We received positive feedback on our recent post on the Vaccine Act, so a recent Sixth Circuit opinion affirming a dismissal under the Act caught our eye. In our last post, we described how the Vaccine Act sets up a no-fault claims process that claimants have to exhaust before they can sue in a
Breaking news here. The Ninth Circuit has upheld a preemption-based dismissal of a Vaccine Act case. See Holmes v. Merck & Co., No. 08-16557, slip op. (9th Cir. Sept. 25, 2012). As the docket number indicates, the Holmes appeal has been pending for over about 4 years. It was resubmitted in 2011 after Bruesewitz …
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…
The other day the Pennsylvania Superior Court (an intermediate appellate court), sitting en banc no less, decided to weigh in on Vaccine Act preemption. See Wright v. Aventis Pasteur, Inc., 2011 Pa. Super 9, slip op. (Pa. Super Jan. 11, 2011). Briefly, the court did the same thing as the intermediate Georgia court did…
OK, not really. But we have had a chance to review yesterday afternoon’s oral argument transcript in Bruesewitz v. Wyeth, and here’s what went down (for a lot of Bruesewitz backstory, click here for our prior posts).
David Frederick argued on behalf of the petitioners. Adhering to the rule of three, Frederick said the Third Circuit was wrong for three reasons when it ruled that the Vaccine Act expressly preempts state-law design defect claims. First, argued Frederick, the language of the Act itself does not explicitly preempt design defect claims. Second, the question of whether or not an injury was “unavoidable” should be determined on a case-by-case basis, rather than triggering a broad express preemption of all design defect claims (Section 22(b)(1) of the Vaccine Act, which lies at the heart of this dispute, states that manufacturers are not liable if the side effects were “unavoidable even though the vaccine was properly prepared and was accompanied by proper directions and warnings.”). Finally, Frederick advanced the “think about the children” policy argument – i.e., preemption of design defect claims exposes kids to unnecessary safety risks. He also suggested that it will be very rare to see a design defect case get out of vaccine court and go to a state court jury, because proving causation and the availability of an alternative design is not easy. In other words, don’t worry about disincentivizing manufacturers with the specter of massive liability, because it is unlikely to happen.
Kathleen Sullivan argued on behalf of Wyeth. Although she was immediately beset by questions, primarily from Justice Sotomayor and Justice Ginsburg, Sullivan was able to argue (persuasively, in our opinion) that the petitioners’ reading of the statute ignores its plain language and meaning. In essence, there are three types of products claims one could bring against a manufacturer: manufacturing defect, design defect, and warning defect. Section 22(b)(1), read as a whole, makes clear that only manufacturing and warning defect claims survive; manufacturers are not liable for unavoidable risks where the vaccine was “properly prepared” and accompanied by proper…warnings.” In other words, if the vaccine wasn’t made right, you lose the protection of 22(b)(1). If you didn’t slap an appropriate warning on the vaccine, you lose the protection of 22(b)(1). Otherwise, you’re protected, since the statute did not include any clauses recognizing design defect claims. Sullivan also hit hard on the policy arguments supporting preemption of design defect claims, highlighting that the legislative history shows Congress was concerned about a vaccine “crisis,” where “manufacturers were being driven out of the vaccine business, imperiling the nation’s…vaccine supply by design defect claims that did survive summary judgment.”
So how did the Justices react to these core arguments? Of course, we have to offer the caveat that it is often a Talmudic exercise to guess at the meaning behind a particular Justice’s question, but the following patterns seem to have emerged:
Chief Justice Roberts, Justice Alito, and Justice Scalia appeared to be most concerned about the plain language of the statute, and the extent to which the Court may go beyond that language to infer (or not infer) that Section 22(b)(1) has preemptive effect. For example:
Chief Justice Roberts asked whether the compensation scheme set up in the Vaccine Act evidenced a Congressional intent to preclude state law claims. Justice Sotomayor, on the other hand, asked Sullivan why Congress did not simply make vaccine court the exclusive forum for recovery, thereby foreclosing state lawsuits.
The Supreme Court will hear oral argument in Bruesewitz v. Wyeth on Tuesday, October 12. Our prior Bruesewitz posts are here. We’ve taken a quick look at the briefs (look for #09-152), and offer the following points for argument watchers to look for:
(1) The most important interplay at oral argument will be how…
When the Levine, Riegel, and Kent cases were briefed in the United States Supreme Court, we provided our readers with “users’ guides”/”guided tours” that summarized the defense side arguments and pointed out whatever we thought was interesting.
Today we’re continuing that tradition with the Bruesewitz (sooner or later we’ll memorize how to spell that) v. Wyeth case on Vaccine Act preemption, which the Court will decide this coming term. Being defense lawyers, we only review our own side’s arguments (in public, at least), but all the Brusewitz briefs are available here on a this nifty website provided by the ABA.
We remember those days well, as we (well, Bexis) defended DTP manufacturers against the same sort of bizarre design defect claims at issue in Bruesewitz – that an alternative “safer” design can render a vaccine categorically defective, even though that design was not FDA approved. See White v. Wyeth Laboratories, Inc., 533 N.E.2d 748 (Ohio 1988) (the Ohio Supreme Court rejecting the theory). See also Wyeth br. at 19-21 (detailing regulatory history of supposed “alternative” designs of DTP). Basically no alternative “acellular” DTP vaccine received FDA approval for use in the relevant age group until 1996 – 4 years after the injury claimed in Bruesewitz.
The other day we learned that the U.S. Supreme Court will decide Vaccine Act preemption in Bruesewitz v. Wyeth. We’ll have plenty of time to obsess about the Bruesewitz case itself in the coming months, so today we’ll just use it as a convenient excuse to get a couple of things out of the way.
Remember Colacicco v. Apotex? At one point it was all the rage – indeed the surge in interest about the original 2006 district court opinion, Colacicco v. Apotex, Inc., 432 F. Supp.2d 514 (E.D. Pa. 2006), in which Bexis was involved as local counsel, was one factor that motivated creation of this blog. For a while we thought that Colacicco would be the case the Supreme Court would take to decide prescription drug preemption. But for a bunch of reasons, not the least of which was consolidation with another case, the wheels of appellate practice ground exceedingly slowly in Colacicco, and it got overtaken by Wyeth v. Levine. The rest, as they say, was history.
We still thought that we might at least get another crack at preemption post-Levine back in the district court in Colacicco. The plaintiff in the case did too, and didn’t like that prospect one bit. So really late in the game, he tried to be slick, sever some claims, and get out of Dodge (or at least Judge Baylson’s courtroom). No such luck. See Colacicco v. Apotex, Inc., 2009 WL 4729883 (E.D. Pa. Dec. 10, 2009) (denying transfer).
Today the Supreme Court granted certiorari in Bruesewitz v. Wyeth., No. 09-152. That means that the Supreme Court will resolve a split between the pro-preemption Third Circuit, and the anti-preemption Georgia Supreme Court regarding whether the Vaccine Act expressly preempts design defect claims in vaccine cases.
In what could be an important development,…