Ensuring Patient Access to Life-saving Medicines

 Ensuring Patient Access to Life-saving Medicines

By Merrill Matthews

The U.S. Supreme Court is in the midst of a momentous term. Paramount among the cases before the nine justices is Wyeth v. Levine, which could determine how the courts should settle conflicts between federal and state law. The Court recently heard oral arguments for Wyeth and is poised to make a ruling in the coming months.

The outcome of Wyeth won’t just be of interest to lawyers and professors. If the high court finds that federal law does not “preempt” state law in matters of drug safety, a flood of frivolous liability lawsuits could cause patients to lose access to critical medicines.

In addition, the decision could ultimately affect whether other industries are subject to lawsuits when a manufacturer has posted, and the federal government has approved, relevant warnings about its product.

Ordinary folks should hope that the court stands up for both current consumers and the development of future products by affirming preemption.

The case before the court pits Vermont resident Diana Levine against pharmaceutical company Wyeth. In the spring of 2000, Levine visited a local medical clinic to get treatment for a migraine. The attending physician’s assistant gave her an injection of the anti-nausea drug Phenergan using a method known as “IV push.” This method of administration runs the risk of exposing an artery to the drug, which can cause gangrene.

The injection was misapplied. Levine developed gangrene and eventually had to have part of her arm amputated.

Levine reached a settlement for damages with the physician, the physician’s assistant, and the health center. She also sued Wyeth, the maker of Phenergan, and was awarded more than $6 million in damages by a Vermont jury. Her attorneys argued that the drug’s label didn’t sufficiently warn patients of the dangers posed by IV push injection.

Levine’s story is obviously tragic, and the physician’s assistant who misused the drug should be — and was — held accountable. But it’s hard to see how Wyeth could be at fault.

Phenergan’s FDA-approved warning label clearly states that “inadvertent intra-arterial injection” can result in “gangrene requiring amputation.” The label recommends using alternative, safer administration methods instead.

It’s also important to remember that the Food and Drug Administration (FDA) approved the contents of the warning label. Officially, the FDA’s team of expert scientists is ultimately responsible for screening and giving the final green light to pharmaceutical labels. Federal regulators conduct highly technical analyses of drugs in an effort to weight the risks — and all drugs come with risks — and benefits of new drugs being considered for approval.

Without a strong preemption principle, the average Americans who serve on juries — and who are not medical experts — would be asked, in essence, to overrule the government scientists and medical experts who oversee the drug-approval process.

Trial lawyers know that jurors are ill-suited to evaluate the merits of drug warning labels, which is exactly why they’re behind this effort. Without preemption we’ll see a swift uptick in frivolous product-liability suits against pharmaceutical firms and other manufacturers.

Opponents of preemption argue that eliminating it would make the drug companies more rigorous in ensuring their drugs are safe. It would more likely make them invention-averse. Lawsuits are expensive, and even the threat of baseless litigation can cause pharmaceutical firms to simply stop creating and developing new or selling their existing products.

Case in point: the removal of Bendectin, a morning-sickness drug, from the market. In 1979, the National Enquirer published a story linking the drug to birth defects. The story turned out to be bogus. As medical researcher Robert Brent concluded in a study published in the American Journal of Obstetrics and Gynecology: “[S]tudies clearly demonstrate that Bendectin has no measurable reproductive risks to the mother or the fetus.”

But the Enquirer story spawned thousands of lawsuits against the drug’s manufacturer, causing the firm to pull Bendectin from pharmacy shelves. Consequently, hospital admission for morning sickness doubled in the intervening years, according to law professor Richard Stewart.

If the Supreme Court affirms preemption, manufacturers won’t be immune from all lawsuits, like those concerning fraud or false advertising. An established principle of preemption simply ensures that the FDA’s expert scientists won’t have their findings concerning the efficacy of a drug’s warning label second-guessed — or even overruled — by non-expert jurors and trial lawyers.

A failure to defend preemption would be disastrous for patients, who would see the supply of necessary medicines plummet and the prospect for future cures fade.

Merrill Matthews is a resident scholar with the Institute for Policy Innovation.