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Biotech / Medical : VICL (Vical Labs)

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From: bob zagorin10/13/2010 1:53:14 AM
   of 1972
 
Supreme Court to decide on vaccine suits
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Tue, Oct 12 2010

By Maggie Fox, Health and Science Editor

WASHINGTON (Reuters) - The U.S. Supreme Court heard arguments on Tuesday in a case that could shake up protections aimed at keeping vaccine makers in business and potentially open the door for a flood of lawsuits.

The case was brought by the parents of Hannah Bruesewitz, now 18, who suffered seizures as an infant after her third dose in 1992 of a diphtheria-tetanus-pertussis (DTP) vaccine, one of the regular childhood vaccines.

Normally, such cases are referred to a special no-fault program that compensates people harmed by vaccines. That court found against Russell and Robalee Bruesewitz, who then sued the vaccine manufacturer, Wyeth, now owned by Pfizer Inc, in state court.

The Bruesewitz family and their supporters say parents of children who believe they are injured by vaccines need an alternate route to the no-fault court and say the threat of lawsuits will keep vaccine makers honest.

The federal government, vaccine makers and doctor's groups say suits such as this one threatened to drive vaccine makers out of business before and could do so again.

At issue is the National Childhood Vaccine Injury Act of 1986.

Congress passed the law to prevent repeated lawsuits against vaccine makers, while at the same time providing compensation for children who really are injured by vaccines.

The Vaccine Court set up by the law has awarded more than $1.8 billion in nearly 2,500 cases, with an average award per case of about $750,000.

It is funded by a tax on vaccines and parents do not have to prove a vaccine caused their child's injury -- they usually just have to show the child had an injury that can be caused by the vaccine.

Hannah's parents say she was a healthy infant until she got the third dose of DTP vaccine, which protects against three deadly infections -- diphtheria, tetanus and whooping cough. They say the vaccine has an outmoded and flawed design and contained toxins that caused the seizures.

"Now a teenager, Hannah suffers from residual seizure disorder and remains developmentally impaired. She will require a lifetime of supervision and care," their written arguments read.

PENDING LAWSUITS

They argue that Wyeth knew the vaccine was old-fashioned and dangerous. The vaccine was taken off the market in 1998 and replaced.

Pfizer argues that there was no safer alternative at the time and notes the vaccine court heard the Bruesewitz case, decided Hannah was not injured by the vaccine, but nonetheless gave the family $126,000 for expenses.

The company, other vaccine makers and doctors groups argue that if the Supreme Court decides families such as the Bruesewitz family can sue outside the vaccine court, a flood of new suits would follow -- many by families who believe that vaccine cause autism.

Many studies have shown vaccines do not cause autism but a small and vocal group of people continue to believe, and try to show, that they do. They have 5,000 suits pending.

The American Academy of Pediatrics, American Medical Association, March of Dimes and other groups said the vaccine court was set up after an onslaught of lawsuits threatened to overwhelm vaccine makers in the 1980s.

"A genuine threat to the public health emerged as manufacturers abandoned or considered abandoning the vaccine market," they said an a friend-of-the-court brief.

The high court is expected to rule by mid-2011.

(With additional reporting by Jeremy Pelofsky; Editing by Jerry Norton)
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