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SUPREME COURT TO CONSIDER DRUG LABELING

The United States Supreme Court heard oral argument in November in a case called Wyeth vs. Levine.The case comes out of a Vermont Supreme Court decision.Diane Levine was a musician who suffered from migraine headaches.A physician’s assistant administered the drug Phenergan during a “push-IV” injection.The PA accidentally injected the drug into Levine’s artery instead of a vein.This caused tissue necrosis, gangrene, and the eventual amputation of her hand and forearm.

The drug Phenergan, manufactured by Wyeth, had a warning label that warned of this risk if the drug was injected into an artery.The Federal Drug Administration (FDA) had approved the label.Levine warned that the label did not warn of the risks associated with hitting an artery during a push-IV. A Vermont jury awarded Levine $6.8 million against Wyeth.Wyeth argued that the approval by the FDA constituted pre-emption by federal law of state law tort claims.The Vermont appellate courts upheld the verdict, and Wyeth appealed at the federal level.

The United States Supreme Court is now considering whether federal law supersedes state law in drug labeling cases.Currently, state law could supercede federal requirements if new information became available about the drug or the FDA failed to disclose certain risks. In this case, however, Wyeth knew of the risk of harm and did in fact warn of the risk.The risk of harm caused by injecting into an artery is a 1 in 20 million chance of a gangrene adverse reaction. Levine argues the warning should have been stronger, specifically that the push-IV method increased the risk of hitting an artery.

The issue here is really whether the FDA sets minimum standards that states are free to enhance through tort liability or whether the FDA makes decisions that states are bound to follow? Federal preemption is one of the hardest fought battles in products liability law.This question will determine whether FDA approval of drugs will prevent patients from suing drug companies when the drug in questions received an FDA approval.

Wyeth argues that removing preemption will result in drug companies listing all possible harm on their labels, causing an undue burden on these companies and possibly lessening the value of information available to the user. Plaintiffs’ attorneys argue that federal preemption will effectively cause patients to lose their right to sue drug companies for harm caused by the drug.

One problem with giving so much power to the FDA is its inherent ineffectiveness.Currently, the FDA is under funded and understaffed to handle the $1.5 trillion dollars worth of goods it must inspect and evaluate.Drug companies can now pay user fees to speed up approval of their products.Further, drug companies bankroll one-fifth of the FDA budget.Arguably, a rush for approval compromises the quality of oversight.Thus, it is not surprising that drug companies want the FDA to have the last word on drug safety. As Maggie Mahar said in her Healthbeat blog:there is no easier regulatory process to navigate than the one you control.

The Journal of the American Medical Association wrote recently in support of Levine that “the drug and device regulation system is at best an inexact and incomplete science.”More is learned about drugs once millions of people start taking them.This information is often more useful than that conducted in the limited trials done by the FDA during the approval process.Drug companies often learn about the dangers caused by their drugs once they are at market; and they do not often report these findings back to the FDA after approval.

Thus, a victory for federal preemption means that the drug companies that are fast tracking their drugs through the FDA’s process cannot later be held accountable for harm their drugs cause.Hopefully, the Supreme Court will see through this problem.We shall see.

If you have a claim or think you have a claim for products liability involving a drug company or drug product, contact the law firm of Robert N. Katz for a free, private consultation.