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Science on Trial: The Clash of Medical Evidence and the Law in the Breast Implant Case
"An accessible, passionate indictment of the ignorance, opportunism and social indifference that enriched lawyers and a few plaintiffs, though the available scientific evidence was against them." ― New York Times Book Review , Notable Books of 1996 In the early 1990s, sympathetic juries awarded huge damages to women claiming injury from silicone breast implants, leading to a $4.25 billion class-action settlement that still wasn’t large enough to cover all the claims. Shockingly, rigorous scientific studies of breast implants have now shown that there is no significant link between breast implants and disease. Why were the courts and the public so certain that breast implants were dangerous when medical researchers were not? The answer to this question reveals important differences in the way science, the law, and the public regard evidence―and not just in the breast implant controversy.
270 pages, Paperback
First published January 1, 1996
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About the author
Marcia Angell
8 books30 followersMarcia Angell is an American physician, author, and the first woman to serve as editor-in-chief of the New England Journal of Medicine. She is currently a Senior Lecturer in the Department of Global Health and Social Medicine at Harvard Medical School in Boston, Massachusetts.
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Displaying 1 - 8 of 8 reviews
August 11, 2009
This book gives a great overview of how research and reality can collide - and often come up with different answers to the same question. Highlighted is the story of breast implants in the 1990's and their rise and fall from grace. The author details how the legal system clashed with the scientific research on whether or not breast implants cause physical harm, and the end result was that they were banned by the FDA despite very little research to support this claim. Although bans on implants are now in the process of being lifted due to the lack of evidence that they cause harm, this book is a great reminder of how important it is for researchers to reach out to the public and to do a better job of explaining the scientific process.
February 13, 2019
Fascinating insight into the silicone scandal. It's refreshing to see the opinion from a scientist rather than some of the people purely spinning the story for profit.
October 21, 2018
I’m mixed on this book. I’m glad I read it. But I was really frustrated by how shallow the author’s understanding of the law was. On the other hand, she’s frustrated at how shallow (at best) the law’s understanding of science is. And as much as I consider myself a science fangirl, she’s absolutely right that I’m not a scientist, and it’s just wacky that I’ve helped make law on the subject. On the other hand, if not me, who? Not seeing a lot of scientists volunteering to do my job.
The author takes as her text the breast implant litigation. She was the editor in chief of the New England Journal of Medicine as the litigation was starting. And she’s absolutely mystified – and offended -- by it. There was, in her view, no real scientific evidence that breast implants caused health problems, and certainly, in her view, no serious scientific evidence that a breast implant caused any particular woman’s health problems at the time US juries were coming down with multi million dollar verdicts, and cases were settling for substantial chunks of change.
Apparently, the evidence in those cases was mostly 1. this woman has a breast implant; 2. this woman had bad health; 3. there was some evidence showing that breast implants are associated with bad health. 4. There was some evidence the breast implant manufacturers covered up comparatively trivial product defects. In the author’s view, that wasn’t enough to justify the verdicts, and certainly not enough, morally, to justify inducing companies to leave the medical device field.
I haven’t worked these cases. And I feel her on one level. The level of scientific ignorance of decision makers is truly staggering. For a non-patent attorney lawyer, I’m a total math/science geek. I can do division! But the fact is, in a civil case, the plaintiff has to prove her case by a preponderance of the evidence. According to her, we don’t accept that epidemiology shows at least a 95% connection. That’s somewhere north of clear, cogent, and convincing. It doesn’t surprise me that courts let in things that the New England Journal of Medicine would not. Totally agree with her that juries should be better educated about science. But I think everyone should be.
She really got up my nose with her condemnation of class actions. Judge Posner said once something like only an idiot or a fanatic sues for $20. If an individual’s damages are too small, then big players can escape liability just by hurting a lot of people a little bit. Class actions are awesome as a response to that.
The kiss of death for me on this book? This paragraph, at 177-78:
“The rebellion [against science] is spearheaded by a variety of groups within American society, each with its own political stance and reasons for turning against science and technology. They include humanists, multiculturalists, environmentalist, ecologists, feminists, and proponents of alternative medicine. Not all members of these groups, of course, reject science. But each movement is notable for having large contingents that do.”
I’m at least five of those things. And I love science. Why insult me? And she claims that it’s feminists leading the anti-vaccine movement; a fact that is so at odds with my experience I don’t know what to do with it.
Anyway. Glad a state supreme court justice not my own called it to my attention. Worth the read. But irritating in its failings.
The author takes as her text the breast implant litigation. She was the editor in chief of the New England Journal of Medicine as the litigation was starting. And she’s absolutely mystified – and offended -- by it. There was, in her view, no real scientific evidence that breast implants caused health problems, and certainly, in her view, no serious scientific evidence that a breast implant caused any particular woman’s health problems at the time US juries were coming down with multi million dollar verdicts, and cases were settling for substantial chunks of change.
Apparently, the evidence in those cases was mostly 1. this woman has a breast implant; 2. this woman had bad health; 3. there was some evidence showing that breast implants are associated with bad health. 4. There was some evidence the breast implant manufacturers covered up comparatively trivial product defects. In the author’s view, that wasn’t enough to justify the verdicts, and certainly not enough, morally, to justify inducing companies to leave the medical device field.
I haven’t worked these cases. And I feel her on one level. The level of scientific ignorance of decision makers is truly staggering. For a non-patent attorney lawyer, I’m a total math/science geek. I can do division! But the fact is, in a civil case, the plaintiff has to prove her case by a preponderance of the evidence. According to her, we don’t accept that epidemiology shows at least a 95% connection. That’s somewhere north of clear, cogent, and convincing. It doesn’t surprise me that courts let in things that the New England Journal of Medicine would not. Totally agree with her that juries should be better educated about science. But I think everyone should be.
She really got up my nose with her condemnation of class actions. Judge Posner said once something like only an idiot or a fanatic sues for $20. If an individual’s damages are too small, then big players can escape liability just by hurting a lot of people a little bit. Class actions are awesome as a response to that.
The kiss of death for me on this book? This paragraph, at 177-78:
“The rebellion [against science] is spearheaded by a variety of groups within American society, each with its own political stance and reasons for turning against science and technology. They include humanists, multiculturalists, environmentalist, ecologists, feminists, and proponents of alternative medicine. Not all members of these groups, of course, reject science. But each movement is notable for having large contingents that do.”
I’m at least five of those things. And I love science. Why insult me? And she claims that it’s feminists leading the anti-vaccine movement; a fact that is so at odds with my experience I don’t know what to do with it.
Anyway. Glad a state supreme court justice not my own called it to my attention. Worth the read. But irritating in its failings.
July 3, 2010
Whatever the pablum peddled by politicians and the media, the public attention span and memory are both short, so it's easy to forget the flap there was in the 1990s about the supposed dangers of silicone breast implants, especially in the wake of the 1992 FDA decision to call a moratorium on the sale and implantation of the devices until their safety could be properly, scientifically established: at first the rumour was that they could cause cancer, but after this nonsense had been laid to rest -- which didn't take long -- the next piece of pseudomedical quackery came along, which was the widespread conviction that they were responsible for the very unpleasant condition called mixed connective tissue disease, a malfunction of the immune system. And this time the rumour must be true, because after all wasn't it being demonstrated time after time in the nation's courts that the lives of poor, defenseless women were being destroyed by these infernal devices . . . with the massive damages awards being levied on the dastardly manufacturers serving as emphasis to the truth of it all?
Well, no. There never was any evidence at all that silicone breast implants represented the slightest health hazard. The "science" produced in court was the kind of stuff Snopes.com was invented to expose. Juries (and judges) were whipped up into hysteria by tort lawyers who realized they could earn themselves enormous fees by playing on people's fears of disease and detestation of ruthless corporations and abjuring any connection with such trivia as facts and reality. As a measure of the virulence of these people, when the first scientific reports came in, from 1994, demonstrating the near certainty that the implants were harmless, not only did the lawsuits continue but also legal attempts were made to silence the scientists who'd done the research! Not only had the inmates taken over the institution, they were being paid handsomely for doing so.
Marcia Angell, who was then Editor of the New England Journal of Medicine, is an excellent teller of this tale of confusion, ignorance, panic and, I'd suggest, criminal abuse of the law. She spells out early on that her own general pre-existing prejudices on approaching the task were those of a liberal feminist, and that some of her preconceptions about the rights and wrongs of the episode were very far from validated: in particular, she reveals that for once the corporations -- companies like Dow Corning, driven into bankruptcy by the fracas -- were the victims. She's right in this, obviously, although it's hard to feel undiluted sympathy for them because they were in good measure responsible for bringing this catastrophe upon themselves: Having grown accustomed, during the years of Genial Uncle Ronnie when human welfare was a distant second to the profits of big business and the greed of the wealthy, to an FDA that was sans teeth, sans eyes, sans taste, sans everything, when David Kessler, appointed by Bush Senior as the FDA's new boss, demanded from the implant manufacturers supportive scientific research to show their products were safe, they essentially didn't bother doing anything -- presumably assuming the silly little man would go away and stop bothering them. In the end, clearly frustrated beyond all bounds of patience and genuinely concerned there might be safety issues lurking behind the manufacturers' inaction, Kessler introduced the moratorium. It was the FDA ban that really opened the floodgates to all the claims of implant-caused illness, because after all the FDA wouldn't have banned them if they weren't really dangerous, would it?
Those of a delicate disposition -- me, for example -- might want to avoid Angell's Chapter Two, which describes the surgical procedures involved in various forms of breast augmentation and then all the many things that can go ruinously wrong with said procedures. I was reading this chapter in a pub in Toronto and was mighty glad I was positioned within easy reach of plenty of stomach-settling beer. (The rest of the pub was watching a World Cup match on t'telly, so assumed my occasional moans and retches were commentary on the state of play.) My only real complaint about the book was that the copy I had was defective, containing at the back a repeat of the first 32pp signature rather than the 32pp that should have been there, containing most of the notes/references, the biblio and, most devastatingly of all, the index. Grr!
Anyway, this is a very good book, and wonderfully readable. Don't be tempted to think its subject is ancient history: although the specifics may have changed a bit, its subject is highly topical in that, at the moment, he have a similar hysterical flap going on over the nonsensical belief that vaccination causes autism . . . to mention just one.
Well, no. There never was any evidence at all that silicone breast implants represented the slightest health hazard. The "science" produced in court was the kind of stuff Snopes.com was invented to expose. Juries (and judges) were whipped up into hysteria by tort lawyers who realized they could earn themselves enormous fees by playing on people's fears of disease and detestation of ruthless corporations and abjuring any connection with such trivia as facts and reality. As a measure of the virulence of these people, when the first scientific reports came in, from 1994, demonstrating the near certainty that the implants were harmless, not only did the lawsuits continue but also legal attempts were made to silence the scientists who'd done the research! Not only had the inmates taken over the institution, they were being paid handsomely for doing so.
Marcia Angell, who was then Editor of the New England Journal of Medicine, is an excellent teller of this tale of confusion, ignorance, panic and, I'd suggest, criminal abuse of the law. She spells out early on that her own general pre-existing prejudices on approaching the task were those of a liberal feminist, and that some of her preconceptions about the rights and wrongs of the episode were very far from validated: in particular, she reveals that for once the corporations -- companies like Dow Corning, driven into bankruptcy by the fracas -- were the victims. She's right in this, obviously, although it's hard to feel undiluted sympathy for them because they were in good measure responsible for bringing this catastrophe upon themselves: Having grown accustomed, during the years of Genial Uncle Ronnie when human welfare was a distant second to the profits of big business and the greed of the wealthy, to an FDA that was sans teeth, sans eyes, sans taste, sans everything, when David Kessler, appointed by Bush Senior as the FDA's new boss, demanded from the implant manufacturers supportive scientific research to show their products were safe, they essentially didn't bother doing anything -- presumably assuming the silly little man would go away and stop bothering them. In the end, clearly frustrated beyond all bounds of patience and genuinely concerned there might be safety issues lurking behind the manufacturers' inaction, Kessler introduced the moratorium. It was the FDA ban that really opened the floodgates to all the claims of implant-caused illness, because after all the FDA wouldn't have banned them if they weren't really dangerous, would it?
Those of a delicate disposition -- me, for example -- might want to avoid Angell's Chapter Two, which describes the surgical procedures involved in various forms of breast augmentation and then all the many things that can go ruinously wrong with said procedures. I was reading this chapter in a pub in Toronto and was mighty glad I was positioned within easy reach of plenty of stomach-settling beer. (The rest of the pub was watching a World Cup match on t'telly, so assumed my occasional moans and retches were commentary on the state of play.) My only real complaint about the book was that the copy I had was defective, containing at the back a repeat of the first 32pp signature rather than the 32pp that should have been there, containing most of the notes/references, the biblio and, most devastatingly of all, the index. Grr!
Anyway, this is a very good book, and wonderfully readable. Don't be tempted to think its subject is ancient history: although the specifics may have changed a bit, its subject is highly topical in that, at the moment, he have a similar hysterical flap going on over the nonsensical belief that vaccination causes autism . . . to mention just one.
December 6, 2021
It was good to read a history of a health panic written by a physician/scientist. (I was a kid when this controversy occurred, so I remember a lot of news reports featuring women who went from active to totally disabled and blamed their implants, followed by a few reports noting that the scientific studies found no link, so this book did a great job filling me in on the history.) She has a great perspective on the scientific history as she was the editor of the New England Journal of Medicine.
One of the things I really liked about the book is how she acknowledged that, as a feminist, she initially assumed there might be something to the reports of Silicone-induced disease. Afterall, women's health conditions were frequently (and still are) dismissed as psychogenic when there are biological causes and silicone breast implants were not extensively tested before being used. However, as she examined the scientific evidence, it became clear that there wasn't a link between this type of implant and the wide range of diseases they were supposed to cause and she became vocal about the absence of a link. She makes it clear that the idea that feminists who believe in "other ways of knowing" are not helping the feminist movement or women in general. This is particularly devastating coming from a feminist. I have found myself in this position: I am a scientist and also a feminist and sometimes find myself annoyed or outraged at anti-scientific comments by feminists.
I also was impressed by the way that she detailed how the proponents of the silicone breast implant chronic disease link blamed the devices for such a wide range of diseases that it was implausible. And with the lack of epidemiological evidence supporting the link, it's very clear in her book that there is no link. She's (deservedly) quite hard on the physicians and scientists who promoted the idea that silicone caused these diseases. It would be quite revealing to find out how many are true believers, how many have always been opportunists and how many believed it at the start and recognized that there is no link but decided to continue to promote it because they were too far in.
In the end, at least one company went bankrupt over nonexistent disease links. It's tempting to say that nobody should cry for a company, but people lost their jobs and people lost savings that were invested in these companies over pseudoscience and the idea that you compensate before you actually determine whether the device causes disease. Women underwent additional surgeries to remove their implants and other women had to live with the fear that their implants may have caused them to develop diseases. The whole panic was an excellent demonstration of how our tort system should not work.
One of the things I really liked about the book is how she acknowledged that, as a feminist, she initially assumed there might be something to the reports of Silicone-induced disease. Afterall, women's health conditions were frequently (and still are) dismissed as psychogenic when there are biological causes and silicone breast implants were not extensively tested before being used. However, as she examined the scientific evidence, it became clear that there wasn't a link between this type of implant and the wide range of diseases they were supposed to cause and she became vocal about the absence of a link. She makes it clear that the idea that feminists who believe in "other ways of knowing" are not helping the feminist movement or women in general. This is particularly devastating coming from a feminist. I have found myself in this position: I am a scientist and also a feminist and sometimes find myself annoyed or outraged at anti-scientific comments by feminists.
I also was impressed by the way that she detailed how the proponents of the silicone breast implant chronic disease link blamed the devices for such a wide range of diseases that it was implausible. And with the lack of epidemiological evidence supporting the link, it's very clear in her book that there is no link. She's (deservedly) quite hard on the physicians and scientists who promoted the idea that silicone caused these diseases. It would be quite revealing to find out how many are true believers, how many have always been opportunists and how many believed it at the start and recognized that there is no link but decided to continue to promote it because they were too far in.
In the end, at least one company went bankrupt over nonexistent disease links. It's tempting to say that nobody should cry for a company, but people lost their jobs and people lost savings that were invested in these companies over pseudoscience and the idea that you compensate before you actually determine whether the device causes disease. Women underwent additional surgeries to remove their implants and other women had to live with the fear that their implants may have caused them to develop diseases. The whole panic was an excellent demonstration of how our tort system should not work.
November 17, 2008
Read this book and weep for our legal system. Anyone who thinks our tort system is a fair way of compensating so-called "victims of corporate greed" MUST read this book.
By the way, all research shows that the Dow Corning breast implants are in all likelihood completely harmless. Though over $5 billion has been paid out to "victims" and, of course, their lawyers.
By the way, all research shows that the Dow Corning breast implants are in all likelihood completely harmless. Though over $5 billion has been paid out to "victims" and, of course, their lawyers.
September 30, 2009
The author's writing leaves a lot to be desired but the content itself is an excellent introduction to the clash between science, law and the media in America.
January 3, 2022
angell's debut. details the conflict between medical and legal evidence building as influenced by the media, the public, and political institutions. good reminder of what science needs to be.
Displaying 1 - 8 of 8 reviews