Legal immunity set for swine flu vaccine makers

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ATLANTA - The last time the government embarked on a majorvaccine campaign against a new swine flu, thousands filed claimscontending they suffered side effects from the shots. This time,the government has already taken steps to head that off.

Vaccine makers and federal officials will be immune fromlawsuits that result from any new swine flu vaccine, under adocument signed by Secretary of Health and Human Services KathleenSebelius, government health officials said Friday.

Since the 1980s, the government has protected vaccine makersagainst lawsuits over the use of childhood vaccines. Instead, afederal court handles claims and decides who will be paid from aspecial fund.

The document signed by Sebelius last month grants immunity tothose making a swine flu vaccine, under the provisions of a 2006law for public health emergencies. It allows for a compensationfund, if needed.

The government takes such steps to encourage drug companies tomake vaccines, and it's worked. Federal officials have contractedwith five manufacturers to make a swine flu vaccine. Firstidentified in April, swine flu has so far caused about 263 deaths,according to numbers released by the Centers for Disease Controland Prevention on Friday.

The CDC said more than 40,000 Americans have had confirmed orprobable cases, but those are people who sought health care. It'slikely that more than 1 million Americans have been sickened by theflu, many with mild cases.

The virus hits younger people harder that seasonal flu, but sofar hasn't been much more deadly than the strains seen every falland winter. But health officials believe the virus could mutate toa more dangerous form, or at least contribute to a potentiallyheavier flu season than usual.

"We do expect there to be an increase in influenza this fall,"with a bump in cases perhaps beginning earlier than normal, saidDr. Anne Schuchat, director of the CDC's National Center forImmunization and Respiratory Diseases.

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On Friday, the Food and Drug Administration approved the regularwinter flu vaccine, a final step before shipments to clinics andother vaccination sites could begin.

The last time the government faced a new swine flu virus was in1976. Cases of swine flu in soldiers at Fort Dix, N.J., includingone death, made health officials worried they might be facing adeadly pandemic like the one that killed millions around the worldin 1918 and 1919.

Federal officials vaccinated 40 million Americans during anational campaign. A pandemic never materialized, but thousands whogot the shots filed injury claims, saying they suffered aparalyzing condition called Guillain-Barre Syndrome or other sideeffects.

"The government paid out quite a bit of money," said StephenSugarman, a law professor who specializes in product liability atthe University of California at Berkeley.

Vaccines aren't as profitable as other drugs for manufacturers,and without protection against lawsuits "they're saying, 'Do weneed this?"' Sugarman said.

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The move to protect makers of a swine flu didn't go over wellwith Paul Pennock, a prominent New York plaintiffs attorney onmedical liability cases. The government will likely call onmillions of Americans to get the vaccinations to prevent thedisease from spreading, he noted.

"If you're going to ask people to do this for the common good,then let's make sure for the common good that these people will betaken care of if something goes wrong," Pennock said.

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