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More On Legal Questions And FDA Experts

By James M. Beck and Mark Herrmann

Sometimes it?s funny how an issue that we all know is out there sits for a long time and then, all of a sudden, it comes back at us from several different directions at once. The recent flurry of interest in the question of whether ?FDA experts? ? usually former FDA employees ? can offer expert opinions on the meaning of the FDA statute (?FDCA?) and FDA regulations is like that. First, the judge supervising the Baycol multidistrict litigation pitches this kind of testimony from a would-be FDA expert. Next, the FDA files a brief arguing that expert testimony about the meaning of its regulations should be inadmissible. Finally, the Seventh Circuit in Caputo blows such opinions out of the water (coincidentally, in a case Bexis briefed on other issues).

All this in the last several months ? after the issue had been sort of bubbling along under the radar for years.

Limits on FDA expert testimony is a question we?ve certainly grappled with for a long time. As long as we?ve been practicing in this field, plaintiffs have wanted to troop out somebody who once worked for the FDA in some (almost any) capacity and put him/her on the stand to call our client criminals and claim that we somehow played fast and loose with this or that FDA regulation. More than 20 years ago that happened in a Coumadin case and one of us ? OK, Bexis was the culprit ? decided to fight it. The result:

As an expert, [plaintiff?s witness] may not testify about what statutes or regulations are or are not applicable to the case at hand. It is the court?s province to determine what law is applicable and to so instruct the jury. Thus, [plaintiff?s witness?] testimony and report are subject to my previous discussion of 21 C.F.R. §§314.8, 201.59, 201.100(c)(2), 201.56, and 201.57. Before plaintiffs introduce [expert] report into evidence, counsel shall insure that it complies with this opinion.

Purnell v. United States, 1987 WL 13790, at *3 (E.D. Pa. July 8, 1987). That, we believe, was the first legal opinion to exclude the testimony of a purported FDA expert on the basis that it was an impermissible opinion on an issue of law.

So what?

Well, something we posted recently on the Caputo case ? that it was the ?the first federal appellate ruling? (emphasis ours) to throw out an FDA expert for offering testimony on legal issues ? got mistranslated in the press (in the March 7 FDA Week, which isn?t online at least for free, but the article, entitled ?Federal Court Backs FDA On Testimony Of Former Officials? can be purchased here). It came out the other end as if we had said, ?this appears to be the first time a federal court has weighed in on the question of allowing former employees to offer regulatory interpretations? (again, emphasis ours).

Don?t make us look dumb, guys (we?re perfectly capable of doing that ourselves).

As lawyers, unlike reporters, we?re supposed to know the difference between appellate cases and any old cases. We?re not blogging to make fools of ourselves any more than necessary. Thus, we feel obligated to make clear to all that we?re not ignorant of the rest of the pre-Caputo law on precluding testimony by FDA experts about what the law is.

So here goes.

The next case after Purnell to throw out an expert who wanted to testify about how to interpret FDA regulations was Moses v. Danek Medical, Inc., 1998 WL 34024164 (D. Nev. Nov. 30, 1998). It was (surprise!) a Bone Screw case. The plaintiff in Moses put together affidavits for two ?experts? of proposed testimony that read suspiciously like prior briefs. We filed a motion to preclude this testimony ? and attached redlined copies of the briefs as exhibits showing how the plaintiff had cut and pasted the supposed expert ?opinions? right out of them. Perhaps not surprisingly, the court threw the lot of it out:

D. Expert Testimony on Issues of Law

Based on Plaintiff's representation. . . the testimony of [two experts] is offered to support the argument that Plaintiff's injury is the result of illegal promotion of the. . .spinal fixation device. To support this claim, these witnesses are prepared to instruct the jury as to whether or not Defendants acted ?illegally;? what is ?promotion? under the FDCA; and the interpretation of statutes and regulations.

Expert testimony is not proper for issues of law. Experts interpret and analyze factual evidence. They do not testify about the law.

In general terms, [Expert 1?s] declaration addresses the fraud and conspiracy claims. [He] declares that Defendants ?engaged in an elaborate marketing campaign to create a market for and promote the sale and distribution of pedicle screw fixation devices outside of any FDA-approved clinical trial and in the absence of FDA approval of clearance of these devices.? [He] then declares that ?in the clear prohibition by the FDA and federal law, [Defendants] established a sophisticated network of sales agents and distributors.?

* * *

Defendants argue that not only is [Expert 2?s] opinion based on Plaintiff's pleadings, but that his opinion has actually been cut and pasted from a pleading filed in the Third Circuit Court of Appeals. Both of these documents have been provided as exhibits, and have been reviewed by the Court.

The Court finds Defendants? contention to be true. [Expert 2?s] affidavit is a reconstruction of a pleading filed in the Third Circuit, complete with legal citations. Plaintiff has merely obtained an expert to bless and restate her legal argument. Plaintiff attempts to produce an expert that restates her arguments. This is an improper use of expert testimony.

Thus, the testimony of [Experts 1 and 2] should be excluded.

Id. at *3-4 (all kinds of citations footnotes and other stuff omitted).

Moses didn?t lead us to the promised land very quickly ? but there wasn?t any 40-year wait either. Five years was more like it. There was a (relatively speaking) rash of decisions on FDA experts in 2003. In Smith v. Wyeth-Ayerst Laboratories Co., the court encountered the redoubtable (we would say, very doubtable) Dr. Lemuel Moyé, this time offering his opinions about the defendant?s compliance with FDA reporting requirements. The court said ?no.? ?Defendant asserts that Dr. Moyé should not be allowed to provide opinion testimony about [the defendant?s] compliance, or alleged lack thereof. The Court agrees since to allow such testimony would infringe upon the jury's role in determining an ultimate issue in the case.? 278 F. Supp.2d 684, 702 (W.D.N.C. 2003) (footnote omitted).

2003 also saw the first state court ruling (at least that we know of) barring expert testimony in a prescription drug product liability action as conclusions of law. The proffered opinion this time was not about FDA regulations, but about whether a drug was ?unavoidably unsafe? within the meaning of an Ohio statute (O.R.S. §2307.767). Testimony about meeting state statutory standards, as well, ?state[d] a legal conclusion, and not an expert pharmacological conclusion.? Kennedy v. Merck & Co., 2003 WL 21658613, at *6 (Ohio App. July 3, 2003).

Finally, there was Steele v. Depuy Orthopaedics, Inc., 295 F. Supp.2d 439 (D.N.J. 2003), in which the court held:

[W]hether the FDA?s approval of a PMA supplement imposes requirements on a particular device is a question of law to be determined by the Court, not a question of fact for the jury. Consequently, [an FDA expert?s] opinion regarding the nature and scope of the FDA?s. . .review of the [device] would neither assist the trier of fact to understand evidence, nor help the jury to determine a fact in issue.

Id. at 446.

Things perked along at the rate of about a decision or two a year after that.

2004 ? In In re Rezulin Products Liability Litigation, 309 F. Supp.2d 531, 548-50 (S.D.N.Y. 2004), more FDA expert testimony was excluded ? ?the proposed testimony about FDA procedures and regulations and disclosure of facts by [defendant] to the FDA is inadmissible.? The reasoning, however, was somewhat muddled by the proposed experts being incompetent as well as offering improper legal opinions. While we put the Rezulin decision in the same line of authority, it lacks a clear holding that expert testimony about the meaning or violation of FDA regulations is inadmissible as a legal conclusion.

An aside: Rezulin and some of the other cases also dealt with (and correctly excluded) supposed expert testimony about corporate intent. But we think that?s a different issue and we?re not discussing that in this post.

2005 ? This was when the district court in the Caputo case pitched the testimony of an FDA expert:

Defendants correctly assert that an expert must not improperly tell the jury why a party?s conduct was illegal. While an expert may testify regarding industry standards and practices, he may not offer opinions that amount to legal conclusions. As a result, [the expert] may not testify about whether Defendants met their obligations under the Safe Medical Devices Act of 1990, because such testimony would constitute an impermissible legal conclusion. For the same reason, [the expert] may not summarily testify that [a document] was ?materially misleading? within the meaning of any statute or regulation.

United States v. Caputo, 374 F. Supp.2d 632, 646 (N.D. Ill. 2005). See Troxclair v. Aventis Pasteur, Inc., 864 A.2d 1147, 1153-54 (N.J. Super. A.D. 2005) (expert testimony on whether vaccine conponent was an ?adulterant? within meaning of Vaccine Act did not create issue of fact because we ?need not accept a plaintiff's experts? opinions when they bear upon construction of a statute or a matter of law?).

2006 ? In Livingston v. Wyeth, Inc., 2006 WL 2129794 (M.D.N.C. July 28, 2006), the court struck testimony offered by an FDA expert. ?[W]hile the summaries of FDA regulatory practices offered by [the expert]. . .may be helpful, the[] application of law to the facts of this case on an ultimate legal question is not.? Id. at *6. See Apotex Corp. v. Merck & Co., 2006 WL 1155954, at *8 (N.D. Ill. April 25, 2006) (?expert testimony ? which reads more like a legal brief than an expert report ? consists of plainly inadmissible legal conclusions concerning [the defendant?s] fraudulent alleged fraud and would be completely unhelpful to the fact finder?).

After that, we?re finally getting to the stuff we?ve discussed already. That was the year of the Strong case, which led to the FDA?s brief decrying FDA expert testimony on issues of law.

So, while the Seventh Circuit?s recent affirmance in Caputo was the first federal appellate decision to address the exclusion of expert testimony about what FDA regulations mean and whether they were violated as inadmissible legal conclusions ? it was hardly the first case of its kind at any level, or even the first appellate decision.

And we knew that ? FDA Week notwithstanding ? because we?ve had to deal with that kind of thing for twenty years now.

Full post as published by Drug and Device Law on March 14, 2008 (boomark / email).