Wat wist Dow Corning

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What did Dow Corning know and when did it know it?

These are the questions Martha Wivell of Minneapolis addressed in a breast implant case that was being tried when Dow Coming went into bankruptcy. (Kavanaugh v. Dow Coming Corp., No. CV526767 (Cal., Sacramento County Super. Ct. 1995).

This is a simple case. It's about what Dow Corning knew, and when it knew it, and what it said to the medical profession and to the public about its silicone gel breast implants.

We are going to provide evidence that Dow Coming claimed the materials in its breast implants were inert, were nonreactive, and did not stimulate the immune system. We will prove that the materials were not inert, that they were reactive. In other words, they degraded and broke down in the body. And, we will prove that those materials were a contributing factor to Gillian Kavanaugh's disease.

Now, we're to the part of the trial called the opening statement, and I get to speak on behalf of Gill. My name's Marti Wivell, and along with Bruce Finzen, we have the privilege of representing Gillian in this case.

We're going to be putting on two kinds of evidence in this case. The first kind of evidence has to do with Dow Corning: what Dow Corning knew, when Dow Corning knew it, and what it said outside the company. The other kind of evidence has to do with Gill--with how the breast implants caused her autoimmune disease and how she's been injured by that disease.

I want to start talking about Dow Coming Corp., but before we do that, I want to talk a little bit about some of the chemistry. If you're kind of like me, your mind may be saying, "Chemistry, that wasn't my best subject at school." But we have some things that may help, and we have some witnesses who may help you.

This case is about three different substances: silicon--no "e"--silica, and silicone. Now, silicon is a basic building-block. It is often not found alone in nature. It's usually hooked up with a couple of oxygen atoms. There's the silicon--no "e"--and when you put it together with a couple of oxygen atoms, it becomes silica. And you can see here, according to the chart, silicon dioxide is Si[O.sub.2].

That's very often how silica is found in nature. In fact, 25 percent of the earth's crust is made up of that compound. It's what you find when you go to the beach. Typically, it's not a problem for us. But we will show that it's been known for over a hundred years that silica stimulates the immune system.

The last basic thing that we need to talk about is silicone. It is a class of chemicals that are man-made. It is not found in nature. Most of these chemicals share a backbone of this Si[O.sub.2] chain. Here you see five of those molecules.

You can think of it sort of like a train, that all of these molecules link together to form silicone, with an "e." And you'll hear us sometimes say, doctor, is that silicon without an "e," or silicone with an "e"?

Another way to think of this is to think of it like a big pot of spaghetti. When a manufacturer makes silicone--with an "e"--there are lots of these chains of molecules put together. And just like a big pot of spaghetti, these molecules have many different lengths. A manufacturer making the silicone cross-links these chains so that the silicone, depending upon the crosslink, can be as liquid as water or as hard as rubber.

Silicone is what the breast implants are made of. The gel is made of silicone. The shell, or the elastomer envelope, is also made of silicone, with one addition. Dow Coming puts silica in the elastomer to stiffen it to make it hard.

Now, what happens is that when you make this pot of spaghetti, some of these little, short chains, these low-molecular weight chains, don't cross-link. these little chains, these chains of four molecules, which are called D4, are the basic building-blocks, the chemical that the manufacturer starts with. You're going to be hearing a lot about D4 in this litigation.

Why? Well, because of gel bleed. Those little D4 molecules bleed out of an implant when it's placed in the human body. This is an exhibit that shows you what the implant that was placed in Gillian Kavanaugh looks like. An envelope inside filled with the silicone gel, or fluid--silicone with an "e." The shell is stiffened with silica, then there is an inner layer of saline surrounded by another envelope. What happens is that the gel bleeds through these two envelopes. The D4 bleeds through and migrates throughout the body, through the body's lymph nodes.

While it's in the body, it interacts with the body's fluids, with the lipids, with the body's proteins. And it causes immune stimulation. We say it is "immunogenic."

Now, our immune system is the part of the body that fights off infection. But the immune system also can be stimulated to cause connective tissue disease. Connective tissue disease is when your body starts reacting against itself.

In Gillian Kavanaugh's case, the silicone leaked out of her implants, because there will be evidence that it was found in the capsule that the body puts around the implant, despite the fact that the implants were intact when they were removed last year.

Let me say that again. There was silicone in the tissue surrounding her implants despite the fact that they hadn't broken. It had leaked out

Now, I want to talk to you about what was known or knowable by Dow Corning when they started putting together these implants back in the early '60s.

The medical literature shows quite a lot was known about the materials that went into these implants. What I'm going to show you are some boards with a summary of the medical literature that have been prepared by one of our experts, Dr. Eric Gershwin.

Dr. Gershwin is the chief of the Department of Rheumatology just down the road at UC Davis. He is a man who has studied silicone breast implants and their effects extensively.

I'm not going to go through these, because these are quite detailed, but you'll see that as early as 1915 it was known that free silicone was the cause of pulmonary fibrosis. "Pulmonary" means "lungs." "Fibrosis" means "scarring."

Now, I should tell you that there are two kinds of silica used in the breast implants. One is crystalline and one is amorphous. Keep those words in mind because, if you look here, in 1922, noncrystalline amorphous silica was reported to have a fibrosing action.

Like I said, I'm not going to go through all of these, but by 1938, Gardner had reported that crystalline and amorphous silica produce fibrosis in the lungs of animals and humans. If you go down to 1957, Schweper's reporting on Dow Coming's amorphous silica found it to be toxic to the lungs of rats.

These are all articles from journals that would not be readily available to the average plastic surgeon but would be available to Dow Coming employees had they gone to the company library and looked.

In 1981, it was reported that silicon used in cosmetic breast surgery can induce--"induce" means "cause"--a skin sclerosis.

Then, Gillian was implanted. All that I've talked about so far is what was known or knowable by Dow Coming before Gillian received her implants in 1982.

Now, in 1982, Gordon reported the possibility of systemic--"systemic" means throughout the body--reactions to the silicone polymer in susceptible patients.

In 1987, it was reported that the notion that silicone is without biological effects may be naive. Prior epidemiological evidence--that means statistical evidence--and the number and consequence of clinical findings suggest that silicone may indeed be associated with an inflammatory process and rheumatic disease. The spectrum of diseases includes seven lupus cases from the literature.

If you look at this chart, lupus is one of the connective tissue diseases that, like scleroderma, is a collagen disease, or connective tissue disease.

In 1989, six cases of auxiliary lymphadenopathy were reported from silicone finger joints. A lupus-like disorder with a breast implant patient was reported in 1989.

Gillian Kavanaugh was still wearing her breast implants. Nobody had told her to take them out

In 1990, Gutierrez reported a 44-year-old woman developed scleroderma, following silicone breast implantation. She got better after she was explanted.

And in 1992, Gillian Kavanaugh was explanted.

All this information was either known or knowable by Dow Corning before she had her implants or after she had her implants, but before they were taken out. But what did Dow say? Dow said in bulletins it sent to medical professionals throughout the years that silicones are extremely inert in the body. Inert.

And what did Dow Corning tell Gillian Kavanaugh's surgeon, Dr. John Finkler, in the package insert? Well, I can't show you, because it's not there. And, I can't show you what the company told him about the immunological stimulation of the immune system, because there's nothing about that in here.

What the company said was, "The silicone elastomers made exclusively by Dow Coming are among the most nonreactive implant materials available." And, I think today, ladies and gentlemen, Dow Corning's lawyers are going to tell you that there is no evidence of an immune response in silicone gel breast implants.

I want to explain one thing in case I didn't make it clear before. You might be asking yourselves, how does this silicone gel bleed, how does this D4 get out of these two elastomer-compound envelopes? And every time you see the word "elastomer," just think envelope.

Well, the answer is that the silicone materials, the elastomers, that are used to make the envelope are permeable. That means things can come out, and body fluids can go in. That's even without it breaking, which is why when you pass it around, you feel a little bit of stickiness.

I want to talk a little bit about Dow Coming. Dow Corning was formed in 1943 by two other corporations, Coming, Inc., and Dow Chemical. They each gave a portion of their name to this new company, and today they are still the sole shareholders of Dow Coming.

Dow Coming was established to make silicone and sell it as a product. The first of the silicone applications were really for military applications.

It wasn't until the 1950s and early 1960s that Dow Coming began to think in terms' of medical applications of silicone. One of the things the company did was to set up a committee to examine injectable silicones, because physicians were asking the company if they could use injections of silicone in human breasts to augment them. Dow Corning knew by the mid-1960s that the fluid used in the silicone gel breast implant killed cockroaches. It was not biologically inert.

Now, with that in mind, I'd like to show you enlargements of some of the documents that show what Dow Coming's employees knew, when they knew it, and, then, what they were saying to the people outside the company.

In 1961, a Dow Coming employee realized and admitted that an attempt to place silicone fluids permanently in the body would lead to other problems.

"If injected directly into the body, the fluids will not remain in the desired locations. If enclosed within a silicone bag made of"--an elastomer like that one over there--"the fluids would tend to diffuse out through the walls of thesilicone rubber because of their permeability and be absorbed into the tissue."

Another silicone committee document admits that "of significance is the fact that the clinical use of silicone liquids in man preceded any responsible and controlled experiments in animals." In other words, Dow Coming put it in people before they had tested it in animals.

1965. Dow Corning was now making breast implants.

November 1965.

Significant questions, however, remain unresolved. First, what is the body distribution

within its tissue of any absorbed material? Second, what is the ultimate fate of the absorbed

material? Third, if significant amounts are absorbed, does the body excrete the material and, if so, how much.... The fate and presence of silicone oil in the human body is unknown.

And other inquiries began to come to Dow Coming. It is my understanding that you are asking for information relative to whether or not our mammary silicone gel migrates. And the answer

is very frankly, gel migration due to breakage of the silicone envelope has not been

a problem nor can I recall when a surgeon has questioned us about this relative to a Dow

Corning product. This is July 1976.

Gel bleed data was obviously sensitive in the company. In fact, physicians outside of Dow Coming started doing work on it because they wanted answers to the questions. People were beginning to see gel bleed and wanted to know what happened to it in the body.

Now, you may say to yourself, well, what about those two envelope implants like Gill got? I mean, if there are two envelopes, two elastomer-compound envelopes, doesn't that prevent the breast implants from bleeding?

And I want to show you some documents from Dow's files that address that issue. This one is from a sales representative, a salesperson who called on Dr. Grazer and reported that Dr. Grazer was "very upset over the performance of our gel ... implants.

"To say that he was upset was putting it mildly. Actually, he was downright indignant. His complaint is that the outer envelope is too greasy and that he is getting excessive gel bleed on all three pairs that were given to him."

We don't know whether that's really what Dr. Grazer said, but the salesman then went on to say: "To put a questionable lot of mammaries on the market is inexcusable. I don't know who is responsible for this decision, but it has to rank right up there with the Pinto gas tank."

I'm going to tell you, ladies and gentlemen, I think there's going to be evidence in this case that shows that Dr. Grazer's implants weren't especially greasy. They were normal.

In 1982, the year Gillian Kavanaugh was implanted with these breast implants, a Dow Corning employee wrote, "I submit the acquisition of implant data on Q72167 and Q72168 gels"--the gels that go together to make up the gel in Gillian's implants. "Further, I recommend that ... the systemic fate of the material in our extract should be studied as well as the metabolic fate."

In other words, does it metabolize in the body? Does it break down?

In 1982, Dow Coming had been selling breast implants for 20 years, and the company didn't know the answer to that question. Yet, the company was claiming the material was inert and nonreactive.

What did Dow Corning say to the outside world when a physician wrote in and said that he had a patient with breast implants who had developed a disease suggestive of chronic lupus? "Dow Corning has performed extensive safety tests in animals on the silicone material from which silastic breast implants are made."

Not a word in this letter about the fact that there is no two-year data, no long-term--longer than 90-day--animal data that's valid.

Now, I mentioned that one of the things that happens when a breast implant is placed in the body is that capsular contracture forms. And there will be evidence in this case that doctors thought that gel bleed caused capsular contracture and, therefore, stimulated immune response. And what did Dow Coming do when doctors began to report capsular contracture in response to breast implants? Did the company fund studies to look at the issue? The answer is, "The well is dry. We cannot give financial support for more studies of capsular contracture in 1974 and 1975. I think our future role in these studies should be to provide input on the technology of silicones."

Those are the documents that are the core of our case, that show what Dow Coming knew, when it knew this, and what it was saying to the public.

The other thing that I want to talk to you about is what Dow Coming did after 1988. In 1987, a Dr. LeVier reported that we ought to find out what the immunological consequences are. Well, Dow Corning didn't do that work. But you're going to hear about studies that it did from 1988 on, where it proved again that the materials that bleed from silicone gel have an adjuvant effect.

And you're also going to hear some talk about some studies that have been done in the last few years, looking at whether women with silicone gel breast implants have an increased incidence of disease. But we're going to have an epidemiologist, someone who studies numbers and statistics and diseases in relation to populations, tell you that those studies aren't big enough to tell us anything about whether there is an increased incidence of scleroderma in women with breast implants. That's because scleroderma, is a very rare disease. And so the epidemiologist is going to tell us there really isn't much we can learn from those studies.

I want to spend a little time explaining to you about Gill's disease.

Gill has the kind of scleroderma, that is called "CREST." Each of those letters refers to a kind of symptom of the disease. The "C" stands for "calcinosis."

The "R" stands for "Raynaud's phenomenon." If you just watch Gill's hands, you'll be able to see it. Basically, her fingers turn blue, and then they turn white, and sometimes they're red. That's Raynaud's phenomenon. Because of the collagen that's been building up in her hands, she has lost function in her hands.

The "E" in CREST stands for "esophageal problems." You're going to hear that Gill has had significant esophageal problems. The esophagus in the part of the body that carries the food to the stomach.

And you're going to hear that she also has sclerodactyly. That's the "S." Now, sclerodactyly means basically hardening of the skin. She also has it on her hands, she has it on her face, and she also has some on her neck.

The last part--the "T"--is "telangiectasis." And that means basically little spider web marks on the face or sometimes a butterfly rash. And Dr. Shapiro will tell you about the fact that Gill has had that. He diagnosed her as having CREST syndrome.

You're also going to hear that Gill has some other problems. She has sicca syndrome. In other words, she has dry eyes and dry mouth, and she uses artificial tears.

You're also going to find out that she has lung problems--two kinds. She has problems with not being able to exchange carbon dioxide for oxygen. And she gets really winded when she walks.

And she also has another problem in her lungs. She has nodules in the apices, or upper portions, of her lungs. It's the kind of thing that miners with silicosis get. And there's going to be an expert who's going to talk about that and show you on X-rays what Gill's lungs look like.

So Gill not only has the CREST syndrome, but she has some other things, too. You're going to hear from some friends who are going to talk about what she used to be like and what she's like today. And you're going to hear from her mom, who is 89 years old and basically now has to take care of Gill, because Gill has problems with things like buttoning buttons and snapping snaps and opening cans because of her hands.

Then you're going to hear from Gill. She's going to tell you what life is like. She's going to tell you she doesn't know when she's going to be sick and when she's going to feel better. But she keeps on hoping, because she's the kind of person who doesn't want to be a quitter.

And you're going to hear about the thing that bothers Gill the most. That's the fact that her mom who was a dressmaker for 70 years now has to take care of her instead of the other way around.

Now, I'm about done, and you have paid terrific attention, and for that I thank you. At the end of this trial, we're going to have the opportunity to ask you to return a verdict for Gillian. We're going to ask you to award damages in her behalf for the wages she has lost in the past, the wages she will lose in the future. We're going to ask you to award compensation to Gillian for the pain she's suffered. We're going to ask you to award compensation to her for the medical bills she's had to pay in the past and the medical bills she'll have to pay in the future.

But most of all, we're going to ask you to award damages for the loss of her enjoyment of life. The way she used to enjoy life versus the way she has to live now.

And, then, ladies and gentlemen, we're going to ask you to find that Dow Corning willfully misrepresented its product to the medical profession and that its product caused Gill's injuries. And we're going to ask eventually that you award punitive damages against Dow Corning for the damages it has caused.

I'm sure that at the end of this trial you will come back with a verdict that's just and that will take care of Gillian for the remaining years of her lifetime, because she has only this one chance.