This post is the work of Bexis alone; Herrmann had to stay on the sidelines today:
“We grow too soon old and too late schmart.”
That’s what the Pennsylvania Dutch say, and now that seems to be the story of the fen-phen litigation. After a fifteen-year run that produced billions of dollars in settlements, a federal judge has ruled that, surprise, the defendant’s label was adequate as a matter of law.
And this happened in a case where the plaintiff claim primary pulmonary hypertension (“PPH”), probably the worst of the various adverse effects alleged by fen-phen plaintiffs.
The name of the case is Longs v. Wyeth, and here’s a copy (it’s now reported at 536 F. Supp.2d 843). We’ve actually had this opinion kicking around for a week, since the folks representing the defendants passed it along, but between the stunning Kent non-event, Herrman being busy, and Bexis being slothful (or was it the other way around?) we didn’t get around to discussing it until now. It’s not like we did nothing, though, since we passed it along to Westlaw (2008 WL 542387), and they’ve decided to publish it. We just didn’t get around to sharing it with you.
Sorry, we’ll try to make up for it.
We’re preemption buffs – but you know that by now. One thing we didn’t think was that there were any new flavors of prescription drug preemption that we hadn’t seen. But we should never underestimate the creativity of counsel on the other side. Longs has a new variant, a judicial response to yet another novel legal theory seeking to usurp the role of the FDA.
In Longs the plaintiff purported to drop any of the usual warning defect claims (you’ll find out why in a bit). Instead she alleged that there was no warning at all that could have prevented the drug in question from being unreasonably dangerous. As stated by the court:, “[p]laintiff’s strict liability and negligence claims [are] that [the product] was an ‘unreasonably dangerous’ drug for which no warning would have been adequate.” Slip op. at 6.
The FDA, however, had approved the drug for sale with the warning the defendant had used.
It’s one thing to say that the warning was inadequate – the FDA doesn’t take the position that all warning defect claims are preempted (the court here cites 71 Fed. Reg. at 3936).
But it’s quite another thing to say that there isn’t any warning on the face of the earth that could make an FDA-approved drug “safe” under state law. That’s the same thing as saying that, as far as state law is concerned, notwithstanding the FDA’s approval, the defendant should never have sold the product.
And for a state to tell the FDA that its approval should never have happened – well, that’s preempted.
And that’s precisely what the Longs court held:
Although Plaintiff asserts that she alleges only that Defendants should not have marketed [the drug], and that she does not argue that the FDA did anything wrong, the court finds that her claim that [the drug] should never have been placed on the market interferes with the FDA’s objectives. Consequently, all claims relating to pre-FDA approval are preempted by the FDA. In addition, to the extent that Plaintiff alleges fraud-on-the-FDA or that Defendants concealed or misrepresented information to the FDA, these claims are preempted as well.
Slip op. at 6. The same fate met plaintiff’s negligence claims, that asserted the defendant waited too long to investigate side effects and should have taken the drug off the market sooner:
to the extent that Plaintiff’s Complaint alleges claims for negligent misrepresentation or negligent failure to investigate or negligence in putting [the drug] on the market, these claims are preempted by the FDCA because, as previously discussed, they conflict with the FDA’s regulatory authority.
Slip op. at 18.
It’s tort claims like these – unheard of twenty years ago – that all but drove the FDA to decide that it had to speak out in favor of preemption. No federal agency could let this kind of claim stand without surrendering its authority to private litigants. And no federal agency will willingly do that, simply as a matter of bureaucratic imperative if nothing else.
The court didn’t, however, hold that post-approval “design defect” claims were preempted. Slip op. at 7. OK – but just what are “design defect” claims in the prescription drug area anyway? Drugs (most of them anyway) are specific chemical compounds. If you “design” them differently you have a different compound, and thus a different drug. Forgive us, if we’re skeptical about the whole concept of design defect in the prescription drug context.
But we move on.
Now we get to the reason why plaintiff purported to drop all the usual warning claims – the defendant’s labeling discussed the PPH risk up one side and down the other. But even having done that, plaintiff couldn’t avoid the defendant’s label.
Unfortunately for plaintiff, by statute, Ohio follows Restatement (second) §402A, comment k. That means that “where a warning for an ethical drug is found to be adequate, then no design defect exists as a matter of law. Slip op. at 9 (O.R.C. §2307.75(D)).
Thus the plaintiff in Longs couldn’t get away from the defendant’s adequate warning even though she dismissed all warning-related claims. Adequate warning is a defense to a design defect claim under Ohio law.
There follows a long discussion about who had the burden of proof under this statute – the defendant to prove its warnings were adequate, or the plaintiff to prove them inadequate. Slip op. at 9-12. Normally, plaintiffs (since they’re trying to take the defendants’ money) have to prove their claims, but this plaintiff tried to turn the statutory definition into an affirmative defense.
Turned out there were other exceptions to the same general rule limiting design defect liability, and courts had required plaintiff to prove their cases as to those. By analogy, the court held that the plaintiff had to prove her case with respect to the adequate warning exception as well. Slip op. at 12.
We don’t really see the need for the lengthy discussion (although we’re happy with the result), because the defendant’s warnings – about PPH – were adequate as a matter of law. Slip op. at 12-16. There are five factors Ohio uses to evaluate adequacy:
- 1) the warning must adequately indicate the scope of the danger;
- 2) the warning must reasonably communicate the extent or seriousness of the harm that could result from misuse of the drug;
- 3) the physical aspects of the warning must be adequate to alert a reasonably prudent person to the danger;
- 4) the warning must indicate the consequences that might result from failure to follow it and;
- 5) the means to convey the warning must be adequate.
The second one wasn’t relevant because there was no misuse claim, but as to the others, the defendant’s label met them in spades. The PPH risk was not only described in the original labeling but reinforced – at great length, and with allcap and boldfaced type – “Dear Doctor” letters. Slip op. at 13-15 (giving all the gory, product specific details). Looking at the prominence with which the defendant had discussed the PPH risk, if this warning wasn’t adequate, none could be.
No wonder the plaintiff had dropped her claims based expressly on warnings.
The fifth factor also followed – Dear Doctor letters sent individually to doctors was an appropriate means to convey warnings. Slip op. at 15.
The label and letters also adequately communicated the risk. Years after the fact, the plaintiff’s prescribers still remembered receiving those letters. Slip op. at 16. Not only that, the plaintiff was lazy, and didn’t even offer any proof of inadequacy. When she lost the burden of proof argument, she was cooked. Slip op. at 16.
Losing on strict liability, the plaintiff nevertheless tried to maintain a claim for negligent design (we’re still not sure what the design should have been). That’s not an easy argument to start with since – as has been drummed into our heads since law school – strict liability is supposed to be the easier claim to prove. Slip op. at 17.
The court evidently found the argument as peculiar as we do. Again, the defendant’s warnings, supplemented by the “Dear Doctor” letters specifically mentioned both the risk and its fatal consequences in bold lettering, so there was no possible warning negligence. Slip op. at 19-20. Not only that, but the prescribers testified that they got the message, and would have discussed these risks with the plaintiff when they prescribed the drug – so the defendant’s warnings couldn’t have caused any injuries either. Slip op. at 20.
And after plaintiffs have litigated the dickens out of fen-phen claims for 15 years, what evidence did this plaintiff offer in support of her liability claims to oppose summary judgment?
Not a thing:
[I]n the face of Defendants’ evidence, Plaintiff has not put forward any evidence that Defendants did not take appropriate steps in providing adequate warnings about [the drug], that Defendants should have taken [the drug] off the market sooner, or that Defendants’ alleged failure to take [the drug] off the market sooner proximately caused [her] injury and/or death.
Slip op. at 20.
Early on in the fen-phen litigation, plaintiffs threatened to bankrupt the defendant with hundreds of thousands of claims. Then they found some sympathetic judges who certified class actions. All this forced a multi-billion dollar settlement.
Even that proved to be too little for some plaintiffs who, like this one, opted out.
And then, when push comes to shove – not a scrap of evidence is offered to prove liability.
So who’s bankrupt now?
As we said at the beginning, courts, like the rest of us (who pay for bogus payouts with increased drug prices), get too late schmart.