Trial Looks For Blame For Tragic Results Of Asthma-Drug Treatment

EVERETT - The doctor who treated a 2-year-old Everett girl with an asthma medication that caused severe brain damage had enough knowledge about the drug to have avoided the tragedy, an attorney for the drug manufacturer said yesterday.

But a professor of pediatrics at the University of Washington said Fisons Corp. didn't notify many doctors of precautions it knew were necessary to use theophylline safely.

``I believe this to be unconscionable,'' Dr. James Wedgwood said in a videotaped deposition shown in Snohomish County Superior Court.

Wedgwood, the first witness in the trial against Fisons, added that the company's behavior makes a mockery of the trust that should exist between pharmaceutical companies and doctors.

Statements by Fisons' attorneys and Wedgwood, who didn't appear in person because he was out of the country, frame the two sides in a three-week trial. It is expected to include testimony from about a dozen expert witnesses on theophylline, a muscle relaxant used to relieve bronchial ailments, its dangers when used in combination with a viral illness, and the responsibilities of pharmaceutical companies.

After the trial, Judge Stuart French has agreed to decide whether Fisons - and maybe Bogle and Gates, the law firm representing the company - are guilty of litigation fraud for allegedly trying to conceal documents damaging to Fisons.

The plaintiff in the case is Dr. James Klicpera, an Everett pediatrician who started caring for Jennifer Pollock in late 1985. On the advice of a pulmonary specialist, Klicpera prescribed Somophyllin, a Fisons brand of theophylline, to treat a serious lung condition caused by Jennifer's premature birth.

Klicpera has sued Fisons Corp., contending the company concealed information about the need to reduce recommended doses of theophylline when a patient has a viral illness.

Klicpera increased Pollock's dosage when she was ill in January 1986, leading to seizures that caused her to become severely retarded.

Fisons, however, contends Klicpera, who has degrees in pharmacy and pharmacology as well as medicine, knew about the drug's dangers from many sources.

In opening statements yesterday, attorney Guy Michelson methodically went through errors that Fisons says Klicpera made.

The central issue in the case, Michelson told jurors, is not the adequacy of the warnings Fisons sent to doctors, as Klicpera's attorneys claim, but whether Klicpera has any responsibility for what happened to Pollock.

Using charts and blown-up replicas of documents, Michelson said Klicpera increased Pollock's Somophyllin dosage several times without checking its levels in her blood. And when Klicpera did conduct such tests, Michelson said, it was at the wrong time.

When Jennifer had the seizures, her Somophyllin blood level was two to three times the recommended maximum.

At stake in the case is the $500,000 settlement Klicpera previously agreed to pay to Pollock and her family. Klicpera contends Fisons should pay that money. But his attorneys also say they are pursuing the case to make other physicians and the public aware that generally recommended doses of theophylline can cause serious side effects, even death, if taken when someone has a viral illness.

Fisons also has settled with the family. Three weeks ago, the company agreed to pay $6.9 million for Jennifer Pollock's care, an amount attorneys for the family believe to be the largest cash settlement of its kind in Washington state.

In agreeing to the settlement, the Massachusetts company didn't admit any wrongdoing. Michelson said the company decided to settle to avoid of the risks and expense associated with a trial. He also noted the family had agreed to limit Klicpera's liability to $1 million if the case had gone to trial, which would have left Fisons to pay the rest of any judgment.

However, French has ruled the $6.9 settlement cannot be introduced as evidence in the Klicpera-Fisons case.

Jurors also won't be told that Klicpera alleges that Fisons withheld important documents for three years until his attorney, Joel Cunningham, stumbled across one and got a court order to compel the company to produce any others. That order led to the disclosure of about 30,000 pages of documents, Cunningham said.

Fisons attorneys said the company didn't break any rules governing what it must release and when.

But the jury has heard about one of the documents released under the court order, an internal Fisons memo sealed until this week to everyone except the U.S. Food and Drug Administration.

In that document, written six months before Jennifer had her seizures, Fisons' director of medical communications recommended that his company consider ceasing promotion of its theophylline products.

``An alarming trend seems to be surfacing in the medical literature and, as a manufacturer of theophylline products, we need to be aware of it,'' Cedric Grigg wrote. ``The trend I am referring to is a dramatic increase in reports of serious toxicity to theophylline in 1985 medical journals.''

Joel Cunningham, one of Klicpera's attorneys, called the Grigg memo a ``smoking gun'' that shows Fisons knew of the danger but failed to tell all doctors that bought its products.

But Michelson said the memo is a marketing document designed to promote Intal, another Fisons drug that competes with some theophylline products. He said Grigg will testify he wrote the memo in frustration at his inability to successfully promote Intal, which doesn't have the same dangerous side effects.

In the memo, written to his supervisor, Grigg said he was concerned about the number of reports he had seen of serious theophylline overdoses.

The trial is scheduled to continue Monday.