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University Accuses Doctors of Several Violations : Investigation: Officials step up legal action, saying UC Irvine fertility specialists undertook procedures without patient consent. The three have denied wrongdoing.

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TIMES STAFF WRITERS

University of California officials Thursday accused a team of prominent fertility specialists at UC Irvine of transplanting patients’ eggs without consent, conducting human research without permission and prescribing fertility drugs not approved by the government.

The new barrage of accusations expands upon a lawsuit filed last week by university officials alleging that internationally known Dr. Ricardo H. Asch used a woman’s eggs for research without her consent, then asked her to sign a retroactive approval form two weeks ago.

In a blistering legal complaint, UC officials said they have been investigating doctors at the Center for Reproductive Health associated with UC Irvine since receiving a whistle-blower complaint in February, 1994, that Asch and his partners, Drs. Jose P. Balmaceda and Sergio Stone, were hiding money.

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Attorneys for all three doctors repeatedly have denied any wrongdoing.

Attorney Lloyd Charton, who represents Asch, said the allegations that his client altered documents to hide improper human egg transplants “are utterly and absolutely false.”

“He never did that, nor did he instruct anybody else to do that,” Charton said. “He would fire anybody he caught doing that.”

John F. Lundberg, a UC regents attorney, said the university filed the new allegations against the physicians fearing that missing patient records and laboratory reports important to their investigation might be destroyed.

“Now that things are public, we felt we could go ahead with allegations we have been investigating,” Lundberg said.

UC Irvine spokeswoman Fran Tardiff said: “There was no other recourse. There are allegations there has been misconduct and wrongdoing. We can’t prove it or defend ourselves against other lawsuits without the records. . . . We’ve had all these allegations since 1994, and we’ve only been able to investigate this partially.”

The 29-page complaint filed in Orange County Superior Court accuses the physicians of blocking the university’s investigations into allegations that the doctors:

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* Implanted “human eggs into certain patients without the consent of the donor patients,” then were “unable or unwilling” to turn over patients’ charts and embryologists’ records that would resolve the allegations.

* Failed to obtain “informed consent” from patients used in research projects. Used eggs of donors without their consent for research purposes and then refused to cooperate with an investigation into the allegations.

* Prescribed a non-FDA approved fertility drug known as HMG Massone, which Asch had “imported, prescribed and then sold to [center] patients.” The drug, which the lawsuit said did not “compromise patient care,” was purchased in other countries, then shipped through the mail, the lawsuit said.

* Removed documents sought by the university April 26--including embryologists’ records, lab records and patient charts--from the fertility clinic and transferred them either to Fountain Valley Regional Hospital or Saddleback Memorial Medical Center.

* Failed to report the full amount of cash payments by patients to the university as required.

Balmaceda’s attorney, Diane F. Wyzga, said she had received the new complaint late Thursday and was not prepared to comment on the allegations. Stone’s attorney could not be reached for comment. Balmaceda and Stone were placed on leave by the university Friday.

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Asch, who resigned from UC Irvine on Friday, has denied knowingly violating the wishes of his patients, blaming any irregularities on administrative mistakes.

The lawsuit comes after two weeks of bitter exchanges between the university and the doctors touched off by UC Irvine’s announcement May 16 that it was terminating its relationship with the clinic amid allegations that the physicians conducted various experiments without patients’ approval.

The university and the National Institutes of Health, which sets and oversees standards for human research, have been conducting separate investigations into the fertility center. Later, the Orange County district attorney’s office announced that it was opening a probe and university officials confirmed that the state auditor started an investigation.

Times staff writer Matt Lait contributed to this report.

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