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----- Original Message ----- From: Toxic Discovery

Undisclosed-Recipient:;

Sent: Saturday, November 01, 2003 10:21 PM

Subject: Toxic News - Houston Chronicle - 11/01/03

Nov. 1, 2003, 10:25PM

Silicone on way back, but debate still alive

Money only victor in years of implant suits By MIKE TOLSON Copyright 2003 Houston Chronicle

The pursuit of curves spawned first an industry, then a cause, and finally one of the most expensive mass torts in history. Now, a decade removed from the opening salvos of the silicone war, breast implants could be back, almost as if the billion-dollar ruckus had never taken place. Make that a couple of billion, or three or four. The final bill from implant litigation will not arrive until Dow Corning, once the largest manufacturer of implants, emerges from bankruptcy with a court-approved plan for paying the women who sued it. Nevertheless, a U.S. Food and Drug Administration advisory panel two weeks ago recommended approving the application of a California company to sell silicone implants to the public after a moratorium that dates to 1992. If the agency agrees, the little bags of goo that mean so much to cancer victims and women hungry for enhancement will reappear on operating tables even while women are collecting on claims that the silicone made them sick. This may defy logic. But from the beginning, the silicone war was less about logic than common sense. Women were getting sick, and silicone was the apparent common denominator. That was enough for some to crusade against silicone implants, and they are not about to apologize for their beliefs or the legal action they spawned. "This is a medical product that failed," said Kathy ley-ston, founder of the anti-silicone group Toxic Discovery Network. "There was no recourse. The companies told women they were on their own." What ley-ston does regret is that the war became a monumental battle in which money became the overriding issue. The question of why so many women with implants felt so bad became secondary to claim grids and global settlements. "I think the women were disserved," she said. "This was about health, not wealth. I think many of the attorneys lost sight of that." In the righteous early days of the silicone war, the story unfolding from coast to coast was always about sick women. Medicine had promised them something almost too good to believe, only to leave them with a leaking plastic sac that seemed to be damaging their bodies. Soon, however, the focus flew to the courtroom, where science and justice were again proving awkward companions. Certain things were easy to prove. The implants ruptured and leaked far more than manufacturers let on. And they had never been properly researched for safety. The gist of the women's complaint -- that the silicone itself caused all manner of autoimmune and connective tissue illnesses -- was a different matter. A few doctors had theories about what silicone did to the body on a cellular level and how it might relate to certain symptoms. None had empirical evidence. Not that it mattered at first. Juries returned multimillion-dollar verdicts in some publicized cases even without a smoking gun. The lesson to be learned, concludes law professor and silicone historian Bernstein, is that when presented with a plausible claim that a product injured a plaintiff and proof the company that made it did little beforehand to research its health effects, juries are not hesitant to presume the worst. And when the defense fails to muster evidence that the product has nothing to do with the injury, a financial incentive takes over and a mass tort is born. Eventually the implant manufacturers were able to produce such evidence. As the 1990s wore on, one study after another failed to establish a connection between implants and illness. The studies in turn emboldened judges to bar much of the plaintiffs' more speculative expert testimony under new "gatekeeping" guidelines laid down by the U.S. Supreme Court. But that would not happen for several years. In the meantime, thousands of lawsuits were filed in Houston alone, alleging illness or the potential for it. Some of the suits around the country ultimately congealed into class actions, though most of the Texas lawyers wanted no part of that: The payoffs were lower and the process too bureaucratic. They wanted Texas courts and Texas juries, especially in Houston. When renowned attorney O'Quinn helped Pamela notch a $25 million verdict in 1992, the rush began in earnest. The County district clerk had to add staff just to process the paperwork. Facing the legal onslaught, the implant companies were in a bind. There was virtually no way to try the cases one by one. Settlement values in certain jurisdictions, including Houston, were very high. "The volume of cases grew so quickly there was no way to keep up with it," said Bernick, a Chicago lawyer who became lead counsel for Dow Corning, which was forced to seek refuge in bankruptcy court. "Dow went Chapter 11 because it could not fight all these claims." Dow could seek the refuge because it was a smaller, silicone-specific spinoff of Dow Chemical. Bankruptcy protection, Bernick said, gave Dow time for the scientific research to mature. Defendants were always confident that science would support their side. The other major implant manufacturers, 3M and Bristol-Myers-Squibb, were too big to immediately seek bankruptcy. They had to settle -- and in many cases settle big. When O'Quinn was once asked about a report his firm was pulling in $13 million a month in implant settlements, he jokingly said that was too low. "Our settlements averaged a million or more per client, with some receiving more or less depending on the degree of injury," said Houston lawyer Mithoff. "We had between 400 and 500, and we were able to settle all of them except the Dow Corning cases." As the scientific reports trickled in, defense resistance stiffened. 3M made a decision to stop paying and start trying cases, even in Texas. "3M knew the handwriting was on the wall if they kept paying on these," said Tekell, a Houston defense lawyer who handled the Texas trials. "More would keep coming. If these mass torts take hold, they can run almost any company into bankruptcy." The cumulative weight of the scientific evidence, which included an important recommendation from a specially appointed scientific panel, forced the endgame. Plaintiffs began to lose in court, and settlement values plummeted. "They were just settling to move them out," Tekell said of his former client. "The plaintiff lawyers were taking very small amounts, maybe $5,000 to $40,000." Now all the lawyers have moved on. Some took a big hit when they were left holding too many cases at the end. Some made a mint. But one cannot help but wonder about the point of all the litigation if silicone implants return to the market accompanied by little more than an expanded warning. Tort reformers see the whole thing as a waste of time, money and public attention. Others are willing to accept a giant "never mind" as the occasional cost of a less-regulated marketplace. "If I had to choose, I'd prefer to have a court system that every once in a while costs us a god-awful amount of money that we shouldn't have had to pay but which overall might keep us from dying," said Swartzman, a lawyer and public health professor at the University of Illinois-Chicago. "Tort liability acts as a safeguard. And over time, the system self-corrects." For some of the women who made silicone their crusade, like ley-ston, the courtroom battles remain a bad memory. The science they seek is still undone. Epidemiology has told them that in general, women with implants do not get sick more often than women without them. But that does not answer their other questions. Is a subset of women susceptible to silicone? Can it trigger a genetic predisposition for autoimmune illness, setting off a disease that might have hit 20 years later? "I still think the final verdict is not in on that," Mithoff said. "Someday we will have an answer. I just hope that a number of women don't have to live through a lot of misery before we do."

-----------------------------

Kathy ley- ston, R.N.

Kathy ley- ston, R.N.Executive Director

TOXIC DISCOVERY601 W. Nifong - Bldg. 5AColumbia, MO. 65203

kkjohnston@...www.toxicdiscovery.com

tel: fax:

(573) 449-2301(573) 445-4700

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