When we first wrote on public universities requiring COVID-19 vaccines, we wondered why there was any controversy.  The government has been requiring vaccines in public schools for decades, and the constitutionality of government vaccine requirements has been settled for more than 100 years.  Courts have agreed—including the Seventh Circuit, as we reported here.

But

We reported two weeks ago on the poorly conceived and ill-fated attempt by students to enjoin a public university from mandating COVID-19 vaccines.  There simply is no fundamental right under the Constitution to refuse vaccination, which has been firmly established for more than 100 years.  Now the Seventh Circuit has agreed.

Let’s be candid about

Sometimes judges save what they really want to say for the end of their orders; and sometimes, even when one side clearly and justifiably prevails in a lawsuit, there are no winners.  That is the sad tale of Doe v. Merck & Co., No. 16-CV-04005, 2019 WL 1298270 (E.D.N.Y. Mar. 21, 2019), which represents

Many of the more senior among the current prescription medical product liability defense bar cut our teeth during the vaccine wars of the 1980s/1990s.  Thus, we noted with grim satisfaction when the junk science progenitor of the purported “link” between vaccines and autism lost his medical license.  A decision we recently came across suggests that

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.


Continue Reading Bruesewitz Blow By Blow

Last Friday, the U.S. Court of Appeals for the Federal Circuit affirmed the second of the three defense verdicts in the test cases alleging that the measles-mumps-rubella vaccine causes autism. Cedillo v. Secretary, HHS, No. 2010-5004, slip op. (Fed. Cir. Aug. 27, 2010). Although the Cedillo decision turns on the specific facts of