Sometimes, we’re not sure why we call this the “Drug and Device Law Blog.” We could call it the “Preemption, Daubert, and Learned Intermediary Law Blog” and still be 90 percent accurate.
Why is that?
Why are preemption, Daubert (the issue of junk science), and the learned intermediary doctrine so critical to pharmaceutical and medical device product liability lawyers? And why is preemption the most important, Daubert the second most important, and learned intermediary a distant third?
Preemption is an extraordinarily powerful defense. If it works, it has the potential to eliminate all product liability claims involving a particular drug or, conceivably, all product liability claims involving all prescription drugs.
See what we’re all worked up about?
The FDA judges the safety and efficacy of our drug, dictates the terms of our label, controls our advertising, and can change things if new information comes to light over time. Allegedly injured plaintiffs should not be allowed to second-guess those expert decisions, saying that our drug was defective or our warning inadequate.
If that defense works, then no one who took that particular drug can sue us for a product liability claim. Lots of cases disappear simultaneously.
And we can win on the preemption issue early in the case. We might be able to win on motion to dismiss, avoiding entirely the cost of discovery. (If those words don’t mean anything to you, see our previous post.) If not, we should be able to win on summary judgment, after introducing evidence of our company’s communications with the FDA.
Preemption is a broad defense, eliminating entire categories of cases at an early stage of litigation.
Daubert — the junk science issue — is next most important. This issue asks whether any reliable scientific evidence supports the plaintiff’s claim. For example, do any peer-reviewed studies really say that aspirin causes brain cancer? If not, the defendant wins.
This defense is not as important as preemption for two reasons. First, the defense applies only one drug and one disease at a time. If I win, I may eliminate all of my “aspirin — brain cancer cases,” but I’m still stuck with all of my “aspirin — appendicitis” and “aspirin — nearsightedness” cases. And I’m still stuck with all of the cases that don’t involve aspirin.
So Daubert is strong — it cures one litigation headache, so to speak — but not as strong as preemption.
Daubert also isn’t as cheap as preemption. I can probably present a preemption defense on motion to dismiss; if not, I can present it on a fairly limited discovery record. But getting to the Daubert issue typically requires doing all of the fact discovery in a case, hiring (expensive) expert witnesses, and not winning until late in the game.
Daubert is important, but not as critically important as preemption.
Finally, the learned intermediary doctrine. If the treating physician did not read my package insert, or knew the supposed risks of the drug from a source other than the package insert, or now knows about the alleged risk of the drug but, even with that knowledge, would still have prescribed it to the plaintiff, the drug manufacturer wins based on the learned intermediary doctrine. Nothing the drug manufacturer did had anything to do with the plaintiff’s alleged injury.
That issue arises in every prescription drug (or device) case; if there’s a prescription, then there’s a doctor — a learned intermediary — in the loop. So drug manufacturers care deeply about the defense.
But the defense is not as powerful as either preemption or Daubert. Winning based on the learned intermeidary defense wins only this one case — the conduct of this one doctor bars this one lawsuit. The learned intermediary doctrine does not eliminate all cases involving the drug (as does preemption) or all cases pleading that the drug caused a particular injury (as does Daubert). Learned intermediary is good, but it’s no silver bullet.
And, by its nature, the learned intermediary doctrine almost always requires the defendant to take testimony from the treating physician. That means that the motion cannot be presented quickly (and cheaply) on motion to dismiss, but rather can be presented only late in the day by summary judgment.
There are, of course, other ways to win product liability cases. The plaintiff may have waited too long to sue and be barred by a statute of limitations, for example. But that issue won’t come up in every case; many plaintiffs sue on time.
And, even if a defendant can’t eliminate a case by motion, it can still win at trial. It might turn out, say, that there’s some evidence that aspirin can cause brain cancer, but this particular patient took only low doses of aspirin many years ago, and had a family history of brain cancer, so the jury decides that aspirin didn’t cause brain cancer in this partiuclar person.
Defendants can win cases on those types of grounds, however, only by spending the money (and running the risk) of a trial, and the cases must be litigated one by one.
So that’s why we spend so much time thinking (and typing) about preemption, Daubert, and the learned intermediary doctrine.
We’ll surely be posting again on one of those three subjects shortly.