The USA’s pharmaceutical representative body has defended the Food and Drug Administration and drug giant Wyeth as the Wyeth vs Levine lawsuit is heard in the US Supreme Court.
The ruling, not expected until next year, is set to shakeup the drug industry and the FDA’s role in drug labels. “The FDA should be allowed to do its job to protect patients by overseeing drug warnings. Federal preemption can play a constructive role in achieving these national goals,” said Ken Johnson, Senior Vice President, Pharmaceutical Research and Manufacturers of America.
PhRMA’s stand follows a lawsuit involving musician Diana Levine who developed gangrene in her arm after receiving Wyeth’s anti-emetic Phenergan (promethazine) that was injected into an artery rather than a vein. Levine’s arm had to be amputated.
She is claiming that the labeling, which mentioned there was a risk of gangrene should the drug be administered via the IV push technique, was inadequate and unsafe.
Earlier this year, Levine was awarded $6.7 million in damages by a Vermont state court. But Wyeth is appealing this ruling claiming that as the FDA had already approved the labeling the manufacturer should not be liable.
The Supreme Court is now seeking to determine whether FDA-approved drug labels can be targeted in state-product liability litigation or whether federal law pre-empts such cases.
“Federal preemption, at its heart, is about protecting patients through nationally uniform and scientifically based warnings on prescription drug labels. Contrary to critics’ assertions, federal preemption is not about providing blanket immunity for America’s pharmaceutical research and biotechnology companies,” Johnson said.
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The USA’s pharmaceutical representative body has defended the Food and Drug Administration and drug giant Wyeth as the Wyeth vs Levine lawsuit is heard in the US Supreme Court.
The ruling, not expected until next year, is set to shakeup the drug industry and the FDA’s role in drug labels. “The FDA should be allowed to do its job to protect patients by overseeing drug warnings. Federal preemption can play a constructive role in achieving these national goals,” said Ken Johnson, Senior Vice President, Pharmaceutical Research and Manufacturers of America.
PhRMA’s stand follows a lawsuit involving musician Diana Levine who developed gangrene in her arm after receiving Wyeth’s anti-emetic Phenergan (promethazine) that was injected into an artery rather than a vein. Levine’s arm had to be amputated.
She is claiming that the labeling, which mentioned there was a risk of gangrene should the drug be administered via the IV push technique, was inadequate and unsafe.
Earlier this year, Levine was awarded $6.7 million in damages by a Vermont state court. But Wyeth is appealing this ruling claiming that as the FDA had already approved the labeling the manufacturer should not be liable.
The Supreme Court is now seeking to determine whether FDA-approved drug labels can be targeted in state-product liability litigation or whether federal law pre-empts such cases.
“Federal preemption, at its heart, is about protecting patients through nationally uniform and scientifically based warnings on prescription drug labels. Contrary to critics’ assertions, federal preemption is not about providing blanket immunity for America’s pharmaceutical research and biotechnology companies,” Johnson said
