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U.S. Supreme Court foils Perdue’s ‘business-friendly’ idea?

Wednesday, March 4th, 2009

In January, Gov. Sonny Perdue told a banquet room filled with business folk that he had a grand plan to make Georgia more attractive for biotech companies.

The plan: He’d direct his floor leaders to introduce legislation that would grant legal immunity to drug companies whose products were approved by the U.S. Food and Drug Administration.

Wrench, meet plans. The U.S. Supreme Court today ruled the FDA’s stamp of approval doesn’t exempt drug companies from product-negligence lawsuits.

In one of the most important business cases in years, the Supreme Court on Wednesday ruled that a drug company is not protected from injury claims in state court merely because the federal government had approved the product and its labeling.

The 6-to-3 ruling went in favor of a Vermont musician, Diana Levine, who was awarded more than $6 million after losing much of her arm following a botched injection of an anti-nausea drug. It was a defeat for the Wyeth pharmaceutical company, which had asked the justices to throw out the award, and by extension other companies that might have pursued Wyeth’s line of argument in similar cases.

The key issue before the justices was whether the Food and Drug Administration’s approval of drug labels should pre-empt lawsuits in state courts contending, as Ms. Levine’s did, that the labels did not contain adequate warnings.

UPDATE: Johnny Legal points out in the comments that Perdue could still pursue his plan. After the jump, another opinion from an anonymous friend familiar with legalese.

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List of recalled peanut butter products

Thursday, January 22nd, 2009

After a peanut plant in Blakely, Ga., was pinpointed as the source of a recent salmonella outbreak, the U.S. Food and Drug Administration has been able to gather a list of affected products. To see which ones have been near “the taint,” visit the agency’s site.

FDA continues blood donation ban for gay men

Monday, July 2nd, 2007

If you’re a man who has sex with other men, forget about donating blood.

The U.S. Food and Drug Administration has decided, once again, to not lift a decades-old policy that doesn’t allow gay men to donate blood. The policy was put in place in 1983 and has never been revised.

According to the FDA, “[Men who have sex with men] are, as a group, at increased risk for HIV, Hepatitis B and certain other infections that can be transmitted by transfusion.” Despite advances in screening tests, the FDA notes that infections can’t always be detected, especially if a person has been infected within three weeks prior to the screening.

But critics say the ban shuts out many healthy people, particularly at a time when there’s a critical need for blood donations. Even the American Red Cross has asked the FDA to reconsider their stance. So has LEAD Georgia, an emergency care training company in Atlanta.

Joseph Mendoza, chief operating officer of LEAD Georgia, says the risk of contracting HIV or hepatitis from a blood transfusion is approximately one in 2 million. The solution to the screening problem, says Chuck Obina, president of LEAD Georgia, is to exclude donors who have engaged in risky sex or used drugs for a month prior to giving blood.

“The policy adopted by the FDA is outdated and prevents potential donors from contributing to blood banks,” Obina said in a statement. “What the FDA is not considering is that refusal to lift the ban and modify policy is now discrimination against the gay community.”

Is it discrimination, or just playing it safe?