No Legal Shield in Drug Labeling, Justices Rule

As someone who works in a pharmaceutical-related industry, I found this article to be interesting and a little disconcerting. It seems that the safety of drugs, etc. being left ot juries rather than the FDA leaves room for potentially underinformed decisions. Each massive lawsuit levied against pharmaceutical companies makes it increasingly difficult for new drugs to make it to the market at all. I see that the public needs to be protected from products that are known risks, but question the rationale of allowing litigation to be decided by a jury of people not versed in scientific implications beyond the arguments painted for them by counsels. And their charisma. As a side note, Wyeth ceased to exist as an entity today.




WASHINGTON — In a major setback for business groups that had hoped to build a barrier against injury lawsuits seeking billions of dollars, the Supreme Court on Wednesday said state juries may award damages for harm from unsafe drugs even though their manufacturers had satisfied federal regulators.

The ruling could have significant implications beyond drug manufacturing. Many companies have sought tighter federal regulation in recent years in part to shield themselves from litigation.
The court, by a 6-to-3 vote, upheld a jury verdict of $6.7 million in favor of a musician from Vermont whose arm had to be amputated after she was injected with an antinausea drug. The drug’s manufacturer, Wyeth, had argued that its compliance with the Food and Drug Administration’s labeling requirements should immunize it from lawsuits.
Pharmaceutical companies were especially disappointed by Wednesday’s decision.
Ronald Rogers, a spokesman for Merck, said, “We believe state courts should not be second-guessing the doctors and scientists at the F.D.A.”
Merck was hit with several huge damage awards over its painkiller Vioxx before agreeing to a $4.85 billion settlement in 2007. Allowing juries to make determinations about drug risks, Mr. Rogers said, would cause “mass confusion.”
The Supreme Court has been sympathetic in recent years to arguments that federal law should pre-empt state injury suits. Last year, in Riegel v. Medtronic, an eight-justice majority of the court ruled that many state suits concerning injuries caused by medical devices were barred by the express language in a federal law. Wednesday’s decision addressed implied pre-emption, a different legal standard.
Drug companies and other businesses, supported by the Bush administration, had hoped the Vermont case would establish broader protections. They relied not on express language in a statute enacted by Congress, as in Riegel, but on what might be implied from federal regulatory standards and policies — in this case, from the drug agency’s authority to approve drug labels.
Producers of goods as different as antifreeze, fireworks, popcorn, cigarettes and light bulbs have sought to take refuge behind federal oversight in recent years to fend off litigation. After Wednesday’s decision, those efforts are most likely to succeed if they are based on express language in a Congressional statute or a specific regulatory action that makes compliance with state requirements impossible.
“This narrows the playing field,” for implied pre-emption arguments, Mark Herrmann, a corporate defense lawyer in Chicago, said of the decision. “This does not eliminate the playing field.”



http://www.nytimes.com/2009/03/05/washington/05scotus.html