Photo of Bexis

Yesterday we were busy … or traveling … or whatever.  Presumably everybody reading this already knows that yesterday the Supreme Court was simply busy – and decided the Bruesewitz v. Wyeth vaccine preemption case.  Not only that, as everybody knows Bruesewitz was decided favorably to preemption by a 6-2 score.  Since we don’t get any brownie points on this one as a breaking news event, we’ll have to go for analysis.
So here are our takeaways from Bruesewitz.

  1. Express preemption has more friends on the Court than implied preemption.
  2. The great DTP versus DPT controversy has been definitively settled in favor of DTP.  As we recall from doing vaccine cases pre-Act, that’s a defense win.
  3. Vaccines have successfully staked a claim to the ultimate public good in our sandbox, and the Supreme Court knows it.
  4. Vaccine manufacturers were “immunized” from warning claims before (assuming compliance) and with design claims now barred, the only thing really left for a non-listed-injury vaccine plaintiff is a defective manufacture/violation claim.  This result could create pressure to list more injuries as within the program.
  5. The amazing now-you-see-it, now-you-don’t presumption against preemption went on walkabout again.  It’s not mentioned anywhere in the majority or concurring opinions (6 justices), and even the dissent relegates it to a footnote.  Dissenting slip op. at 18-19 n.15.  Over the last few years the presumption (if that’s what it is) has performed the legal equivalent of a round-off back handspring.  It started off as an express preemption concept (a purported means of statutory interpretation) and has ended up as primarily a creature of implied preemption.
  6. “Unavoidable” means what it says.  Thus design claims, which would make avoid-ability a moving target, are gone as a matter of straight-forward statutory interpretation.
  7. There are only three basic products liability claims – manufacturing, design, and warning.  The “triumvirate” quote, slip op. at 8, at aspect could come in useful in cases where plaintiffs pursue other theories, such as “failure to test.”
    (8)  Pure risk/utility balancing involving alternative designs – a common type of design defect litigation (including the Third Restatement) – takes a hit.  The Supreme Court (quite rightly) calls it “amorphous” and impossible to apply, so that as a test, risk/utility “probably ha[s] no real world effect.”  Slip op. at 8 n.35.  The problem is that most alternative tests for design defect are even worse.
  8. Comment k takes a hit, too.  It’s “defined by a hodge-podge of criteria and a few examples” and suffers from “lack of clarity.”  Slip op. at 9.  Again, the problem is that a world without comment k is worse – see the discussion of risk/utility balancing, above.  The Court takes Alexander’s approach to the Gordian knot, and simply cuts comment k loose.  Id. at 9.  That simplifies things, even if it probably does some violence to what Congress actually thought it was doing.
  9. The Court’s list of “across the board” comment k states will be useful when we’re in those states.  Slip op. at 10 n.41.  It’s basically the same point we made over two years ago with our own state-by-state list, here.  The Court comes back to the point on pages 18-20, pointing out that “widespread disagreement” as to the meaning of comment k precludes the use of any judicial gloss on the statutory “unavoidable” language.
  10. Grammarians will love the discussion of “concessive subordinate clauses” on p. 11.  The rest of us will feel like we flunked the sixth grade because we didn’t diagram enough sentences.
  11. We love this sentence, “But the rule against giving a portion of text an interpretation which renders it superfluous does not prescribe that a passage which could have been more terse does not mean what it says.”  Slip op. at 12.  Just because draftsmen weren’t the absolute best isn’t a carte blanche to ignore what they did say.  In statutory interpretation, the perfect should not be the enemy of the good.
  12. We wish footnote 48 (slip op. at 12) were longer, because if it were, the Bates “use the interpretation that restricts preemption” language probably would have explicitly bitten the dust.  As it stands, footnote 48 recognizes it as obiter dictum, labeling it superfluous in the context of Bates.
  13. 90 FDA regulations are enough to “pervasively regulate” vaccine manufacturing.  Slip op. at 13.  Geez, how many drug regulations do we have?
  14. In order to “cost the manufacturer its regulatory-compliance defense” a regulatory violation must be “material.”  Slip op. at 13.  That could also come in handy in device preemption cases.
  15. “Drug manufacturers often could trade a little less efficacy for a little more safety, but the safest design is not always the best one.”  Slip op. at 13.  We like it – especially since the Court for some reason is referring to “drugs,” not vaccines.
  16. The Court’s rationale (slip op. at 14) that the relative lack of FDA “guidance” concerning designs, combined with extensive labeling and manufacturing regulations, is supportive of express preemption by omission is another proposition that strikes us as potentially being useful in the context of medical device preemption.
  17. Governmental incentives are an acceptable alternative to tort litigation as a means of encouraging safer product design.  Slip op. at 15.
  18. We’ve often considered warning claims to be the last refuge of the scoundrel (with apologies to Samuel Johnson) plaintiff with no real case.  The Supreme Court seems to award that distinction to design defect claims.  “[D]esign-defect allegations are the most speculative and difficult type of products liability claim to litigate.”   Slip op. at 15-16.  We’ll remember that when a prescription drug design defect claim comes to the Court post-Levine.
  19. Some things never change.  Justice Scalia still hates legislative history as a means of interpreting statutes.  Slip op. at 16 (“those of us who believe”).
  20. The Court blows out “post-enactment legislative history” as not having any place in statutory interpretation.  Slip op. at 17-18.  Funny how a different author not long ago blithely relied upon 70 years of just such post-enactment history (and by negative implication, no less) in Levine.
  21. “Permitting the legislative history of subsequent funding legislation to alter the meaning of a statute would set a dangerous precedent.”   Slip op. at 18.  The Obama administration should file this quote away for possible use with respect to health care reform.
  22. Justice Breyer may not be the most consistently pro-preemption justice, but when he’s good, he’s very, very good.  “To allow a jury in effect to second guess those [government] determinations is to substitute less expert for more expert judgment, thereby threatening manufacturers with liability (indeed, strict liability) in instances where any conflict between experts and non-experts is likely to be particularly severe.”  Concurring op. at 5.

Finally, as a purely atmospheric matter, it is refreshing to see the court softening the anti-preemption tone that former Justice Stevens set in Levine.  While it’s hard to get one’s hopes up given the battering that prescription drug preemption has taken since the benighted decision, the Court’s comments on design defects leave us some reason for optimism that the extreme conflict cases in the prescription drug area, such as Wimbush and Bartlett, stand a chance of favorable consideration before the Court.