United States: Can Plaintiffs Preempt The Preemption Defense By Demanding Preemption Discovery?

The whole business of discovery in civil litigation is dreary and depressing. In a mass tort, a defendant can rack up defense verdicts yet still incur discovery costs that exceed the damage amounts sustained by defendants found liable in other torts. Little wonder that the mass of defense lawyers in mass torts lead lives of quiet desperation. At least, that's true for the poor drudges who must review documents for responsiveness and privilege.

We've been thinking about Henry David Thoreau. An anniversary is almost here. Walden was published on August 9, 1854. Thoreau built a cabin near the shore of Walden Pond and began living in it on July 4, 1845, "alone in the woods, a mile from any neighbor." It was a declaration of independence. He lived there for two years, two months, and two days. The book took eight years to write, and there is much more artifice in it than straight nature reporting. Whatever you think about American exceptionalism, Thoreau exemplified many traits that, for better or worse, seem at the core of the American ethos: embrace of self-reliance and ecological preservation, and stand-offishness with respect to politics and society. We wondered whether Thoreau wrote anything about discovery. Our well-worn volume of Walden contains an index, but we found no reference to "discovery." Nor was there a word about document requests. The best we could do was the famous passage in the "What I Lived For" chapter that explains the project at hand: "I went to the woods because I wished to live deliberately, to front only the essential facts of life, and see if I could not learn what it had to teach, and not, when I came to die, discover that I had not lived." There's that word "discover," but we suspect Henry had something else on his mind.

Thoreau never had the misfortune to encounter Federal Rules of Civil Procedure 26, etc. Had he, he might have drafted an interrogatory about discovery: "whether it is necessary that it be as bad as it is, whether it cannot be improved as well as not." Most of what we do in civil litigation is discovery, and most of that is a waste of time. Such time wasting would have mightily irked Henry: "As if you could kill time without injuring eternity." From Thoreau's revelatory prose we now turn to a judicial opinion that makes those of us who spend time opposing discovery want to retreat to the woods.

Today's case is In re: Genentech Herceptin (Trastuzumab) Marketing and Sales Practices Litigation, 2017 WL 9939631 (N.D. Okla. May 8, 2018). The defendants wanted to argue preemption, and the plaintiffs engaged in what has become the typical response of insisting on wide-ranging discovery to test the preemption defense. "Wide-ranging" is an understatement. From the court's description, it seems that the plaintiffs wanted pretty much everything. The defendants countered with something less than everything. And so we end up with cross discovery motions. The plaintiffs filed a motion to compel while the defendants filed a motion for a protective order regarding all unanswered preemption discovery requested by the plaintiffs. The court granted every one of the plaintiffs' motions to compel discovery responses, and denied every one of the defendants' motions for protective order. The opinion is a sadness machine. That machine is fueled by two all-too-common judicial impulses: (1) letting plaintiffs conduct any discovery they want, and (2) hostility to the preemption defense. Why, it is almost as if the court was unhappy with the defendants for even raising the preemption defense.

At least the court was convinced that the preemption issue should be decided prior to class or merits discovery. But the court entertained what it called "a more realistic view of the discovery required for resolution of the preemption motion." "Realistic" turns out to mean exceedingly broad. According to the court, the defendants' preemption motion "relies upon evidence regarding its communications with FDA and its manufacturing process, both of which Plaintiffs are entitled to explore before responding to the motion." Consequently, the "preemption defense opened doors in discovery that may well have stayed closed if the only issue was breach of a state-law warranty." Open doors are bad. They let in all sorts of unwanted things – traffic noises, heat, peddlers and, bugs, to name a few. And bad ideas.

Here, the court opened the door very wide indeed. For example, the plaintiffs wanted all correspondence between the manufacturer and the FDA relating to product labeling – both pre and post approval. They also asked for all Establishment Inspection Reports, FDA Form 483s, and Warning Letters issued by the FDA relating to the labeling. That scope might make sense if the defendants were raising Wyeth v. Levine "clear evidence" preemption. But they weren't. Rather, the defendants argued that the proper inquiry is whether they could "independently do under federal law what state law requires" and whether they could, as a matter of law, "make a unilateral label change that would satisfy the state-law obligation alleged in Plaintiffs' Complaint." That's Mensing/Bartlett. That's different. That's straightforward. That's binary. The defendants quite logically argued that they were "not raising a Wyeth-type preemption defense and that Plaintiffs 'have no need for discovery relating to an argument [they] will never make.'" The defendants also argued that even under the Wyeth changes-being-effected analysis, the plaintiffs could not possibly unearth any "newly-discovered information" that would prompt a labeling change, because it was clear that the FDA knew the relevant information. End of story. End of inquiry. End of discovery.

The defendants were being very Thoreauvian. They wanted to "simplify, simplify." But the court, perversely, was having none of it. Here is what the court said: "This Court – and not Defendant – will ultimately decide how to apply Supreme Court law to the evidence presented. Plaintiffs are entitled to advocate for the Wyeth standard, and their requested discovery is relevant to the impossibility preemption analysis in Wyeth."

And here we must digress. We are reminded of a story about a legendary D.C. Circuit judge who had stayed on the bench a bit too long. His practice for oral argument was to consult index cards filled with questions written up by his clerks. By " consult," we mean that he would read off the questions, word for word. At one argument, he read off a question and managed to stump a polished advocate. Said polished advocate was stumped because the question had absolutely nothing to do with the case. Awkward silence. Then the clerk ran up to the side of the bench and whispered frantically, " That's the next case, the next case." The elderly judge was having none of it. He sputtered, " We're not getting to the next case until this lawyer answers my question!"

In the In re Herceptin case, it is as if the judge was listening to a different case – certainly a different argument. No wonder, then, that the discovery analysis is so wrong. Granting the discovery requests would require search of "an extensive regulatory database containing over four million documents." The defendants argued proportionality, but the court finds "this proportional to the needs of the case, considering the importance of the issues raised in this multi-district litigation action, the substantial amount in controversy, Defendant's access to relevant information, Defendant's resources, and the importance of the discovery in resolving the issues." So now, in addition to the court's laissez-faire (or is it les bon temps roulez?) attitude toward discovery, evident disaffection with preemption (at one point, the court bemoans how the plaintiffs "will be deprived of resolution of their state-law claims if the [preemption] defense is successful"), and misconstruction of the defense arguments, we get that other discovery bugaboo about how an MDL can make even the most extravagant plaintiff discovery request seem proportional. There is good authority to the contrary (see here, for example), but you won't see it cited by this court.

Thus, the plaintiffs walk off with a clean sweep win. They will get communications occurring prior to FDA approval relating to the "Chemistry, Manufacturing and Controls" because such information could be relevant to an obstacle preemption defense that the defendants are not raising. The plaintiffs will get discovery on the approval process for the purpose of exploring whether FDA "weighed the competing interests relevant to the particular requirement in question, reached an unambiguous conclusion about how those competing interests should be resolved ... and implemented a conclusion via a specific mandate ..." Hmm. That "unambiguous" bit sounds like the Third Circuit's Fosamax analysis that is sure to be trashed by SCOTUS next year. To be clear, it is hard to blame the plaintiffs for their approach. They smartly asked for as much as the court would give them, which turned out to be the whole kit and caboodle.

But wait. There's more. The plaintiffs will not only get everything under the sun involving the product labeling, but will also get all documents and communications touching on the mass, volume or density of the medicine available in a vial. Naturally, inevitably, ineluctably, the court rejected the defendants' argument that, "even if additional documents exist, they would be cumulative and would not meaningfully alter the preemption analysis." Why? Here is the court's answer: "If one document certainly exists saying ' x,' – which is relevant to overcoming a preemption defense – it is not overly speculative that other similar documents exist in Defendant's files." Huh? That's like saying that no evidence could ever be cumulative. If there is some evidence of something, we must collect all such evidence.

The defendants even lost an argument that should have been a sure winner – that discovery on "the number of rejected lots is irrelevant because these batches never reached customers." Nobody bought those products. But the court wasn't buying the argument, because the preemption defense "is not devoted to the substantive claims." Well, if a defense is not devoted to substantive claims, it is not really a defense, is it?

The court's opinion in In re Herceptin leaves us dissatisfied and puzzled. Near the end of Walden, Thoreau tells us that he "left the woods for as good a reason as I went there. Perhaps it seemed to me that I had several more lives to live, and could not spare any more time for that one. It is remarkable how easily and insensibly we fall into a particular route, and make a beaten track for ourselves." To our mind, the court's all-in approach to discovery in Herceptin is an overly-beaten track. It is certainly insensible.

This article is presented for informational purposes only and is not intended to constitute legal advice.

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