Re: Vaccine Maker ask MO. Supreme CT to overturn Award $$$ - contracted Polio

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_http://money.cnn.com/news/newsfeeds/articles/apwire/c863e88d0066d764fbb7d4668

8447912.htm

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(http://money.cnn.com/news/newsfeeds/articles/apwire/c863e88d0066d764fbb7d466884\

47912.htm) Vaccine maker asks Mo. Supreme Court to overturn $8.5M award

for man who contracted polio

September 05, 2008: 11:14 AM EST

NEW YORK (Associated Press) - A vaccine maker asked the Missouri Supreme

Court to throw out an $8.5 million jury verdict for a St. Louis man who

contracted polio after receiving an oral vaccine for the disease.

Cortez Strong was an infant when he contracted the disease in June 1987,

shortly after receiving a second dose of the polio vaccine Orimune, made by

American Cyanamid Co. He now has limited use of his left arm and right hand.

Strong sued American Cyanamid and the pediatrician who administered the

vaccine. In 2005, a St. Louis jury cleared the doctor of liability but ordered

American Cyanamid to pay Strong $1.5 million for pain and suffering, $2 million

for future lost earning and $5 million for future pain and suffering.

New Jersey-based Wyeth bought American Cyanamid in 1994, and the vaccine

that was given to Strong was discontinued in 2000.

American Cyanamid's appeal asks the Supreme Court to set the verdict aside,

reduce the damages awarded by the jury or order a new trial.

Thursday's oral arguments focused on whether American Cyanamid followed

federal regulations for testing the safety of vaccines and whether Strong

proved

that a faulty vaccine caused his partial paralysis.

Polio is caused by three types of viruses. Oral vaccines for the three types

were derived from strains that use living but weakened virus. American

Cyanamid grew larger volumes of the vaccine by passing it through the kidney

cells

of monkeys, which results in " production seeds. " Federal regulations

required that the " seeds " be tested on monkeys to determine if they could cause

illness.

Attorney Chip on, representing Strong, told the court that American

Cyanamid skipped mandatory testing for some of the intermediary " seeds " that

were used for steps early in the production. By not testing at that point,

on said the oral vaccine became defective.

" This vaccine was made more dangerous than it should have been, " on

said.

Tom Bozzo, a former compliance officer for the U.S. Food and Drug

Administration, testified during the initial trial that American Cyanamid

should have

been testing the particles used to make the " seeds " and then the vaccines.

Bozzo said that the vaccine maker wasn't following regulations by not

conducting

those tests.

But attorneys for American Cyanamid told the Supreme Court that Bozzo was

wrong about whether federal regulations required the tests, and that he

shouldn't have been allowed to testify at the trial.

The federal government, though not a party in the lawsuit, filed a brief

with the Missouri Supreme Court saying regulators only require testing of the

" seeds " used to make a vaccine and not those particles used earlier in the

process.

Yoerges, representing American Cyanamid, told the judges Thursday that

based on the FDA's explanation of its own regulations, the company did the

tests it was supposed to. He said the jury's verdict is based on a faulty

interpretation of what tests are required and should be tossed out.

" As a matter of law, this case should not have gone to the jury because the

definition of what a 'seed' is, is a question of law, " Yoerges said.

Yoerges also argued that Strong's paralysis may have been caused by an

adverse reaction to a normal vaccine and that he should have been forced to

prove

otherwise.

If that were the case, on countered, vaccine makers _ who are

protected from lawsuits if they follow all regulatory procedures _ would have

an

incentive to skip testing.

" Why waste the money on testing when they can't prove that they wouldn't

have gotten it any way? " on said.

The Supreme Court's ruling in the case is expected within a few months.

(http://money.cnn.com/news/newsfeeds/articles/apwire/c863e88d0066d764fbb7d466884\

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