Is there anyone left in America who still thinks that just because a medication is approved for sale by the U.S. Food and Drug Administration it's perfectly safe and without product defects?

If so, he or she should type the words "heparin recall" or "Vioxx recall" or "Zyprexia weight gain" into a search engine. The FDA approved all of those drugs, and all of them turned out to cause big problems. The companies that made the drugs found themselves defending thousands of product-liability lawsuits.

But next month, the U.S. Supreme Court will hear what could turn out to be a landmark case. At issue is whether people harmed by prescription drugs should be allowed to recover damages for their injuries by suing in state courts.

The pharmaceutical industry says that such suits should be prohibited because drugs must be approved for sale by the FDA. That approval, the industry says, should protect drug-makers from liability.

Last spring, the Supreme Court ruled in favor of the manufacturers of medical devices, which made a similar argument. A similar decision in this case effectively would grant "get-out-of-responsibility free" cards to makers of drugs that turn out to be dangerous.

People such as Diana Levine, a 62-year-old musician from Vermont, would be out of luck.

Make that "former musician." In 2000, Levine lost her right hand after receiving an injection of an anti-nausea drug. That ended her career as a guitarist and pianist.

The drug she received, Phenergan, usually is injected into a muscle. Sometimes, it is injected into a vein. But if it comes in contact with oxygen-rich arterial blood, it causes gangrene — a condition in which bone, muscle and skin tissues die. Affected limbs must be amputated.

The drug's label, also approved by the FDA, warned that mistakenly injecting the drug into an artery can cause "gangrene requiring amputation." But it did not include a similar warning about a method of administration called "IV push," which is what caused Levine to lose her hand.

A jury in Vermont awarded Levine $6 million in damages. The Supreme Court is being asked to overturn the judgment — not because she wasn't harmed, but because the FDA-approved label didn't warn against the IV-push method.

Drugs are tested for safety on small groups of people before being approved for wider distribution; testing on larger groups would be cost-prohibitive and potentially dangerous. But sometimes, the number of test subjects is so small that side effects don't become apparent.

Drug companies pay for those safety tests and control how the results are written and distributed, and some firms have been known to play down problems. In some instances, problems have come to light only after injured people brought lawsuits for the damage the drugs caused.

Recent revelations about the health effects of a psychiatric medicine called Zyprexia, which can cause rapid and uncontrolled weight gain leading to diabetes and increased risk of heart attack, came about that way.

Vioxx was a best-selling arthritis and pain drug before a broader FDA study revealed in 2004 that Vioxx users were more likely to suffer a heart attack or sudden cardiac death than those taking other types of drugs. And earlier this year, the FDA came under criticism for mistakenly approving distribution of a shipment of defective Chinese-made heparin, a blood-thinning agent.

Prohibiting suits in state court by people injured by prescription drugs is profoundly unfair, particularly when drug-safety tests are considered "proprietary information" owned by drug companies.

The larger question is whether the justices will require manufacturers — of all sorts — to stand by their products, or allow them to blame government for their failures.

REPRINTED FROM THE ST. LOUIS POST-DISPATCH.

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