UCI Fertility Scandal : Fertility Doctors Face New Suit : Medicine: In stunning legal move, UC Irvine accuses three experts at its famed clinic of transplanting eggs without donor approval and prescribing a drug not approved by the FDA.

In a stunning attack Thursday on three of its most prominent doctors, the University of California accused a team of fertility specialists of transplanting patients’ eggs without consent, conducting human subject research without permission and prescribing a fertility drug not approved by the government.

The blistering legal complaint by university officials broadens misconduct allegations filed last week against Dr. Ricardo H. Asch and his partners, and includes charges that the team hid cash payments from administrators at UC Irvine.

University officials revealed that they have been investigating Drs. Asch, Jose Balmaceda and Sergio Stone at their internationally famed Center for Reproductive Health since receiving a whistle-blower complaint in February, 1994, alleging unreported income.

Thursday’s allegations further raised concerns about unprecedented legal and moral ramifications of misconduct in the little regulated industry of making babies.

“If it’s true that children were created without the express permission of the donors to use their eggs, it’s hard to imagine what would be a more devastating betrayal of the infertile couple,” said Dr. Arthur Caplan, director of biomedical ethics at the University of Pennsylvania. “It’s a breach of trust that will reverberate through the whole practice of assisted reproduction.”

The doctors, through their lawyers, have repeatedly 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, an attorney for the UC Board of Regents, said Thursday that the university filed the new allegations against the physicians in fear that key missing patient records and laboratory reports in their investigation might be destroyed.

The lawsuit asks a judge to issue a court order to keep the doctors from hiding, altering or destroying any records and to force them to deliver the records to the university or the court.

Lundberg said university officials have evidence that the eggs of two of Asch’s former patients had been harvested and, without their consent, then implanted into other women. One woman later gave birth to a boy. The second woman delivered twins, Lundberg said.

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

Added UCI spokeswoman Fran Tardiff: “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.”

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

* 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 who were used in research projects and used the eggs of donors without their consent for research purposes, then refused to cooperate with an investigation into the allegations.

If true, many of the allegations about the doctors’ research would have “serious ramifications for both the quality of patient care and the accuracy and integrity of the defendants’ medical research,” the suit said.

* 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 suit said. Asch admitted to dispensing the drug to two patients, but documents showed that he had given it to at least nine, the suit said.

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

* Removed documents sought by the university on April 26--including embyrologists’ records, lab records and patient charts--from the fertility clinic and transferred them either to their clinics at either Fountain Valley Regional Hospital and Medical Center or Saddleback Memorial Medical Center in Laguna Hills.

The university also accused the doctors of obstructing its investigation and an inquiry conducted by the auditing firm KMPG Peat Marwick, saying the three men were “unable or unwilling” to provide investigators with patient charts and other records necessary to resolve the allegations against them.

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Specifically, the doctors failed to supply records from the patients named as “alleged unconsenting and unwitting donors” of human eggs, according to the complaint.

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 last Friday.

Asch, who resigned from UC Irvine last Friday, has denied knowingly violating the wishes of his patients, saying that if any administrative mistakes were made, the university must share the blame.

“The only thing I can think of when I think of Dr. Asch is that he would try to do anything to take away the heartbreak of infertility,” said Ginger Canfield, 39, one of Asch’s earliest patients in Orange County.

The Buena Park woman, who gave birth seven years ago to a daughter through in-vitro fertilization, said that, despite the mounting allegations, she has complete confidence in Asch and his partners.

“I consider myself a very good judge of character and I can’t be that wrong,” Canfield said.

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Andrea Feiner, 43, another of Asch’s former patients, said the latest allegations have not affected her high regard for the doctor who helped her give birth to a son 3 1/2 years ago.

“I don’t believe any of it,” said Feiner, of Anaheim. “I don’t care what they say. It hasn’t been proven to me. They are only allegations and we certainly know in this world people can make any charges they want to hurt someone, to bring someone down.”

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

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

Gary B. Ellis, head of the NIH’s investigation, said Thursday that he plans to review the suit as part of his inquiry. The office grants UCI $14 million a year, a sum that can be denied if the NIH finds on-site violations, Ellis said.

The allegations shocked many of the doctors’ former patients and colleagues at the university, many of whom described them as pioneers in their field. Ashe, 47, gained international recognition in 1984 when he developed the infertility treatment known as GIFT, gamete intra-Fallopian transfer.

Wednesday, Asch’s attorney contended that the allegations were made public after his client received a letter attempting to extort $100,000 from each of the doctors. The typed letter threatened that if Asch and the other doctors failed to turn over the money, the letter-writer would give incriminating documents to the media.

Law enforcement officials, who are investigating the allegations of blackmail, said Thursday that the new allegations may aid them in their criminal probes into the doctors and the center.

Supervising Deputy Dist. Atty. Charles Middleton said Thursday that he is looking forward to reviewing the lawsuit to see if there are any leads investigators can follow.

“We’re interested in whatever information we can get on this case,” said Middleton. “Especially information that shows if [doctors] were compensated” for any wrongdoing.

Middleton said the mostly likely statute to apply in the case would be grand theft. He said there are no laws dealing specifically with the allegations involved in the case.

“Hopefully, no matter what happens with this case, at least maybe the Legislature will look into this and come up with something that can keep up with the technology,” Middleton said.

Ronald Brower, who has been retained by Asch to represent him in any potential criminal charges, said his client did not violate any criminal laws.

Brower said Asch never “intentionally misused” human eggs nor violated state or federal criminal laws with respect to fertility drugs. Brower added that the allegations of improper bookkeeping did not warrant criminal review.

“I’m aware of the allegations and that has nothing do with the criminal law,” he said.

Also on Thursday, an administrator at a local hospital denied the UCI lawsuit’s allegations that his hospital refused to turn over records to the university.

Nolan Draney, chief operating officer at Saddleback Memorial Medical Center, said the fertility clinic adjacent to the hospital in a medical office building and operated by Balmaceda “belongs to the physicians and we don’t have control over them.”

He said the university in its lawsuit wrongly implies that the hospital has authority to seize the records. “They are tenants of the office building we own but we don’t have control over any of the records of our tenants in the building,” Draney said.

Times staff writers Rene Lynch, Rebecca Trounson, Matt Lait, Mark Platte, Anna Cekola and Leslie Berkman contributed to this report.

(BEGIN TEXT OF INFOBOX / INFOGRAPHIC)

What the Lawsuit Alleges

The University of California has filed suit against three of its top researchers at their Center for Reproductive Health, alleging a wide range of improprieties that violate legal and ethical standards.

The Principals Ricardo H. Asch Sergio Stone Jose Balmaceda

Allegations The university contends that the defendants: 1. Transplanted patients’ eggs into other patients without obtaining donors’ consent 2. Prescribed a fertility drug not approved by the Food and Drug Administration for use in this country 3. Conducted research using humans without first obtaining either approval from the appropriate university committee or proper consent from patients 4. Failed to provide documents to investigators pursuing whistle-blower allegations of income-reporting irregularities, unapproved drug use and improper human egg transplants

From the Complaint “The University is informed and believes . . . Defendants have used University premises and facility for unlawful and unethical practices.”

Source: Times reports

(BEGIN TEXT OF INFOBOX / INFOGRAPHIC)

Medical Inquiry: A Case Chronology

The University of California revealed blistering new charges Thursday against three doctors at its famed fertility clinic. Here’s an account of how university officials discovered the clinic’s alleged problems:

1990

* Center for Reproductive Health established at UC Irvine. Drs. Ricardo Asch, Sergio Stone and Jose Balmaceda, medical doctors and staff members of the UCI Medical Center, run the private clinic.

1994

* February: University receives whistle-blower complaint accusing doctors of underreporting income from clinic. Complaint charges that Asch imported, prescribed and sold the drug HMG Massone to patients, although it was not approved by the Food and Drug Administration.

* September: Another whistle-blower complaint suggests doctors implanted human eggs into patients without donor consent, repeats allegations of financial misconduct and improper prescription of HMG Massone.

* October: UCI launches investigation, appointing clinical panel of doctors and hiring auditing firm KPMG Peat Marwick to look into financial misconduct allegations.

* Fall: Clinical panel finds “plausible evidence” that doctors implanted human eggs without donor consent, a practice an expert says would be “the most serious violation of ethical trust” ever in the field of reproductive technology. Asch admits dispensing HMG Massone to two patients, but panel finds evidence he gave it to at least nine.

* Fall: The three doctors refuse to provide documents to Peat Marwick.

1995

* January: U.S. Department of Health and Human Services files complaint alleging research misconduct, saying the three doctors failed to obtain authorization for human subject research. University launches investigation.

* February: Three doctors tell university they will cooperate with investigation, promise to deliver research records, agree not to conduct further research pending investigation.

* March 17: University launches another investigation, targeting allegation that doctors used donor eggs in research without consent.

* April 5: University notifies doctors that inquiry is being conducted and that it plans to take custody of all original data relating to medical research.

* April, 1995: Doctors allegedly remove records from clinic, transfer them either to Outpatient Surgery Center of Fountain Valley Regional Hospital and Medical Center or Saddleback Memorial Medical Center in Laguna Hills.

* May 10: Asch allegedly tries to alter records by contacting a patient to obtain after-the-fact consent to research and treatment conducted in 1993 and 1994.

* May 16: University files lawsuit against doctors alleging misconduct, contending among other things that Asch used woman’s eggs for research without her consent, then asked her to sign retroactive approval form.

* May 19: University receives “additional evidence” that doctors, specifically Asch, attempted to alter documents to hinder investigation and cover improper activities at clinic.

* May 25: University files amended complaint to lawsuit seeking restraining order to prevent destruction of records, as well as unspecified damages. Complaint accuses doctors of transplanting patients’ eggs without consent, conducting human subject research without permission, prescribing drugs not approved by the government and blocking investigations.

Source: Times reports

Researched by JODI WILGOREN / Los Angeles Times

* INSIDERS BLEW WHISTLE

Separate complaints last year led to startling charges. A35