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Saturday, August 20, 2005

Last implant gasp?

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Silicone breast implants just moved a step closer to federal regulators' approval. That's bad news for personal injury lawyers involved in implant litigation. And they appear to be getting pretty desperate.

The Food and Drug Administration issued an "approvable" letter to silicone breast implant (SBI) manufacturer Mentor Corp. July 28. The letter does not yet mean SBIs may be marketed. But it does mean Mentor's SBIs are approvable under FDA negotiable conditions.

The conditions may require plastic surgeons to have special training, patients to receive an education and informed consent materials, establishing a patient registry and continued collection of data on the devices.

The "approvable" letter is consistent with the recommendations of an FDA expert panel convened in April. SBI opponents aren't happy and are throwing everything but the kitchen sink at the FDA and Mentor.

The usual anti-implant front groups -- including organizations like the Command Trust Network, National Organization for Women and Public Citizen -- are dredging up an FDA criminal investigation of Mentor closed in 2002 with no wrongdoing found. Unhappy with the agency's investigation, the anti-implanters want Congress to investigate the FDA too.

At an anti-implanter news conference this week, NOW President Kim Gandy said of the FDA commissioner, "Lester Crawford is a veterinarian, but at the FDA he's treating women like dogs." This trashing of FDA apparently signals the end of any implanters' plans for constructive engagement.

Scientific study after scientific study, and expert panel after expert panel gave SBIs a clean bill of health. If approved by the FDA, SBIs would merely be an option available to women who want them. What could possibly drive the anti-implanters to such furious attacks on the FDA and Mentor?

The answer seems to be personal injury lawyers who well understand FDA approval of SBIs would finally expose their multibillion-dollar litigation against previous SBI manufacturers as nothing more than junk science-fueled, highway robbery. Consider just some of the connections between the lawyers and the anti-implant activists.

The Command Trust Network, the original anti-implant activist organization, is led by Sybil Niden Goldrich, who once responded in a television interview to a question about science not supporting anti-implant hysteria: "The science? The devil with science. It doesn't matter any more." Command Trust's other founding member, Kathleen Anneken, quit years ago, noting with disgust its PR firm (Fenton Communications) worked "more for the lawyers than they do for us."

In a 1997 deposition, Ms. Goldrich admitted Command Trust never got a bill from Fenton. Instead, the bills went to the Women's Institute for Silicone Education and Research, on whose board Ms. Goldrich served along with Rick Laminack of O'Quinn & Laminack -- a prominent personal injury law firm that has made tens of millions of dollars from SBI litigation. The Fenton Web site still lists O'Quinn & Laminack as a client.

Diana Zuckerman, a vocal anti-implant activist who is president of the National Research Center for Women & Families has also run around Washington for years scaring anyone who will listen about SBIs. Past tax returns for Ms. Zuckerman's group indicate it has been funded mostly by the Tides Foundation, a mysterious entity that seems to be financial laundromat for left-leaning donors, possibly including trial lawyers. Who is the Tides Foundation's PR firm? Fenton, of course.

Then there's the ostensibly Hollywood-based group called In The Know, supposedly led by actress Mary McDonough ("The Waltons"). In The Know recently took out full-page ads attacking SBI safety in Capitol Hill newspapers like Roll Call and the Congress Daily. In The Know's Web site is registered to Suzanne Turner, now of Turner Strategies, a D.C.-based PR firm. Ms. Turner's former employer was Fenton Communications.

In addition to using activists to recreate SBI hysteria, the trial lawyers also are going after the legal foundation that has significantly reduced the likelihood junk science will make it into a courtroom -- the 1993 Supreme Court decision in Daubert v. Merrell Dow Pharmaceuticals. A group of activist-researchers have formed something called the Project on Scientific Knowledge and Public Policy. Its purpose is to find a strategy for circumventing Daubert.

The Project is funded by something called the Common Benefit Trust, an expense account originally set up to compensate SBI plaintiff lawyers for legitimate services and expenses incurred in connection with SBI litigation. But the Common Benefit Trust has also sponsored newspaper ads depicting SBIs as ticking time bombs. To overlook this seeming misappropriation of Common Benefit Trust monies to fund anti-implant activities, guess who's a trustee? Command Trust's Sybil Niden Goldrich.

In the 1990s, personal injury lawyers asked NOW to get involved in the SBI litigation. So it should be no surprise NOW is part of the attack on the FDA and Mentor, as is the personal injury lawyer-loving Naderite group Public Citizen.

Almost three years ago, I reported good news for breast cancer survivors and other women who want SBIs: "Silicone breast implants are coming back." After watching the SBI saga unfold over the years, the return's best part is the richly deserved permanent black eye it will give unscrupulous SBI lawyers.

Steven Milloy publishes JunkScience.com and CSRwatch.com, is adjunct scholar at the Cato Institute, and is author of "Junk Science Judo: Self-defense Against Health Scares and Scams" (Cato Institute, 2001).

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