Thursday, September 06, 2007

Joining Issue In Vaccine Act Preemption - Ferrari Gets A Red Flag

It certainly didn’t take long.

Back in late July we posted about the extraordinarily restrictive view of Vaccine Act (and indeed of all) preemption taken in Ferrari v. American Home Products Corp., 2007 WL1933129 (Ga. App. July 5, 2007).

In our view Ferrari had taken the presumption against preemption to an “unprecedented” extreme – allowing it to trump clearly stated Congressional intent. Looking under the hood, we wondered what had happened to that supposed “ultimate touchstone” for measuring preemption? We analyzed Ferrari’s novel analysis of some dictum in Bates v. Dow Agrosciences LLC, 544 U.S. 431, (2005), and found it wasn’t running on all cylinders.

Apparently we aren’t the only ones. In short order the plaintiffs’ bar wheeled their shiny new Ferrari into other courts. In just as short order another court to pointed out where Ferrari had run out of gas.

Bruesewitz v. Wyeth, Inc., 2007 WL 2463378 (E.D. Pa. Aug. 24, 2007), presented exactly the same Vaccine Act preemption question as Ferrari – what were the applicable legal standards after a plaintiff had rejected a Vaccine Court award and filed a civil suit? The plaintiffs claimed that the defendant was strictly liable because it could have developed a better vaccine design (an acellular diphtheria component for DPT), even though it did not have FDA approval for that design at the time (it came later). They also claimed they should have been warned directly and that the FDA-approved warnings were deficient. 2007 WL 2463378, at *3.

As discussed in the prior post, the Vaccine Act proscribed these claims for various policy-related reasons. The question in Bruesewitz was whether to follow several prior pro-preemption decisions (Sykes v. GlaxoSmithKline, 484 F. Supp.2d 289 (E.D. Pa. 2007); Blackmon v. American Home Products Corp., 328 F. Supp.2d 659 (S.D. Tex. 2004); Militrano v. Lederle Laboratories, 810 N.Y.S.2d 506 (N.Y.A.D. 2006)) or the “admittedly novel application” of Bates in Ferrari.

We’re happy to say that the Bruesewitz court opted for the road more traveled. Of course, it probably didn’t hurt that Judge Baylson is also the author of Colacicco v. Apotex, Inc., 432 F. Supp.2d 514 (E.D. Pa. 2006) – familiar to regular readers of this blog as one of the best-reasoned preemption decisions in the prescription drug area. In similar fashion, Bruesewitz begins by pointing out that Bates dealt with a much different statute (FIFRA) that left design claims entirely outside the language of a limited express preemption clause:

[T]he Supreme Court [in Bates] first noted, “FIFRA [is] not a sufficiently comprehensive statute to justify an inference that Congress had occupied the field to the exclusion of the States.” Next, it held, “Nothing in the text of FIFRA would prevent a State from making the violation of a federal labeling or packaging requirement a state offense.” Finally, the Court found the ban on states imposing a “requirement” did not preempt the creation of an “inducement.” The plaintiffs’ claims were for defective design, as well as violation of an express warranty, rather than a defective warning label. The Court reasoned the duties imposed by such common law rules might induce the pesticide manufacturer to change its labeling; however, an adverse jury verdict would not require the manufacturer to change. As such, design defect claims at common law are not preempted by the express language of the FIFRA preemption provision.

2007 WL 2463378, at *10 (Bates citations omitted). Thus – as we said here the last time – the outcome in Bates was not based upon presumptions or anything of that nature, but rather on the limited scope of the preemption clause itself. Indeed, as Bruesewitz goes on to point out, claims more directly tied to labeling were held preempted in Bates. 2007 WL 2463378, at *10 (discussing the fate of “fraud and failure-to-warn claims”).

Judge Baylson then frontally “rejects” Ferrari’s reading of Bates. 2007 WL 2463378, at *11. The court determined that Ferrari took one small piece of Bates “out of its context, and gives it broader scope than is appropriate.” 2007 WL 2463378, at *11. That, in Bates, the Supreme Court “opted for the reading that disfavors preemption” when “faced with two plausible alternative readings of the. . .preemption statute” did not create an inflexible rule to be applied regardless of underlying legislative intent. 2007 WL 2463378, at *11. “Bates does not require a court to automatically accept a plausible interpretation of a statute which disfavors preemption.” 2007 WL 2463378, at *11.

Bruesewitz also pointed out what we noted in our post – that “Bates itself relies on the congressional intent behind FIFRA when applying the rule.” 2007 WL 2463378, at *11. Thus Ferrari went off the track by considering Bates to create a “rule disfavoring preemption [that was] ‘outcome determinative,’ irrespective of congressional intent.” 2007 WL 2463378, at *11. No “presumption against preemption” justifies ignoring congressional intent – rather it is the preemption that must give way to what Congress intended:


[A] court must look to whether that presumption accords with Congress’ intent in enacting a specific law. . . . This question is basically one of congressional intent. Did Congress, in enacting the Federal Statute, intend to exercise its constitutionally delegated authority to set aside the laws of a State? If so, the Supremacy Clause requires courts to follow the federal, not state, law.
Id. Here Bruesewitz quoted and followed the recent decision in Pennsylvania Employees Benefit Trust Fund v. Zeneca Inc., 2007 WL 2376312, at *6 (3d Cir. Aug. 17, 2007), which – as we also discussed – adopted a much broader view of preemption.

When preemption is the issue, it also helps to be in the Third Circuit.

The court thus disagreed with Ferrari in drawing such a global conclusion from a Supreme Court case “moored” so “tightly to the specific preemption clause at issue.” 2007 WL 2463378, at *11 (quoting Mills v. Giant of Maryland, LLC, 441 F. Supp.2d 104, 107 (D.D.C. 2006)). Instead,

Bates merely underscores the need to pay close attention to the scope of the federal statute’s preemption clause and assists the court in framing the questions to be addressed. Bates does not decide the question whether the Vaccine Act preempts all design defect claims, or whether there must be a case-by-case determination as to whether a vaccine is unavoidably unsafe.

2007 WL 2463378, at *11. In short, the Bruesewitz court had a head-on collision with Ferrari, entirely rejecting the notion in that the Supreme Court dictum in Bates brought about some sub silentio reworking of fundamental preemption doctrine.

We’re relieved that somebody agrees with us. Maybe the quick disagreement in Bruesewitz will lead the Georgia Supreme Court to take an appeal in Ferrari (here, we disclaim any inside information about further proceedings in this case).

Anyway, with the Bates issue out of the way, it wasn’t difficult for Judge Baylson to conclude that the plaintiffs’ claims in Bruesewitz were preempted, given the strength of congressional intent. The court followed the four conclusions reached in Sykes (another Eastern District of Pennsylvania case) – and an opinion we also liked.
  • Allowing case-by-case inquiries into whether a particular vaccine is unavoidably unsafe would do nothing to protect vaccine manufacturers from suit from design defects, as congress intended.
  • Congress also intended to provide an umbrella under which manufacturers would improve the safety of their products while remaining immune from design defect claims made possible by the successful innovation of safer alternative designs.
  • The Vaccine Act’s no-fault compensation scheme reflects a congressional balance between the policy of widespread distribution of childhood vaccines and the need to compensate those injured by that policy.
  • Although similar to Restatement §402A, comment k, the unavoidably unsafe product defense conferred by the Act is “broader,” so that the Act preempts state law determinations of whether a vaccine is unavoidably unsafe, and therefore entitled to comment k immunity.
2007 WL 2463378, at *12-13.

Beyond that, the court makes some Pennsylvania law rulings that are of interest to Bexis but that don’t bear on the preemption question.

We have no doubt that Ferrari has not yet been totaled, despite this initial burn out. We can only hope that other courts follow Bruesewitz in recognizing that its interpretation of Bates was a dead end.

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