The Holiday season is also the cinema season. We’re giddy about movies right now. Today sees the release of the trailer for No Time to Die, the 25th Bond film (counting only the “official” EON productions – sorry about that, Casino Royale (1967) and Never Say Never Again (1983)). No Time to Die (hereinafter
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…
Last Wednesday an article appeared on the front page of The Wall Street Journal, “Mistakes in Scientific Studies Surge,” that got our attention. Retractions of articles from scientific journals have been climbing at a staggering rate. While the number of articles has increased by 44% since 2001, the number of retractions has…
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:
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.
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…
Rarely, if ever, have we come across litigation as socially detrimental and scientifically baseless as the claims, mostly centered in the Vaccine Court, that mercury-containing Thimerosal, or vaccines generally, cause autism. We’ve commented on this litigation before, mostly in the context of “junk science.”
Well, stick a fork in it, it’s just about done. Yesterday, the Federal Circuit affirmed the first of several decisions by Vaccine Court that firmly reject any link between childhood vaccines and autism. Hazlehurst v. Secretary, HHS, No. 2009-5128, slip op. (Fed. Cir. May 13, 2010).
Interestingly enough, when push came to shove, even the plaintiffs ditched the claim that Thimerosal caused autism. Slip op. at 2. (“in post-hearing briefing they relied on the theory that [claimant’s] autism was caused by the MMR vaccine alone”). It says something about this causation theory when even the plaintiffs don’t feel that it passes the red face test on appeal.
The phony causation opinions of Dr. Andrew Wakefield featured strongly in the opinion:
The special master found that Dr. Wakefield’s work had been largely discredited within the scientific community and that none of the studies indicating the presence of measles virus in autistic children had been successfully replicated by an accredited laboratory independent of Dr. Wakefield or Unigenetics. In particular, the special master found that Dr. Wakefield’s early 1990s research on persistent measles infections was reviewed by the Medical Research Council of the United Kingdom and found to lack important controls and sufficiently specific reagents for detecting measles virus. She also found that Dr. Wakefield’s subsequent research was dismissed by the scientific community as methodologically unsound. In that regard, she noted that 10 of 12 co-authors on Dr. Wakefield’s controversial 1998 article in the medical journal The Lancet subsequently retracted their support for the article’s conclusion that there is a potential causal link between the MMR vaccine and autism.
Slip op. at 7.
The BBC is reporting that the British Medical Journal Lancet has issued a full retraction of the notorious 1998 article that claimed there was an increased risk of autism associated with use of the MMR vaccine. Among the grounds for the retraction: the lead author “was in the pay of solicitors who were acting for…