Usually when we analyze a case we skip through the preliminaries and try to cut straight to the chase. That means reading past the standard of review and the generally applicable rules governing the procedure at hand. Some people act the same way when they write briefs. They assume it is all interchangeable and doesn't much matter. So they plug in the same-old-same-old for, say, summary judgment or Daubert. But that is a mistake. A lot has been said by a lot of courts on those standards, and some things we like better than others. Shame on any briefwriter who does not spend time and ink emphasizing the best bits of the relevant procedural standard. And shame on us for not espying the hints provided by the court early on that almost make the ultimate substantive result seem inevitable.
Something like that happened in Brown v. Roche Laboratories, Inc., 2013 U.S. Dist. LEXIS (N.D. Ga. June 6, 2013), where the court came out with a very good Daubert and summary judgment decision, and where the court supplied the foundation for that decision up front. In Brown, the plaintiff had taken Bactrim for a sinus infection. No, this case is not about Bactrim, not really. But the Bactrim usage ended up dooming the plaintiff's expert's causation opinion. After the Bactrim usage, the Brown plaintiff experienced a fever, headache, and other symptoms. Her doctor feared that she had developed bacterial meningitis. Accordingly, the doctor administered doses of Rocephin. The doctor was aware of the plaintiff's penicillin allergy, and knew of the potential cross-reactivity between Rocephin and penicillin. Nevertheless, the doctor believed that the potential risk was outweighed by the benefit of treating suspected meningitis. That is the sort of thing that doctors do. As far as we can tell, the plaintiff in Brown had no complaint about any alleged medical malpractice. Subsequently, the plaintiff came down with SJS/TEN, a terrible disease about which there has been much high-stakes litigation and about which we have written before. There are many terrible consequences of SJS/TEN. At least in Brown, bad law was not one of them.
The plaintiff filed claims in Georgia state court against the manufacturers of both Rocephin and Bactrim. The case was removed to federal court. Then, for reasons not clear in the opinion, the plaintiff dismissed her claims against the Bactrim defendants. So now all the plaintiff's litigative guns were trained on the makers of Rocephin. The plaintiff sought to present the testimony of their hired expert, a Dr. Wolff, on causation and warning adequacy. The defendants brought a Daubert challenge, arguing that Dr. Wolff was not qualified and that his opinions were not reliable. As we suggested above, the court's preliminary comments signal the result. Here the signal was good. In addition to the usual Daubert bromides, the court emphasized that it is the proponent of the expert testimony who bears the burden of demonstrating that the testimony satisfied the requirements of Fed. R. Evid. 702. We think that is correct. A tie goes to the opponent. If the qualifications and methodology are in any way unclear or confusing, it is time to lower the gate. For reasons that are mysterious and/or frustrating, there are courts that resist the burden formulation. Some like to say that the proponent of the expert testimony bears no burden, but simply must come forward with evidence to show adequate qualifications and methodology. Perhaps that is merely a semantic difference, but beware the court that avoids the burden language. It is as if the court is reluctant in its bones to keep anything from the jury. Maybe cross-examination or juror common sense will end up letting the judge off the hook. But that is not the way it is supposed to work. While it is true that the proponent does not need to demonstrate that the expert is actually right, it does bear the burden of showing that the expert is qualified and that the expert's methods pass scientific muster. The Brown court did not shy away from Daubert's mandate, and the opinion is a refreshing antidote to those courts that express annoyance with defendants who have the temerity to file any Daubert motions. Watch out for those court's that wax poetically on the "flexible" aspects of Daubert; too often that ends up being a code word for abdication of the gatekeeper role.
The Brown court did its job and scrutinized Dr. Wolff's background. He might be a very smart man and a very accomplished man, but he was found to be unqualified for the task at hand. Dr. Wolff had a Ph.D in pharmaceuticals but no specific expertise with the drug or disease state at issue. For some courts, having a medical license or a Ph.D is enough. Not so here. Dr. Wolff had "basic familiarity" with Rocephin. Again, for some courts that would be enough to invoke flexibility, etc. and call it a day. But the Brown court asked whether Dr. Wolff had conducted any research or published any articles on Rocephin. He had not. He also had done no research on SJS/TEN. These gaps in the expert's qualifications mattered. They always do. In Brown (as in most of these cases), there was a real issue of alternate causation. The court saw just as much data connecting SJS/TEN to Bactrim as Rocephin, and it appeared that Dr. Wolff had no basis to choose one over the other. So much for qualifications on medical causation. The qualifications to opine on warning adequacy were even thinner. (Again, that is almost always the case. The proffered warning opinions are inevitably plaintiff lawyer closing arguments in disguise -- and not much of a disguise.) Dr. Wolff had never consulted with the FDA regarding the content of a drug package insert. He vaguely recalled contributing to the parts of an insert that described pharmacological properties of a drug (which actually furnishes him with more background than most of the experts trotted forward on this issue), but had never drafted warnings. For some courts, that might have passed Daubert matador-muster. But not this court.
Even if Dr. Wolff had the requisite qualifications, his methods flunked even a generous application of the Daubert analysis. Specifically, the expert's specific causation opinions were insufficiently reliable. General causation was not in dispute, but Dr. Wolff had a weak position for attributing specific causation in this plaintiff's case to Rocephin, as opposed to the Bactrim or anything else. As in so many cases, the expert's specific causation opinion boiled down to a temporal association. That is not enough, as other courts have said and as we have reported. If there is one bit of Latin that most lawyers learn, it is the fallacy of post hoc ergo propter hoc. In any event, the temporal association in this case was frail, or even nonexistent, as the plaintiff was already suffering initial symptoms of SJS/TEN even before she ingested Rocephin.
Without Dr. Wolff's proffered expert opinions on medical causation and warning inadequacy, there was no case left and summary judgment was inevitable. There was no evidence of a design or manufacturing defect, and the failure to warn claim had no support from the disallowed expert. Just as important, the failure to warn claim had no support in reality. The Rocephin label counseled caution in giving the drug to penicillin-sensitive patients. So the label was flat-out adequate. In any event, the learned intermediary rule precluded the claim, inasmuch as the doctor knew of the risk and made a considered decision to prescribe the drug in spite of the risk. No expert in the world could solve that problem for the plaintiff.
In addition to the straight product liability claims, there were also the usual hangers-on -- claims for breach of warranty and misrepresentation. Those claims failed here for the reasons that they usually do. The warranty claims were simply clumsy reframings of the failure to warn claim. They all fell down like dominoes. Plus, the warranty claim lacked an allegation of privity, which is required by Georgia (as with many other states). Finally, the misrepresentation claim did "not come close to meeting the special pleading requirements of Federal Rule 9(b)." Id. at *23. The plaintiff also asserted claims titled "Joint and Several Liability," "Plaintiff's Damages," and "Punitive Damages." Whatever they were meant to be, they were "derivative" of the plaintiff's substantive claims. Goodbye to them, goodbye to all claims, and the clerk was directed to close the case. In our expert opinion, this was a nice result and we attribute it to good work by the defendants and the court
In fact, all of the dismissals and the good work and the sound reasoning of the case are "derivative" of the Daubert analysis. The rigorous application of Daubert in the Brown case could well be applicable in many cases where plaintiffs bring in wind-up witnesses who do not know what they are talking about and whose real expertise lies in playing the litigation game, mouthing platitudes, and cashing checks.