Fw: RECORDER: Long Road Back ... Propaganda to the Max

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From: " ilena rose " <ilena2000@...>

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Sent: Friday, February 06, 2004 10:22 AM

Subject: RECORDER: Long Road Back ... Propaganda to the Max

>

> Long Road Back

>

> http://www.law.com/jsp/ca/PubArticleCA.jsp?id=1075219876886

>

> Mike McKee

> The Recorder

> 02-03-2004

>

>

> Silicone breast implants seemed headed for museum shelves as failed

> relics of the American culture's obsession with cosmetic surgery after

> thousands of lawsuits took them off the market in 1992, driving one

> manufacturer into bankruptcy.

>

> But Inamed Corp., a Santa Barbara medical products company that has

> sold the implants in 60 countries worldwide for years, is trying to

> bring them back to America. An expert panel of the Food and Drug

> Administration approved Inamed's request in October, but the agency

> deferred a final decision on Jan. 8, citing a need for more

> information about the implants' safety and failure rate.

>

> Yet it appears likely that Inamed will eventually get the green light,

> which raises the question: Why plunge into the shark-infested legal

> waters that in 1994 forced Dow Corning Inc., the nation's largest

> implant manufacturer, out of the business?

>

> The reason, plaintiffs lawyers and defense attorneys say, is that

> science is on Inamed's side. Recent studies favor breast implant

> manufacturers, they contend, and warning labels that didn't exist a

> decade ago greatly reduce liability.

>

> " There's an awful lot of science in the last 10 years that supports

> the safety of silicone as an implantable product, " says Gordon & Rees

> partner Jack " Skip " McCowan Jr., who has represented Dow Corning in

> several different proceedings.

>

> " There is no association between silicone and any auto-immune

> disease, " he says. " Any company coming into the market would have the

> benefit of that science. "

>

> Hersh & Hersh partner Hersh disagrees about implant safety,

> pointing out that most studies have been paid for and promoted by

> manufacturers.

>

> " I don't believe those studies, " she says. " I've seen too many people

> who had the same injuries. "

>

> Nevertheless, Hersh, who represented many women in suits against

> implant manufacturers, agrees that the mass litigation seen in the

> '90s isn't likely to occur again.

>

> Silicone breast implants were first developed in the early 1960s for

> breast augmentation and reconstruction, with Texas native Timmie Jean

> Lindsey becoming the first recipient in 1962.

>

> A Houston attorney won the first suit against a manufacturer in 1977,

> but litigation didn't spread until 1984, when San Francisco lawyer

> Bolton, then with the Hersh firm, obtained a $1.5 million

> judgment for a Nevada woman.

>

> Bolton followed up as a solo practitioner in 1991 with a historic $7.3

> million judgment based on the theory that leaking silicone causes

> connective tissue disorders, leading to problems such as joint pain,

> rashes, dry mouth and eyes and chronic fatigue. A year later, the FDA

> requested a moratorium on new implants and manufacturers complied.

>

> An alternative -- saline implants -- is still available in the U.S.,

> though they are considered less desirable than silicone.

>

> Dow Corning, which declared bankruptcy in 1994, eventually reached a

> $3.2 billion global settlement with more than 300,000 plaintiffs, but

> no money has been doled out to date. McCowan said he doesn't believe

> Dow Corning has plans to get back into the business.

>

> " Claimants are anxiously awaiting payment on a plan they

> overwhelmingly voted approval for several years ago, " says

> Cabraser, a partner at Lieff, Cabraser, Heimann & Bernstein, which was

> a leader in the suits against manufacturers.

>

> Inamed officials didn't respond to several calls and e-mails asking

> why they want to produce silicone implants for American use, or

> whether they anticipate heavy litigation. But defense lawyers say the

> company must have read the tea leaves and sees no problems.

>

> " My guess, " Sedgwick, Detert, Moran & Arnold partner Dunne says,

> " is they've done very careful analysis to look at the science in terms

> of causation and in the design of the product, and they feel like

> they've come up with a product that reduces the risks of side

> effects. "

>

> Dunne, who has defended several implant manufacturers, including

> Bristol-Myers Squibb Co., reiterates that if there are warnings on the

> product, " there is no basis for a lawsuit. " At worst, he says, a

> manufacturer could be sued for an individual defect if an implant has

> a weak spot that ruptures.

>

> Cabraser predicts that's likely to happen, noting that silicone

> implants have a rupture rate of up to 90 percent over 10 years.

>

> " They break early and often, " she says. " They are simply not well

> designed to survive intact within the human body for more than a few

> years. "

>

> Cabraser also points out, however, that despite the possibility of

> ruptures causing permanent scarring and disfigurement -- " an ironic

> outcome given the cosmetic goals of implantation " -- demand by women

> remains high. And that could further insulate manufacturers.

>

> " Companies, attuned to this demand and the profit potential, may be

> willing to bear the risks of future litigation if new-generation

> implants prove as defective as their predecessors, " she says.

>

> Cabraser insists that manufacturers " lucked out, " arguing that women's

> problems weren't properly studied.

>

> " This should have made implant manufacturers more cautious, not less,

> in research and development of the product, " she says. " As it was,

> nearly a million women became guinea pigs in the breast implant

> experiment, and well over one-third of them have made disease, rupture

> or injury claims. "

>

> McCowan says it's sour grapes.

>

> " That's sort of a very typical response you get from plaintiffs

> lawyers when the science developed by honest and ethical scientists

> doesn't support their position in a lawsuit, " he says. " Scientists go

> to great lengths to ensure they are not biased in their science, in

> their findings and in the protocols they develop for their studies. "

>

> McCowan also warned any plaintiffs lawyers against initiating a new

> legal war on silicone implants, noting the " latter history of the

> breast implant litigation -- which was defense victory after defense

> victory.

>

> " The science, " he says, " caught up with the plaintiffs lawyers. "

>

> ~~~~~~~~~~

>

> For factual information on the risks of breast implants, the FDA's

> Disapproval of Inamed implants and legal info, please visit:

>

> www.BreastImplantAwareness.org

>

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