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

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:

Statutory Construction:

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.


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It always seems to happen – even with a site recommended by the Supreme Court’s own website.  In our users’ guide post last week to the defense-side (we’ll stay away from jargon like “top” and “bottom”) briefs in the Bruesewitz Vaccine Act preemption case, we missed one – the Chamber of Commerce’s amicus brief

A sharp-eyed reader (who wishes to remain nameless) yesterday put together our Bruesewitz user’s guide with our post last Tuesday about the Superior Court affirming (and confirming) in the Lance case that strict liability design defect claims don’t don’t lie against the manufacturers of prescription medical products in Pennsylvania.

The reader’s comment was:  “Do you

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’ll start, of course, with the brief filed by respondent (that means it won in the court below) Wyeth, the defendant maker of the DTP vaccine at issue in Bruesewitz.  As we’d expect, the brief starts off by reminding the court of the spectacularly beneficial effect that vaccines have on the public health, and takes the Court back to those dark days in the 1980s when product liability plaintiffs came very close to doing to vaccines what they’d done to Bendectin – drive them off the market through litigation costs and potential liability, regardless of the product’s actual risks.  Wyeth br. at 1, 5-9.

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.


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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,

Remember Bruesewitz v. Wyeth?  That’s the case about the Vaccine Act and express preemption.  It made our top ten list last year.  Bruesewitz and it’s evil twin, Wyeth v. Ferrari, appeared for a while to be headed for the Supreme Court together – there being a direct conflict between the two. 

We’re heard through the grapevine that vaccine preemption is taking a tortuous path in the U.S. Supreme Court — but a path that makes a grant of cert likely.

In the first of the two cases in which a party recently petitioned for cert in a vaccine preemption case, American Home Products Corp, dba Wyeth

The Third Circuit has just affirmed summary judgment on grounds of express preemption under the Vaccine Act in Bruesewitz v. Wyeth, No. 07-3794, slip op. (3d Cir. March 27, 2009). Interpreting the statute’s legislative history as demonstrating congressional intent to preempt sufficient to overcome any presumption against preemption, the court creates a split of