Healthy Skepticism Library item: 14560
Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.
Publication type: news
Megget K.
PhRMA stands by federal preemption in Wyeth/Levine case
PharmaTimes 2008 Nov 4
http://www.pharmatimes.com/WorldNews/article.aspx?id=14677
Full text:
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.
“Upholding federal preemption will not deny patients their day in court. State judges and juries may still levy damages against manufacturers that fail to comply with FDA standards. But those state judges and juries should not be permitted to interfere with an important public health goal: Uniform, science-based risk communication.”
Johnson said the threat of liability litigation could have the effect of discouraging firms from developing new innovative products.
“[Furthermore] for 70 years, Congress has charged the FDA with ensuring that medicines are adequately labeled to warn about potential side effects. Patients and healthcare providers should be concerned that, without adequate preemption, personal injury lawyers and individual states could require information that conflicts with FDA’s expert judgment. These inconsistencies may be, at best, confusing or, at worst, life-threatening, because patients and providers could be scared away from needed medicines.”
“America’s patients benefit from a regulatory system that is one of the world’s best at balancing safety and access. Permitting state law actions to undermine this inherently federal function could serve to impede patient access to needed medicines, while adding no real benefit.”
Earlier this year, the US Supreme Court ruled in favour of federal preemption regarding medical device maker Medtronic after a man sued the company after he claimed he was harmed by a catheter. In this case the eight-Justice majority determined medical device companies were protected by the law, but drug manufacturers do not have this immunity.
PharmaTimes World News will have extensive coverage of the verdict and the post verdict arguments once the ruling is announced.
