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A pimply-faced 13-year-old began taking the anti-acne drug Accutane in 1997. In her early 20’s she had to have her rectum and colon removed and must wear a bag that collects her waste. Two years after starting her acne cream, she began suffering from severe gastrointestinal distress, including bloody diarrhea. Experts link inflammatory bowel disease, suicidal ideation, and other problems to Accutane.

Accutane came with warnings to discontinue use if the patient suffers abdominal pain or bloody diarrhea, but the 13-year-old didn’t make the connection. The warnings were buried in 3,000 words of small print listing every trivial side-effect. You’ve heard the drug ads on TV where the announcer speed reads an exhaustive list of side-effects, usually including anal leakage. When this Accutane-user was 19 and her physician had her sign two informed-consent forms containing warnings dealing mostly with pregnancy. Buried in the small print were specific warnings to stop using the drug if she had intestinal symptoms. The woman did not make the connection between her intestinal symptoms and Accutane until her grandmother saw a lawyer’s TV ad in 2004 suggesting Accutane caused inflammatory bowel disease. By then the young woman was suffering severe symptoms that would ultimately require surgeons to remove her entire colon and rectum.

In December 2005, a New Jersey jury rendered a $10.5 million verdict in favor of the woman and against Roche Holdings, the manufacturer of Accutane.

Roche appealed and the appeals court reversed the ruling over decisions the trial judge made regarding evidence Roche could put on. But Roche also argued the case should have been dismissed before trial, because the plaintiff missed the two-year statute of limitations to file her case. The appeals court acknowledged that the plaintiff had long suffered from intestinal problems, but found that she did not discover the cause until after her grandmother saw the ad.

The pro-drug manufacturer take on this decision is summed up well by a Forbes blog I read on the subject in which the author states:

I find the decision interesting for the questions it leaves unanswered. Such as: If 3,000 words of warnings aren’t sufficient, will 5,000 do the trick? Or should courts take a look at the extensive literature showing consumers don’t read warnings anyway? In that case the practice of letting a jury decide whether a warning is complete is an exercise in futility, an argument about a hypothetical.

For manufacturers, the case demonstrates … the “damned if you do, damned if you don’t” nature of drug litigation. Put a Food and Drug Administration-authorized label on the product and a consumer can still sue, saying her particular condition wasn’t mentioned, or as in this case, should have been highlighted along with the other, perhaps more severe conditions that she didn’t happen to suffer from. Or maybe there were just so many words, the consumer couldn’t see her particular tree for the forest. For all their discussion of public policy and holding manufacturers accountable for their products, courts don’t have much advice on how to predict what a jury will determine was an appropriate warning. They can only point out ones they think have failed.

  • These observations are not without merit, but I disagree with the premise. The point of the criticism of the Accutane warning is not that there are only 3,000 words, or that a better warning would have 5,000 words. The point, which I believe the public understands (and suspect the Forbes author does too), is that a better warning would be much shorter and would emphasize with conspicuous, bold letters, the risk of inflammatory bowel disease and suicide. It’s easy to bury those warnings among the small print in a 3,000 word warning. It’s not the court’s job to craft an alternative warning, and criticism of the court decision for failing to do so is misplaced. Roche has a huge marketing budget, and it’s Roche’s job to craft understandable warnings that don’t bury the risk of having to wear a crap-bag at age 23 along with the risk of dry skin. Roche could have crafted a conspicuous warning that caught the eye of this 13-year-old’s prescribing doctor (Accutane is a prescription drug). But the doctor in the case was unaware of the causal connection. That’s why I don’t understand the criticism of the 13-year-old and her parents in the Forbes blog. Is a 13-year-old likely to question her doctor about safety of the acne medicine her doctor prescribed? Maybe she should have gone behind the doctor and done her own medical research! That’s not the real world. In the real world, patients put faith in their doctors’ decisions regarding prescription medications. Unfortunatley, doctors knowledge about prescription medications is often limited to what they hear from the drug sales reps who are plying the doctors with free gifts. Not even the doctors are reading the fine print. They are too busy dealing with insurance forms!

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