We recently commented on claimants who manipulate and evade the Vaccine Act by making vaccine claims, only then to make no effort to pursue them. Their play is to abandon their claims after the statutory 240-day waiting period and file lawsuits, where they stand a better chance of recovering more money. Because we think the
Vaccine Act
Terrible Decision Contravenes the Vaccine Act’s Purpose and Would Gut Its Protections

Some of us on the Blog are veterans of the original vaccine wars – those that preceded the enactment of the Vaccine Act, 42 U.S.C. §§300aa-10, et seq. That litigation, involving DTP and certain other childhood vaccines, nearly destroyed this country’s ability to vaccinate its children against often deadly diseases – much to the delight of antivaxxers everywhere. After Congress acted in 1986, much to the delight of everyone else, the Act’s alternative compensation system, combined with its strong preemption provisions restricting post-compensation system litigation have largely restored the nation’s childhood vaccine supply to a sound footing. The Supreme Court did its part in Bruesewitz v. Wyeth LLC, 562 U.S. 223, 231-33 (2011), holding that the Vaccine Act preempted all design defect claims asserted by claimants who rejected Vaccine Act awards and sought to litigate their claims instead.…
Thoughts on a Vaccine Act MDL

Bexis recently returned from speaking at the 2022 National Vaccine Law Conference. As a veteran of both the DTP and thimerosal vaccine litigations, he was generally interested in vaccine-related product liability issues, so he stayed for the entire conference. He was most interested in learning more about the compensation systems provided by the National Childhood Vaccine Injury Act and the PREP Act. The Vaccine Act, 42 U.S.C. §300aa-10 et seq., seemed most relevant, since the layers of preemption imposed by the PREP Act make product liability litigation over use of PREP Act “covered countermeasures” (which include vaccines) extremely unlikely.…
D. Nevada Dismisses Gardasil Vaccine Lawsuit

Happy Star Wars Day. May the Fourth be with you.
If all FDA approved medicines enjoyed the preemption protection that vaccines do, the DDL product liability litigation landscape would be leaner and less nonsensical. Flores v. Merck & Co., 2022 U.S. Dist. LEXIS 46442 (D. Nev. March 16, 2022), shows why that is so.…
Vaccine Act Dismissal Affirmed—An Intended Component Cannot Be A “Contaminant”

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…
Vaccine Act Preemption – Post-Bruesewitz

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 …
Notes on 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…
Why Bother?

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…
Bruesewitz Blow By Blow
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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Continue Reading Bruesewitz Blow By Blow
Bruesewitz Oral Argument – Some Things To Watch For

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…