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The Federal Drug Administration (FDA) is, in theory, in place to regulate the safety, marketing, and labeling of pharmaceutical drugs. However, its ability, or propensity, to do just that is doubted by some that believe the FDA does not hold drug manufacturers accountable for product dangers occurring after the product is on the market. In that latter instance, law suits filed by the injured party(ies) may provide the only means by which a drug company may be held accountable, or responsible, for its acts or omissions.

In that regard, the United States Supreme Court is set to rule on arguments it recently heard in Wyeth v. Levine. Depending upon which party the Court sides with, the decision could amount to blanket immunity for drug manufacturers from liability for injuries caused by their products, or allow a jury with no medical experience to substitute its judgment for those of medical professionals assessing patient studies and clinical trials.

In Wyeth v. Levine, Wyeth’s drug Phenergan was administered to plaintiff Diane Levine for her severe migraine headache. The physician’s assistant administered the drug using an intravenous push, and accidentally injected the drug into an artery instead of a vein. This caused Levine to develop gangrene, which ultimately resulted in amputation of her right arm.

The FDA has approved Phenergan for use through either deep intramuscular injection or through intravenous push. The drug’s labeling, authorized by the FDA, states that IV administration produces clinical effects quicker than intramuscular injection, but with more risks. The drug label also warns of the risk of gangrene and provides detailed instruction on how to minimize arterial blood mixing.

Levine claims that Wyeth should have included a label stating, “Do not use this drug intravenously.” A Vermont jury agreed, and awarded $7.4 million in damages. Wyeth appealed, and oral arguments were heard in the Supreme Court on November 3.

The ruling by the Supreme Court in this case could have dramatic effects on the civil justice system. When regulating pharmaceutical drugs, FDA scientists analyze clinical studies and other documentation submitted by the drug companies before making a decision on the drug’s marketing and warning labels. David Ferrera, a partner with Nutter McClennen & Fish LLP specializing in drug and medical device litigation, argues that a jury of laypeople, with no medical training or experience, should not be able to substitute their opinions for those of medical professionals who have studied the effects of the drug in depth. If the court finds in favor of Levine, he claims, drug companies may find that each state may dictate different labels through verdicts. Additionally, a jury focuses on the single case at hand, rather than the broader social benefits such as public health, which “simply defies all logic,” Ferrera believes.

Nan Aron, President of Alliance for Justice, argues in favor of Levine, stating that the ability of consumers to threaten drug manufacturers with lawsuits – as a way of holding the companies accountable for defects and dangers in their drugs – is of paramount importance. If a danger appears after a drug goes to market, there is no effective system in place to force recalls, leaving little incentive for the drug companies to remove the drug from the market. Aron also states that the FDA staff went so far as to tell the Bush administration that their permission to market a product is never a guarantee of safety. If the Supreme Court finds in favor of Wyeth, she believes, consumer protection will be compromised.

In the end, does the American public, which includes our government and courts, trust the FDA to regulate the pharmaceutical industry in a thorough and comprehensive fashion? Has the FDA (or any other governmental agency) demonstrated an ability – or desire – to so regulate? Have we not seen the results of no or lax regulation over the past number of years? Do we trust corporations (whose primary, overriding goal is to make money for the shareholders) to regulate themselves? The answer is likely to be a resounding “no”. Litigation is one effective check and balance on the pharmaceutical industry, and Corporate America in general. If the Court rules in favor of Wyeth, we have taken another step towards Corporate Immunity in America – which is not what our founders had in mind when they drafted the Constitution. If our founders trusted juries to decide a convicted person’s sentence, perhaps a death sentence, then surely they also trusted jurors to decide the merits and damages of a civil case. Jurors are American citizens and they are quite capable of deciding these issues.

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