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Don't Mess With Bexis!

By James M. Beck and Mark Herrmann

This post was written by Herrmann alone. I'm coming to the defense of my co-conspirator, Bexis.

As soon as the Supreme Court decided Wyeth v. Levine, we published a post analyzing the implications of the case. We represent drug companies in product liability cases, so we naturally weren't delighted by the result. We did, however, explain the circumstances in which the preemption defense would still be available despite the Supreme Court's rejection of the defense on the particular facts of Levine. And, as any regular reader of this blog knows, we presented the defense point of view with our usual passion.

We objected to the Supreme Court majority's characterization of the facts in Levine: "there are the 'facts' concerning Phenergan. We put quotation marks around the word facts because we don?t agree particularly with the majority?s view of them." We explained that preemption will still be available if defendants "prove, in as much detail as possible, that the FDA gave serious consideration and review to not only the particular drug, but to the particular risk as well. Given how the majority chose to frame the question (probably to keep itself together) this drug-specific and case-specific door has not been shut on implied conflict preemption."

We concluded that the Supreme Court's "manner of restating the defense argument further demonstrates that the majority in Levine wasn?t willing to rule out preemption in other, more limited, circumstances," and we explained what some of those circumstances might be.

In particular, we explained that the preemption defense would remain available if "the FDA affirmatively conduct[ed] its own investigation and arrive[d] at its own warning ? a warning contrary to what the plaintiff demands[.] Affirmative, contrary FDA action is the best scenario left for preemption in litigation involving prescription drugs."

In the pending litigation involving Seroquel, the preemption defense is awfully strong. The FDA did exactly what we suggested in the bolded language three sentences back: The agency ordered a bunch of companies to provide data to it, independently analyzed that data, and then drafted its own warnings that it required the companies to use. That's exactly the situation that we said would support preemption.

But -- wouldn't you know it? -- plaintiffs' counsel took our earlier post and stuck a bunch of ellipses in it, deleting the sentence suggesting that preemption would continue to exist in that situation. Plaintiffs' counsel then used a distorted version of what we wrote to suggest that we think there wouldn't be preemption in that context. And they did that in a case in which Bexis's firm represents the defense. (Here's a link to the offending brief; the quote that has us up in arms is at page 23, note 51.)

Now, look: Don't mess with Bexis!

Don't quote us out of context; if you want to quote from this blog, please quote enough to give a court a true sense of what we wrote. In particular, don't delete the sentence that squarely supports the defense position in your case, and suggest that we wrote in favor of the plaintiff.

If you don't, we'll have to get mean!

We'll show the court (and the world) that we in fact support the defense point of view! We'll start articulating defense-side positions, which might gain some traction in the world and help our clients! We'll publish articles explaining the logic behind industry's position in legal journals and in the popular press! We'll . . . wait a minute. We already do all that stuff. Maybe we've already used all of our bullets.

Well, heck -- maybe we're powerless in this situation. But we trust this incident will make readers understand why we watch so carefully the things we say here. Even when we say things that in fact help our clients' cause, we can still be taken out of context and our words used against us.

We'll just hope that enough people are putting our words to their intended uses to make up for the few bad actors.

Full post as published by Drug and Device Law on April 13, 2009 (boomark / email).