Get a group of experienced lawyers together and it won’t be long before there is a one-upsmanship game of Crazy-Things-Judges-Have-Done. A learned and revered colleague tells the story of how he went to argue before a law and motion judge many years ago and low comedy ensued. Being a diligent sort of fellow, said learned colleague arrived at the courtroom early. His motion was far down the docket so he sat and watched other arguments. He figured he might learn something about this judge’s methods. He did learn something. Maybe he learned the ultimate something. It was not something expected.
He perked up upon hearing that the motion immediately before his involved the same legal issue and very similar facts. What good luck! Even better, the judge ruled exactly the way our friend wanted for his case. As you can imagine, our friend confidently planted himself in front of the lectern when it was his turn and said, “Your Honor, my motion will be very easy for you to decide, because it is precisely the same fact pattern you confronted a mere two minutes ago, it implicates precisely the same statute, and it warrants precisely the same outcome.” He grinned when he said this. That grin soon disappeared.
The judge proceeded to ask impertinent questions, voiced bizarre policy concerns, induced the opposing side to make arguments nowhere in the briefs, and then announced he was going to rule against our befuddled friend. Before packing up his brief bag in disgust, our friend could not help himself and voiced frustration to His Honor: “Judge, I simply cannot understand how I came in here and saw you rule my way in a case on all fours with mine, and yet you went against me. What ever happened to precedent?” The judge showed no annoyance. Rather, he beamed with beneficence, wearing a smile that seemed to acknowledge the difficulties in finding fairness in a world full of indignities, shook his head, and said, “Ah ah ah: fifty-fifty.”
Rough justice, indeed. It is one thing to face a judge who reliably rules pro-defense or pro-plaintiff. You get what you expect, be it a jolly or awful moment. It is quite another to face a judge who is visibly aiming for fairness, but whose idea of fairness is little more than splitting the difference, spinning a roulette wheel, or, as in our friend’s experience, alternating rulings — “fifty-fifty.” One almost prefers the punch in the nose from a hostile judge to being tripped up by a clumsy one. Note that we said “almost.”
While looking through Daubert decisions, we tripped over a case that is now over a half a year old. The case is In re Smith & Nephew Birmingham Hip Resurfacing (BHR) Hip Implant Prods. Liab. Litigation, 2021 WL 781682 (D. Md. March 1, 2021). The defendant moved to exclude various opinions offered by plaintiff expert opinions. The main issues were expert qualifications and … preemption. Right away, that seems a bit weird. Usually, the Daubert issues are qualification, reliability, and fit. But we‘ll never turn down a dinner date when preemption is on the menu. So let’s dig in, shall we?
Then again, maybe this case won’t be so appetizing. It begins with the court fretting over “the difficulty of drawing precise lines that anticipate every iteration of an opinion that may be offered in support of a specific claim that itself is yet to to be precisely defined in the context of an individual case.” That is the sound of reluctance, not decisiveness. That is something we often hear from judges who deny Daubert challenges or motions in limine without prejudice. They’d rather rule in real time at trial. You know – after the plaintiff’s witness has already waved the bloody stump or tossed the skunk into the jury box. (That “yet to be precisely defined” bit also sounds like a case that maybe does not pass muster under the pleading requirements of Twombly and Iqbal.)
Then the court tells us that Rule 702 “was intended to liberalize the introduction of relevant expert evidence.” Ouch. (Our prescription for deadening the pain of this malady is a dose of Bexis’s write-up on the proposed revisions to Rule 702. Find it here.) To be fair, the court was quoting from a Fourth Circuit case, but that quotation seems to wish away Daubert, reliability, and judicial gate-keeping. Then we get a list of Daubert factors, but also an admonition that the list is not a checklist. Get ready for loosey-goosey.
There is something in the Smith & Nephew opinion for everyone. That is true for preemption. The court held that several of the plaintiffs’ claims were preempted: strict liability, duty to change the label, duty to warn patients and doctors, liability for claiming the product was safe, and liability for representations the FDA required. But the court held that other claims, “to the extent they parallel federal obligations, are not necessarily preempted.” The plaintiffs focused on conditions imposed as part of the FDA’s approval of the hip implant system, including implementation of a surgeon training program and submissions of analyses of adverse events and complaints.
The latter seems in obvious tension with Buckman preemption of fraud-on-the-FDA claims. How did the Smith & Nephew court resolve this tension? The court excluded anything related to the PMA approval process, but did not exclude any expert opinions that the defendant failed to make adequate disclosures in its required annual reports after receiving premarket approval. To our defense hack eyes, all that stuff is subject to preemption, be it express (statutory) preemption, implied preemption, or Buckman preemption.
Similarly, the court held that a “claim which challenges a representation the FDA blessed in the approval process is preempted, while a claim challenging a warranty above and beyond any guarantee that was explicitly or implicitly approved by the FDA is not preempted.” The court also excluded testimony relating to Dear Doctor letters and other communications to the medical community or patients, but reasoned that testimony opining that the defendant “had a duty under the PMA or another federal requirement to disclose certain information to the FDA directly could still be relevant to a parallel state law failure to warn claim … so long as that claim can be proved based on a violation of a condition imposed by the FDA.” That all feels a bit fifty-fifty-ish, but the court clamped down on the plaintiffs’ claim that the company had a duty to modify its training program. The court also excluded any expert opinions that the defendant had a duty to withdraw its products. Only the FDA has authority to withdraw approval from a device.
The plaintiffs offered opinions from their experts regarding the duties of a reasonable manufacturer and whether the product was unreasonably dangerous. The court held that to the extent “any expert testimony seeks to rely exclusively on state law duties that are not pinned to federal requirements, they are irrelevant to the remaining claims in this case.” But one expert asserted that there were violations of a federal regulation or condition of approval, and the court refused to exclude that opinion. Expect plaintiff experts to drive a big-rig, tractor trailer through that hole, whether or not they have a commercial driver’s license or any similar driving expertise.
That brings us to the court’s discussion of expert qualifications. It is a dismal discussion. Most gaps or shortcomings in expertise went to weight, not admissibility, were fodder for cross-examination, etc. One expert was permitted to opine whether a surgeon training program was adequate from a clinical perspective, but could not opine as to whether it satisfied FDA regulatory requirements.
The court imposed some limitations on speculative testimony, historical-factual narratives, and legal conclusions (“except in a case involving a specialized industry where such a conclusion may be helpful to the trier of fact” – excuse us while we groan at another Mack truck-sized hole).
What do we think of the Smith & Nephew court’s rulings on the proffered expert testimony? Fittingly, perhaps, we are fifty-fifty.