Thursday, July 26, 2007

Vaccine Preemption – A Murder At The Bates Motel?

How many times have we heard that, in deciding preemption issues the “purpose” or “intent” of congress is the “ultimate touchstone” that the courts must respect? Lots. We can start with Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996), the express preemption case involving medical devices and the Medical Device Amendments to the FDCA:

[O]ur analysis of the scope of the statute’s pre-emption is guided by our oft-repeated comment, that the purpose of Congress is the ultimate touchstone in every pre-emption case. As a result, any understanding of the scope of a pre-emption statute must rest primarily on a fair understanding of congressional purpose.
519 U.S. at 485-85 (emphasis original). See, e.g., Lorillard Tobacco Co. v. Reilly, 533 U.S. 525, 541 (2001) (“Congressional purpose is the ultimate touchstone of our inquiry”) (citing Cipollone v. Liggett Group, Inc., 505 U.S. 504, 516 (1992)). Throwing the three terms “purpose,” “touchstone,” and “preempt!” in the same paragraph in Westlaw produced 16 hits just in the United States Supreme Court – as recent as Watters v. Wachovia Bank, N.A., 127 S.Ct. 1559, 1578 (2007), just a few months ago. Basically, respect for congressional intent/purpose is something that turns up in most of the big tort preemption cases – as is no doubt desirable.

Something we’ve also noticed is that respect congressional intent is just as often embraced by judges finding against preemption as those finding in favor of it. Lohr, after all, found against medical device preemption, and the Watters citation was in a dissent opposing preemption.

So what exactly has the Supreme Court considered this “touchstone” to be? The Watters dissent opposing preemption looked to: the “complex history” of the statute in question, related statutes, and Federal Register statements of the relevant agency. 127 S. Ct. at 1578-79. In Lorillard the Court examined a “predecessor pre-emption provision and the circumstances in which the current language was adopted,” 533 U.S. at 542, which included a three-page nalysis of legislative and administrative history. Id. at 543-46. In Lohr, the Court relied upon “legislative history,” 518 U.S. at 491, 494, and the FDA’s interpretation of the preemption provision. Id. at 496-97. In Cipollone, the Court discussed two related statutes, their “regulatory context,” and their respective legislative histories. 505 U.S. at 519-23. The other “touchstone” cases likewise rely on a variety of sources:
  • Pharmaceutical Research & Manufacturers of America v. Walsh, 538 U.S. 644, 685 (2003) (other statutory sections, House report) (concurring and dissenting opinion supporting preemption).
  • Livadas v. Bradshaw, 512 U.S. 107, 122-28 (1994) (extensive prior labor law precedents; provisions of collective bargaining agreement).
  • District of Columbia v. Greater Washington Board of Trade, 506 U.S. 125, 136-37 (1992) (“both the legislative history of [the statute] and prior holdings by this Court”) (dissenting opinion opposing preemption).
  • Gade v. National Solid Wastes Management Ass’n, 505 U.S. 88, 98-100(1992) (related statutory sections, legislative history, and administrative “contemporaneous interpretation”).
  • Ingersoll-Rand Co. v. McClendon, 498 U.S. 133, 141-43 (1990) (other sections of statute; legislative history).
  • Fort Halifax Packing Co. v. Coyne, 482 U.S. 1, 9 (1987) (legislative history).
  • Pilot Life Insurance Co. v. Dedeaux, 481 U.S. 41, 45-48(1987) (other statutory sections; legislative history).
  • California Federal Savings & Loan Ass’n v. Guerra, 479 U.S. 272, 284 (1987) (“the background of [the statute’s] legislative history and historical context”).
  • Wisconsin Dept. of Industry, Labor & Human Relations v. Gould, Inc., 475 U.S. 282, 290 (1986) (prior labor precedent).
  • Metropolitan Life Insurance Co. v. Massachusetts, 471 U.S. 724, 751-57 (1985) (legislative history; lack of legislative history).
  • Allis-Chalmers Corp. v. Lueck, 471 U.S. 202, 212-13 & n.6 (1985) (multi-factor judicial test).
  • Malone v. White Motor Corp., 435 U.S. 497, 504-12 (1978) (other sections of statute; subsequent amending statute; legislative history of subsequent statute)

Anyway, one thing that seems pretty clear to us is that in deciding whether there’s preemption or not, the Supreme Court has routinely looked beyond the statute itself, to things like legislative history, regulatory history, prior statutes, and the like. It's examined legislative history specifically in maybe three quarters of its preemption cases ... maybe more.

But strange things happen – especially in state court – when preemption is applied to product liability actions. A case in point is the recent decision in Ferrari v. American Home Products Corp., 2007 WL 1933129 (Ga. App. July 5, 2007), concerning the National Childhood Vaccine Injury Compensation Act (“Vaccine Act”). Ferrari is an express preemption case interpreting a clause stating:

No vaccine manufacturer shall be liable in a civil action for damages arising from a vaccine-related injury or death. . .after [Oct. 1, 1988] if the injury or death resulted from side effects that were unavoidable even though the vaccine was properly prepared and was accompanied by proper directions and warnings.

42 USC §300aa-22(b)(1).

There’s rock solid legislative history establishing that the intent of this limitation was to mandate that in every case involving a covered vaccine there was to be an across-the-board “unavoidably unsafe product” defense derived from Restatement (Second) of Torts §402A, comment k (1965):

Subsection (b) Unavoidable Adverse Side Effects; Direct Warnings. – This provision sets forth the principle contained in Comment K of Section 402A of the Restatement of Torts (Second) that a vaccine manufacturer should not be liable for injuries or deaths resulting from unavoidable side effects even through the vaccine was properly prepared and accompanied by proper directions and warnings.

The Committee has set forth Comment K in this bill because it intends that the principle in Comment K regarding “unavoidably unsafe” products, i.e., those products which in the present state of human skill and knowledge cannot be made safe, apply to the vaccines covered in the bill and that such products not be the subject of liability in the tort system. The vaccines addressed in this legislation certainly present the hardest case for the application of Comment K. In such a case, the plaintiff is almost invariably a young child, often badly injured or killed, and free from wrongdoing. And, even if the defendant manufacturer may have made as safe a vaccine as anyone reasonably could expect, a court or jury undoubtedly will find it difficult to rule in favor of the 'innocent' manufacturer if the equally “innocent” child has to bear the risk of loss with no other possibility of recompense.

The Committee believes that this bill offers another, better, alternative[,]. . . a no-fault compensation system that goes far beyond even the most expensive ruling issued by in a court in a vaccine case. . . .

Given the existence of the compensation system in this bill, the Committee strongly believes that Comment k is appropriate and necessary as the policy for civil actions seeking damages in tort. . . . [I]f [Vaccine-injured persons] cannot demonstrate under applicable law either that a vaccine was improperly prepared or that it was accompanied by improper directions or inadequate warnings should pursue recompense in the compensation system, not the tort system.

H.R. Rep. 99-908, at 25-16, 1986 U.S.C.C.A.N. 6344, 6366-67.

You can’t get much more explicit than that. Prior to Ferrari, every court that had considered Vaccine Act preemption had found non-comment-k claims preempted. Sykes v. Glaxo-SmithKline, 484 F. Supp.2d 289, 299-302 (E.D. Pa. 2007); Blackmon v. American Home Products Corp., 328 F.Supp.2d 659, 663-66 (S.D. Tex. 2004); Militrano v. Lederle Laboratories, 769 N.Y.S.2d 839, 843 (N.Y. Sup. 2003), aff’d, 810 N.Y.S.2d 506 (N.Y.A.D. 2006).

So how did Ferrari come out the opposite direction? Recognizing the obvious, it observed that the Act’s provisions concerning the unavoidably unsafe product defense “expressly convey Congress’s intent to supersede, or preempt, state tort law standards.” 2007 WL 1933129, at *3. Having so conceded, in the next breath the Ferrari court simply ignored what Congress had said. So what happened to the supposed “touchstone” of preemption analysis?

Based upon an apparently unprecedented reading of certain language in Bates v. Dow Agrosciences LLC, 544 U.S. 431, (2005), Ferrari held that the good old “presumption against preemption” trumped congressional intent. 2007 WL 1933129, at *4. The Ferrari court found three statements from Bates pertinent:

  • Bates found that the defendants there had not offered any “plausible alternative reading” of the statute that supported broad preemption, and that “[e]ven if” there had been a plausible alternative reading, “we would nevertheless have a duty to accept the reading that disfavors pre-emption.”
  • “Because the States are independent sovereigns in our federal system, we have long presumed that Congress does not cavalierly pre-empt state-law causes of action.”
  • “In areas of traditional state regulation, we assume that a federal statute has not supplanted state law unless Congress has made such an intention clear and manifest.”

2007 WL 1933129, at *4 (quoting Bates, 544 U.S. at 449).

These statements in Bates, the court held, “changed traditional preemption analysis.” 2007 WL 1933129, at *4. Supposedly, they turned what had been a mere “rebuttable” presumption against preemption into “a duty to accept the reading of an express preemption statute that disfavors preemption.” Id. Second, the court held “preemption analysis ends with an examination of the statutory language alone” and “legislative history should no longer be examined to discern Congressional intent when an express preemption clause has two plausible alternative readings.” Id.

Wow. We’re going to find against preemption, congressional intent be damned. It looks like the court figuratively ran the Stars and Bars back up the flagpole on the Golden Dome in Bexis’ home town. The “independent sovereign” state of Georgia is now going to ignore congressional intent whenever and wherever possible in preemption cases.

Having thus established the controlling “law,” Ferrari finished the job by pointing out that the Vaccine Act itself only recited the comment k “unavoidably unsafe” standard. 2007 WL 1933129, at *4. The court then divined “two alternative, plausible readings” for the Act. One reading – supported by pages and pages of legislative history and unanimous prior precedent – required states to apply comment k to all covered vaccines. The second reading – supported by nothing – would give states leeway to apply comment k on a “case by case basis.” Id.

So which preemption “alternative” must a court pick? The one “that when the contemporaneous legislative history. . .is examined,” shows that “Congress’s intent to preempt this issue [is] clear”? Id. at *5. Or the one that preempts more narrowly, but is contrary to congressional intent? Why the latter, of course, because under Bates “we have a duty to accept the reading of the Vaccine Act that disfavors pre-emption, and we cannot resort to an examination of legislative history to discern Congress’s intent.” Id. (quoting Bates). The result may be “anomalous” given what Congress actually said, but the “broad” pronouncement in Bates demanded it. Id.

Like we said, strange things happen when state courts encounter preemption in product liability litigation. Here we have Ferrari holding, in effect, that the United States Supreme Court was wrong to consider legislative history in Lohr, Lorillard and literally scores of other preemption cases. That’s a pretty extraordinary claim, and we’re like Carl Sagan in this regard – extraordinary claims require extraordinary support.

If that support is to be found anywhere, it’s got to be in Bates. Did the Supreme Court really go psycho without us hearing about it? Let’s see if there’s really a preemption version of the Nullification Act in Bates.

So what was Bates about? Bates involved express preemption and the Federal Insecticide, Fungicide, and Rodenticide Act (“FIFRA”). Obviously FIFRA had an express preemption clause: “State[s] shall not impose or continue in effect any requirement for labeling or packaging in addition to or different from those required under FIFRA.” 7 USC §136v(b).

The Bates Court observed, first, that the statute also expressly allowed states to “regulate the sale or use” of a regulated product as long as it did “not permit any sale or use prohibited” by federal law. 544 U.S. at 439 (quoting statute). Given this statutory allowance, there was ample room for States and localities to supplement federal efforts.” Id. at 442.

After rejecting the plaintiffs’ claim that “requirements” did not include common law actions, 544 U.S. at 443, the Bates Court turned to the heart of the argument – what was the “scope” of the statute’s preemptive reach. Id. at 443. There were two scope-related limits: first, preemption only reached state requirements “for labeling or packaging,” and second, preemption only reached state requirements that were “in addition to or different from” federal law. Id. at 444.

The court found that lower court preemption rulings had outstripped these limits. First of all, there were many product liability claims (defective design, defective manufacture, negligent testing, and breach of express warranty) that did not mandate changes to “labeling or packaging,” and thus could not possibly be preempted. Id. at 444. A broader test that would have preempted claims thought to “induce” changes to labeling or packaging was rejected in light of the aforementioned “ample room” that FIFRA otherwise left for state regulation. Id. at 445-46. None of the language that the Ferrari court seized upon appeared in that part of Bates.

Bates next analyzed so-called “equivalent” fraud and negligence claims. Id. at 431. Here, the Court held that the statute’s other limitation preserved certain state-law claims that were “equivalent to, and fully consistent with, FIFRA’s misbranding provisions.” Id. at 447. Given what we know about congressional intent in the Vaccine Act, the statutory context of Bates seems to us to be diametrically the opposite of what not even the court denied was at issue in Ferrari.

Nevertheless, it was in connection with the defendants’ arguments for preemption of these “equivalent” claims that Bates made the statements relied upon in Ferrari. The Court held that the defendants had not offered any “plausible” reading of FIFRA that did not read the “different/additional” limitation “out of the statute.” Id. at 448. That alone was enough to establish that “equivalent” claims were not preempted. Id. at 449 (“That Congress added the remainder of the provision is evidence of its intent to draw a distinction between state labeling requirements that are pre-empted and those that are not.”).

That was it. The discussion of preemption could have ended there.

Instead, Bates launched into its “even if” discussion that Ferrari quoted. That’s classic dictum folks – discussion in an opinion beyond that necessary to decide the issues before the court. So the first place where Ferrari went wrong is to rely on mere dictum to effect a radical change in “traditional” preemption analysis.

But that’s not the only place that Ferrari went off the tracks.

Unlike Bates where no plausible alternative reading was offered, there was such an alternative in Ferrari – the across-the-board reading supported by extensive legislative history. Thus, because there was no alternative at all in Bates, the court never had to decide the effect of legislative history upon statutory construction. Where a preemption clause (or any other part of a statute, for that matter) is unambiguous, there’s no reason to resort to legislative history. Exxon Corp. v. Hunt, 475 U.S. 355, 362 (1986). That rule has never been extended to a situation where – by definition – there is more than "plausible" reading, in short, an ambiguity.

Is there anything at all in Bates that bears upon the rule barring consideration of legislative history that Ferrari purported to tease out of that opinion? Yes there is. In Bates, the Court in fact did consider extra-statutory material such as legislative history – and did so more than once.

Initially, the Bates court found that the evolution of the statute over time supported a reading that left “equivalent” claims unpreempted:

[T]his history emphasizes the importance of providing an incentive to manufacturers to use the utmost care in the business of distributing inherently dangerous items. Particularly given that Congress amended FIFRA to allow EPA to waive efficacy review of newly registered pesticides (and in the course of those amendments made technical changes to [the preemption clause]), it seems unlikely that Congress considered a relatively obscure provision. . .to give pesticide manufacturers virtual immunity.

544 U.S. at 450. Then the Court did it again a few pages further along:

The legislative history of the 1972 amendments suggests that Congress had conflicting state labeling regulations in mind when crafting [the preemption clause]. [quotation omitted] Hearings on Federal Pesticide Control Act of 1971 before the House Committee on Agriculture, 92d Cong., 1st Sess., 281-283 (1971) (statement of Robert L. Ackerly). By contrast, the lengthy legislative history is barren of any indication that Congress meant to abrogate most of the common-law duties long owed by pesticide manufacturers.

544 U.S. at 452 n.26.

Thus, the assertion in Ferrari that Bates somehow created a presumption against preemption on steroids that bars resort to legislative history in determining the scope of ambiguous express preemption clauses is belied by what actually happened in Bates itself. The so-called “rule” in Ferrari is nowhere found in Bates – neither in the holdings of the Court nor in the manner in which it conducted its preemption analysis.

It’s no wonder that, more than two years after Bates, Ferrari could find only one unpublished intermediate court decision supposedly recognizing a similar rule. 2007 WL 1933129, at *4 (citing the Matter of: Blue Flame Energy Corp., 2006 WL 3775856, at *9 (Ohio App. Dec. 26, 2006)). Even that case does not support Ferrrari. Blue Flame did no more than cite the Bates dictum as a boilerplate proposition – and then promptly turned to legislative history in deciding the non-tort preemption question before it. Blue Flame, 2006 WL 3775856, at *10 (discussing legislative history of the National Securities Market Improvement Act of 1996).

On the other hand, it is quite common, post-Bates, for courts to go beyond the four corners of the statute itself in deciding preemption issues in cases as to which the court has (rightly or wrongly) asserted a presumption against preemption. We’ve already pointed out the extensive discussion of statutory history and administrative interpretation in the Watters Supreme Court dissent. It just so happens that Justice Stevens, who wrote that dissent, also authored Bates. Plainly, he recognized no such limitation upon the extra-statutory sources that courts can appropriately consider. Likewise in Merrill Lynch, Pierce, Fenner & Smith, Inc. v. Dabit, 126 S. Ct. 1503, 1514 (2006), the court relied upon legislative history in a post-Bates preemption case.

Against the one (inapposite) case that Ferrari cited in support of its supposed “rule,” there are probably hundreds of other post-Bates decisions that go the other way and continue the time-honored reliance upon legislative history in presumption cases. A Westlaw search that’s might well be underinclusive (requiring use of the phrase “legislative history”) turned up over one hundred – including as recently as three days ago. See VivaA International Voice for Animals v. Adidas Promotional Retail Operations, 2007 WL 2080000, at *6 (Cal. July 23, 2007). To add just a few more cases relying on “legislative history” is preemption/presumption situations: National Ass'n Of State Utility Consumer Advocates v. F.C.C., 457 F.3d 1238, 1257 (11th Cir. 2006); City of Chicago v. Comcast Cable Holdings, L.L.C., 2007 WL 1453055, at *10 (Ill. App. May 17, 2007); Giordano v. Giordano, 913 A.2d 146, 148 (N.J. Super. A.D. 2007); Charvat v. Telelytics, LLC, 2006 WL 2574019, at *9 (Ohio App. Aug. 31, 2006); Cf. Allen v. Wright, 644 S.E.2d 814, 820 (Ga. 2007) (resorting to state legislative history to determine preemptive effect of state statute in light of similar state anti-preemption presumption).

To us, Ferrari’s tilt at the windmill of the Supremacy Clause is looking more and more like a Lost Cause.

And that’s not the end of it. For the sake of argument, let’s say that Bates did everything that Ferrari says it did. Even then, a state-law attempt to eliminate the Vaccine Act’s unavoidably unsafe product defense through “case by case” analysis would be preempted – if not expressly, then impliedly by reason of the direct and conceded conflict with the manner in which Congress specified that this defense is to be applied.

In this regard, we’d first point out the paucity of Supreme Court precedent supporting the existence of any sort of presumption against preemption in cases that arise directly under the Supremacy Clause by virtue of actual conflict with federal law. See our previous post on that subject. Ferrari has followed many other lower courts into the error of applying a constitutional presumption in a context where there is no Supreme Court authority for it.

Putting that aside – since so far we’ve just been shouting into the wind on that issue – one thing that is pretty clear in preemption jurisprudence is that whatever happens with express preemption doesn’t affect, one way or the other, the applicability of implied so-called “conflict” preemption. The two are quite “different”:

[T]his Court traditionally distinguishes between “express” and “implied” pre-emptive intent, and treats “conflict” pre-emption as an instance of the latter. . . . [T]he Court has never before required a specific, formal agency statement identifying conflict in order to conclude that such a conflict in fact exists. . . . To insist on a specific expression of agency intent to pre-empt. . .would be in certain cases to tolerate conflicts that an agency, and therefore Congress, is most unlikely to have intended.

Geier v. American Honda Motor Co., 529 U.S. 861, 884-85 (2000). That there is “an express definition of the pre-emptive reach of a statute. . .does not mean that the express clause entirely forecloses any possibility of implied pre-emption.” Freightliner Corp. v. Myrick, 514 U.S. 280, 289 (1995). “At best” that would “support[] an inference” against implied preemption. Id. at 290. See Ingersoll-Rand, 498 U.S. 142 (“[e]ven if there were no express pre-emption in this case, the [tort claim] would be pre-empted because it conflicts”).

The Geier court went on to analyze the circumstances of the history of the regulation before it that supported implied conflict preemption notwithstanding more than mere statutory silence. There was actually an express saving clause in Geier. 529 U.S. at 885-86. We won’t bore you with the details, but Geier went through pages and pages of legislative, administrative, and other history (id. at 874-81) before concluding that – notwithstanding lack of express preemption – the tort claim (for failure to install airbags) at issue fell in the face of its conflict with readily apparent congressional and administrative intent:

The rule of state tort law for which petitioners argue would stand as an “obstacle” to the accomplishment of that objective. And the statute foresees the application of ordinary principles of pre-emption in cases of actual conflict. Hence, the tort action is pre-empted.

529 U.S. at 886.

So in our view, Ferrari’s torturing of Bates to extract from it rules that even Bates itself doesn’t follow was not only cruel and unusual, but totally unnecessary. Assuming that it were even possible for Bates to displace legislative history from express Vaccine Act preemption (which it certainly didn’t), all that would accomplish is to open the door for consideration of the same legislative history under the rubric of implied conflict preemption. Even Ferrari concedes that, once legislative history is considered, the conflict with the plaintiffs’ view of Georgia common-law is obvious.

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