By ALEXANDRA R. MOSES 

DETROIT (AP) - Women with silicone breast implants who voted against a $3.2 billion settlement plan offered by Dow Corning Corp. are now free to sue its corporate parents, a federal judge has ruled. 

If upheld, the ruling could unravel the complicated deal aimed at ending years of legal battles over claims that silicone implants caused illnesses in hundreds of thousands of women around the world. 

U.S. Bankruptcy Judge Arthur Spector ruled late Tuesday that any woman who voted against the settlement approved last month could sue Dow Corning's corporate parents, Dow Chemical Co. and Corning Corp., each of which owns half of Dow Corning. 

The settlement barred further lawsuits against Dow Chemical and Corning Corp. over silicone implants. The clause is one of the keys to the settlement, part of a $4.5 billion bankruptcy reorganization plan for Dow Corning. 

The clause is ``fundamental to the plan,'' said Dow Corning spokesman Michael Jackson. ``Without the release, there's no plan.'' 

Dow Corning will appeal the opinion, Jackson said. 

Spector said he lacked the power to grant a release to Dow Chemical and Corning, and that the plan didn't appear designed to grant such a release anyway. Jackson said Dow Corning disagreed on both points. 

Spector's opinion also said women who voted to approve the settlement would be barred from suing the companies. It's unclear how many women his opinion might affect; 112,774 women voted on the plan earlier this year, with 94 percent approving. 

Spector said there was no reason to assume allowing claims from women who voted no would create an undue burden on the companies. He said many such claims already have been filed. 

The companies estimate claims have been filed by 170,000 women or people representing their estates. 

The no-lawsuit release in the settlement had been fought by lawyers for a group of women in Nevada, where the state's supreme court has upheld damages against Dow Chemical over silicone breast implants, opening the door for similar lawsuits. 

Geoffrey White, one of the lawyers representing the Nevada women, called Tuesday's ruling ``a major victory.'' 

Dow Corning, which no longer makes silicone breast implants, declared bankruptcy in 1995 after thousands of women sued over implants. Women have blamed leaking gel from the implants for lupus, rheumatoid arthritis, body aches, fatigue, memory loss and hardening of the breasts. 

Under the proposed settlement, women who blame illnesses on Dow Corning silicone breast implants could get between $12,000 and $300,000 each. Women could also receive up to $25,000 for ruptured or leaking implants, and up to $5,000 for implant removal. 

Detroit Free Press, Dec. 1, 1999 

Breast Cancer Research and Patient Education Haven't Gone Far Enough  

DIANA ZUCKERMAN  

EVERY autumn, newspapers and magazines and the Internet are filled with helpful information aimed at increasing our awareness of breast cancer.  

The goal is to improve early detection, and it works. Nevertheless, the sad truth is that many of the 175,000 women who will be diagnosed with breast cancer next year will not have all the information they need to get the treatment that is best for them. 

This year, 6,500 Michigan women will have been diagnosed with breast cancer -- more than 43 other states. They are beginning a terrifying journey, one that will involve making life-changing decisions. For many, these decisions will be based on inaccurate and misleading information rather than "informed consent."  

Medical experts are finding, for example, that many women are not told about the excellent safety record of lumpectomy -- the removal of the cancer and the tissue around it. This procedure is less traumatic for many women than losing an entire breast, but many women are never told about that option. Older women, poor women, and women in the Midwest and South are especially likely to have unnecessary mastectomies. 

Michigan is one of the few states that requires that newly diagnosed breast cancer patients receive information about lumpectomies. Unfortunately, research indicates that this law has had limited success -- after an initial increase in lumpectomies, there was a return to the old surgical habits. Recent increases in lumpectomies are apparently due to slowly changing habits, rather than legal requirements. 

Meanwhile, many mastectomy patients choose breast reconstruction, but this too provides options rather than objective information. Reconstruction using the woman's own tissue is increasingly popular, but there are very few studies evaluating the safety of the various procedures.  

Even more shocking, the Federal Drug Administration has never approved any kind of breast implants as safe and effective, even though implants have been sold since the 1960s. The saline implants that have become increasingly popular in recent years have not been evaluated in any major studies.  

Two weeks ago, the manufacturers of saline implants were required to submit safety studies to the FDA for the first time. Which manufacturers submitted safety studies and what do those studies indicate? None of that information is public, and it will be months before any of these studies are available to patients or doctors. Even then, since the manufacturers' economic well-being depends on the conclusions, it would be difficult to consider these studies objective. 

Members of Congress from Detroit and elsewhere have worked hard to increase funding for government research on breast cancer, and yet our government has never funded a single study of the safety of breast implants for mastectomy patients. It's difficult to believe, but former officials at the National Institutes of Health decided it was too complicated and expensive to study what happens to breast cancer patients who get breast implants.  

When Congress required the National Cancer Institute to study the safety of breast implants, NIH ignored its plea to include mastectomy patients. It's crazy but true: When the government's study is published in the next few months, it will not include even one mastectomy patient. 

McGhan Corp., a breast implant manufacturer, recently conducted a five-year study of mastectomy patients. It showed terrible problems: One out of four of the women need additional implant surgery within a year, and one out of four had their implants removed within two years.  

The study results were provided to the Institute of Medicine for their expert panel's recent review, but perhaps because it was unpublished, those experts didn't think these problems were important enough to mention in their widely publicized report. As a result of this omission and others like it, the headlines gave implants a clean bill of health instead of warnings for mastectomy patients. 

"It was hard enough losing my breast to cancer -- I was devastated to lose it again when the implant failed" is a comment I have heard from many cancer survivors, whether they tried silicone or saline breast implants.  

Even worse are the stories from cancer patients who describe terrible pain, infections that wouldn't go away, and sores or lesions on their breasts, back or arms. When these terrible side-effects were duly noted by their doctors and reported to the manufacturers or the FDA, they were referred to as merely "local complications."

Meanwhile, breast cancer patients and their doctors read the headlines about the safety of breast implants, and assume that implants are safe for mastectomy patients. They are not warned about the lack of research on mastectomy patients, or told that the few existing studies indicate the need for multiple surgeries, many of which are unsuccessful. 

Tuesday's $3.2-billion settlement by Dow Corning Corp. represents a bittersweet compensation victory for the 170,000 women who claimed injury from their silicone breast implants. But for those women who chose implants after being diagnosed with breast cancer, better information about the risks of implants and alternatives to mastectomies could have enabled them to avoid the heartache of additional health problems and a lawsuit.  

Public support for medical research has probably never been higher. Awareness campaigns are working. But isn't it time we spent more of those resources to make breast cancer patients aware of the safe alternatives to mastectomy and to develop the safest possible reconstruction options for women who truly need them? 

Diana Zuckerman, Ph.D.

Executive Director

National Center for Policy Research for Women and Families

1444 Eye Street, NW

Suite 900

Washington, DC 20005

Brain Scans Suggest Damage In Veterans With Gulf War Illness 

CHICAGO, Nov 30 (AP) - Brain scans of soldiers who believe they suffer from Gulf War illness indicate their brains were damaged by chemical exposure during the 1991 conflict, researchers reported Tuesday.

``This is the first time ever we have proof of brain damage in sick Gulf War veterans,'' said the lead researcher, Dr. James Fleckenstein, a professor of radiology at the University of Texas Southwestern Medical Center in Dallas.  

``There's hope, now that these guys have a disease,'' he said. ``They can be believed they're not malingering, they're not depressed, they're not stressed. There's a hope for treatment and there's hope for being able to monitor the progress of the disease.''  

As many as 30,000 veterans of the war have complained of mysterious maladies, including fatigue, joint pain and memory loss, that they say are related to their service in the Gulf.  

A presidential panel looking into Gulf War illnesses said in August that it can't pinpoint causes of the ailments and recommended further study into whether there are potential genetic reasons.  

In the new study, magnetic resonance spectroscopy, which uses radio waves to measure body chemistry, found that veterans who believe they have the illness have up to 25 percent lower levels of a certain brain chemical than healthy Gulf War veterans.  

Lower-than-normal levels of the chemical, N-acetyl-aspartate, in the brain stem and basal ganglia suggest a loss of neurons in those areas, said the researchers, who were to present their findings today at the 85th annual meeting of the Radiological Society of North America.  

The brain stem controls some of the body's reflexes. The basal ganglia are switching stations for nerve impulses controlling movement, memory and emotion. The basal ganglia, for example, are where the malfunctioning occurs that causes Parkinson's disease.  

Fleckenstein said treatments are being explored by his colleague, Dr. Robert Haley, an associate professor of internal medicine and chief of epidemiology at UT Southwestern.  

Haley helped define Gulf War syndromes and identify toxic exposures associated with the likelihood of having them. He also revealed enzyme abnormalities that may be linked to the disease.  

Fleckenstein said brain scans of 22 sick veterans revealed levels of N-acetyl-aspartate 10 percent to 25 percent lower than those in 18 healthy veterans. The finding held up in an additional six sick Gulf War veterans drawn from a different part of the military.  

The study was blinded, meaning radiologists interpreting the results did not know which patients complained of symptoms and which were healthy.  

Researchers believe soldiers who became ill were those who had a genetic vulnerability to certain chemicals used in the war, including nerve gas, the insecticide DEET, pet flea collars some wore to repel pests and the drug pyridostigmine bromide. PB was administered to as many as 250,000 soldiers in the belief it would protect them from the toxic effects of nerve gas.  

Last month, the Pentagon raised the possibility for the first time of a connection between Gulf War illness and PB. It said more scientific study is needed before it can confirm or rule out a connection.  

Lt. Col. Dian Lawhon, a spokeswoman for the Department of Defense's office for Gulf War illnesses, which helped fund Fleckenstein's study, said her office could not comment on the findings until it sees a complete report. Only an abstract was available.  

``This is part of our continuing effort to find out what might be making Gulf War veterans sick,'' she said. ``We haven't seen anything that would say that they found the smoking gun, though.''  

Product Liability Lawyer Blizzard on Implant Cases: Comment 

Philadelphia, Nov. 30 - Edward Blizzard, a product-liability specialist at Houston's Blizzard & McCarthy law firm, comments on a judge's approval today in Bay City, Michigan, of Dow Corning Corp.'s $4.5 billion bankruptcy plan of reorganization, which includes about $3.2 billion to settle claims of women who may have suffered injury or disease from the company's silicone breast implants.  

``There were about 150,000 claims filed by women with Dow Corning breast implants,'' Blizzard said. ``I was in the group that negotiated the settlement, the Tort Claimants' Committee. We're pleased with the court's ruling today confirming the plan.  

``The U.S. District Court (in Detroit) now has to approve a case management order to implement the plan, and objectors can appeal to the District Court. We expect District Judge Denise Page Hood to affirm (Bankruptcy Court Judge Arthur) Spector's decision as soon as possible (for) the women who have waited so long.''  

``There will still be case litigation against Dow Corning for women who have opted-out'' of the settlement, with a fund of about $400 million to pay them judgments, he said.  

Nov/30/1999 18:29

c The Associated Press 

By JIM IRWIN 

BAY CITY, Mich. (AP) - A federal bankruptcy judge today approved Dow Corning Corp.'s $4.5 billion plan to emerge from bankruptcy, which includes $3.2 billion to settle claims from women with breast implants. 

U.S. Bankruptcy Judge Arthur Spector confirmed the settlement during a 20 minute court hearing, saying he would elaborate in an opinion to be issued next week. 

He has previously said his ruling would focus on one of the settlement's most contentious parts - a provision barring further lawsuits against Dow Corning's corporate parents - Dow Chemical Co. and Corning Corp. - oversilicone breast implants. He has also said he will consider the settlement's ban on punitive damages. 

It was not immediately clear what his ruling today included. 

The implants settlement provides $3.2 billion to settle claims from 170,000 women who say their implants caused various illnesses. The bankruptcy plan also includes $1.3 billion to settle other claims, including those from creditors and health-care organizations. 

Spector said he anticipated appeals that could hold up payment to the claimants. 

``There's an awful lot ahead before any money is passed,'' he said. After the appeals are exhausted, he said the settlement money may not be paid out ``until well into the year 2000, if not later.'' 

Objectors to the plan include 50 women with implants from Nevada, where that state's Supreme Court has upheld a civil decision against Dow Chemical. Geoffrey White, a lawyer for those women, argues the settlement takes away their right to sue, making it ``patently illegal and unconstitutional.'' 

White said Monday that a Spector ruling unfavorable to his clients would prompt his appeal to the 6th U.S. Circuit Court of Appeals in Cincinnati, then to the U.S. Supreme Court if necessary. 

Dow Corning spokesman T. Michael Jackson said the implant settlement was approved by 94 percent of 112,774 women in the case. 

Dow Corning, which no longer makes silicone breast implants, declared bankruptcy in 1995 after thousands of women sued over implants they said made them sick. 

According to a settlement worked out between the company and attorneys for many of the women, those who blame illnesses on Dow Corning silicone breast implants could get between $12,000 and $300,000 each. Women also can get up to $25,000 for ruptured or leaking implants, and up to $5,000 for implant removal.

Women who have no problems with their Dow Corning implants but still filed claims against the company also can settle for $2,000 with no questions asked. The plan lets women file claims for 15 years after it goes into effect. 

And it covers claims for women whose implants were made by other companies but filled with Dow Corning silicone gel.  

The plan also provides a pool of up to $400 million for individual claims, allowing women who choose to reject the offer to file lawsuits on their own. 

Dow Corning estimates about 179,000 women around the world are covered under the settlement. 

Current Events 

Confirmation Hearing News & Post-Hearing Update (Last updated on November 8, 1999) The bankruptcy court has set a status conference for Friday, November 12, 1999 in Bay City, Michigan. The TCC believes that this conference will provide information on when to expect an opinion from the court. We will update our website over the weekend of November 13 with any new information from that conference. Please check back with the TCC website at that time. 

Inamed's New President, Ilan Reich, Helps Turnaround, WSJ Says 

Santa Barbara, California, Nov. 22 Inamed's shares have nearly quadrupled since it named Ilan K. Reich as president, an attorney convicted of fraud in the Ivan Boesky insider-trading scandal of the 1980s, the Wall Street Journal reported. Since Reich, 45, joined in December, the breast-implant maker has made an acquisition and several alliances, raised $87 million in a stock offering, and settled an implant lawsuit and accounting questions. ``It was as messy a situation as I've ever been in,'' Reich told the Journal, referring to Inamed's troubles.  

In September, Santa Barbara, California-based Inamed bought Collagen Aesthetics Inc. for $142 million to move into the lucrative collagen-injection market.   

SYDNEY, Nov 21 (Reuters) - Former silicone gel implant maker Dow Corning Inc said on Sunday it hopes it will receive court approval for its Chapter 11 bankruptcy reorganisation plan by the end of November.  

Dow Corning, a joint venture between Dow Chemical Co. and Corning Inc., filed for protection from its creditors in May 1995 after it was hit with thousands of lawsuits from women alleging the implants caused health problems. The company denies the implants cause disease.  

Dow Corning chief executive Dick Hazleton told Australian television's Business Sunday programme on Channel Nine that the proposed settlement with the committee representing claimants had been accepted by 94 percent of the claimants in a ballot to approve the deal.  

"It's going through the final legal processes and we hope that by the end of November, we will have a ruling from the judge that the plan is confirmable and can go forward," Hazleton said.  

The US$3.2 billion settlement reached last year must be approved by a bankruptcy court judge to become effective.  

Wednesday, November 03,1999 - 06:31 PM ET  

(KWCH) Cheryl Kelly of Dodge City is in the fight of her life. And it's a fight for her life. 

Kelly told her story to Eyewitness News Reporter Kristi Tedesco, who followed Kelly's life for nine months, through a special operation in Denver that removed her leaking breast implants. 

In 1966 Kelly went to a doctor for a breast augmentation. At that time they injected silicone gel directly into the breast tissue. 

Five years later, suffering from gangrene, she underwent a double mastectomy. 

In an effort to reconstruct her breasts, she opted for silicone implants in 1973. 

And those implants ruptured. 

For years Kelly said she suffered the ill affects of the silicone...she was diagnosed with Fibromyalgia. Doctors said she was "unable to do repetitive work with her arms," and was a good candidate to have the silicone removed. 

But insurance companies didn't want to pay for it. 

Lynda Roth, the founder of the group called Silicone Survivors, says Cheryl's case is one of thousands. 

"Beg, borrow or whatever to remove them," Roth said. "Don't wait for your insurance because while you're waiting your health can worsen dramatically."  

The implants and the sickness that went along with them, Kelly says, also drive her to the brink of financial ruin. 

She lost her show dogs and a half-dozen horses as her finances dwindled. 

She was so bad off the gas to her home was shut off because she couldn't pay the bill. 

Kelly missed a deadline for a class-action lawsuit and was at her wits end. 

She got help from a group called "Toxic Discovery." They led her to a private foundation, which agreed to pay the $6,000 cost of having her implants removed. 

The procedure is called an "in-block." Only five percent of plastic surgeons know how to perform it. 

Kelly went to Denver to see Dr. Linda Huang. 

"I feel if I didn't get this taken care of, it would cost me my life, eventually," Kelly said. "I plan on staying around for 100 years or so." 

The operation was a success, but she is still fighting an infection. 

Kelly is back home in Dodge City and she's grateful for the support given to her by the private foundation and from other women who have had to have their implants removed. 

She is still trying to raise enough money to pay her bills and get the gas turned on so she can have heat. 

A fund has been set up to help her: 

For Cheryl Kelly

Sunflower Bank

2408 First Avenue

Dodge City, Kansas 67801  

R E L A T E D L I N K S 

Plateau Consulting  

Toxic Discovery Network  

National Evalutation Panel possibly tainted.

The Coalition Of Silicon Survivors

Health 4 Her.com Breast Augmentation

Plastic Surgery Information Forum

Dr. Creasman Breast Implant Site

Breast Implant Information Booklet

Moratorium From 1992 Called on Silicone Breast Implants

Dow Corning Confirms Consensual Plan to Resolve

Breast Implant Claims

What is an Implant Made From

A Definition on Silicone

Jury Rules Against Dow on Breast Implant Case

Breast Implant Studies Update Page by The Schmidt Firm

Detroit Free Press's Summary of Implant Case Settlement

Breast Augmentation Introducted In Reconstructive

Surgery After Mastectomy

Dow Mails Out Requests To Approve Settlement

Silicon Implant Survivors

Newswire About the Effects that Implant Leakages Have on the Body

Informative 1998 Release from OBGYN.net

A General Healthcare Information Page

About.com Search on Breast Implants

Plastic Doctors Shop Online Map of Surgeons in Your Area

Medical Description of Mammary Implants

Does Having Implants Make it Harder to Spot Breast Cancer?

Information on Implants: A Thesis From Several Doctors

Breast Implants on Trial

Book Online From The Committee on the Safety of

Silicone Breast Implants

Breast Implants Not Associated With Connective Tissue Disease?

Implants On Skeptics.net

Information By Kathy Nye On Breast Implants

Anatomic Vs. Round Breast Implants

Dow Corning Implant Information Booklet

Independant Report on Silicone Gel Implants

Building a Better Breast Implant

FDA Breast Implant Information

Mother Jones's Take On Implants

National Center for Policy Research for Women  

Punishing the Innocent : The Implant Controversy

by Charles Colson 

Radio Show Aired on 11/04/99 

A cartoon shows a buxom woman sitting in the witness box in a courtroom. The judge declares, "There's zero evidence that silicone breast implants cause disease!" Then he orders, "Give the plaintiffs three billion [dollars] anyway!" The cartoon-and the entire implant controversy- illustrates our culture's growing disregard for simple justice. 

A federal panel recently convened by the National Academy of Sciences concluded that there is indeed some risk associated with silicone breast implants, like infections caused by leakage. But the panel said there is no evidence to substantiate claims that implants damage the immune system or cause diseases such as cancer, lupus, or rheumatoid arthritis. 

The report came too late to help Dow Corning, the maker of the breast implants. In 1995, facing thousands of lawsuits over alleged injuries caused by its product, the company filed for bankruptcy protection. Last year, the firm reached a $3.2 billion settlement with attorneys representing 176,000 women who claim they were injured by the implants. 

The National Academy of Sciences panel was only the latest in a series of panels all concluding that no link exists between silicone breast implants and serious illness. But if the implants are not causing disease, then why did Dow Corning have to pay billions to settle the case against them? It's because contemporary American law has, in some serious respects, lost sight of the classic meaning of justice. 

Not that long ago, the goal of tort law was to uphold justice by properly assigning blame for an alleged injury. The plaintiff was required to present evidence that clearly linked the alleged injury to the activities of the defendant. Expert opinion had to be consistent with scientific consensus on the issue. 

What's more, if victims somehow contributed to their plight, they were either barred from collecting damages or saw those damages reduced. Finally, the doctrine of informed consent meant that if, after being thoroughly informed of the possible risks associated with the procedure, patients went ahead with it anyway, they could not turn around then and collect damages. 

None of this happened in the Dow Corning case. Despite the lack of solid evidence that Dow Corning's product was at fault, the case was allowed to proceed. 

In the end, Dow Corning chose to settle rather than fight. The company knew that in today's cultural climate, it didn't stand a chance. No doubt Dow-Corning imagined the public relations nightmare if the media were to show a courtroom full of suffering women up against a multi-billion-dollar company. 

Emotionalism and the manipulative power of trial lawyers has redefined justice. And yet the entire episode ought to cause grave concern to all of us. If our legal system persists in punishing people despite the evidence, then why should we trust the courts? What good is the rule of law if the law itself is arbitrary and capricious? We need to help our neighbors understand the real issues involved in cases like these. The idea that judges can declare a company innocent and then punish it anyway ought not to happen in real-life courtrooms. Law and impartial justice MUST go hand in hand if citizens are to retain confidence in the rule of law. 

BREAKPOINT EDITORIAL STAFF

Executive Editor: Nancy R. Pearcey

Managing Editor: Anne Morse

Associate Editor: Roberto Rivera

Research Associate: Kim Robbins

Research Associate-Assistant Editor: Douglas C. Minson

Production Manager: Lori Whaley

Administrator: David Carlson

Website Content Manager: John Shaw 

THIS IS A RUSH TRANSCRIPT. THIS COPY MAY NOT BE IN FINAL FORM AND MAY BE UPDATED. 

For product requests or to make a donation, please call 1-800-995-8777 

BIRMINGHAM, AL - Private health care payors seeking to intervene in the national breast implant litigation class action pending in a Birmingham federal court have settled their claims against Baxter Healthcare Corp., Bristol-Myers Squibb Co., McGhan Medical Corp., 3M Company and Union Carbide Corporation. The private health care payors, who represent over two-thirds of the U.S. private health benefit providers and insurers, settled their claims for $50 million. They will continue to press their claims against Dow Corning Corporation in the bankruptcy action currently pending in Michigan. 

Private health care payors have incurred substantial expenses treating women with breast implants. In March 1994, Susman Godfrey L.L.P., representing a number of health care payors across the country, filed the first intervention in the national class action to assert subrogation rights against breast implant manufacturers. Subsequently, numerous other health care payors filed identical claims. Susman Godfrey partner Neal S. Manne said: "This is the first time in history that private health care payors brought an action to intervene in a mass-tort class action. This settlement clearly demonstrates the viability of this ground-breaking action, and shows that health care payors can act collectively to recover fair compensation." 

Pursuant to the settlement, the health care payors will receive $50 million, after confirming that pending appeals are moot and agreeing to let a newly-proposed settlement of the national breast implant class action go forward. The health care payors are still entitled to press their claims against Dow Corning in bankruptcy. 

Mr. Manne further stated: "This settlement is a great result for everyone involved. The implant manufacturers are now free to settle the claims brought by women who received implants, the injured women can get the funds that they need, and the private health care payors who have been taking care of these women will get back a portion of their expenses." He added: "The settlement will permit the private health care payors to focus their full energies now on the largest defendant: Dow Corning." 

Susman Godfrey is a unique 36-member law firm with offices in Houston, Dallas, and Seattle, specializing in both plaintiff and defendant cases and offering creative solutions to difficult legal problems. In pursuing this novel case, Susman Godfrey worked closely in consultation with Healthcare Recoveries, Inc., and Sharps & Associates, PSC, both of Louisville, Kentucky. HRI is the largest national provider of subrogation services. Sharps & Associates emphasizes its practice on healthcare subrogation. 

3M Wins Breast Implant Trial in San Diego 

ST. PAUL, Minn., Nov. 4 /PRNewswire/ -- 3M (NYSE: MMM) announced today that a jury in Judge Robert J. O'Neill's court, of the Superior Court of California, County of San Diego, Calif., found 3M not guilty of all counts alleged against it by plaintiff Marva Smith. Over the past five years, 3M has won in cases involving 18 plaintiffs, losing with just one plaintiff. 

During the trial, Judge O'Neill granted 3M's motion to dismiss the plaintiff's claims of fraud, misrepresentation and breach of warranty claim; he also dismissed the plaintiff's claim for punitive damages. The jury found for 3M on the plaintiff's claims of negligent design and failure to warn. 

"The safety of medical products should be determined by legitimate scientists, not plaintiffs' attorneys and their hired experts," said Carol Ley, M.D., 3M's associate medical director. "We deserve accurate and well-researched information about silicone breast implants. Verdicts such as this are evidence that solid science will continue to prevail." 

SOURCE 3M  

3M Found Not Liable to Woman in Breast Implant Case 

San Diego, California, Nov. 4 -- Minnesota Mining & Manufacturing Co., maker of 50,000 consumer and industrial products, is not liable to a California woman who claims the company designed defective silicone breast implants and failed to warn her doctor about them, a jury ruled.  

The 12-member jury, which deliberated less than two hours, rejected the woman's claims of implant-linked ailments today after a nine-day trial in San Diego County Superior Court. Jurors had been asked to award Marva Smith, a 43-year-old single mother, more than $1 million in damages.  

It's the first breast-implant suit against the St. Paul, Minnesota-based company to reach a verdict in California. A dozen more cases are pending statewide against 3M, which makes products ranging from Post-it Notes to surgical supplies.  

``The jury found that 3M is a responsible company that provided appropriate warnings for women who considered using implants,'' said 3M lawyer Stephanie Mendelsohn. ``Second, the evidence showed that whatever problems this woman had, 3M was not responsible.''  

Smith, a San Diego resident, got breast implants in 1983, after the birth of a child. Both implants were removed in 1993 after the right one ruptured, resulting in multiple surgeries and scarring.  

Presiding Judge Robert J. O'Neill didn't allow Smith's attorneys to present evidence of systemic illnesses she alleges she suffered, such as chronic fatigue and numbness, saying there's no proof they are linked to the implants.  

Smith went to trial because she opted out of a 1995 settlement under which 3M, along with fellow implant makers Baxter International Inc. and Bristol-Myers Squibb, paid millions of dollars to women who claimed leaky implants harmed them.  

Roy Cannon, an attorney for Smith, couldn't immediately be reached for comment.  

3M has won 18 out of the 19 cases nationwide over the past five years that women have brought against the company and taken to trial, Mendelsohn said. Its only loss resulted in a $30,000 award to a woman in Albuquerque, New Mexico, whose lawyers asked for more than $100 million in damages, she said.  

Last December, a panel of scientists that studied the health risks of silicone gel at a federal judge's request found little evidence linking the implants to the most serious illnesses found in implant recipients. 3M's shares rose 1/4 to 94 3/4 on the New York Stock exchange.

by Margery Eagan

Thursday, November 4, 1999 

How much is a nipple worth?  

I ask this question today because the current Massachusetts Lawyers Weekly reports that a 35-year-old woman underwent breast reduction surgery and ended up with no nipple. Her left nipple, in fact. She settled the case for $100,000 and while I certainly can't speak for you, ladies, the sum seemed a tad paltry to me. 

In this age of multi-million dollar pain and suffering settlements, a nipple is worth a mere $100,000? 

Should it be worth more, or less, say, than an entire breast? Than a finger? A leg? Is there some sexism here? What price would the courts put on a male nipple? Or a testicle? They come in pairs, too. 

There are so many unknowns here. What about breast feeding? Suppose this woman were to have twins? 

She is an unmarried 35-year-old, I should add, leaving her to figure out at what point in future dating relationships she should reveal her tragedy. And since we calculate lost earnings into any settlement suit, surely her lawyer should have calculated lost potential in marriage. 

``I suspect much tut-tutting about a woman going in to have breast reduction in the first place,'' said one sympathetic nipple analyst yesterday. ``Occasionally I've read about the wrong arm or leg coming off, the wrong foot, whoops! But just imagine what this poor woman would have had to endure on a witness stand to establish the importance of that particular nipple. 

` `Now excuse me, ma'am,' '' she said, playing the role of the insurance company lawyer. `` `How much did you really care about your breasts? You wanted to reduce their size, didn't you? You do not earn a living from your breasts, do you? You're not an exotic dancer, are you?' No? Then one nipple is all you need to carry on a full and productive life.' '' 

Melissa White, attorney for the plaintiff, said this week it is impossible to place a dollar figure on body parts, that cases like this are much more complicated. 

``Other factors may be totally unrelated to a particular body part, such as the strength and weaknesses of the negligence, things about the patient, the defendant, all that is factored in.'' 

But she couldn't go into particulars because this case was settled based on an agreement by all parties to keep quiet. Boston medical malpractice lawyer Leonard Simon said insurance companies typically insist on such confidentiality agreements, thus preventing future patients from even knowing about a doctor's errors.  

``It would be virtually impossible to find this out,'' he said, adding that the state's Board of Registration in Medicine is ``comatose, unfortunately.'' 

Plus, said Simon, of those medical malpractice cases that do go to trial, not settle, doctors win 95 percent of the time. Which means this poor woman may have wound up with nothing. 

Still, I can't help feeling our anonymous nipple-less lady got stiffed. 

It is too bad, really, that no one put the nipple question last night to would-be president Warren ``Shampoo'' Beatty at the Harvard lovefest. He has doubtless seen more nipples than any man alive, now that Wilt Chamberlain is no longer with us. Clearly, the nipple, not campaign finance reform, is far closer to Beatty's area of expertise, despite his self-important and bratty lectures to the contrary. 

As long as I'm on the subject, let me say that the very jowly Beatty is no Paul Newman nor Sean Connery nor even the wizened Clint Eastwood as he sails into the sunset of his decades out to stud. 

But we have a double standard for aging actors and aging actresses. 

The former can actually become semi-serious candidates for high office while the latter, typically, just disappear. 

It's the same double standard we have, I fear, despite the good lawyer's assurances otherwise, about male vs. female body parts. 

``I've long considered trying to reduce my upper thighs,'' said one concerned friend yesterday. ``Suppose I lost part of my right buttock during the procedure. What value would I put on that? I don't know. But the nipple? The deus ex machina, the piece de resistance of the entire operation? I think she deserved $500,000. Just to start.''  

8 November 1999

The stuff in the backyard shed

The pesticide is effective and sells like mad. But is it safe for everyone? 

BY JIM MORRIS 

Every morning over a period of several weeks in 1971, 16 inmate volunteers reported to the hospital at the Clinton Correctional Facility in Dannemora, N.Y. Under the supervision of two scientists and a physician, they were divided into four groups. Three of the groups received pills containing different doses of the pesticide Dowco 179, made with a little-known nerve poison called chlorpyrifos. One received placebos. The prisoners' blood and urine were analyzed, and they were monitored for signs of distress. 

By March of 1972, the results of this curious experiment were in. Although 12 of the inmates were fed chlorpyrifos, none became violently ill. Volunteer No. 3, in the highest-dose group, "complained of a runny nose, blurred vision, and a feeling of faintness" but was treated for a cold and recovered. All four members of that group also experienced a sharp drop in levels of an enzyme called plasma cholinesterase--evidence of toxic insult. But the readings were back to normal four weeks after the dosing ended. 

At this point, the study's sponsor, the Dow Chemical Co., had two options: step back and ponder the safety of chlorpyrifos, which it began selling in 1965, or forge ahead and try to grab a bigger share of the lucrative pesticide market. Dow chose the latter, while continuing to test. Sales grew steadily. Marketed by a subsidiary under the names Dursban (for structures) and Lorsban (for agriculture), the pesticide was being applied 20 million times a year in homes, schools, and offices by the 1990s. 

Made by Indianapolis-based Dow AgroSciences, chlorpyrifos is the active ingredient in about 1,000 products, including Ortho's Flea-B-Gon and Spectracide's Dursban granules. It dispatches termites, fleas, cockroaches, and other vermin with cold efficiency. Dow AgroSciences earns upward of $100 million a year from sales of the pesticide and stands firmly behind it. "This compound is safe as used, according to the label," says Craig Barrow, director of science policy and regulatory affairs. Barrow says it takes a "sledgehammer" dose to inflict harm. 

A U.S. News investigation presents a more complicated picture. Since June 1992, Dow AgroSciences, a predecessor company called DowElanco, and other pesticide manufacturers have sent the Environmental Protection Agency some 7,000 reports of adverse reactions to chlorpyrifos. An EPA analysis found that the chemical was suspected in 17, 771 incidents reported to U.S. poison-control centers between 1993 and 1996. More than half the cases involved children under 6. In a draft report released last week, the EPA said that those who come in contact with the product in its granular and powdered forms--whose dust is easily inhaled and absorbed through the skin--could receive up to 100 times the safe amount. Dow AgroSciences says the document is riddled with errors and omits important data. 

This much, at least, is certain: Chlorpyrifos is nearly everywhere. A survey of 1,000 Americans in 1994 found that 82 percent had its residue in their urine. A survey of 46 California school districts in 1997 found that almost half routinely applied pesticides containing chlorpyrifos. In New York the same year, Dursban Pro was the most popular bug killer: State records show that 3.5 million pounds and 665,000 gallons were applied. 

New studies suggest that chlorpyrifos poses a particular threat to the developing nervous system, attacking it in ways that can lower intelligence and cause behavioral problems. It may be more toxic in combination with other chemicals than alone, or more toxic in repeated small doses than in a single large one. "It should not be used inside the home," says Mohamed Abou-Donia, a professor of pharmacology and cancer biology at Duke University. 

Dow AgroSciences has spent more than $100 million on 3,600 studies that suggest chlorpyrifos is harmless when properly applied. Why, then, has it elicited 274 lawsuits since 1990? "It's been the biggest kid on the block for a long, long time," says Guy Relford, the company's global legal counsel. "Historically, [it has been] one of the most prevalently used insecticides in the world, and when you're out there in the marketplace like that, then you're going to be a target." Relford can draw from an impressive pool of scientists. There's Rudy Richardson, Dow professor of toxicology at the University of Michigan, who says: "Caffeine will kill you at the same sort of dose that chlorpyrifos will kill you, and you don't hear too much conversation about banning caffeine from beverages." Richard Kingston, an assistant professor of pharmacology at the University of Minnesota, examined 36,183 known and suspected chlorpyrifos exposures called in to poison-control centers over a 10-year period. His conclusion: Nearly 96 percent "resulted in no significant health effects." 

Anecdotal evidence. Others aren't so sanguine. At the EPA, health statistician Jerome Blondell says his figures on individuals exposed to chlorpyrifos?and other organophosphate pesticides like malathion--might be low because not all exposures are reported to poison centers. And the adverse-reaction reports filed by the manufacturers include worrisome anecdotes like these: 

"Home interior sprayed for carpenter ants. Dursban used while children were present. Lady re-entered in three hrs.; headache, nausea, dizzy . . . ." 

"Lady had two serious reactions to Dursban in 1988 and 1998. Electric feeling through torso like a seizure, sleep disruption, deadened nerves." 

"Flea & tick collar was chewed by dog; dog died." 

U.S. News has spoken with more than a dozen people who believe that chlorpyrifos has made them or other family members chronically ill. Hours after the inside of her house in Burnsville, Minn., was sprayed for fleas with Dursban in 1991, a still-ailing Diane Lang thought she was going to die. "I hurt so bad all over. My head was just pounding with a headache like I'd never experienced. Shafts of lightning would just go through my vision. I was confused." There are many similar stories. 

Tragic--but not our fault, responds Dow AgroSciences. The chlorpyrifos exposures in all these cases, Relford says, were well within the "safe zone." But what if the zone isn't safe for everyone? New research supports the notion that there is a hypersensitive minority, susceptible to quantities of chlorpyrifos that wouldn't faze the average person. In experiments on mice bred without a crucial pesticide-fighting enzyme, a team from the University of California-Los Angeles and the University of Washington noted a dramatic increase in sensitivity to an oxidized form of chlorpyrifos. It's a concept the EPA must bear in mind as it struggles to carry out its regulatory duties: Is this substance short-circuiting some people's brains even as it snuffs out bugs? 

The origins of chlorpyrifos can be traced to the late 1930s, when the German conglomerate IG Farben developed the organophosphate pesticides tabun and sarin. Appropriated by the Nazis as prospective weapons during World War II, the compounds cause symptoms ranging from blurred vision to asphyxia. All organophosphates inhibit cholinesterase, an enzyme that regulates nerve transmission in the body. The result can be overstimulation of the nervous system; in extreme cases, "you can't run, you can't walk, you can't breathe," says Janette Sherman, a physician in Alexandria, Va. "That's the way it kills the insect." 

Dow came out with chlorpyrifos in 1965, just as DDT and other pesticides were falling into disrepute. The EPA banned DDT in 1972, opening new markets for organophosphates, but it wasn't until 1988, when the agency blackballed the widely used termite-killer chlordane, that sales of chlorpyrifos took off. The chemical was effective, cheap, and seemed fairly benign. 

But there was already a substantial--and troubling--body of knowledge on organophosphates. In 1930, during Prohibition, 50,000 Americans who drank an alcoholic extract of Jamaica ginger experienced numbness of the arms and legs, followed by either temporary or permanent paralysis. The U.S. Public Health Service blamed the epidemic on triorthocresyl phosphate, used to cut the strong ginger taste. Dow's experiment on the New York inmates--limited though it was by lack of follow-up--yielded more clues. The runny nose, blurred vision, and faintness suffered by Volunteer No. 3 were dead giveaways, says David Wallinga, a senior scientist with the Natural Resources Defense Council. "That's what people get when they get poisoned." 

Limited withdrawal. Under pressure from the EPA, DowElanco agreed in 1997 to withdraw the compound from a few specialized markets, such as indoor total-release foggers and pet shampoos. But the EPA didn't touch the chemical's main residential and agricultural uses. "The agreement with Dow is inconsequential in terms of the overall risk to public health," says Jay Feldman, executive director of the National Coalition Against the Misuse of Pesticides. Feldman and others find it even less palatable in light of allegations that the company has hidden or misstated evidence of its product's toxicity. In 1994, DowElanco agreed to discontinue what the New York attorney general characterized as deceptive claims in a Dursban brochure. In 1995, the EPA fined the company $876,000 for belatedly reporting 288 possible adverse reactions to chlorpyrifos. In June, the agency alleged that Dow AgroSciences waited too long to report ailments of a Kansas couple whose home had been treated for termites with Dursban TC. 

Dow AgroSciences gives not an inch on any of these matters. Relford, the corporate counsel, says the statements in the supposedly deceptive Dursban brochure were grounded in science. The late submission of the 288 cases occurred because the company and the EPA had different interpretations of federal law. DowElanco struck the 1997 deal with the agency not because it believed consumers and animals were being hurt by chlorpyrifos, but purely as a precaution. Dow AgroSciences could make the pending complaint go away by paying a modest $5,000 fine, but it won't do so as a matter of principle. 

Even in the fractious world of environmental health, the discord over chlorpyrifos is striking. Duke's Abou-Donia is convinced that chlorpyrifos can ravage the developing nervous system under common exposure scenarios. "A pregnant woman should never be exposed to this chemical," he says. But Dow AgroSciences neurophysiologist Patrick Donnelly argues that Abou-Donia is dosing his laboratory animals with unrealistically high levels, which are "irrelevant for the purposes of . . . regulatory decision making." 

The EPA is expected to complete its lengthy reassessment of chlorpyrifos next year and may impose further restrictions on the chemical. "We are certainly not bashful," says Deputy Assistant Administrator Stephen Johnson. "We will take action to mitigate a risk." 

Trend against suits. Absent an EPA clampdown, detractors of chlorpyrifos will have to make their case in court. So far, they haven't had much luck: Of the 16 Dursban lawsuits resolved this year, 15 were dismissed and one was settled for $1,000. Attorney Stuart Calwell, of Charleston, W.Va., bucked this trend in 1995, securing an eight-figure settlement for Joshua Herb, a paralyzed Charleston boy who had been exposed in utero to Dursban and another organophosphate, propetamphos. DowElanco had been prepared to go to trial, Calwell says, until animal tests performed by Abou-Donia showed that chlorpyrifos, when combined with the other chemical, caused "catastrophic destruction" of the nervous system in lower doses than it would have alone. From a tactical standpoint, Dow AgroSciences counsel Relford doesn't regret the decision to settle: "We were facing a jury trial in West Virginia, in state court, involving a 51/2-year-old little boy who was a paraplegic and respirator-dependent," he says. "And we couldn't look at that case . . . and not have a huge amount of sympathy for Joshua Herb." Nor, presumably, could the jury. Relford worries, however, that the payout might be misinterpreted as an admission that chlorpyrifos is hazardous. "You won't see another settlement like that," he says. 

Despite the plaintiffs' poor litigation record, lawsuits continue to trickle in. One says that on the afternoon of July 31, 1993, Joey Walker applied a granular fire-ant killer called Green Light to his yard in Liberty Hill, Texas. Dressed in a T-shirt, jeans, and boots, Walker was using a hand-held spreader--just as the label instructed--and inhaled the compound, absorbed it through his sweaty skin, or both. That evening, he collapsed on the sofa, complaining of flulike nausea, fatigue, and headache. In April 1994, he suffered a grand mal seizure while watching his oldest son play Little League baseball. "He turned blue," his wife, Margaret, recalls. "All his muscles drew right up, like the Incredible Hulk." Walker was in and out of hospitals for 15 months. In August 1995, he was admitted to a nursing home, where he remains in a vegetative state. Walker had used Green Light without incident the year before he got sick. Does this mean, as Relford says, that "hypersensitivity just doesn't hold up"? Or does it mean, as Abou-Donia theorizes, that the effects were cumulative? Walker, now 43, is oblivious. "He can look around," his wife says, "but we're not sure what he sees." 

Many people use chlorpyrifos, of course, with no repercussions. A blood test confirmed that Walker has extremely low levels of paraoxonase, an enzyme that offers protection against chlorpyrifos. The trouble is, there's no practical way to know--before a potentially devastating reaction--just who's in this vulnerable group. It may, for instance, include children like Christie and A. J. Ebling of New Albany, Ind., who developed seizures, learning disabilities, and incontinence after a pest-control service repeatedly sprayed their apartment with Dursban and an organophosphate mixture called Creal-O in 1994. "The fact that this occurred in two children simultaneously is pretty hard to ignore," says Roger Pardieck, the family's attorney in a lawsuit against Dow AgroSciences. "Their doctors have looked for every other possible explanation, and there is none." The company is contesting the suit. 

A.J., 6, has been seizure-free for 21/2 years and is finally potty trained. Nine-year-old Christie is another story. "She's gone downhill," says Cindy Ebling, her mother. On the afternoon of August 11, she was admitted to a hospital following a round of intense seizures. "I found her face-down in her eggs," Cindy Ebling said in the hospital room that evening. Christie sat on her bed a few feet away, gaping at a visitor, drooling, and hooting as she struggled to assemble a simple puzzle. "I have a hard time even looking at Christie anymore," says her father, Todd Ebling, recalling how bright she once was.