Monday November 3, 2008 (foodconsumer.org) -- When you are injured by a medicine or die from taking it, the drug maker is almost certainly not responsible for your misery, according to the federal law.

The federal law, which preempts state products safety laws enacted in some states, does not permit such lawsuits as long as the drug is made to meet the standards set by the Food and Drug Administration and used as the label indicates.

A Vermont female guitarist lost part of her right arm after an anti-nausea drug called Phenergan made by Wyeth was administered improperly by injection in her arm incidentally injuring an artery – an injury that requires amputation.

Diana Levine was awarded in her state $7 million in damages. Her attorneys said Wyeth is responsible for the injury because the drug company should have given stronger warnings about the potential danger of administering the drug in the way she experienced.

Now the case is in the hands of the U.S. Supreme Court where the preemptive federal law is ultimately interpreted. The justices will have to rule based on their interpretation of the law concerning whether the label is faulty.

Bert Rein, an outside lawyer for Wyeth, said in an interview with Reuters that the company strictly adheres to the labeling requirement by the FDA, meaning that the company is free of any liability.

The case could affect millions of other businesses that face liability lawsuit constantly; the U.S. Chamber of Commerce was cited as saying.

Chances are that Levine would lose her case.   Earlier this year, the Supreme Court voted 8-1 for the medical device maker Medtronic Inc after a man sued the company for the injury he received due to use of a catheter manufactured by the company during an artery-clearing procedure.

The pharmaceutical industry has been trying for years to seek protection under the federal preemption law, which is favored by the Bush Administration, media reports.   It would be very much easier for the industry to influence the Congress than all the state governments.

Drug companies are held responsible only in cases that they fail to meet the FDA standards regardless of how many injuries or deaths resulting from taking any FDA-approved drug.

The case has been closely watched. Democrats in Congress have indicated that they would act if the Supreme Court ruling would end up in favor of Wyeth to pass legislation to protect patients’ right to sue under state law.

A health observer commented that the best protection comes from patients themselves. They should by all means take good care of themselves so that they do not have to receive risky prescription drugs or treatments or procedures.