Dan Bolton, the original attorney

[Guest guest]

http://www.homestead.com/siliconecity/fatal_litigation_1_1.html

Excerpt:

The kind of lawyer willing to tackle such a case in its virgin state tends to be a true believer, a zealot on a mission. He completely buys into the notion that his client has been grievously injured by a heartless corporation, and he's out for justice, the financial risk be damned. And if he doesn't yet have the proof, well, he thinks, it's just a matter of time. After all, evidence of A.H. Robins's problems with the Dalkon Shield intrauterine device wasn't exactly handed to plaintiffs on a silver platter. It is cases like that one that sustain the true believer, that fire his imagination. Rarely does he realize that he's laying the foundation for a mass tort. But that's what he's doing.

In the breast-implant litigation, the truest of true believers is a San Francisco lawyer named Dan Bolton. "There is no doubt in my mind," he says firmly, "that silicone breast implants cause auto-immune disease." He could not be more sincere in his belief that breast implants can have terrible effects--that the silicone gel in the implants somehow causes a breakdown in a woman's immune system, resulting in everything from achy joints and fatigue to such classic auto-immune diseases as lupus and scleroderma. That a flurry of recent studies have cast grave doubt on this theory does not move him. Like many lawyers in the breast-implant case, he views his clients' anecdotal evidence--they had breast implants, after all, and they also have an auto-immune disease of one sort or another--as far more compelling than any scientific study. And his belief that Dow Corning made and marketed a product that it knew could cause such problems is, if anything, even more firmly held. "Dan Bolton," says one defense lawyer, "hates Dow Corning."

Like all the other lawyers in the early days, Bolton fell into his first breast-implant case more or less by accident. In 1982 a woman named Stern walked into a small plaintiffs firm in San Francisco, complaining of a ruptured implant. She also suffered from chronic fatigue and joint pains. Her doctors, unable to fix on the cause of her symptoms, told her that the leakage of silicone gel into her body might be at the root of the problem. Though no scientific literature supported this theory, her doctors thought that it might at least be a possibility.

Stern wanted to sue Dow Corning, which had made her implant, not just for manufacturing a defective product but for selling her something that had made her ill. No one had ever made that allegation before--at least not in a lawsuit--and the lawyer she went to see immediately understood the inherent difficulty in pursuing such a case. Nonetheless, he took Stern on as a client, and threw the case to Bolton, whom he had recently hired out of law school.

Though he didn't realize it at first, Bolton had two great advantages in gunning for this particular product. The first was that, even though they were put into the human body, silicone breast implants, like all medical devices at the time, were only loosely regulated. Even though they'd been on the market since 1964, they had never been put through the kind of premarket wringer that the Food and Drug Administration requires for, say, new pharmaceuticals.

Bolton's second advantage was, to put it bluntly, that he was going up against Dow Corning. Founded in 1943 by Dow Chemical and Corning (then known as Corning Glass Works)-which remain its sole shareholders--its only mission has been to find new applications for silicone, which is derived from silicon and is one of the most useful substances ever created. This it had done with great success, generating $2.2 billion in annual sales by 1994 and churning out some 8,700 silicone products. Its medical-devices division alone makes everything from pacemaker parts to shunts for relieving water on the brain. (Breast implants occupied a small and not especially profitable corner of the company.) Over time the company culture had instilled in its employees an almost childlike awe at the wonders of silicone.

Perhaps because it had to report to only two sympathetic shareholders, it was an insular, even naive company. Its Midland, Michigan, headquarters was filled with cheery Midwesterners who had never had to face down the threat of sustained litigation, let alone a bout of bad publicity. In this, it could not have been more different from its co-founder and neighbor, the much larger Dow Chemical, which had been toughened up over the years by exposure to both. Dow Corning was an innocent in a dangerous world.

This was perhaps never better illustrated than when Bolton finally got the court to agree--after the usual lengthy struggle with the company's lawyers--to his demand to visit Dow Corning and search for documents. For a lawyer with a theory he can't prove, this "discovery" phase of litigation can be a crucial fishing expedition. Ordered by the court in 1984 to give Bolton access to certain documents, Dow Corning actually bought him the airline ticket--first class, no less--and paid for his hotel room. That week, Dan Bolton found his case.

To this day, Bolton can remember his growing excitement as he realized what a treasure trove Dow Corning had opened up for him. In the 20 years it had been manufacturing silicone breast implants, Dow Corning had compiled thousands upon thousands of memos relating to every aspect of the product--including the question of whether the gel could cause an immune reaction. Many of those memos were written in language so strong as to border on the inflammatory. Bolton found a 1983 memo, for instance, that concluded: "As Product Steward...I must strongly urge that Bill's group be given an approval to design and conduct the necessary work to validate that these gels are safe...only inferential data exists to substantiate the long-term safety of these gels for human implant applications." Another 1983 memo said, "However, I want to emphasize that to my knowledge we have no valid long-term implant data to substantiate the safety of gels for long term implant use." To Bolton, these were "classic smoking-gun-type documents. I was amazed."

He also stumbled upon a raging controversy within the company during the 1970s over a side effect called "contracture"--in which the tissue around the implant could harden--as well as over "bleed." Gel bleed was a phenomenon well known among plastic surgeons in which minuscule amounts of gel escaped through the implant shell. The controversy resulted from the fact that a number of plastic surgeons, feeling that Dow Corning implants both bled excessively and caused an unacceptably high rate of contracture, had stopped buying implants from the company. The salesmen were beside themselves about the loss of business, and the internal memos they wrote to their higher-ups provided Bolton with yet more ammunition. "Several of our customers," wrote the author of the most damning such memo, "asked me what we were doing. I assured them, with crossed fingers, that Dow Corning too had a 'contracture/gel migration' study under way. This apparently satisfied them for the moment but one of these days they will be asking us for the results of our studies."

Bolton was delighted. "With all our little goodies, we felt like Santa Claus," he recalls now. "We came back very, very up about the case."

One could argue, as Dow Corning later did, that these documents represented an ongoing internal debate, and that for every scientist who worried about the effect of implants on the immune system, there were others who were equally convinced of their safety. One could offer various innocent explanations for things that were in the documents. And one could point out that while the "Dow documents" (as they later became known) weren't exactly reassuring about the safety of breast implants, they didn't show them to be unsafe either. On the central question of the lawsuit--did silicone breast implants cause an immune reaction in women?--they were silent.

What Bolton understood, however, was that none of this mattered. In the hands of a good plaintiffs lawyer, the 800 pages of documents he came back with would make Dow Corning appear negligent while obscuring the fact that the central allegation remained unproven. Combined with the other elements he had put together--an ex-employee who had agreed to testify against Dow Corning; a handful of "experts" he had found who were willing to theorize that silicone affected the immune system; the sympathy that Stern herself was likely to arouse in a jury--the Dow documents gave Bolton the upper hand. Even Dow Corning could see that; in the spring of 1985, just before the trial was set to begin, it offered to settle. Bolton said no.

That July his bet paid off when a jury awarded Stern $1.7 million. Of that, $1.5 million was punitive damages, meaning that the jury believed Dow Corning had done bad things that deserved serious punishment. (The company and Stern settled the case for less while it was on appeal, a very common outcome.)

Bolton had shown the way: You could allege in court that silicone breast implants caused disease, and you could win a lot of money.

http://www.homestead.com/siliconecity/fatal_litigation_1_2.html

To Bolton's surprise, though, the Stern verdict did not create much of a stir. It was the legal equivalent of a tree falling in the forest: If no one heard it, did it really make any noise? After the trial, the court ordered Bolton to return the Dow documents to Dow Corning and forbade him to talk about what was in them. In the plaintiffs bar, the belief endured that these were difficult cases and, Stern notwithstanding, not especially remunerative. That's because so much of the award was in punitive damages, which quite often get reduced or thrown out on appeal.

For any complicated lawsuit to sprout into a mass tort, something more is needed than a victory or two against a company. There has to be a climate of fear surrounding the product, and a group of angry users who want to make the company suffer as they themselves have suffered. Once potential claimants are on the verge of a stampede, then a big jury award can set it in motion.

Which is why, as important as the Stern case was, Bolton's second big breast-implant trial six years later was infinitely more so. It wasn't that the facts were especially different; Bolton's new client, a woman named nn Hopkins, had a ruptured implant and a history of joint pain, fatigue, and weight loss. And Bolton tried the case in much the same way he'd tried the Stern case, relying on the Dow documents (which he'd retrieved from Dow Corning), his "experts," and so on. But the context was different. And that changed everything.

By then, there had been an increasingly loud drumbeat of publicity, as reporters began to pick up on the charges that breast implants caused disease. Television magazine shows are particularly powerful purveyors of fear about products; to this day, everyone on both sides of the breast implant litigation remembers a broadcast by Connie Chung in late 1990 about the breast-implant allegations. The show had a tremendous ripple effect, as women with implants started up support groups to share information and to vent their anger at the makers of breast implants. It was a tremendously emotional issue--how could it not be?--and there were instances when women with implants panicked upon hearing the allegations. In one infamous case, a woman tried to cut her own implants out with a razor. Meanwhile, Sidney Wolfe, who runs Ralph Nader's Health Research Group, was loudly calling for breast implants to be banned and selling litigation documents to plaintiffs attorneys for $750.

Added to this volatile mix was one other element, perhaps the most crucial of all in creating the atmosphere for this mass tort: The federal government began to bear down hard on breast implants. Having finally concluded that implants needed to be strictly regulated, the FDA was in the process of applying to them the same tough standards it applies to drugs. The process wasn't going well for Dow Corning, because it hadn't done enough science. And FDA Commissioner Kessler appeared to be in no mood to cut the company any slack; according to an FDA source, he was continually pushing the FDA staff to finish up its breast-implant investigation quickly.

In November 1991, a scientific panel convened by the FDA held a widely publicized hearing on breast implants, which turned into a contentious, highly charged affair. Although the panel ultimately concluded that implants should remain on the market, its decision was barely noticed. For by that time the Hopkins jury had reached a verdict. In mid-December 1991, a jury awarded nn Hopkins not the $1.7 million Stern had gotten but $7.34 million, of which $6.5 million was punitive damages. Suddenly there wasn't a plaintiffs lawyer in the country who didn't understand the rare opportunity in breast implants.

And Dan Bolton still had one last card to play. Enraged by Dow Corning's continued insistence that breast implants were safe, he decided that Kessler should see the Dow documents. Violating a court order that they be kept under seal, he managed to get them to Kessler, who was reportedly appalled. On January 6, 1992, the FDA commissioner, claiming that the documents contained information "that has increased our concern about the safety of [implants]," announced a temporary moratorium on their use (though, oddly enough, he said they could still be used for women who needed them for reconstructive surgery after breast cancer). "We owe it to the American people to see to it that these questions are thoroughly investigated," he added.

In a less litigious society, a government official would be able to say out loud that a medical device needed further study, and that's what would happen: There would be further study. Instead, Kessler's call for an implant moratorium became the spark that finally lit the blaze. Within weeks, 100 lawsuits had become 1,000 lawsuits. The stampede had begun.