Supreme Court Refuses To Limit Drug Co. Lawsuits

[Guest guest]

CBS/AP) The Supreme Court on Wednesday upheld a $6.7 million jury award to a

musician who lost her arm because of a botched injection of an anti-nausea

medication. The court brushed away a plea that it limit lawsuits against drug

makers.

In a 6-3 decision, the court rejected Wyeth Pharmaceuticals' claim that federal

approval of its Phenergan anti-nausea drug should have shielded the company from

lawsuits like the one filed by Levine of Vermont.

Levine, 63, struggled with her emotions when told of the ruling in a phone call

from an Associated Press reporter Wednesday: " Oh, my God. I'm so, so happy. I

can't believe this phone call, " she said.

" I've been waiting for so long, and I had no idea of what the chances were, "

Levine said. " I'm just ecstatic. I'm going to have to sit down. "

The decision is the second this term to reject business groups' arguments that

federal regulation effectively pre-empts consumer complaints under state law.

" In the short term, it's likely that the ruling will increase the number of

lawsuits against drug companies. Some of these cases will be legitimate. Some

will not be. In the longer term, the ruling is likely to push companies like

Wyeth into enhancing their labels - into making them safer before litigation -

and perhaps as well push FDA regulators as well to be less beholden to the

industry they regulate, " writes CBS News legal analyst Cohen.

A Vermont jury agreed with Levine's claim that Wyeth failed to provide a strong

and clear warning about the risks of quickly injecting the drug into a vein.

Gangrene is likely if the injection accidentally hits an artery - precisely what

happened to Levine.

The company appealed and, backed by the Bush administration, argued that once a

drug's warning label gets approval from the Food and Drug Administration, the

label can't be changed without further FDA approval and consumers cannot pursue

state law claims that they were harmed.

Justice s, writing the majority opinion, said Wyeth could

" unilaterally strengthen its warning. "

s said he was persuaded that until a recent change by the FDA, the agency

" traditionally regarded state law as a complementary form of drug regulation "

because it monitors 11,000 drugs.

Justice Clarence agreed with the outcome of the case, but did not join

s' opinion.

Justice Alito wrote a dissent that was joined by Chief Justice

and Justice Antonin Scalia.

" This case illustrates that tragic facts make bad law, " Alito said. " The court

holds that a state tort jury, rather than the Food and Drug Administration, is

ultimately responsible for regulating warning labels for prescription drugs. "

The FDA has approved the use of Phenergan by injection, including the method at

issue in Levine's case. The drug has been available for decades to treat nausea

and when used properly, both sides agree it is safe and effective.

The Bush administration and business groups aggressively pushed limits on

lawsuits through the doctrine of pre-emption - asserting the primacy of federal

regulation over rules that might differ from state to state.

The Supreme Court had largely agreed, ruling last term that FDA approval shields

medical devices from most lawsuits. That case turned on a provision of federal

law prohibiting states from imposing their own requirements on the devices.

The Levine case drew a lot of attention because the administration and Wyeth

contended that, although the federal Food, Drug and Cosmetic Act lacks a similar

provision, drug manufacturers also are protected from most suits over federally

approved drugs.

http://www.wwj.com/Supreme-Court-Refuses-To-Limit-Drug-Co--Lawsuits/3960010