Witness for the Defense

This morning I woke to an ad. You know the type. “Have you been a victim? Have you or a loved one been injured? If so, call the Law Offices of So-and-So.” When did this country become so litigious that every bump and scrape has to have its own 800 number? I’m appalled at the number of people who want to sue for the risks of being alive on this planet. I’m also appalled that there’s an industry that not only serves those people, but generates them. For the most part, I ignore those ads, those people, and that industry. Not today.

Usually, I’m not familiar with the product that the suspect law office assures me I have a claim against: I’ve never taken Ephedra, never needed Vioxx. But today they were attacking Accutane. Stand back, boys, because now you’ve got my attention.

Accutane is a powerful acne medication that is only prescribed after all other methods have failed. For those with disfiguring acne, it is a God-send worth any associated risk. On and off for more than a decade, I’ve been taking Accutane and I can speak with no little authority on the subject.

Accutane is NOT an easy drug to get your hands on. So-and-So is right about one thing: there are risks involved. But not one of those risks is a secret to the patient. Not one.

In order to be prescribed Accutane, the patient must undergo consultation about the drug and sign consent forms detailing all the risks. A female patient must prove that she isn’t pregnant and is warned not to become pregnant during or soon after treatment. The patient consents to regular blood work, monitoring the liver. This rigorous process decides only if you might get the drug, and even for those who’ve been taking it safely for years it’s unavoidable.

The warnings do not end with the prescription. The packaging is daunting. The box itself must be unfolded, revealing all warnings about the drug. Inside the box, atop the pills, there is a layer of paper documentation. Underneath, in a bed of 10, each pill lies in its own press-through compartment. Guarding that compartment is a preventative backing that must be removed before the pill can press through. On that backing, in case you missed all the warnings in the doctor’s office; in case you can’t or didn’t read the packaging; each pill has its own graphic warning: the profile silhouette of an obviously pregnant woman under the universal “no” symbol – a red circle bisected by a red line. It’d be easier to break into Fort Knox than to extract a single dose of Accutane without adequate warning. The risk of birth defects is certainly the most prominent among the warnings, but it is not the only one on the product. Adverse side effects may not have been known to the public, but it’s impossible that they were unknown to a patient.

To have a case against the manufacturer, one should be able to prove that the manufacturer was in some way irresponsible, that they knew of risks yet failed to warn the consumer. Yet, despite a battery of consent forms and warning labels, So-and-So claims the manufacturer is still liable for injury. How can that be?

By acknowledging my risks, I consider that I’ve waived the manufacturer’s liability for anything about which I was warned. I made that decision. And if I, duly warned, chose to get pregnant then suffered a miscarriage, premature delivery, or mongoloid birth the fault would be mine. But in this dog-sue-dog world, I’m beginning to fear that consenting adults will soon be prevented from making informed decisions and willingly taking risks because the options will disappear. We are a nation of people who sue because our coffee is hot. The result of that suit was an increase in labeling. What happens when the labeling already exists? Will the product be removed from the market? Vioxx and Ephedra have already been pulled from shelves. I don’t know what, if any, warnings were supplied with those products. I do know that Accutane supplied ample warning and that no one who suffered did so uninformed.

Anyone who ignored the risks made their own bed. I know the risks and I’m still in mine. If I want to pull an Accutane cover over my head, it should be my choice, risks and all. Back off, So-and-So.