Law

With the arrival of Spring, we flipped the mattresses, moved the snowblower behind the lawnmower, and refilled the bird-feeder. We sprayed deer repellent on the tulips. It did not work, but at least now our front yard smells like coyote urine. Sadly, our poor plantings, unlike the daisies and violets in Shakespeare's "Spring," shall never "paint the meadows with delight." We also made a brief pilgrimage to Clearwater, Florida to view the 2012 version of the Phillies. Hope Springs eternal. Yes, Spring brings taxes. And Spring brings mud. But Spring mostly brings good things.

Spring was only a day old when we received yet another judicial opinion curtailing the purported testimony of that World's Foremost Authority, Suzanne Parisian. On March 21, 2012, Judge Graham Mullen ruled on Novartis's Daubert motion in a Zometa case, excluding large portions of the opinions of Dr. Parisian. Lemons v. Novartis Pharms. Corp., No. 3:08-cv-00361 (W.D.N.C. Order March 21, 2012). We're not stalkers or anything like that, but you probably know that we've been compiling a list of Dr. Parisian's recurring performances as a plaintiff's expert, with a view toward highlighting those courts that decided Dr. Parisian was not qualified or that her opinions flunked Daubert, Frye, Fraubert, or the judicial smell-test. The Lemons case comes out of the Aredia-Zometa MDL. Judge Mullen refused to preclude the entirety of Dr. Parisian's opinions. It goes without saying that the authors of this blog would have granted the defense motion in a nanosecond. Heck, Bexis would probably have ordered the witness manacled and placed in an orange jumpsuit.

But the court turned Lemons into lemonade when, after conducting a Daubert hearing where Dr. Parisian was cross-examined, it disallowed any testimony from Dr. Parisian about Novartis's conduct in interacting with the FDA because "Dr. Parisian does not possess the requisite experience or expertise, as an employee or insider of a pharmaceutical drug sponsor, to opine on the conduct of Novartis." Slip op. at 10. For the same reason, the court barred Dr. Parisian from commenting on Novartis's communication of the risks at issue in the litigation to health care providers. Id. The Court also found that Dr. Parisian was not qualified to testify regarding Novartis's pharmacovigilance efforts or its internal investigation of the alleged association of its drug with the adverse event. Dr. Parisian was further barred from offering testimony "regarding NPC's intent, NPC's monitoring of its clinical trials, ghostwriting, legal conclusions, or causation." Id. at 12. Dr. Parisian's testimony was limited to a generic discussion of the role of the FDA and the responsibilities of pharmaceutical companies and to commenting on Novartis's interactions with the FDA on the subject of labeling. We call that a win and congratulate the good folks at Hollingsworth LLP and Faegre.

We'd like to forget Winter. We don't mean the season; this year, Winter seemed almost tropical. The only really bad snowstorm took place on Halloween. No, we mean the wretched case of Winter v. Novartis Pharms. Corp., No. 06-4049-CV (W.D. Mo. March 8, 2012). Same defendant. Same expert (plus some others). Same Daubert issue. Different result. And it is not as if the court keeps you in suspense. When the court up front emphasizes how "Daubert was not written as a barrier to the admission of expert testimony, but as the rejection of a rigid prerequisite to admissibility incompatible with Rule 702" (a half-truth, at best) and how "we can neither rule out, nor rule in, for all cases and for all time the applicability of the factors mentioned in Daubert, nor can we now do so for subsets of cases categorized by category of expert or by kind of evidence" -- well, we know we are in for some nasty weather. Slip op. at 3. Thus, with hardly a raindrop's worth of reasoning, the court "denies NPC's motion to preclude Dr. Parisian from quoting or summarizing documents. She may testify about industry standards for the pharmaceutical industry and whether … NPC may have violated industry standards." Id. at 7. Thus, the court "denies NPC's motion to exclude Dr. Parisian's testimony about labeling and warnings." Id. Thus, the court "denies, in part, NPC's motion to exclude discussion by Dr. Parisian of clinical trials and other bisphonate drugs regulated by the FDA." Id. The court "may reconsider its ruling in this area if Dr. Parisian's testimony strays too far from the issues the jury here must decide and a timely objection is made at trial." Id.

Here's the thing: Dr. Parisian is guaranteed to "stray." That is what she is really expert in doing. Still, even in the slush, a lonely crocus flower sprouts. The court granted NPC's motion to "exclude Dr. Parisian's opinions about NPC's intent and personal opinions about NPC's and its employees' states of mind, motivations, or subjective intent." Id. As the Classics scholars would say, mirabile dictu! Somehow Dr. Parisian failed to convince this generous judge that she was a mind-reader. Perhaps one should be grateful for small favors.

We're certainly not mind-readers, so there's little point in trying to figure out how the Winter court got it so wrong. In "Winter in America," Gil Scott-Heron sang about vultures circling under dark skies. Those vultures would circle over the Winter opinion forever without finding a morsel of Daubert logic. We suspect it is significant that the court did "not believe a Daubert hearing at this late stage would be helpful or is necessary in order to rule." Slip op. at 5. Sometimes it helps to see a witness to disbelieve her. There have been cases (like this one) where it was Dr. Parisian's live Daubert testimony -- utterly evasive and adversarial -- that sunk her. It's a pity that the Winter court did not even take a look and get a preview of what Dr. Parisian would try to do on the witness stand. But we should not be too surprised at anything the Winter court does. As we reported here last year, the Winter court has already produced a ghastly ruling on the significance of Dear Doctor letters. As in Game of Thrones, we are seized with dread at the thought that Winter is coming.

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Posted By Steve McConnell to Drug and Device Law at 3/26/2012 07:00:00 AM

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