O.C. Doctor Sued for Using Liquid Silicone

Federal authorities filed suit Friday to stop a Newport Beach dermatologist from injecting patients with industrial-grade liquid silicone to correct skin conditions such as wrinkles and acne scars.

The complaint was filed against Dr. James E. Fulton, a co-developer of Retin-A, the Vitamin A derivative that has been touted as an effective anti-wrinkle, anti-aging hope.

Fulton has also developed other cosmetic products that purportedly soften and smooth wrinkles and scars and are administered at the three Newport Beach clinics that he operates.

The civil suit, filed in U.S. District Court in Los Angeles, also names the Acne Research Institute, described as a nonprofit research foundation, and Vivant Inc., both of Newport Beach.

Fulton was unavailable for comment. In a letter to federal prosecutors in October, he argued that his use of silicone was not illegal, according to the lawsuit.

The complaint charges that Fulton has administered liquid silicone despite warnings from its manufacturer, Dow Corning Corp., and the U.S Food and Drug Administration.

“Consumers should know that liquid silicone injections have never been scientifically evaluated for safety and effectiveness,” FDA Commissioner David A. Kessler said in a press release announcing the suit. “People who undergo these injections are exposing themselves to unknown, potentially dangerous risks.”

Officials with the state Medical Quality Assurance Board said Friday they were unaware of the lawsuit, but would now determine whether Fulton should be investigated for malpractice.

“We’d like to take a look at this complaint and if it looks like he’s doing something illegal we’ll go from there,” said Felix Rodrigues, administrator of the medical board’s Santa Ana office.

Rodrigues said Fulton is not currently under disciplinary action but, citing confidentiality rules, he would not say whether the board is investigating any complaints about his use of silicone injections.

In addition to Fulton’s challenged use to smooth wrinkles, silicone injections have been used to augment lips.

In a recent segment of the television program “60 Minutes,” patients who had been injected with silicone complained of pain, scarring and other disorders stemming from the treatments.

And silicone gel breast implants have come under intense scrutiny recently after disclosures that the products may have been marketed without adequate study of the health consequences.

Last month, the FDA’s Kessler called for a voluntary moratorium on the sale and use of implants until an FDA study determines whether they should remain on the market.

Leaking silicone gel has been linked to cancer and autoimmune diseases.

Under the Federal Food, Drug and Cosmetics Act, liquid silicone falls under a class of drugs that requires pre-market approval by the FDA for use in humans. Exceptions to the pre-market approval can be granted to investigate the effectiveness of such drugs, but Fulton has not sought a waiver, according to government attorneys.

The suit states that in 1990 Dow Corning wrote Fulton, warning him that injection of the silicone fluid into humans constitutes a “misuse” of the product.

Fulton allegedly obtained industrial-grade silicone from sources outside California and also from the manufacturer under false pretenses.

“He did not disclose to them when he ordered it that (use on humans) would be the purpose,” said Assistant U.S. Attorney Suzanne H. Segal.

In June of last year, an undercover FDA investigator visited Fulton’s Newport Beach office, ostensibly to consult him about possible treatment of facial scarring.

At that time, the investigator was offered silicone injection treatments and was given a consent form that read, in part: “I understand that silicone is not approved by the FDA for general use, but that individual physicians are free to use it.”

Government attorneys wrote to Fulton in September that his use of liquid silicone violated federal law.

Laguna Niguel dermatologist Dr. Lorrie J. Klein said Friday that the lawsuit would probably prompt re-evaluation of the use of silicone among some Orange County physicians.

“I know both plastic surgeons and dermatologists who talk about using liquid silicone,” Klein said. “It is advertised in periodicals. I don’t think there’s a general awareness they are breaking the law.”

Klein said she did not know Fulton well but thought he is generally well-regarded by colleagues.

She said Fulton has published extensively in recent years about dermabrasion as a technique of removing skin deformities.

“I think he used to be more known for basic research, but now I gather is more involved on the clinic side,” she said.

The lawsuit seeks to prevent Fulton from ordering, processing, distributing and promoting liquid silicone or treating patients with the substance. It also asks that he be required to destroy, under FDA supervision, all silicone products in his possession.

Meanwhile, the FDA also reported Friday that three New York doctors have signed an agreement to stop treating patients with silicone injections.