Friday, March 30, 2012

Major Pain Pump Decision

We've just been informed of Miller v. Stryker Instruments, No. CV 09-813-PHX-SRB, slip op. (D. Ariz. March 29, 2012), which decided both Daubert and summary judgment motions in a pain pump case.  Part of it's good, part not so good, and part of the not so good part is a little hard to understand.  Probably the best part of Miller, at least from the broader perspective, is the court's exclusion of - you guessed it - Suzanne Parisian.  Slip op. at 14-19.  Dr. Parisian was excluded for the usual reasons:  She offers improper regulatory opinions on legal matters that invade the province of the court.  She offers other regulatory opinions that have no discernable basis in fact.  She offers non-expert opinions that invade the province of the jury.  She has no coherent methodology.  She offers causation opinions that are incompetent.  She offers examples of "less than admirable conduct by Defendant" that are entirely irrelevant to the case.  Most of her report "state[s] facts that could be directly presented to the jury and then make[s] legal conclusions."

Yup, that's Dr. Parisian in a nutshell.  Miller excludes it all.

Certain challenged portions of another plaintiff expert, Dr. Busman, are also excluded.  Dr. Busman seems to be offered mostly as a medical causation expert, but he tried to stray into other areas.  The court excluded his attempted regulatory opinions - after the plaintiff fell on his sword and effectively withdrew them.  Dr. Busman was also excluded as a warnings expert.  Since some courts have allowed medical experts to opine on warnings, simply because they have medical degrees, what Miller holds in this regard is also of note:

Plaintiff does not assert that Dr. Busfield is a warnings or humans factor expert, nor does Plaintiff contend that Dr. Busfield has a special methodology for interpreting warnings.  Rather, Plaintiff argues that Dr. Busfield should be able to state “what the words of the labeling communicate to him” as a licensed, qualified orthopedic surgeon.  The Court agrees with Defendant that Dr. Busfield is not an expert on the adequacy of warnings and that only Plaintiff’s surgeon, Dr. Hofstedt’s understanding of the label is relevant.

We confess to having some trouble following how the court purports to distinguish Talley v. Danek Medical, Inc., 179 F.3d 154 (4th Cir. 1999) - one of our prior Bone Screw wins.  See Slip op. at 15 n.11.  Miller admits that the plaintiff here "is arguing that Defendant was negligent or strictly liable at least in part because it marketed its pain pumps for [a] use when it knew this specific indication had not been cleared by the FDA."  Slip op. at 15.  Well, that's exactly what was going on in Talley, as off-label marketing was essentially all that the Bone Screw cases were about.  Marketing without a license is like driving without a license - an insufficient ground for arguing negligence per se.  It's not anything to do with "quality or proper labeling."  Since, according to Miller, the pain pump had not been cleared for the use in question, that use wasn't on the label.  Nor is the pump alleged to have been of poor quality.  We can see a failure-to-warn claim based on off-label promotion, if some risk was left unstated, but the discussion of Talley doesn't get into that.  Without an allegation of failure to warn, marketing without a license is just that.  Ultimately, though, it might not matter much, since the issue involved Dr. Parisian's testimony, and all that was excluded.  We do feel protective of our Bone Screw wins, however.

More turgid overanalysis is found in the discussion of the defendant's alleged testing (or lack of same).  Miller, slip op. at 26-28.  The same result could have been reached in no time flat under the usual rubric that evidence of a failure to test is admissible as part of a claim of failure to warn, which is standard stuff.  Instead, we're treated to the court's discussion of why a duty to test "is not fictitious."  Slip op. at 26.  It may not be, but duties to test, including under the Third Restatement, certainly are "subsumed."  Id.  There are only three types of defect in the Third Restatement, and the discussion of testing in comment m is explicitly entitled "reasonably foreseable uses and risks in design and warning claims."  Further, Miller's reliance on the FDA's refusal to clear the device, slip. op. at 27, bears the hallmarks of a sub rosa attempt to shift the burden of proof.  In the regulatory context, the manufacturer has the burden of affirmatively establishing safety and effectiveness.  In the tort context, by contrast, the plaintiff has the burden of affirmatively establishing lack of safety (or effectiveness, but that's not at issue here).  There's nothing in the FDA's "no evidence" finding that proves lack of safety.  So the whole "testing" issue seems to us to be a red herring, offered in an attempt to get around the plaintiff's need to establish the state of the art in warning cases.  There is no "duty to test" separate from accepted design/warning claims, and the entire structure of the Third Restatement makes that clear.  Unfortunately, the Miller opinion is less than clear.

While the defendant's summary judgment motion on design defect also failed, we don't have anywhere near the problem with Miller's reasoning on that score.  Essentially, and as indicated in Bexis' book (citing  Arizona follows the case-by-case approach to comment k.  We don't like it, but that's what the law is there.  So a defendant is unlikely to win by arguing the opposite.
Gaston v. Hunter, 588 P.2d 326 (Ariz. App. 1978)),

Finally, we would be remiss not to point out that Miller granted summary judgment against the plaintiff's punitive damages claim, finding as a matter of law that the evidence did not establish the requisite "evil mind."  Slip op. at 32-34.  It's completely fact specific, but if you're defending pain pump cases, it's something you'd want to know.
Slip op. at 14 (emphasis added).  The Miller court thus seems to recognize that physician adequacy opinions amount to impermissible "reasonable physician" testimony on matters that the learned intermediary rule requires be proven through the prescribing physician.