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Surgeon Allowed to Sue Implant Manufacturers as Consumer

October 13, 1995

NEW YORK (AP) _ A judge has ruled that a plastic surgeon can proceed with a lawsuit against the makers of breast implants on the grounds that doctors, like their patients, are consumers of implants.

The ruling is the first in which a judge has found a doctor, like a consumer, is covered under the 1976 Medical Device Amendments Act, attorney David A. Green, who represents the surgeon, said Friday.

The act requires manufacturers to disclose safety information about a product to the Food and Drug Administration. It also allows anyone injured as a result of a violation to sue.

Green filed the lawsuit on behalf of Dr. Robert V. Vitolo, a cosmetic surgeon with offices in Manhattan and Staten Island, against Dow Corning Corp. and Bristol-Myers Squibb Co.

Dow Corning is jointly owned by Dow Chemical Co. and Corning Inc. The attorney representing the company, Sheila Birnbaum, was out of the office Friday and could not be reached for comment. Bristol-Myers spokeswoman Jane Kramer said the company would not comment.

Judge John Leone of state Supreme Court on Staten Island issued the ruling on Wednesday.

Vitolo charged that the manufacturers failed to advise doctors of problems with silicone implants rupturing, although they knew about them.

``I was misled by these manufacturers who did not provide proper test results,″ Vitolo said Friday, ``and as a result I sustained economic losses to my practice and I also sustained a loss to my reputation.″

Vitolo said that before implants were banned by the FDA in 1992, they accounted for about 30 percent of his practice. He said he performed about 1,800 implant operations between 1978 and 1992.

He has lost more than $500,000 from malpractice cases brought against him as a result of faulty implants, but he said that protecting himself against further malpractice suits was not the thrust of his case.

``My reputation has been tarnished by this through no fault of my own ... and it took me 20 years to build it,″ Vitolo said from his Staten Island office. ``Now I find myself lumped in with these implant manufacturers who acted out of nothing more than greed.″

Green said he believes Vitolo is the first doctor to file a suit against the manufacturers.

Last week, three manufacturers offered to settle suits brought by thousands of women, limiting individual claims to a range of $10,000 to $750,000, depending on the woman’s age and health. A federal judge overseeing the case has ruled that the women can opt out of the settlement to pursue their claims against the companies individually.

Vitolo, who says he’s spent $250,000 over the past 18 months just trying to get the lawsuit into court, hopes other doctors will join him.

``I feel outraged at being so misled and I urge other doctors who feel the same to join me.″

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