Photo of Bexis

We’ve seen two adverse preemption decisions over the last couple of weeks that have us scratching our heads. These opinions are Barnhill v. Teva Pharmaceuticals USA Inc., No. 06-0282, 22 BNA Toxic Law Rptr. #20 (S.D. Ala. Apr. 24, 2007), and Kelly v. Wyeth, 2007 WL 1302589 (Mass. Super. Apr. 12, 2007). Neither of them are particularly ground-breaking in what they say. Indeed, the reasoning in Barnhill is in our judgment one of the least persuasive anti-preemption decisions we’ve seen because:

(1) Barnhill never really come to grips with how the scope of labeling changes for generic drugs is more restricted than for so-called “pioneer” prescription drugs. Instead, it uses the general provision it prefers (21 C.F.R. §314.70(c) – as always) to override the more specific provision (that is, solely applicable to generics) that would require preemption (21 C.F.R. §314.150(b)).
See Slip op. at 6-8. Instead, Barnhill cites non-ANDA opinions indiscriminately.

(2) The “best reasoning” that Barnhill cites for ignoring the FDA Final Rule, slip op. at 9, no longer exists because the footnote in Desiano v. Warner Lambert & Co., 467 F.3d 85, 97 n.9 (2d Cir. 2006), was amended specifically to delete the Second Circuit’s original and ill-conceived (and never-briefed) dictum in that case.

(3) Barnhill states that only Colacicco has afforded deference to the FDA’s position. Slip op. at 11. That’s just plain wrong, and omits three other opinions, all of which deferred to the FDA with significant reasoning. See Sykes v. Glaxo-SmithKline, 2007 WL 957337, at *19-23 (E.D. Pa. March 28, 2007); In re Bextra & Celebrex Marketing Sales Practices & Product Liability Litigation, 2006 WL 2374742, at *6-9 (N.D. Cal. Aug. 16, 2006); Conte v. Wyeth, Inc., 2006 WL 2692469, at *5-6 (Cal. Super. San Francisco Co. Sept. 14, 2006). In addition, two other cases deferred to FDA amicus briefs saying essentially the same thing before the Final Rule was promulgated in January, 2006. Needleman v. Pfizer, Inc., 2004 WL 1773697, at *4-5 (N.D. Tex. Aug. 6, 2004); Dusek v. Pfizer, Inc., 2004 WL 2191804, at *6 (S.D. Tex. Feb. 20, 2004). That a federal court would make such a flat factual error gives us pause concerning the presentation of preemption argument.

(4) Barnhill doesn’t analyze the Supreme Court agency inconsistency precedent at all. It just states there was an FDA “about-face,” slip op. at 10, and leaves it at that. Again, this is simply wrong since the deference cases – going back to Chevron itself, 467 U.S. at 863-64, state repeatedly that courts should respect changes in administrative position as long as they are explained.

Another problem we have with Barnhill is that the case was decided on a motion to dismiss. That means there was no factual record at all, only the allegations of the complaint, before the court. We don’t think that’s a good idea. When moving on the basis of conflict preemption it’s far preferable to have as strong a factual record as possible demonstrating the conflict. Without that record, the chance for success, both at the trial court and appellate levels, is lessened.

With respect to Kelly, the most salient point for us is why a preemption motion was brought at all in a state trial court in Massachusetts – a known pro-plaintiff jurisdiction. There’s certainly no history of success with preemption motions in prescription medical product cases in Massachusetts. See Brown v. DePuy Spine, Inc., 2007 WL 1089337 (Mass. Super. Apr. 9, 2007); Belanger v. Safeskin Corp., 20 Mass. L. Rptr. 51, 2005 WL 2542936 (Mass. Super. Sep. 6, 2005); McNulty v. Hijikata, 3 Mass. L. Rptr. 562, 1995 WL 809930 (Mass. Super. Apr. 20, 1995) (all denying preemption). That’s three strikes even before Kelly. Massachusetts is even hostile to ERISA preemption, which isn’t even particularly controversial anymore in most states. See DeSantis v. Commonwealth Energy System, 864 N.E.2d 1211 (Mass. App. 2007).

Part of preemption strategy is choosing the jurisdictions in which such motions would have a reasonable likelihood of success. In plain English, you gotta pick your spots. If defendants go running helter skelter into courts filing preemption motions no matter how hostile the jurisdiction – well, the result is going to be decisions like Kelly. That doesn’t do the filing defendant any good. Nor does it do anyone else defending prescription drug cases any good.

Barnhill and Kelly share a common thread. In both cases the unsuccessful motions were filed by the same defendant, Teva Pharmaceuticals. Teva is a manufacturer of generic drugs. That might not seem important, because anybody can lose two in a row. The generics’ preemption argument seems pretty powerful to us, since the FDA flatly forbids them from deviating from the so-called “pioneer” drug’s label.

But it’s not just that. One of the facts of life in our business is that the so-called “pioneer” manufacturers that we both represent and the generics like Teva don’t like each other. Actually, it wouldn’t be too strong to say that the pioneers and the generics spend much of the time suing the living daylights out of each other for any number of good and sufficient business reasons which we won’t get into.

One consequence of that is that the same law firms can’t represent pioneers and generics in defending product liability litigation, because there’s too much legal adversity elsewhere. We know we can’t.

So ne’er the twain shall meet. That’s troubling. We’re worried that, in preemption, this animosity is having deleterious effects. Most of the largest firms that have done the most sophisticated preemption thinking – here we are guilty of flattering ourselves – tend to represent the pioneers. That’s because, historically, the pioneers tend to get sued more often, because, well, they’re pioneers and thus out front with new drugs having new risks. As importantly, pioneers get sued about the same thing sooner than the generics, because generics have to wait for patent expirations.

The preemption cases are demonstrating what is a fact of life in pharmaceutical product liability – with more generic drugs being used, there will as time goes on be more product liability litigation involving these products. In a lot of ways product defendants are in the same boat doing battle with plaintiffs. We’re afraid that, because of the longstanding (and justifiable) commercial animosity, the generics aren’t getting the benefit of the hard-fought experience that the pioneers and their counsel have obtained in this area. Decisions like Barnhill and Kelly can be the result.

Preemption in product liability is one place where the interests of pioneer and generic manufacturers are aligned. We both want to beat the plaintiffs. Decisions like Barnhill and Kelly don’t help anyone except the plaintiffs. Ben Franklin said if we don’t hang together, we’ll all hand separately. Sort of the same thing applies here.

In Kelly, we wish that more attention was paid to the court in which the motion was filed. Sometimes, for the good of the developing law, one has to “take one for the team” – choose to refrain from raising preemption particular case. In Barnhill, we wonder (but don’t know for sure) whether the briefing was as good as it could have been, since a well-informed court wouldn’t be citing to language in a case that’s been deleted by subsequent amendment, and wouldn’t be stating that there’s only one case for a proposition when there are at least 4 (and arguably 6).

Also we think it would have been preferable to wait in Barnhill and file
the preemption motion as a summary judgment motion with a full record demonstrating the conflict. It might not have made a difference, but it could have.

We’re not trying to bash either Teva or its counsel here. We’re sure they’re doing the best job they can with the hand they’ve been dealt. What we want to do is advance the defense cause generally, because that’s in the interest of our own clients, as well as to the development of the law generally. That’s why this blog tries to address cutting issues. It’s public, on the Web, and available for any and all to see. That means it’s accessible to generic manufacturers and their counsel, who might not share in the information networks available to pioneer manufacturers.