Therapeutic Dose: Be Careful What You Wish For

Aug. 18, 2008
Decisions on product liability and labeling may make it harder for consumers to sue, but could decrease industry profits and make clinical trials longer and more litigious than they already are.

I was recently re-watching Jurassic Park. Jeff Goldblum’s character, a mathematician, espouses Chaos Theory to warn of Nature’s unexpected results. He uses the “butterfly effect”—you know, “If a butterfly flaps its wings in San Francisco, there might be a hurricane in New York”— to illustrate his point. It made me think of some upcoming Supreme Court cases, and the fact that the most disputed or borderline decisions, or those that appear to pertain to a single incident or client, often have lasting effects on society.

Remember the Dred Scott decision, on whether a human being can be property, or the Roe v. Wade verdict? This fall, the Supremes will hear cases that put product liability and labeling front and center. In one case, a Vermont woman filed suit against Wyeth when she was improperly administered Phenergan, an antinausea drug. The label indicated that the drug should be administered intra-muscularly (IM) or, in rare cases, intravenously. Some of the drug was inadvertently injected into the patient’s artery, leading to complications that resulted in the loss of the arm.

The plaintiff’s lawyer has argued that the label did not warn of the possibility of such dire consequences, and lower courts awarded the patient over $6 million. Now before the Supreme Court, the case hinges on the company’s defense that its labeling was approved by FDA and, since federal law supersedes state law, they are immune from prosecution in state courts. FDA has come in as a friend of the court siding with Wyeth.

Big Tobacco won a huge victory recently when a Manhattan appeals court reversed a ruling in favor of a lung cancer victim who had argued that Philip Morris was guilty of false advertising when it downplayed the hazards of its “light” cigarettes. The label did not specifically state that smokers of the light cigarettes were just as susceptible to disease as smokers of regular cigarettes (affectionately known as “coffin nails”). The Philip Morris argument: the labels complied with federal trade commission (FTC) guidelines.

Both cases are similar to a recently decided case involving device-maker Medtronic, which claimed that 1976 amendments to the Food, Drug, and Cosmetic Act imply that FDA approval of a device preempts product liability lawsuits in state courts. The court agreed, ruling that a suit could not be filed under state law if federal regulators had already approved the device in question. Things are becoming “curiouser and curiouser” by the day—Big Pharma, Big Tobacco, FDA and FTC all appearing before the Supreme Court, asking that there be, in effect, less consumer protection.

If they continue to get their way, what could happen? It would help keep business expenses down, wouldn’t it? Certainly, we wouldn’t have as many consumers receiving big payouts for driving with hot coffee between their legs. What about cases like the Vioxx suit? The recent climate would certainly make it harder to sue drug companies for deleterious side effects. But there is one other consequence not thought out as yet: longer clinical trial times! If an approval by FDA precludes lawsuits for long-term or unexpected sideeffects, it is logical that the Agency will set more stringent limits. There would be more oversight, extended trials, involving more patients, and even more statisticians.

The motive would be to make sure the product was as safe as possible before granting it approval for sales. I can see years and years added to Phase III trials for nearly every drug, and certainly ones used for chronic conditions (the Lipitors and such). How happy would Big Pharma be with a potentially smaller sales window before a product goes generic? Well, you might say, merely extend the patent life for a proprietary product.

The howls of indignation from both generic houses and AARP! In the long run, we may well have even MORE lawsuits than we do now. Remember when Jeff Goldblum (Jurassic Park) said, “Nature always finds a way.” He was referring to limiting the reproduction of dinosaurs, but here we refer to lawsuits. Do we really think we can stop the wave of lawsuits so easily? Harumph! And do we still believe that cockroaches will be the only living things to survive a nuclear war? The cockroaches will need someone to represent them, won’t they?

About the Author

Emil W. Ciurczak | Contributing Editor