Saturday, March 31, 2007

We like Sykes

Judge Stengel did some nice work on Wednesday, March 28. In 65 nicely reasoned pages, he came out in favor of both Vaccine Act and FDA prescription drug preemption. If that doesn't make your spine tingle . . . well, why are you reading this blog, anyway?

In Sykes v. Glaxo-SmithKline, et al., No. 06-1111, slip op. (E.D. Pa. Mar. 28, 2007) (sorry -- we can't find it on the web, and we can't post it on a databus from where we're blogging, so we can't provide a link), Sykes' parents brought strict liability and negligence claims against GSK, Wyeth, and Bayer for injuries allegedly suffered by Sykes due to his exposure to vaccines and a biologic containing the preservative thimerosal. Since discovery had been stayed to allow a decision on the preemption issue, Judge Stengel treated the defendants' motions for summary judgment as motions for judgment on the pleadings.

Judge Stengel started by ruling in favor of Vaccine Act preemption. The Vaccine Act preempts design defect claims because (1) "the purposes of the Vaccine Act would not be served if defective design claims could be tried before juries. A case-by-case determination of whether a vaccine was unavoidably unsafe would defeat the protection the Act was intended to provide vaccine manufacturers," id. at 21, (2) the "structure of the Vaccine Act read as a whole" suggests that allowing design defect claims "would destroy the uniformity Congress intended to establish with the Vaccine Act," id. at 22, (3) "the legislative history" of the Vaccine Act "clearly supports the conclusion that Congress intended to protect vaccine manufacturers from liability for defective design claims," id., and (4) the rationale of Comment k (to Restatement (Second) of Torts Sec. 402A) supports the notion that manufacturers should not be liable for injuries caused by "unavoidably unsafe" products that were manufactured and marketed appropriately. Id. at 23.

Design defect down, failure to warn to go. First, failure to warn patients themselves. The Vaccine Act by its terms bars "claims based on a vaccine manufacturer's failure to provide warnings to an individual who receives its vaccine." Id. at 27.

Next, failure to warn learned intermediaries. Claims that a manufacturer failed to warn health care providers about the risks of a vaccine can be overcome if a plaintiff pleads and proves that the manufacturer withheld relevant information from the FDA. Plaintiffs therefore pleaded (as night follows day) that the manufacturers had defrauded the FDA. Since Judge Stengel was ruling on motions for judgment on the pleadings, he could not consider the affidavits and documents submitted by defendants to prove that they had complied with the FDA's requirements. Id. at 27. He therefore could not hold that plaintiffs' claims were preempted. (Readers should remember that courts have held that state law fraud-on-the-FDA exceptions are preempted under Buckman. See, e.g., Garcia v. Wyeth-Ayerst Laboratories, 385 F.3d 961 (6th Cir. 2004). The issue of federal-federal, rather than state-federal, displacement of a fraud-on-the-FDA exception requires a different analysis, but defendants shouldn't give up hope here. The issue apparently wasn't raised in Sykes.)

In any event, Judge Stengel found that plaintiffs had not pleaded fraud with particularity and that, in light of recent FDA pronouncements about the safety of thimerosal, repleading would be futile. The court therefore dismissed with prejudice all failure-to-warn claims against the vaccine manufacturers. Sykes, slip op. at 30.

So much for Vaccine Act preemption. On to conflict preemption under the FDA regulations governing biologics. This issue turned in large part on the deference due to the FDA's recent "Preemption Preamble," 71 Fed. Reg. 3922-27 (Jan. 24, 2006), so Judge Stengel's analysis applies equally to all biologic and prescription drug cases. Judge Stengel reasoned, first, that the FDA had said in 1999 that it found no "evidence of harm from the use of thimerosal as a vaccine preservative." Id. at 38. That was presumably also the FDA's position in 1996, when Sykes was exposed to thimerosal. Plaintiffs could not seek to hold manufacturers liable "for disclosure failures involving unsubstantiated risk information that the FDA has considered and rejected." Id. at 42.

Plaintiffs asserted that the manufacturers could have unilaterally strengthened their products' labels. The court rejected this argument because, as a practical matter, manufacturers typically consult with the FDA before implementing labeling changes. Id. at 43. (We would add that, as a legal matter, the FDA can punish manufacturers who unilaterally implement labeling changes that the FDA believes are false, but Judge Stengel did not mention that point.)

Finally, the recurring question in drug preemption cases: What deference is due to the FDA's position in favor of preemption as set forth in the "Preemption Preamble" and recent amicus curiae briefs? (For a complete analysis of those amicus briefs, see our earlier post on that topic here.) "[T]he Supreme Court has held that the FDA's position on the preemptive scope of its regulatory authority 'is dispositive' as long as Congress does not clearly express its intent or other developments do not occur that reveal a change in the agency's position." Sykes, slip op. at 46. And "such preemptive intent may properly be communicated in amicus briefs as well as in 'regulations, preambles, interpretive statements and responses to comments.'" Id.

Plaintiffs asserted that the FDA's position on pharmaceutical preemption has not been consistent over time. Judge Stengel rejected that argument on many grounds. First, "inconsistency does not translate into dismissal of the FDA's position." Id. at 49. An agency is permitted to change its mind as it gains more experience with an issue. Second, "to the extent there was a change, the government has provided a reasoned analysis in the Preemption Preamble as to why certain state law tort claims are now preempted." Id. Third, "since 2000, the FDA has been very consistent in its preemption position." Id. at 49-50. Finally, "the 2000 statement in the Federal Register referred generally to the regulations and did not address the situation in this case -- where the plaintiffs' proposed warnings would have misbranded the biologics or were found scientifically unsubstantiated by the FDA." Id. at 50.

Here, Judge Stengel drops a footnote dismantling the usual plaintiffs' arguments that (1) the FDA failed to involve the states in the rule-making process before issuing its preemption decision and (2) applying the Preemption Preamble to existing cases somehow improperly applies that Preamble retroactively. Id. at 50-51 n.27.

Finally, Judge Stengel distinguished the few 2006 federal district court decisions decided after the Preemption Preamble that found no preemption of state law despite the FDA's position on the matter. (For a complete listing of all drug preemption cases decided during 2006, see our earlier post collecting those cases here.) "[S]ome of the [2006] cases do not even mention the Preemption Preamble, the cases that do mention the Preemption Preamble dismiss it with little or no analysis, none of the cases are binding authority, and none of the cases rely on an amicus brief produced by the FDA." Id. at 52.

At the end of the preemption discussion, a few stray state law claims against Bayer remained undecided. The plaintiffs resided in Virginia and the underlying facts giving rise to Sykes' injury occured in Virginia, which raised both choice-of-law and venue issues. Judge Stengel therefore gave guidance about Pennsylvania law in a series of footnotes and then granted Bayer's motion to transfer the case to Virginia.

Although we disagree with a few small aspects of the Sykes opinion, we are generally very, very pleased with it. Judge Stengel's decision does a magnificent job of explaining itself, and we hope that the Third Circuit panel that decides Colacicco and McNellis will give this reasoning the credit that it deserves.

1 comment:

Kathleen Seidel said...

Thanks very much for helping to make this decision understandable to those of us who aren't lawyers.

Here's my perspective on Sykes and her "vaccine safety" campaign.