Implied preemption in prescription drug cases basically comes down to how a judge feels about whether a manufacturer can unilaterally change its label to “strengthen” warnings under 21 C.F.R. §314.70(c) – the so-called “Changes Being Effected” (CBE) regulation. Our side claims that the CBE regulation doesn’t change anything fundamentally, because the FDA still has to approve any such changes, and can find the revised labeling false and misleading. We also argue that the CBE regulation applies only to “new” risk information, and thus can’t possibly apply to a risk that the FDA’s already considered.

Plaintiffs say that the CBE labeling regulation gives companies a blank check to strengthen any warning at any time – even with no scientific proof of causation (we kid you not) – thereby showing that FDA approved labeling is only a “minimum standard.” As for the subsequent FDA approval requirement, to the extent plaintiffs bother with it at all, they claim that the FDA’s a rubber stamp and never disapproves this kind of label change, or they call the argument “speculative” because the manufacturer never submitted a CBE change (or if it did, didn’t risk FDA prosecution when the FDA said “no”).

Some courts have come out on our side. Tucker v. SmithKline Beecham Corp., 2007 WL 2726259, at *9-10 (S.D. Ind. Sept. 19, 2007); Colacicco v. Apotex, Inc., 432 F. Supp. 2d 514, 527-28, 535-36 (E.D. Pa. 2006); In re Bextra & Celebrex Marketing Sales Practices & Product Liability Litigation, 2006 WL 2374742, at *8 (N.D. Aug. 16, 2006), to name three. Others have bought the plaintiffs’ arguments. Those you can go find yourself – we’ve said before we don’t do plaintiffs’ research on this blog – but the universe of recent cases is in our preemption scorecard.

In short, we’re in a run for our money. We’ve got a federal court of appeals. Pennsylvania Employees Benefit Trust Fund v. Zeneca, Inc., 499 F.3d 239 (3d Cir. 2007). So do they. We’ve got a state appellate court. Prohias v. AstraZeneca Pharmacerticals, L.P., 958 So. 2d 1054 (Fla. App. 2007). So do they. We’ve got the FDA on our side at the moment. They might later. Basically, there’s law out there for just about any proposition either side wants to argue.

That’s what keeps us lawyers employed.

So, let’s think the unthinkable here. What happens if the good guys (for us, that’s our clients, the pharmaceutical companies) lose? Suppose the Department of Justice doesn’t get off its duff (come on guys, time’s a-wasting) and file the requested amicus brief on the Levine certiorari petition, and as a result the Supreme Court doesn’t get around to deciding the implied preemption issue until after – say, President Edwards takes office and appoints some notorious plaintiffs’ expert witness as FDA Commissioner. The FDA promptly reverses all of its preemption positions and, for good measure, determines that plaintiffs should be able to file negligence per se suits against regulated companies despite the FDCA’s exclusive enforcement provision. 21 U.S.C. §337(a).

In short, the world goes to hell in handbasket. So what do we recommend that the pharmaceutical industry do – short of relocating to China or South Korea? Well, we think that, at that point it probably becomes a matter of “be careful what you ask for, you just might get it.”

If the FDA becomes of the view that manufacturers can unilaterally “strengthen” their warnings at will, then that’s probably what it will get. Although there would undoubtedly be some internal resistance from not only the marketing folks, but also doctors worried about unduly alarming patients and deterring use of beneficial medicine, the cost of product liability being what it is, we’d expect to see a lot more CBE filings at the drop of an anecdotal adverse reaction report. If the system decides it’s liability uber alles, then so what if, say, putting suicide warnings on antidepressants increase the number of unmedicated depressed patients who go on to commit suicide?

If that’s how the law gets interpreted, drug manufacturers will follow the law.

If the courts hold that there’s no preemption because the defendant’s argument is “speculative” in that it never submitted a CBE application to the FDA and had it rejected – then we’d once again expect to see the FDA inundated with CBE requests. Only this time, we wouldn’t be surprised if some of these changes are really scantily supported. If it’s the rejection that does the trick on preemption, then the courts will have created a really perverse incentive structure. If rejections prompt preemption (as well as keep scientifically unsupported risk claims off the label) then we’d have to expect rational companies to respond to the incentives that are out there. To us that would seem rather like a charade. But that’s the logical effect of accepting the plaintiffs’ argument on the point.

Finally, if even the FDA’s flat “no” to a CBE labeling change isn’t enough to ward off litigation, then the industry’s really pushed into a corner. It’s damned if it does and damned if it doesn’t. At that point, liability could have one of several effects. One possibility is anarchy. The industry (or pieces of it), driven by fears of possible multi-billion dollar liability for doing exactly what the FDA orders, might decide to risk FDA prosecution. Plaintiffs like to claim that the FDA is understaffed and underfunded and thus has to rely largely on voluntary industry compliance. Well, they ain’t seen nothing yet. If the industry were to be driven to prefer battling the FDA to battling plaintiffs, the current system of drug regulation would probably break down completely in rather short order.

Now, we may be Luddites, but we’re not nihilists. We doubt we’d ever advise a client to ignore an FDA refusal to permit a label change and fight a misbranding prosecution instead. If the law were to evolve so that plaintiffs can sue a company for not disobeying the FDA, we’d probably advise them: (1) You’re going to have to fight the suits on whatever grounds you have and hope most juries have good sense. (2) Unfortunately, not all juries will show good sense (and there are a lot of really persuasive plaintiffs’ lawyers out there), so you’re going to get hit with some frequency – therefore raise your prices to cover those instances when you’re held liable because you obeyed the FDA. (3) Liability for not disobeying the FDA is something like being that proverbial fish in the barrel that’s getting shot at. If the hits get too bad, then you’ll have to make a business decision. A pharmaceutical company is not a charity. If litigation makes it impossible to make a profit selling the drug, then stop selling it.

Our clients make medicines that save lives and improve people’s health. Because of that, we wouldn’t like being in a position to advise a client that its only sensible economic choice would be to pull the plug on a drug that we know is beneficial to a lot of people. But the basic problem is that it’s a really bad idea (“crazy” would not be too strong an adjective) to make pharmaceutical manufacturers pay plaintiffs because the companies did exactly what the FDA told them to do – or didn’t do what the FDA told them not to do – or the other situations in which the FDA says these days that there should be preemption. For courts to accept the snake oil that the plaintiffs are peddling about preemption would have real, adverse, and concrete effects on the delivery of health care in this country. And those effects wouldn’t be pretty.

That’s why we don’t want to be forced to think the unthinkable.

Happy Thanksgiving to all!