Thursday, September 20, 2007

Getting the Judge to Notice the FDA

Today we’re thinking about evidence – specifically FDA evidence. There’s a lot of different kinds. There are FDA approval letters, something we usually want to get in. There are FDA warning letters, Something that we always want to keep out. The same can be said for adverse drug and medical device reports, which we've already discussed. There are FDA reports and other correspondence, where our position varies depending on the document. The rules here are complicated and the cases (not surprisingly) are less than completely consistent. Bexis devotes half a chapter to all this in his book, Beck & Vale, Drug & Medical Device Product Liability Handbook, §11.01[1][a-f] (2004). If you’re truly a glutton for punishment, the folks at Law Journal Press will be happy to sell you a copy for only a couple of hundred bucks.

But today we’re confining ourselves to just one type of FDA-related evidence. It’s the gold standard. We’re talking about when the FDA feels strongly enough about something that it goes through the administrative gauntlet to publish something in the Federal Register. For all those out there who aren’t administrative law geeks, the Federal Register is the official government publication for all major decisions by regulatory agencies, not just the FDA. It comes out daily, and as you might expect runs through more pages each year than any one person could possibly hope to read.

There’s a lot of stuff in there, and some of it can be quite useful to our clients in the cases we have to try. Here’s an example. Compliance with FDA regulations is something we’ve discussed before in the context of presumptions and even adequacy as a matter of law. But more generally, even states that don’t give either conclusive or presumptive effect to our clients’ compliance with what the FDA tells them to do at least let us admit compliance into evidence. After all, doing what the FDA says is at least some evidence that our clients’ products aren’t defective. E.g., Carlin v. Superior Court, 920 P.2d 1347, 1353 (Cal. 1996); MacDonald v. Ortho Pharmaceutical Corp., 475 N.E.2d 65, 70-71 (1985); Odgers v. Ortho Pharmaceutical Corp., 609 F. Supp. 867, 879 n.24 (E.D. Mich. 1985).

Thus, if “the trier of fact may assign FDA approval the weight it deserves,” Toner v. Lederle Laboratories, 732 P.2d 297, 311 n.12 (Idaho 1987), then just offering evidence of a client’s compliance isn’t going to be enough. We want to show the jury that compliance is, in fact, a big deal – that it should accord our client’s compliance a lot of “weight.” So we don’t want to stop just the (usually) incomprehensible language of the FDA regulation itself. That’s only the first step. We want to show the jury why the FDA thought the issue was important enough to write the regulation the way it did. That requires some examination, not just of the regulation itself, but of the FDA’s rationale for it.

We could go back in time to our Bone Screw days and draw on some examples there, because we did this a lot back in the day. But rather than offer something stale, let’s demonstrate what we mean with something a little more recent. We hear from plaintiffs’ counsel over and over how we should have added a warning about this, and we should have added a warning about that. “Here a warning, there a warning, everywhere a warning, warning....” We want to explain to the jury that there’s a reason why the FDA doesn’t require a warning about everything under the sun. Actually, we want the FDA to explain it for us. So we look in the Federal Register, and we find that the FDA has discussed this problem – the drawbacks of so-called “overwarning.”

Here’s what the FDA said on that score within the last couple of years.

Exaggeration of risk could discourage appropriate use of a beneficial drug. Liability concerns. . .creat[e]pressure on manufacturers to expand labeling warnings to include speculative risks and, thus, to limit physician appreciation of potentially far more significant contraindications and side effects. . . . [L]abeling that includes theoretical hazards not well-grounded in scientific evidence can cause meaningful risk information to lose its significance. Overwarning, just like underwarning, can similarly have a negative effect on patient safety and public health. . . . [A]dditional warnings can lead to labeling that does not accurately portray a product's risks, thereby potentially discouraging safe and effective use of approved products or encouraging inappropriate use and undermining the objectives of the [FDCA].
71 Fed. Reg. 3922, 3935 (FDA Jan. 24, 2006). We’d like the jury to hear all that, not just from our mouths but from the FDA - a disinterested and authoritative non-party. (Actually, we’d like there to be preemption, but for the purposes of this post, we assume there isn’t any.) So, what’s the quickest and easiest way to get something like this into evidence?

Judicial notice.

Again, so that non-lawyers aren’t left scratching their heads, “judicial notice” is when something is so definitively known (for any number of reasons) that it doesn’t have to be proven with first-hand testimony of that fact. Judicial notice is usually concerned with facts that aren’t really subject to dispute, such as did a particular date fall on a Tuesday, or is a town being located in a particular county or state. In such situations, it’s a waste of time to require evidence to prove that kind of fact. So the judge “notices” it – conclusively declaring it to be so.

But there are other ways that judicial notice can operate. One of them is by statute. The legislature can mandate judicial notice. That’s what’s happened with the Federal Register. Congress didn’t want people to have to jump through a bunch of hoops just to prove what federal administrative agencies have said. So it passed a law that requires all courts – state and federal – to admit anything that’s published in the Federal Register into evidence, as long as what’s been published passes the usual test of being relevant to what the case is about:

[F]iling of a document, required or authorized to be published [in the Federal Register], except in cases where notice by publication is insufficient in law, is sufficient to give notice of the contents of the document to a person subject to or affected by it. The publication in the Federal Register of a document creates a rebuttable presumption –

(1) that it was duly issued, prescribed, or promulgated;
(2) that it was filed with the Office of the Federal Register and made available for public inspection at the day and hour stated in the printed notation;
(3) that the copy contained in the Federal Register is a true copy of the original; and
(4) that all requirements of this chapter and the regulations prescribed under it relative to the document have been complied with.

The contents of the Federal Register shall be judicially noticed and without prejudice to any other mode of citation, may be cited by volume and page number.
44 U.S.C. §1507 (emphasis added). The relevant portion of §1507 is short, to the point, mandatory (“shall”) and does not make any exceptions. See Lexecon Inc. v. Milberg Weiss Bershad Hynes & Lerach, 523 U.S. 26, 35 (1998) (“the mandatory ‘shall’. . .normally creates an obligation impervious to judicial discretion”). What part of “the contents of the Federal Register shall be judicially noticed” is it hard to understand?

A bunch of courts have thus judicially noticed Federal Register statements under §1507. Here are a few appellate citations. E.g., Getty Petroleum Marketing, Inc. v. Capital Terminal Co., 391 F.3d 312, 325 n.19 (1st Cir. 2004); United States v. Woods, 335 F.3d 993, 1001 (9th Cir. 2003); Denius v. Dunlap, 330 F.3d 919, 926-27 (7th Cir. 2003); Mora v. Vasquez, 199 F.3d 1024, 1028 n.7 (9th Cir. 1999); United States v. Wolny, 133 F.3d 758, 764 (10th Cir. 1998); Powers v. United States, 996 F.2d 1121, 1125 n.3 (11th Cir. 1993); Crimm v. Missouri Pacific Railroad Co., 750 F.2d 703, 710 n.3 (8th Cir. 1984).

Under §1507, therefore, we’re entitled to get the FDA’s published views about “overwarning” into evidence simply by having the judge tell the jury that this is what the FDA has concluded – as long as it’s relevant. See Wolny, 133 F.3d at 765 (judicial notice not “mandatory, when a matter that appeared in the Federal Register is irrelevant”). Since juries are allowed to consider the “weight” to be afforded to FDA compliance, that pretty much by definition makes the FDA’s views about overwarning relevant any time that a plaintiff is arguing that, even though our client said everything the FDA wanted it to say, we should have said something more. See In re Ephedra Products Liability Litigation, 393 F. Supp.2d 181, 195-96 (S.D.N.Y. 2005) (agency statement in Federal Register admissible to bolster expert testimony by showing that “the FDA makes the same inferences from good but inconclusive science as the [party’s] experts”).

We think §1507’s pretty cool. Having the judge “notice” something is better than having the jury hear it from us or from paid or otherwise biased witnesses. We’ve found a number of cases, in which the courts have invoked mandatory judicial notice in the context of FDA publications in the Federal Register. In re Watson, 517 F.2d 465, 472 & n.2 (Cust. & Pat. App. 1975); County of Thuringer v. American Red Cross, 2006 WL 406353, at *3 (N.D. Iowa 2006); Santa Clara v. Astra USA, Inc., 401 F. Supp.2d 1022, 1024 (N.D. Cal. 2005); Elsroth v. Johnson & Johnson, 700 F. Supp. 151, 161 (S.D.N.Y. 1988); Baker v. Smith & Nephew Richards, Inc., 1999 WL 811334, at *7 n.53 (Tex. Dist. June 7, 1999).

As Baker indicates, judicial notice under §1507 is just as mandatory in state court as it is in federal court.

Texas courts must take judicial notice of the laws of the United States. . . . Administrative rules adopted by boards, departments, and commissions pursuant to federal statutes are also matters of judicial knowledge. When such regulations are published in the Federal Register a federal statute provides that their contents shall be judicially noticed.
Ex parte Medellin, 223 S.W.3d 315, 359 n.2 (Tex. Crim. App. 2006). “Our research has not found any case in which a state appellate court ruled that a trial court is free to refuse to judicially notice the contents of the Federal Register.” O’Daniel v. PNB Corp., 1988 WL 94760, at*5 (Tenn. App. Sept. 14, 1988). “Federal laws and regulations are binding on state courts and are subject to their judicial notice.” Associated East Mortgage Co. v. Young, 394 A.2d 899, 902 (N.J. Super. 1978). Accord Schmidt v. Royer, 574 N.W.2d 618, 624 n.16 (S.D. 1998); Quinn v. Walters, 881 P.2d 795, 810 n.7 (Or. 1994); Yankee Atomic Electric Co. v. Secretary of the Commonwealth, 526 N.E.2d 1246, 1253 (Mass. 1988); Black v. Financial Freedom Senior Funding Corp., 112 Cal. Rptr.2d 445, 458 n.13 (Cal. App. 2001).

Now we’re not saying the judicial notice conclusively establishes anything (not in this post, anyway). We don’t ask (in this context) for judicial notice of the “truth” of the FDA’s position. See One Hour Cleaners v. Industrial Claim Appeals Office, 914 P.2d 501, 505 (Colo. App. 1995) (§1507 requires judicial notice “that a certain document exists” not “the truth of the statements contained”). That would be back-door preemption. As we’ve discussed above, as much as we like preemption, we’re assuming for present purposes that there isn’t any, for whatever reason. What §1507 does is admit into evidence of the position and reasoning of an expert agency. See Green Mountain Chrysler Plymouth Dodge Jeep v. Crombie, 2007 WL 1601518, *1 (D. Vt. June 4, 2007) (judicially noticing Federal Register excerpts to “set forth [the agency’s] position on various issues. . .not. . .as facts”). When we’re trying to persuade a jury that compliance matters, that’s precisely what we want the jury to hear.

1 comment:

Edward Ezrailson, Ph.D. said...

All of the above is dependent upon the pharmaceutical company's truthful submission. Exclusions and omissions with relevant scientific basis are never addressed.