Supreme Court rules States cannot add to FDA regulatons

2008-07-27 18:59:20 (GMT) (WiredPRNews.com - Law)

Dallas, Texas (WiredPRNews.com) America is facing a tough call deciding who should hold the final say when it comes to the accountability of pharmaceutical and drug companies. Thus far, the Supreme Court has ruled in favor of pre-emption (i.e. that federal regulations automatically overrule state laws). The Supreme Court case of Wyeth vs. Levine may potentially create a precedent for all future related drug-company liability cases (by placing the FDA above state courts).

The case involves a musician from Vermont, Diana Levine, who lost her arm to gangrene caused by an anti-nausea drug. The drug was injected by means of a method that was not specified in the label (called the IV-push method). After settling with her health care provider, she sued Wyeth (the drug company) and was awarded $6.7 million by a Vermont jury. On appeal, The Vermont Supreme court upheld the ruling and found that the drug company could have been held accountable according to state standards and additional labels validating the risks involved with the IV-push method could have been added (without interfering with the FDA).

Wyeth’s lawyers argued that different states could not hold drug companies to different standards. In addition, the drug company argued that the FDA’s required label was not to be considered a minimum requirement/standard but the best, most effective and most informative. The final and most effective argument was that the State of Vermont could not rule to prohibit the administration of the drug via the IV-push method, as that would interfere with the FDA.

The Supreme Court ruled 8-1 in favor of Wyeth based on preemption and thus further increasing the power of the federal government (as has been the trend since the beginning of the 20th century). The ruling in this case could set a precedence that may shield tobacco and drug companies from liability lawsuits and any state regulation (as such responsibility is explicitly within domain of the federal government not the state).

Legal News Desk