00:50:08different.

00:50:08The studies were

00:50:09remarkably consistent.

00:50:11This study found

00:50:11no statistically

00:50:12significant association

00:50:13between silicone

00:50:14breast implants

00:50:15and scleroderma.

00:50:16No association

00:50:17was seen between

00:50:18their conclusions

00:50:18were in total conflict

00:50:20with what was happening

00:50:21in the courts.

00:50:22This study found

00:50:23no evidence

00:50:24that women...

00:50:24While such studies

00:50:25did not exclude

00:50:25the possibility

00:50:26of a small association

00:50:28for perhaps a tiny

00:50:29subset of women,

00:50:30they effectively ruled

00:50:31out a large association

00:50:33between breast implants

00:50:34and connective tissue disease.

00:50:38In June 1995,

00:50:40researchers at the

00:50:41Harvard Medical School

00:50:42reported perhaps

00:50:43the best study so far

00:50:45in the New England

00:50:46Journal of Medicine.

00:50:48They too could find

00:50:49no association.

00:50:50This was a larger study

00:50:53than the Mayo Clinic

00:50:54study.

00:50:54It looked at roughly

00:50:5690,000 nurses.

00:50:59Again, a very old database

00:51:01looking at things

00:51:03that had happened

00:51:04in the past

00:51:05before all of the publicity.

00:51:07And this too

00:51:09could find no connection

00:51:11between breast implants

00:51:13and connective tissue diseases

00:51:15or symptoms,

00:51:16certain symptoms

00:51:17of connective tissue diseases.

00:51:18So these were the two studies

00:51:21that the New England

00:51:22Journal of Medicine

00:51:22published,

00:51:24both very well-designed

00:51:26epidemiologic studies,

00:51:28neither one of which

00:51:29could find a connection.

00:51:31Only one epidemiologic study

00:51:33has reported

00:51:34a possible small association.

00:51:36It was published

00:51:37in this week's

00:51:38Journal of the American

00:51:38Medical Association.

00:51:39But the authors claim

00:51:42the increased risk

00:51:43is too small

00:51:43to mean anything,

00:51:45as the study

00:51:45is based on questionnaires

00:51:47that women filled in

00:51:48after 1992.

00:51:50The authors say

00:51:51the effect is as likely

00:51:52due to the influence

00:51:53of the media frenzy

00:51:54as to implants.

00:51:57Back in 1992,

00:51:59Elizabeth Connell,

00:52:00the chairperson

00:52:01of the FDA Committee

00:52:02on Breast Implants,

00:52:03had bemoaned the lack

00:52:04of good scientific studies.

00:52:07Now there seemed

00:52:08to be an emerging consensus.

00:52:09One of the major

00:52:11recommendations

00:52:12of the panel

00:52:13was to have

00:52:14good scientists

00:52:15from good institutions

00:52:17go out and do

00:52:18good studies

00:52:19and put them

00:52:20into good journals.

00:52:22I think it's critical

00:52:24for people to recognize

00:52:26that without exception,

00:52:28these well-done studies

00:52:30have shown no,

00:52:32I repeat,

00:52:33no association

00:52:34between silicone

00:52:37breast implants

00:52:38and autoimmune disease

00:52:39or any type

00:52:41of autoimmune response.

00:52:45For Dow Corning CEO

00:52:46Dick Hazleton,

00:52:47the studies provided

00:52:48some emotional relief.

00:52:50Whatever else people

00:52:51accused them of,

00:52:52the science seemed

00:52:53to be supporting

00:52:53their claim

00:52:54that breast implants

00:52:55did not cause

00:52:56systemic disease.

00:52:57last October Hazleton

00:53:00agreed to go on

00:53:01the Oprah Winfrey show

00:53:02to try and get

00:53:03this message out.

00:53:04Do you want to respond

00:53:04to what she said?

00:53:05Yes, if I may.

00:53:07I'm here for two purposes

00:53:08with Stephanie today.

00:53:09One is to try to

00:53:11speak to the issues

00:53:12of what women

00:53:13with breast implants,

00:53:14what their questions are

00:53:15and how we should do that

00:53:16and I'd like to do that

00:53:17in a way that is based

00:53:19on science and facts

00:53:20and not solely driven

00:53:22by perhaps understandable

00:53:23anger from people

00:53:24who disagree with me.

00:53:25We are the evidence.

00:53:26Yes.

00:53:27Well,

00:53:27The study is we

00:53:34sitting here.

00:53:35The study is the

00:53:36440,000 women

00:53:37who have claims

00:53:38in the settlement.

00:53:40That's a study.

00:53:41We can't buy science

00:53:42like you people can.

00:53:45Really,

00:53:46I don't think you can

00:53:47challenge the ethics

00:53:47of places like

00:53:48the Mayo Clinic,

00:53:49Harvard University,

00:53:50the University of Michigan.

00:53:51But that's just

00:53:58what the women

00:53:58and their lawyers

00:53:59were claiming.

00:54:00Dow is engaged

00:54:01at the present moment

00:54:02of buying science

00:54:03with their fortune,

00:54:07of buying the research

00:54:09that favors them.

00:54:11Dow is engaged

00:54:12in a public relations campaign

00:54:14with some of the most

00:54:15powerful public relations

00:54:17companies

00:54:17to put out

00:54:19the big lie

00:54:20the big lie.

00:54:24You even read it

00:54:24in the New York Times.

00:54:27This is all about

00:54:28something called science

00:54:30and what does science say

00:54:31and science doesn't say

00:54:32you're right

00:54:32so therefore you're wrong

00:54:33and so therefore

00:54:34we have done no wrong.

00:54:36Hi, it's me.

00:54:37Is he around?

00:54:39First,

00:54:39let's get over the myth

00:54:40that just because Harvard

00:54:42or the Mayo Clinic

00:54:43or Yale

00:54:44says something

00:54:44that it's correct.

00:54:46We know where

00:54:47the bread is buttered.

00:54:48We know

00:54:49who gives the funding.

00:54:51Manufacturers fund,

00:54:53scientists do their studies.

00:54:56It's not at all credible.

00:54:57These are great institutions.

00:55:00Harvard and the Mayo Clinic

00:55:01are great institutions.

00:55:03The New England Journal of Medicine

00:55:04is a great institution.

00:55:06We would be crazy

00:55:08to allow ourselves

00:55:10to be bought

00:55:11by a company.

00:55:13More than half

00:55:14of all the medical research

00:55:16in this country

00:55:17is funded by private industry.

00:55:19If we were to dismiss

00:55:22all science,

00:55:24all biomedical research

00:55:26that was supported

00:55:27by private industry,

00:55:29we would decimate

00:55:31the science in this country.

00:55:33The issue is

00:55:35how does the funding flow?

00:55:37What are the conditions

00:55:38of the funding?

00:55:40And institutions

00:55:40such as Harvard

00:55:41and the Mayo Clinic

00:55:42have very clear-cut conditions

00:55:45for private industry

00:55:47that wants to support work

00:55:49on subjects

00:55:50that they have an interest in.

00:55:53First of all,

00:55:54the grant is given

00:55:55to the institution,

00:55:56not to the individuals.

00:55:58Dow Corning doesn't walk up

00:55:59to Shireen Gabriel

00:56:00and say,

00:56:01here's a bunch of money,

00:56:02do research

00:56:03and make sure

00:56:03it comes out my way.

00:56:04it goes to the institution

00:56:06and there are strings attached.

00:56:11And Angel argued

00:56:12there was a curious

00:56:13double standard

00:56:14in the plaintiff lawyer's

00:56:15protestation

00:56:15that science could be bought.

00:56:17They hired a series

00:56:19of scientists

00:56:19to appear in court for them

00:56:21and they were paid very well.

00:56:25Dr. Mark LaPay

00:56:26has given expert testimony

00:56:27dozens of times

00:56:28and currently charges

00:56:29$3,000

00:56:30for a day of his time.

00:56:33Dr. Nier Kosofsky

00:56:34charges $750 an hour

00:56:36for expounding

00:56:36his theories

00:56:37of silicone toxicity.

00:56:40And Houston hematologist

00:56:41Dr. Robert Louie

00:56:42makes $625 an hour.

00:56:47But much more dubious,

00:56:48critics argued,

00:56:49was the fact

00:56:49that plaintiff lawyers

00:56:50frequently referred women

00:56:51to some of these same doctors

00:56:53for diagnosis and treatment

00:56:54and paid their medical bills.

00:56:56Doctors or lawyers?

00:56:58These physicians,

00:56:59probably most of them,

00:57:00get a vast percentage

00:57:01of their referrals

00:57:02from lawyers.

00:57:04So that there has now developed

00:57:05and actually even in 92

00:57:06it already developed

00:57:07a network of doctors

00:57:09who were seeing patients

00:57:10largely referred by lawyers

00:57:11in which case

00:57:13the plaintiff

00:57:14went to the lawyer first

00:57:15and the lawyer

00:57:16arranged for the consultation.

00:57:19But the lawyers

00:57:19had another argument

00:57:20with the studies.

00:57:22They claimed

00:57:22that most scientists

00:57:23had not understood

00:57:24what was going on

00:57:25with the women

00:57:25they represented.

00:57:27They claimed

00:57:28the stories

00:57:28in the files

00:57:29proved beyond doubt

00:57:30the women had

00:57:31a new disease

00:57:32that medical science

00:57:33had yet to come

00:57:33to grips with.

00:57:35Here's what convinced me.

00:57:37As I flipped through

00:57:38years and years and years

00:57:39of each woman's medical records

00:57:41what I saw

00:57:42was complete frustration.

00:57:45Obviously someone

00:57:46who is sick

00:57:46and doctors struggling

00:57:48to figure it out.

00:57:49And without question

00:57:50if you look through

00:57:51the medical records

00:57:52you will see stuff like

00:57:53lupus-like disease.

00:57:55Yes she has lupus

00:57:56says this doctor.

00:57:57No she doesn't

00:57:58says this doctor.

00:57:59Maybe it's MS

00:58:00says one doctor.

00:58:01No I don't think

00:58:02it's MS

00:58:02says this doctor.

00:58:04From woman to woman

00:58:05it is unbelievable

00:58:07how you see

00:58:08that same thing occurring.

00:58:10Doctors struggling

00:58:11not to determine

00:58:11if they're sick

00:58:12but exactly

00:58:13what is this

00:58:14we're dealing with.

00:58:15And after you see

00:58:16that hundreds

00:58:16and hundreds

00:58:17of times

00:58:18you understand

00:58:19the common denominator

00:58:20is the silicone.

00:58:21obviously we're dealing

00:58:22with something new

00:58:23because it doesn't

00:58:24pigeonhole

00:58:25into anything

00:58:26so no it's not

00:58:27in the textbook.

00:58:29You know

00:58:29a point in time

00:58:31neither was polio

00:58:32or AIDS

00:58:33or

00:58:33I mean that doesn't

00:58:35mean these people

00:58:35aren't sick

00:58:36and something's

00:58:37not causing it.

00:58:38Nobody says

00:58:39that this product

00:58:41causes classic lupus.

00:58:44Instead it causes

00:58:45a disease of the immune

00:58:46system

00:58:47that is in some ways

00:58:48like lupus

00:58:49and in some ways

00:58:50it's not like lupus.

00:58:52So this is a new disease?

00:58:53A new disease.

00:58:55And they're finessing

00:58:57the thing by saying

00:58:57well you haven't proved

00:58:58it causes the old diseases.

00:59:00That's not what

00:59:01we're trying to say.

00:59:03Fine.

00:59:03If they have a hypothesis

00:59:05that there's a new disease

00:59:06tell us what it is

00:59:08and I'm sure scientists

00:59:09will be interested

00:59:10in studying it.

00:59:12An enormous number

00:59:13of symptoms

00:59:14were now attributed

00:59:15to silicone

00:59:15and new ones

00:59:17were being added

00:59:17all the time.

00:59:19This according to Angel

00:59:20was the problem.

00:59:21You can't study a disease

00:59:23unless you know what it is.

00:59:25If the symptoms

00:59:27that people believe

00:59:28are important

00:59:29are ever changing

00:59:30and ever vaguer

00:59:32then how can you

00:59:33do a study of them?

00:59:35You have to describe

00:59:36what it is

00:59:37you're looking for

00:59:38before you can look for it.

00:59:40This so-called

00:59:41this putative new disease

00:59:42that they talk about

00:59:43to me

00:59:43looks like

00:59:44what is described

00:59:45as fibromyalgia.

00:59:47It consists of

00:59:48diffuse aches and pains

00:59:49poor sleep patterns

00:59:50tenderness in various

00:59:51parts of the body

00:59:52stiffness in the mornings

00:59:54when they get up

00:59:54and so forth.

00:59:55These are generally

00:59:56women who don't meet

00:59:57criteria for any of

00:59:58the so-called

00:59:58autoimmune diseases

00:59:59who have a lot

01:00:01of symptoms

01:00:01and I can't see

01:00:03any difference

01:00:03in the way

01:00:04those symptoms

01:00:05break out

01:00:05from the population

01:00:06of people that I see

01:00:07who would meet criteria

01:00:08for fibromyalgia.

01:00:10But the lawyers

01:00:11claim they did have

01:00:12some science

01:00:13on their side

01:00:13that provided

01:00:14objective proof

01:00:15of a new disease

01:00:16special blood assays

01:00:18that claim to be able

01:00:19to test if silicone

01:00:20had altered

01:00:20the immune system

01:00:21of women with implants.

01:00:24One such laboratory

01:00:25in Memphis

01:00:26was widely used

01:00:27by doctors

01:00:28who believed

01:00:28they were seeing

01:00:29a new silicone

01:00:30induced disease.

01:00:35For $350

01:00:36they claim

01:00:37to be able

01:00:38to tell

01:00:38whether the patient's

01:00:39immune system

01:00:40had been exposed

01:00:41to silicone

01:00:41leaking from

01:00:42breast implants.

01:00:44If true

01:00:45these tests

01:00:46gave some credence

01:00:47to the notion

01:00:47that silicone

01:00:48could produce

01:00:49a full-blown

01:00:50immune response.

01:00:53But were they true?

01:00:56Plastic surgeon

01:00:57Dr. Leroy Young

01:00:58from the University

01:00:59of Washington,

01:01:00St. Louis

01:01:00was very skeptical

01:01:01so he decided

01:01:03to test

01:01:04the Memphis test.

01:01:05he got six women

01:01:08volunteers

01:01:08without breast implants,

01:01:10took blood samples,

01:01:11and sent them

01:01:12to Memphis

01:01:12with made-up

01:01:13medical histories

01:01:14claiming they had

01:01:15implants

01:01:15and various symptoms.

01:01:19Since these women

01:01:20did not in fact

01:01:21have breast implants,

01:01:22if the Memphis test

01:01:23was reliable,

01:01:24then these women's tests

01:01:25should come back

01:01:26negative.

01:01:27All six

01:01:29tested positive.

01:01:31All six of these

01:01:32people tested positive

01:01:34despite the fact

01:01:35that none of them

01:01:36had implants.

01:01:38Young repeated

01:01:39the test

01:01:40and again

01:01:40it failed.

01:01:42He began

01:01:42to study the area

01:01:43and discovered

01:01:44that most immunologists

01:01:46were highly skeptical

01:01:47of these blood tests.

01:01:49So was the FDA.

01:01:51They have recently

01:01:52been taking

01:01:53a tough line

01:01:54with people

01:01:54marketing diagnostic

01:01:56blood tests.

01:01:57The inventors

01:01:58of this one,

01:01:59Detexil,

01:02:00were ordered

01:02:00to stop selling it

01:02:01until they could

01:02:02prove it worked.

01:02:04There is an

01:02:04extraordinary amount

01:02:05of junk science.

01:02:06These physicians

01:02:07certainly don't reflect

01:02:08the mainstream.

01:02:09They're way out

01:02:09on the end.

01:02:10I don't know

01:02:11any solid,

01:02:12well-respected

01:02:13immunologist

01:02:13who is reporting

01:02:14any of this stuff.

01:02:16The studies

01:02:16are done

01:02:17with poor controls,

01:02:19poor planning,

01:02:20and largely

01:02:20by people

01:02:21with no prior history

01:02:22of working

01:02:23in that particular area.

01:02:24And as somebody

01:02:25who worked in immunology

01:02:26some earlier

01:02:27in my career,

01:02:28I can tell you

01:02:28that most of these

01:02:29areas require

01:02:30enormous technical skill

01:02:32that usually takes

01:02:33years to acquire

01:02:34and many internal

01:02:36controls when the

01:02:37tests are run

01:02:38in order to be certain

01:02:39that what you're seeing

01:02:40is not some artifact.

01:02:41Tests are being done,

01:02:43not FDA approved.

01:02:45Treatments,

01:02:46sometimes extremely expensive

01:02:48and a few even dangerous,

01:02:50are being given to women

01:02:51in the total absence

01:02:52of any data

01:02:54that would suggest

01:02:55that they would be helpful

01:02:57and the shuttling

01:02:59of women

01:03:00back and forth

01:03:01between a segment

01:03:02of the legal profession

01:03:03and a segment

01:03:04of the medical profession

01:03:06to me

01:03:07is one of the most

01:03:08incredible,

01:03:08amazing,

01:03:09and distressing things

01:03:10to come along

01:03:12out of this entire scenario.

01:03:15Plaintiff lawyers

01:03:16like O'Quinn

01:03:17stand by the blood tests,

01:03:19insisting they do work.

01:03:20I mean,

01:03:21these women are sick.

01:03:22There's no question

01:03:23about that they're sick

01:03:24and they report sickness.

01:03:26The testing shows

01:03:27that their immune system

01:03:29has been triggered

01:03:30to react with silicon.

01:03:33The testing shows

01:03:34that their immune system

01:03:35has been altered.

01:03:38The key doctor

01:03:39who told Gladys Loss

01:03:40that she was crippled

01:03:42with a new

01:03:42silicon-based disease

01:03:44was neurologist

01:03:45Dr. Bernard Patton.

01:03:47Patton's fame

01:03:47was such that

01:03:48he attracted thousands

01:03:49of patients

01:03:50to his Houston offices

01:03:51for expensive

01:03:52diagnostic tests

01:03:53and treatments.

01:03:58Patton's diagnosis

01:03:59of Gladys

01:03:59and other breast implant

01:04:00patients

01:04:01depended to a large extent

01:04:02on a series of nerve

01:04:04and muscle biopsies,

01:04:05small pieces of tissue

01:04:06that are removed

01:04:07and examined

01:04:08under the microscope.

01:04:10Neurologists

01:04:11sometimes use them

01:04:12as a last resort,

01:04:13searching for evidence

01:04:14that the myelin sheath

01:04:15surrounding nerves

01:04:16has degenerated.

01:04:20Neuropathologist

01:04:21Dr. Hannes Vogel,

01:04:22an expert on nerve tissue,

01:04:23has examined

01:04:24the medical records

01:04:25of 50 of Patton's

01:04:26breast implant patients.

01:04:27In 48 of them,

01:04:29he found no detectable

01:04:30nerve damage.

01:04:31Gladys was one of two

01:04:32who did have a mild loss

01:04:34of nerve fibers.

01:04:35Did this indicate

01:04:36a serious systemic disease?

01:04:38Absolutely not.

01:04:39It was not a substantial loss.

01:04:42I would rate it as mild.

01:04:44There was no evidence

01:04:45in this nerve biopsy

01:04:46of a serious

01:04:47life-threatening situation.

01:04:50Such loss of nerve fibers

01:04:51is not that uncommon

01:04:52and might be the result

01:04:54of many things

01:04:55other than silicone.

01:04:57Given such weak evidence

01:04:58for a new silicone-based disease,

01:05:00some of Patton's colleagues

01:05:01are concerned

01:05:02that patients like Gladys

01:05:03may not only have undergone

01:05:05aggressive and possibly

01:05:06dangerous therapies,

01:05:08but also may have missed

01:05:09getting appropriate

01:05:10diagnosis and treatment.

01:05:15Until last year,

01:05:17Patton worked at Baylor

01:05:17College of Medicine

01:05:18in Houston.

01:05:19He took early retirement

01:05:21following a disagreement

01:05:22over his ideas

01:05:23on breast implants.

01:05:25He was regarded

01:05:26by many in this community

01:05:28as a pariah

01:05:29and somebody whose

01:05:33scientific legitimacy

01:05:35was questionable.

01:05:37We found Dr. Patton

01:05:39in Hawaii

01:05:40en route to lecture

01:05:41in Japan.

01:05:43Despite examining

01:05:431,500 women

01:05:44for silicone-induced disease,

01:05:47he denies claiming

01:05:48a scientific link

01:05:49has been proved.

01:05:50I don't believe

01:05:51that connection

01:05:52has been scientifically proven.

01:05:54and what we're doing

01:05:56is merely collecting data

01:05:57to look at that possibility.

01:06:01We have reported

01:06:02a group of women

01:06:03who are undeniably ill

01:06:05and they have circulating

01:06:07antibodies against

01:06:08the nervous system

01:06:09and they need treatment.

01:06:12But the actual causal connection

01:06:14between the implant

01:06:15and their disease

01:06:16has not yet been established.

01:06:18That's what we're working on.

01:06:20But if the connection

01:06:23isn't scientifically proven,

01:06:24why then, critics asked,

01:06:26did he tell patients

01:06:27like Gladys

01:06:28that they had silicone-induced disease

01:06:30and begin

01:06:30such aggressive treatments?

01:06:32In the real world,

01:06:34we have to deal

01:06:35with sick people

01:06:36and we have to do our best

01:06:38to try and help them

01:06:39and we can't be

01:06:40450,000% scientific

01:06:44when we're trying

01:06:45to save someone's life

01:06:46or restore them to health.

01:06:48Patton is one

01:06:50of several doctors

01:06:51being investigated

01:06:51by the FBI

01:06:52for health care fraud

01:06:53and abuse.

01:06:55He argues that he only

01:06:56wanted to help his patients.

01:06:58But in his desire to help,

01:07:00did he and other

01:07:01silicone doctors

01:07:02mislead women,

01:07:04telling them

01:07:04they had a new disease

01:07:05before there was

01:07:06any hard scientific evidence

01:07:08that it existed?

01:07:09We are the evidence!

01:07:11What I would say

01:07:11to people who disagree with me

01:07:13is that I know you're sick.

01:07:14I'm not saying

01:07:15you're not sick

01:07:16and I don't say that.

01:07:17I believe these women hurt.

01:07:19I believe these women

01:07:19have a problem.

01:07:21The only question is

01:07:22why should it be attributed

01:07:23to their silicone breast implants?

01:07:26People are very quick

01:07:28to attribute new diseases

01:07:30to something that happened.

01:07:32You know,

01:07:32the rooster takes credit

01:07:33when the sun comes up

01:07:35and people,

01:07:36in general,

01:07:38people who develop

01:07:38a disease like

01:07:39rheumatoid arthritis

01:07:40or lupus

01:07:40or scleroderma,

01:07:42many people

01:07:43will examine carefully

01:07:44everything that's happened

01:07:45in the previous

01:07:46two or three or five years

01:07:47and wonder,

01:07:48you know,

01:07:49maybe I shouldn't have

01:07:49started taking vitamin E

01:07:51or maybe I shouldn't have

01:07:52started that exercise program.

01:07:54It's just natural to do that.

01:07:56And so I think

01:07:57a lot of these women

01:07:58are,

01:07:58almost all of them

01:07:59as a matter of fact,

01:08:00I think have real complaints

01:08:01and they're doing

01:08:02the kinds of thing

01:08:03that people do

01:08:05when they're faced

01:08:06with an unusual disease.

01:08:07what's the difference here

01:08:08is that that question

01:08:10that is a natural one

01:08:11to ask

01:08:11is all of a sudden

01:08:12being fired by this

01:08:13or fueled by this

01:08:14huge plaintiff-lawyer interest.

01:08:18I think that Dr. Sargent

01:08:20is wrong.

01:08:22We have more information

01:08:23than they do

01:08:24on many levels.

01:08:26We know

01:08:27how many women

01:08:28were affected.

01:08:29I hear from those women.

01:08:31By last spring,

01:08:33the office administering

01:08:34the global settlement

01:08:35had heard from

01:08:36440,000 women,

01:08:38vastly more

01:08:39than anyone expected.

01:08:41Despite the scientific evidence,

01:08:44Dow Corning's hopes

01:08:44of putting the litigation

01:08:45behind them

01:08:46began to seem unrealistic.

01:08:49And last May,

01:08:50in a move that shocked everyone,

01:08:51they filed for

01:08:52Chapter 11 bankruptcy.

01:08:54The effects were immediate

01:08:56and dramatic.

01:08:57The global settlement

01:08:58fell into shambles.

01:08:59Thank you for calling

01:09:00the breast implant

01:09:01settlement information line.

01:09:03Judge Borner

01:09:03has preliminarily concluded

01:09:05that there is no justification

01:09:07for keeping

01:09:08the current settlement in place.

01:09:11Without Dow Corning,

01:09:13it was hopelessly underfunded.

01:09:15Claimants were put on hold

01:09:16while the lawyers scrambled

01:09:17to build another deal

01:09:18with the remaining manufacturers.

01:09:22For Laminack and O'Quinn,

01:09:24it was even worse.

01:09:25As long as Dow Corning

01:09:26remained in bankruptcy,

01:09:28no cases could be tried.

01:09:30And for clients like Gladys,

01:09:33who had already had

01:09:34their day in court,

01:09:35but whose case had been appealed,

01:09:37everything was up in the air.

01:09:43Rick Laminack struggled

01:09:45to maintain his client's morale

01:09:46and convince those of them

01:09:48who had had Dow Corning implants

01:09:50all was not lost.

01:09:52The first thing that I want to address

01:09:54generally tonight

01:09:55is the Dow situation.

01:09:59Brief history.

01:10:02Recall Dow file bankruptcy.

01:10:05You will also recall

01:10:06that for many months

01:10:08we anticipated

01:10:09that this would happen

01:10:10and began to build a case

01:10:13against who we perceive

01:10:15to be the real power

01:10:16and the real company

01:10:18behind the implant fiasco,

01:10:22and that's Dow Chemical.

01:10:24And the plan that we put in place

01:10:27is very simple.

01:10:30Have a claim in the bankruptcy court

01:10:33against Dow Corning on one hand

01:10:35and a lawsuit

01:10:37against the parent company,

01:10:40Dow Chemical,

01:10:41on the other hand.

01:10:44Dow Corning was 50% owned

01:10:46by the giant Dow Chemical,

01:10:49America's second largest

01:10:50chemical company.

01:10:51If we don't cause water pollution,

01:10:54there'll be no need

01:10:55to clean up water pollution.

01:10:57While Dow Chemical

01:10:57had never made

01:10:58or sold breast implants,

01:11:00plaintiff lawyers argued

01:11:01that they bore responsibility

01:11:02for the actions

01:11:03of Dow Corning

01:11:04because in the past

01:11:05Dow Chemical knowledge

01:11:07and testing facilities

01:11:08had been used.

01:11:09Dow lets you do great things.

01:11:15These arguments were used

01:11:16by lawyer Rick Ellis

01:11:18in a landmark trial

01:11:19in Reno, Nevada

01:11:20in October 1995

01:11:21in which plaintiff

01:11:23Charlotte Malum

01:11:24and her husband Marvin

01:11:25brought a breast implant suit

01:11:27in which Dow Chemical

01:11:28was the sole defendant.

01:11:30With the fortunes

01:11:33of a huge American corporation

01:11:34now at stake,

01:11:35there was great interest

01:11:36in the Malum case.

01:11:37The jury sat through

01:11:38a month of complex

01:11:39scientific testimony.

01:11:41Dow Chemical marshaled

01:11:42a stack of epidemiological studies

01:11:44from Harvard,

01:11:45Mayo,

01:11:45and elsewhere.

01:11:47Plaintiff lawyers

01:11:47attacked these studies

01:11:48and put their own experts

01:11:49on the stand.

01:11:50I'm standing from the bailiff

01:11:52that the jury has...

01:11:53The jury deliberated

01:11:54for only seven hours.

01:11:56We at the jury

01:11:56in this action

01:11:57find for the plaintiff

01:11:59Charlotte Malum

01:11:59and against defendants...

01:12:01The jury awarded

01:12:01Charlotte Malum

01:12:02$3.9 million

01:12:04plus $10 million

01:12:05in punitive damages.

01:12:08Dow Chemical

01:12:08was shocked.

01:12:10The vast weight

01:12:11of evidence

01:12:12supports the proposition

01:12:14that breast implants

01:12:14are safe,

01:12:15that they do not

01:12:16cause autoimmune disease.

01:12:18So the question

01:12:19really is

01:12:20where is...

01:12:21What did Dow Chemical

01:12:22do that should merit

01:12:24a $10 million punishment?

01:12:25It's sort of

01:12:29Alice in Wonderland

01:12:30and Never Neverland.

01:12:31When you have

01:12:32the courts

01:12:33saying one thing

01:12:34and science

01:12:35saying another thing,

01:12:36you ask me

01:12:36can society tolerate it?

01:12:39Well, in a sense,

01:12:40yes,

01:12:41but it isn't

01:12:42a good society.

01:12:44And insofar

01:12:45as the courts

01:12:46undermine

01:12:48the scientific process,

01:12:51it bodes ill

01:12:52for all of us.

01:12:53So what about

01:12:55the Food and Drug

01:12:56Administration

01:12:57whose actions

01:12:57had ignited

01:12:58the controversy?

01:13:00Kessler and his staff

01:13:01saw themselves

01:13:01as part of

01:13:02the scientific community

01:13:03and sided with them.

01:13:05Look, I just picked up.

01:13:06That's fine.

01:13:06Commissioner Kessler

01:13:07had absorbed

01:13:08the many studies

01:13:08on silicone

01:13:09and autoimmune disease.

01:13:11And on this question,

01:13:12at least,

01:13:12he was reassured.

01:13:14The good news

01:13:15is that there is

01:13:16not a large

01:13:17increased risk

01:13:18of typical

01:13:19connective tissue disease.

01:13:21The cause and effect

01:13:22is simply not there.

01:13:24I can't tell you

01:13:25that that's not

01:13:27going to change

01:13:27in the future.

01:13:29But there is

01:13:30no evidence

01:13:30that supports

01:13:31the association

01:13:32between silicone

01:13:34and either typical

01:13:36or atypical

01:13:37connective tissue diseases.

01:13:39The scientific evidence

01:13:40just is not

01:13:42there to support

01:13:43that association.

01:13:44He still had

01:13:46some concerns

01:13:47about rupture.

01:13:48Estimates of rupture rates

01:13:50varied from 5%

01:13:51to more than 50%.

01:13:52But he urged people

01:13:54to put the rupture issue

01:13:55in perspective.

01:13:56Could rupture,

01:13:58could,

01:13:58when these devices break,

01:13:59could they cause

01:14:00certain local complications?

01:14:02Of course.

01:14:03We know that.

01:14:04But that's not

01:14:05the same thing

01:14:06as saying

01:14:07that they're really

01:14:08going to end up

01:14:09killing people.

01:14:10Do you solemnly swear

01:14:11that the testimony

01:14:12you will give

01:14:13before the subcommittee

01:14:14will be the truth,

01:14:15the whole truth?

01:14:16Last summer,

01:14:17Kessler faced

01:14:17tough questioning

01:14:18by Congress

01:14:19about what he intended

01:14:20to do next.

01:14:22When are we going

01:14:23to have a decision?

01:14:24When is there going

01:14:25to be some resolution?

01:14:27The bottom line

01:14:28is the responsibility

01:14:29of the manufacturer

01:14:30to submit data.

01:14:31It is a paradox

01:14:32that the crisis

01:14:33that was set off

01:14:34by the FDA

01:14:35cannot be undone

01:14:36by the FDA alone.

01:14:37For Kessler

01:14:39and the FDA

01:14:39to change their ruling

01:14:40on silicone implants,

01:14:42they not only need

01:14:43to be fully satisfied

01:14:44of their safety,

01:14:45they need the manufacturers

01:14:46to resubmit

01:14:47an application

01:14:48to market them.

01:14:50But that is not

01:14:50likely to happen.

01:14:53Dow Corning

01:14:53and the other

01:14:54big manufacturers

01:14:55have abandoned

01:14:56silicone breast implants

01:14:57for good,

01:14:58and only one

01:14:59tiny company,

01:15:00Mentor,

01:15:01continues to make them

01:15:02for clinical trials.

01:15:04In another

01:15:04unexpected twist,

01:15:06Dow Corning

01:15:07is seriously considering

01:15:08closing its entire

01:15:09medical division,

01:15:11which supplies

01:15:11medical-grade raw silicone

01:15:13to other companies

01:15:14for the manufacturer

01:15:15of devices like

01:15:15pacemakers,

01:15:16shunts,

01:15:17heart valves,

01:15:18and catheters.

01:15:20If this happened,

01:15:21the medical device

01:15:21industry fears

01:15:22that key life-saving

01:15:23devices might start

01:15:24to disappear.

01:15:26They have appealed

01:15:27to Congress

01:15:27to curb the powers

01:15:28of tort attorneys,

01:15:30arguing that the

01:15:31current legal climate

01:15:31is stifling innovation.

01:15:34Many scientists agree.

01:15:35I would be very

01:15:37reluctant,

01:15:37for example,

01:15:38if I were in the

01:15:38business of making

01:15:39some kind of

01:15:40biomedical material

01:15:41that would be

01:15:41implanted,

01:15:41like heart valves,

01:15:43to look at a new

01:15:44material.

01:15:44I would be scared

01:15:45to look at a brand

01:15:46new material

01:15:47that had never been

01:15:49implanted in anybody

01:15:50before because of this,

01:15:52because it's quite

01:15:53clear that science

01:15:54is not what's ruling

01:15:55this discussion.

01:15:57It's the plaintiff-lawyer

01:15:58frenzy.

01:16:00O'Quinn dismisses

01:16:02such arguments

01:16:03as corporate propaganda,

01:16:04aimed at getting

01:16:05Congress to pass

01:16:06sweeping tort reform.

01:16:08There's a very famous

01:16:09poem that says,

01:16:10do not ask for whom

01:16:11the bell tolls.

01:16:13It tolls for thee.

01:16:15And right now,

01:16:16the bell's tolling

01:16:17for the women

01:16:17that have breast implants.

01:16:21Next year,

01:16:22it'll be some other

01:16:22product.

01:16:23And the same arguments

01:16:25will be trotted out.

01:16:27Same arguments.

01:16:28Where's the scientific

01:16:29evidence?

01:16:31Same arguments.

01:16:33How can corporate

01:16:34America possibly survive

01:16:35if they can't make

01:16:36and sell bad products

01:16:38and get away with it?

01:16:39Same arguments.

01:16:41And if they convince

01:16:43Congress to pass laws

01:16:45that make it legal

01:16:48to sell bad products

01:16:49and not have to pay

01:16:51compensation,

01:16:52there will be more

01:16:53bad products.

01:16:55There will be more

01:16:56injured consumers.

01:16:58And you know who's

01:16:59going to pay the bill?

01:17:00We're going to pay the bill.

01:17:05It is perhaps ironic

01:17:06that a bag weighing

01:17:07a few ounces

01:17:08has caused so much

01:17:09conflict involving

01:17:10so many people

01:17:11in so many fields.

01:17:14The implant controversy

01:17:16has left in its wake

01:17:17a series of pressing

01:17:18questions.

01:17:20Has mass tort litigation

01:17:22become so powerful

01:17:23that it threatens

01:17:24important parts

01:17:25of American industry?

01:17:26Or does the legal system

01:17:28itself need to be reformed?

01:17:31How are ordinary people

01:17:33who make up juries,

01:17:34for example,

01:17:34supposed to weigh

01:17:35the opinions of expert

01:17:36witnesses appearing

01:17:37for the plaintiff

01:17:38against those appearing

01:17:39for the defense?

01:17:41Should courts have

01:17:42specially appointed

01:17:43neutral experts

01:17:44to advise them?

01:17:44And perhaps most

01:17:46important,

01:17:47what does it mean

01:17:48when large groups

01:17:49of citizens

01:17:49think nothing

01:17:50of dismissing

01:17:51the results

01:17:51of scientific researchers

01:17:53from the top institutions

01:17:54in the land?

01:17:55We, as a scientific community,

01:17:59have been appalled

01:18:00at the way researchers

01:18:02and their institutions

01:18:03have been attacked.

01:18:06I can't think of anything

01:18:07in my lifetime

01:18:08that has been as destructive

01:18:10to women

01:18:11and their potential

01:18:12for good health care.

01:18:14But Sybil Goldrich

01:18:15sees it rather differently.

01:18:17I think it has been

01:18:18a wonderful boon

01:18:19to women's health care

01:18:20because women now look

01:18:22at the medical

01:18:22and manufacturing establishment

01:18:24with question marks,

01:18:27appropriate question marks.

01:18:29And that's what people need.

01:18:32They need to think

01:18:33about themselves

01:18:34and what is appropriate

01:18:35for them.

01:18:36Just because a doctor says

01:18:38that this implant

01:18:38will last a lifetime

01:18:40obviously is not true.

01:18:43Women know that now

01:18:44and they know to come forward

01:18:45and they know to argue.

01:18:50The operation

01:18:52that Timmy Jean Lindsay

01:18:53pioneered 33 years ago

01:18:55is now the center

01:18:56of a bitter controversy

01:18:57and it's not clear

01:18:58just how it will end.

01:19:01Timmy Jean,

01:19:02who still has

01:19:02the same implants

01:19:03put in in 1962,

01:19:05has watched the events

01:19:06with interest.

01:19:07Whoa!

01:19:09That's it!

01:19:09And how has

01:19:10her health been?

01:19:12Well, my health

01:19:13is real good

01:19:14except for

01:19:15just some arthritis

01:19:16in my body

01:19:18but otherwise

01:19:19I'm pretty healthy

01:19:21and of course

01:19:23I had a knee

01:19:24the knee surgery

01:19:26and I'm planning

01:19:27to have it

01:19:28on my left knee

01:19:29total replacement

01:19:30and

01:19:32but other than that

01:19:34I'm doing real good.

01:19:36Come on,

01:19:36let's get down

01:19:37and ride on the bus.

01:19:39But she doesn't think

01:19:39her breast implants

01:19:40caused these problems

01:19:41but something

01:19:42much more ordinary.

01:19:43I think it's just

01:19:46part of aging

01:19:47getting older

01:19:48is what I think.

01:19:51It makes me feel

01:19:52kind of proud

01:19:53that I got to be

01:19:54a pioneer

01:19:55among women.

01:19:57Yeah, it makes me

01:19:57feel kind of proud

01:19:59kind of pleased

01:20:01that well

01:20:02maybe this is

01:20:04my mark on life.

01:20:07Gladys, by contrast,

01:20:08is convinced

01:20:09that her illness

01:20:10was caused by silicone.

01:20:12So far,

01:20:12the scientific evidence

01:20:13hasn't swayed her.

01:20:15I don't have a doubt

01:20:16in my mind.

01:20:17I know that

01:20:18the Dow companies

01:20:19fund a lot

01:20:20of these studies

01:20:21so that right there

01:20:22puts a big

01:20:23question mark

01:20:24on the validity of it.

01:20:26But what I find

01:20:27very interesting is

01:20:28is that

01:20:30most things

01:20:31that come up like this

01:20:32come up last wall

01:20:34and go away.

01:20:36But this does not

01:20:36go away.

01:20:38And that's what

01:20:39I find interesting.

01:20:42Glory, glory,

01:20:43hallelujah,

01:20:46his truth

01:20:48is marching

01:20:50There's no shortcuts.

01:20:52Passion,

01:20:52anecdote,

01:20:53claims,

01:20:54testimonials,

01:20:55they will not

01:20:56settle this issue.

01:20:57This is a scientific issue.

01:20:59It can only be settled

01:21:01by science,

01:21:02and it will be settled

01:21:03by science.

01:21:05Glory, glory,

01:21:07hallelujah,

01:21:07glory, glory,

01:21:08the implant controversy

01:21:09is far from over.

01:21:12Neither side

01:21:13is about to back down.

01:21:15His truth

01:21:18is marching on.

01:21:24Visit

01:21:24Frontline on the

01:21:25World Wide Web

01:21:26at pbs.org

01:21:28for an online

01:21:29supplement to this report.

01:21:30Link to the newsletters

01:21:32for women with implants

01:21:33or the FDA's website.

01:21:36Learn more here

01:21:37about silicone,

01:21:38tort reform,

01:21:39and science

01:21:40in the courtroom.

01:21:41Do silicone breast implants

01:21:43cause disease?

01:21:45Examine statements

01:21:45of doctors

01:21:46who say yes

01:21:47and studies

01:21:48which say no.

01:21:50It's all here

01:21:50at Frontline Online

01:21:52at this internet address.

01:21:54Off the net,

01:21:54please respond

01:21:55to the program

01:21:56by fax

01:21:57at 617-254-0243

01:22:00or send your comments

01:22:01to this address.

01:22:06And now,

01:22:07more response

01:22:08to Frontline's

01:22:09Gulf War series.

01:22:11America had rushed

01:22:12Patriot missiles

01:22:13to Israel and Saudi...

01:22:14The Raytheon Company,

01:22:15builder of the Patriot missile,

01:22:17and others

01:22:17were critical

01:22:18of statements

01:22:18that the Patriot

01:22:19performed poorly

01:22:20in Israel.

01:22:22Saudi Arabia's

01:22:23ambassador to Washington,

01:22:25Prince Bandar,

01:22:25wrote to Frontline.

01:22:26I have no

01:22:30first-hand knowledge

01:22:31of what Patriot

01:22:32did or didn't do

01:22:33in Israel or why.

01:22:35However,

01:22:35I know exactly

01:22:36what happened

01:22:36in my country.

01:22:38And I'm surprised

01:22:39that your program

01:22:39didn't even mention

01:22:40the kind of

01:22:41outstanding performance

01:22:42that Patriot achieved

01:22:43in protecting

01:22:44our citizens.

01:22:45Ask me.

01:22:46I was there.

01:22:48And the most

01:22:49beautiful sight

01:22:50in the world

01:22:51that I have ever seen

01:22:52in my life

01:22:52was that Patriot

01:22:53streaking across

01:22:54the capital of Saudi Arabia

01:22:56hitting those

01:22:56scuds.

01:22:57And the Saudi people

01:22:58think this weapon

01:22:59system is perfect.

01:23:02Another letter

01:23:03came from the commander

01:23:03of Patriot forces

01:23:05in Saudi Arabia.

01:23:07Major General

01:23:07Joseph Garrett

01:23:08told us

01:23:08the Patriot

01:23:09was never designed

01:23:10to defend

01:23:11large metropolitan areas

01:23:13against enemy missiles.

01:23:14But he said

01:23:15it rose to the challenge.

01:23:17The system

01:23:18exceeded our expectations

01:23:19and delivered

01:23:20a solid performance.

01:23:22The U.S. Army

01:23:23performed a detailed

01:23:24shot-by-shot analysis

01:23:26based on every shred

01:23:28of data and supporting

01:23:29material that existed.

01:23:31The result of that

01:23:32assessment showed

01:23:33that Patriot

01:23:34achieved an excellent

01:23:35success rate

01:23:36more than 70%

01:23:38within the Saudi Arabia

01:23:40theater of operations.

01:23:41I can tell you

01:23:42that Patriot served

01:23:43our country well

01:23:44in the Gulf

01:23:44and will continue

01:23:46to serve us well

01:23:47in the future.

01:23:47For more information

01:23:50on the Patriot controversy,

01:23:51visit Frontline's

01:23:52Gulf War website

01:23:53on the World Wide Web

01:23:55at pbs.org.

01:23:57And next time...

01:24:03A kid can get a gun

01:24:05easier than you

01:24:05buy a pencil.

01:24:08You may think

01:24:09you know this story.

01:24:11The inner city

01:24:12is violent.

01:24:13These kids live here.

01:24:16A kid kills.

01:24:17Watch Frontline.

01:24:18We're going to win this fight.

01:24:25We're going to win it

01:24:26because we're right.

01:24:28And we're going to win it

01:24:29because like no case

01:24:31I've ever worked on.

01:24:33This is the champion

01:24:35of all of them.

01:25:35Funding for Frontline

01:25:52is provided by

01:25:53the Corporation

01:25:54for Public Broadcasting

01:25:55and by annual

01:25:58financial support

01:25:59from viewers like you.

01:26:02Frontline is produced

01:26:04for the Documentary Consortium

01:26:05by WGBH Boston

01:26:07which is solely responsible

01:26:08for its content.

01:26:15For videocassette information

01:26:17about this program

01:26:18please call this toll-free number

01:26:201-800-328-PBS1

01:26:24This is PBS.

01:26:34This is PBS.

Category

Transcript

Recommended