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Coming in at number 2 on our list of the top ten worst court decisions of 2007, was the Missouri opinion Strong v. American Cyanamid – for a lot of reasons, including the court’s allowance of thinly-disguised FDCA-based negligence per se claim contrary to Missouri law, and the court’s expansive reliance upon expert testimony on matters of law: whether the defendant violated certain FDA regulations that were key to the negligence per se claim.
At that time we thought there was no further possibility of appeal, because a transfer to the Missouri Supreme Court in Strong had been denied. Shows how much we knew. Apparently it’s possible to get more than one bite at the transfer apple in Missouri. A few weeks later we found out that the second time was the charm, and the case had in fact been accepted for transfer by the Missouri Supreme Court.
Busybodies that we are, we were naturally interested.
We had no idea how interesting the Strong appeal could be.
A few days ago the FDA itself weighed in in Strong with an amicus brief, copy here, containing a very apt indictment of the practice of relying upon paid “experts” to construe FDA regulations.
The plaintiff’s FDA expert in Strong, one Thomas Bozzo, was allowed to present to the jury a construction of certain FDA vaccine regulations that “was different from the agency’s longstanding interpretation.” FDA amicus br. at 2. The court allowed the plaintiff’s paid expert’s testimony about what the regulations meant to go to the jury on the same footing as the FDA’s own interpretation, that the Agency had been formally stated in the Federal Register. Id. at 5-6. Naturally, the FDA didn’t think very much of that.
The substantive dispute over the meaning of these particular regulations is quite involved and arcane – so we’ll leave that to the FDA, which knows best what its own regulations are supposed to mean. That’s not what really interests us, anyway. What grabs us is the broader question, applicable to every case where the meaning of an FDA pronouncement is at issue (a lot of cases), of whether expert testimony on that subject is even permissible.
The FDA said no, and we agree. We posted earlier how such testimony is really about issues of law, and it’s the job of the judge to charge the jury on the law, not the role of experts to offer “opinions” on legal matters. Perhaps the pithiest quote on the point was uttered by the DC Circuit some years ago: “Each courtroom comes equipped with a ‘legal expert,’ called a judge, and it is his or her province alone to instruct the jury on the relevant legal standards.” Burkhart v. WMATA, 112 F.3d 1207, 1213 (D.C. Cir. 1997).
The FDA’s position in Strong is, first, when the opinion of a paid litigation expert is given as much weight about what a regulation means as that of the responsible administrative agency, federal law is disrespected:

The trial court should have interpreted FDA regulations with deference to the agency’s longstanding interpretation. In allowing the jury itself to interpret FDA regulations based on testimony of Mr; Bozzo, a former agency official, the trial court failed to give appropriate respect to federal law…. [T]he trial court had the responsibility to discern for itself the meaning of FDA’s regulations, giving full deference to FDA’s interpretation of its own regulations. The court erred in leaving the interpretation to the jury, based on testimony of a former FDA official that the regulations meant something different from what the agency itself said.

FDA amicus br. at 8. The official position of a federal agency is not to be equated with the litigation-motivated “opinions” of a paid expert. Rather, the agency’s determination is entitled to deference – indeed “controlling weight” as a matter of settled administrative law. Id. at 16. Nor does deference depend upon whether the agency is a party to the case. Id. at 16-17.
Then the FDA turned to the heart of the matter – whether expert testimony on what is, at bottom, a question of law, the interpretation of an administrative regulation (it could just as well be the FDCA itself, the principle is the same) – is admissible at all.
The FDA said no – that the meaning of something having force of law is a legal matter for courts to decide, not a factual matter about which expert witnesses are qualified to offer their opinions and let the finder of fact (the jury) decide who’s right:

[T]he interpretation of a regulation is question of law; it is precisely the type of legal question that courts generally are expected to address. United States v. Faltico, 687 F.2d 273, 276 (8th Cir. 1982), cert. denied, 460 U.S. 1088 (1983) (upholding trial court’s refusal to allow testimony interpreting regulations, because “any questions of law are determined exclusively by the court”); see also Williams v. Department of Building Development Services, 192 S.W.3d 545, 547 (Mo. Ct. App. S.D. 2006) (“the interpretation of a city ordinance is a question of law”); Richard v. Missouri Dept. of Corrections, 162 S.W.3d 35, 37 (Mo. Ct. App. W.D. 2005) (“The interpretation of a statute is a question of law.”); HHC Medical Group. P.C. v. City of CreveCoeur Bd. of Adjustment, 99 S.W.3d 68, 71 (Mo. Ct. App. E.D. 2003) (“The interpretation of an ordinance is a question of law.”). It follows that a court errs when it abdicates its judicial function by handing the matter off to a jury of laymen. White v. Reitz, 129 Mo. App. 307, 108 S.W. 601, 603 (1908) (“[I]t was not proper to leave it to the jury to interpret those sections [of the code] and apply them to the facts in the case as was done by the instruction. It was the duty of the court to have interpreted the sections read in evidence to the jury.”).

FDA Amicus br. at 18-19. Where an expert’s “testimony conflicted with FDA’s official interpretation of its regulation, the court should not have allowed the jury to decide between the two.” Id. at 19. It was error for a court to surrender its judicial function to a paid litigation expert: the “erroneous[] assum[ption] that the trial court did not itself have the responsibility to interpret the regulations and to give guidance when it instructed the jury.” Id. at 20 (emphasis original).
Moreover, to rely on paid litigation experts for interpretations of federal regulations invites a great deal of mischief because it’s difficult for a party to obtain an authoritative statement of the government’s views. The FDA, like every other governmental agency, has regulations (called “Touhy” regulations after the leading Supreme Court case) that prevent its personnel from being called to testify in private litigation. FDA amicus br. at 20. Litigants thus can’t fairly be penalized for not presenting active FDA personnel as witnesses. Id.
As a philosophical matter, we agree wholeheartedly with the view that expert witnesses should not be permitted to give conflicting opinions on what FDA regulations mean, and then leave matters to the jury to sort out. What a regulation means is a question of law, for the judge to determine and then to instruct the jury. E.g. VII Wigmore on Evidence §1952, at 103 (Chadbourne rev. ed. 1978 & Supp. 1991); Nieves‑Villanueva v. Soto‑Rivera, 133 F.3d 92, 99 (1st Cir 1997); Bammerlin v. Navistar International Transportation Corp., 30 F.3d 898, 900-01 (7th Cir. 1994).
There are scores of other cases for this same point. Decisions specifically involving expert testimony about the FDCA include: Livingston v. Wyeth, Inc., 2006 WL 2129794, at *6 (M.D.N.C. July 28, 2006); United States v. Caputo, 379 F. Supp. 2d 632, 646 (N.D. Ill. 2005); In re Rezulin Products Liability Litigation, 309 F. Supp. 2d 531, 546-47 (S.D.N.Y. 2004); Steele v. Depuy Orthopaedics, Inc., 295 F. Supp. 2d 439, 446 (D.N.J. 2003); Smith v. Wyeth-Ayerst Laboratories, Inc., 278 F. Supp. 684, 700 (W.D.N.C. 2003); Moses v. Danek Medical, Inc., 1998 WL 34024164, at *3 (D. Nev. Dec. 9, 1998); Purnell v. United States, 1987 WL 13790, at *3 (E.D. Pa. 1987), aff’d without op., 853 F.2d 920 (3d Cir. 1988); Troxclair v. Aventis Pasteur, Inc., 864 A.2d 1147, 1153-54 (N.J. Super. A.D. 2005); Kennedy v. Merck & Co., 2003 WL 21658613, at *7 (Ohio App. July 3, 2003).
Now, while we agree that FDA experts should not come into court purporting to give legal opinions, that’s not to say that we always reflexively file motions to exclude on this basis. In fact, we usually don’t. The reason is that what’s sauce for the goose is sauce for the gander.
We defense lawyers have our own stable of FDA experts, and we think that our FDA experts are better than the other side’s. We expect our FDA experts to give better legal opinions and to be more persuasive to a jury than the plaintiffs’ similar witnesses. Thus, lots of times we’re willing to let the jury decide – especially if we think that an instruction from the judge might be less beneficial to our clients than a battle of experts.
So as a practical matter, it’s basically a crapshoot. On the one hand, is it better to have everything sent to the jury rather than nothing sent to the jury? On the other hand, a dispute over the admission of expert testimony is subject to more deferential appellate review – the abuse of discretion standard – than a judge’s charge to the jury on a matter of law, which is usually reviewed “de novo” (that means with no deference to the legal ruling of the trial judge). So if there’s a fair chance of a loss (purely hypothetical, of course, since the two of us are never, ever in that position), then it’s more beneficial to have regulatory interpretation go up on appeal as a purely legal issue – and to be able to raise, as well, the legal question of whether expert testimony on questions of law should be admissible.
So, legally, the FDA’s got it right. Judges should instruct the jury on what the law is, not paid litigation “experts.” As a practical matter, though, it’s a much tougher call.