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JUDGE SEALS FILES THAT DETAIL RISKS OF DRUG

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According to this week's cover of Newsweek magazine, Halcion is the most widely prescribed sleeping pill in the world.

"But," the cover asks, "is it safe?"That question may be tougher to answer today in the wake of a ruling by a Salt Lake federal judge. U.S. District Judge J. Thomas Greene Monday ordered sealed - perhaps forever - thousands of pages of documents reportedly about the risks associated with Halcion use.

The documents were prepared by Halcion's manufacturer, Upjohn Co. They included a publication titled "List of Murders/Attempted Murders/Threat of Physical Attack Reported With Triazolam."

Triazolam is the generic name of Halcion.

Upjohn reportedly required the sealing of the documents as part of an out-of-court settlement with Utahn Ilo Grundberg. Grundberg sued the company for $21 million, claiming she pumped eight bullets into her mother because of the intoxicating influence of Halcion.

Grundberg and her attorney had previously urged Greene to make 8,200 pages of the documents public, saying the public and the medical community had an urgent need to know what the documents said.

Instead, U.S. District Court clerks turned the reams of controversial documents over to Upjohn attorneys Wednesday afternoon.

The documents could be viewed at this point only with Upjohn's permission or under a court order. A court order from other judges isn't likely, several attorneys said. Judges don't like to challenge one another's rulings on such matters.

Monday's ruling - essentially a rubber-stamp approval of the agreement between Upjohn and Grundberg - renews debate over the wisdom of sealing documents that affect the public.

"In cases of public interest, I think the practice of sealing court files is abusive and counter to the open court system we ought to have," said attorney Ross C. Anderson.

Anderson helped local media fight to obtain sealed records in the Utah Power & Light settlement with Wilberg Mine widows.

"The court shouldn't simply rubber-stamp an order to seal files simply because the plaintiff and defendant agree to it," he said.

Grundberg's attorney, Neal Pope, failed to return four Deseret News phone calls. Upjohn officials refused to comment on the question of public health except to say, "Upjohn continues to support Halcion tablets."

First Amendment attorney Pat Shea agreed that judges shouldn't routinely approve secrecy agreements that affect public health. A judge may properly seal Halcion trade secrets that have commercial value to Upjohn, he said.

"But matters of public health - such as the potentially adverse effects of the drug itself - should be disclosed so that citizens of this country could be protected."

In matters like Monday's ruling, the general public has no voice in the courtroom, said First Amendment attorney Randy Dryer.

The attorneys who forge the secret settlement care about their clients' interests. Judges seldom change those agreements, simply giving a judicial nod of approval instead, he said.

"The court has to assume the role of balancing the benefit to the public that can come from disclosing court records against the interests of the litigants," Dryer said.

Laws should be passed that require a public hearing over the sealing of records that affect the public welfare, he suggested.

A growing number of cases point to the need for such laws, he said.

But both Dryer and Shea noted companies may seek to avoid laws and judges who watch out for the public interest in reviewing requests to seal documents by avoiding the public court system altogether. In some states, companies can already hire retired judges - dubbed "rent-a-judges" - to privately hear cases, thus avoiding any public record at all.

"People who could afford to would go to private arbitrators or private forums, and people who couldn't afford to would go to the public courts. You would have a two-tiered judicial system," Shea said.

In product liability cases like the Halcion case, manufacturers will continue to buy secrecy with their out-of-court settlements and victim's lawyers will continue to agree to it without aggressive judges or disclosure laws, Anderson said.

"I have agreed to sealing files. Even though I often don't agree with the practice, if it's a condition of a settlement I have to go along with it in the interest of my client."

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(Chart)

Time line of troubles for controversial drug

1977 - Halcion approved for sale in some world markets.

1979 - Reports of unusual Halcion side effects lead to its withdrawal from markets in Belgium and the Netherlands

1982 - Halcion approved for sale in United States

1987 - FDA reports that during its first three years on the U.S. market, Halcion racked up to 30 times as many adverse-reaction reports as the next two more popular sleeping pills combined.

France and Italy pull the 0.5 mg dosage off the market.

1988 - Upjohn stops making the 0.5 mg tablet, marketing only the 0.25 and 0.125 tablets. A new FDA study shows that Halcion continues to generate up to 45 times as many adverse-reaction reports as Restoril, another popular sleeping pill.

1990 - FDA compares numbers of violent acts associated with 329 prescription drugs. Halcion ranks first.

Source: Newsweek