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 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 Vaccine Act, Wyeth points out, was drafted partly in response to the proliferation of such “design defect” claims. It has several preemption provisions:
No vaccine manufacturer shall be liable . . . for damages arising from a vaccine-related injury or death . . . if the injury or death resulted from side effects that were unavoidable even though the vaccine was properly prepared and was accompanied by proper directions and warnings.
42 U.S.C. §300aa-22(b)(1) (emphasis added).
“[A] vaccine shall be presumed to be accompanied by proper directions and warnings if the vaccine manufacturer shows that it complied in all material respects with all [FDA] requirements.
42 U.S.C. §300aa-22(b)(2). We won’t go into it, but the Wyeth brief (pp. 11-15) extensively describes these FDA requirements.
“No State may establish or enforce a law which prohibits an individual from bringing a civil action against a vaccine manufacturer . . . if such civil action is not barred by this part.
42 U.S.C. 300aa-22(e). See Wyeth br. at 10-11.
The vaccine in question – “Tri-Immunol” – was very effective. Its widespread use reduced the number of pertussis cases in the United States by more than 99% and the number of pertussis deaths by 99.5%. Wyeth br. at 18.
After losing their Vaccine Act administrative compensation case – failing under even the Act’s more liberal causation standards – plaintiffs exercised their right to reject the administrative judgment and sue. Wyeth br. at 22. Among other claims, they brought a design defect claim of the sort the Act was directed against.
The big fight is about whether design defect claims are barred outright by the Vaccine Act or whether the Act allows such claims on a “case by case” finding that the injury wasn’t really “unavoidable.” Wyeth br. at 29. Wyeth’s first argument is straightforward statutory construction:
Congress’s choice of the definite article, “the vaccine,” is consistent only with a reading that preserves manufacturing-defect and failure-to-warn claims, not design-defect claims. “The vaccine” refers to the vaccine that was actually administered and . . . for which the manufacturer is being sued. As to that administered vaccine, a manufacturer may be found liable for manufacturing defect if it did not adhere to the vaccine’s FDA-approved specifications, or for failure to warn if the manufacturer did not comply with regulatory requirements or withheld information from FDA.
Wyeth br. at 31 (emphasis original) (citations omitted). That’s because, while the manufacturer can control and adjust its labeling and manufacturing processes, any change in design would “create a new vaccine that must be separately approved by FDA.” Id. It’s a fair point – one we’ve already made about design claims involving drugs.
Plaintiffs’ argument would effectively remove the qualifying language that defines “unavoidable” – “even though the vaccine was properly prepared and was accompanied by proper directions and warnings” – from the statute. Id. at 32. Those words define “unavoidable” solely in terms of manufacturing and warning criteria and don’t mention design at all. Id. at 32-33. Thus, they preclude plaintiffs’ nonsensical reading of the Act:
It makes no sense to read the statute to absolve a manufacturer of liability “even though” it does everything correctly. It does, however, make sense to address side effects that could not have been avoided through proper warnings and manufacturing, and the statute does so by preempting tort claims arising out of vaccine-related injuries that occurred even though the vaccine was properly manufactured and had proper warnings.
Wyeth br. at 33.
Plaintiffs’ truncation of the Vaccine Act in Bruesewitz sounds familiar to us. It’s an attempt to read the Act as giving defendants something they don’t need, something that’s legally useless. That’s because, if a defendant didn’t do anything wrong, then it needs no absolution – it’s simply not liable. It’s the same cockamamie reasoning we see with the heeding presumption, where plaintiffs argue that only “adequate” warnings are presumed to be read. Again, a defendant doesn’t need such a presumption because, if the warning’s already “adequate,” then the defense isn’t liable for that reason alone. As Wyeth puts it:
[I]f read as Petitioners propose, Section 22(b)(1) would preempt design-defect claims only under circumstances where the manufacturer would already have won the case on state-law grounds. No State in 1986 imposed (or today imposes) design-defect liability on manufacturers for injuries that could not have been avoided under any circumstances.
Br. at 34. Thus, Wyeth argues that the “straightforward” way to read the Act is: (1) allowing all manufacturing defect claims; (2) allowing warning defect claims subject to the presumption that FDA-approved warnings aren’t defective; and (3) prohibiting design defect claims. Id. at 35.
In addition to its textual approach, Wyeth argues that the structure of the Vaccine Act as a whole supports preemption. First, the Act, with its “predominantly regulatory scheme,” evinces Congress’ preference for administrative rather than jury resolution of vaccine claims because juries tend to discount overall societal utility of a product when confronted with an injured person. Wyeth br. at 36-39; see also our post here commenting on a multi-million dollar verdict in a recent vaccine case where the risk was one in a million. Second, the Act provides an alternative administrative compensation system to replace and limit the effects of the tort system on vaccines. Wyeth br. at 39-40.
In the part of Wyeth’s brief that’s of most interest to non-vaccine defense counsel, it discusses the Vaccine Act’s relationship to Restatement (Second) of Torts §402A, comment k (1965). While the Act was influenced by comment k’s “unavoidably unsafe product” concept, it didn’t outright codify comment k:
Restatement § 402A, to which Comment k is appended, addresses only actions for strict liability. Section 22(b)(1), by contrast, is far broader, preempting any “civil action for damages” – including claims for negligence, breach of implied warranty, and all other causes of action regarding vaccines.
Wyeth br. at 41. Conversely, “while Comment k is not confined to any particular type of product, [§22(b)(1)] applies exclusively to the small number of childhood vaccines covered by the Vaccine Act. Id.
Wyeth further points out the absurdity of plaintiffs’ comment k argument given the undisputed fact that Congress intended the Vaccine Act to restrict common-law liability for covered vaccines. The common-law courts of the time were “deeply divided” on whether to adopt a case-by-case or a more defendant-protective “categorical” reading of comment k to preclude design defect claims. Wyeth br. at 43-44. To read the Act as adopting case-by-case would thus reduce the protections accorded to vaccines in states that followed the categorical approach:
[That] would have the perverse consequence of leaving vaccine manufacturers worse off under state law than they were before the Vaccine Act. . . . [T]hose States . . . providing categorical Comment k protection to all vaccines would now have to allow case-by-case adjudication of design-defect claims in cases covered by the Vaccine Act. Such an outcome cannot be squared with the Act’s genesis in congressional concern that the litigation burden on manufacturers was so severe that it threatened the nation’s vaccine supply.
Wyeth br. at 44. That’s always been the aspect of the plaintiff-side Vaccine Act argument that we – as defense lawyers who deal deal with comment k in non-vaccine cases all the time – found most bizarre. Even before the Third Circuit got it right in Bruesewitz, we blogged about this state-law divide created an inherent contradiction in the plaintiffs’ position here.
Then, in what we’d like to think of as an indication of the strength of the defense position, Wyeth saves what we think is the best for last – not getting to the legislative history of the Vaccine Act until page 45. The legislative history of the Act itself, as every court (even ones like Ferrari that ruled against preemption) has recognized, clearly expresses an intent to prohibit design defect claims entirely:
Given the existence of the [no-fault] compensation system in this bill. . ., [v]accine-injured persons will now have an appealing alternative to the tort system. Accordingly, if they cannot demonstrate under applicable law either that a vaccine was improperly prepared or that it was accompanied by improper directions or inadequate warnings [they] should pursue recompense in the compensation system, not the tort system.
Wyeth br. at 46-47 (quoting 1986 House Report). Wyeth goes on to demolish the various odds and sods that the plaintiffs toss out in the guise of legislative history. Id. at 48-53 (statements made after the Act was passed, or by individuals, some of whom were not even legislators).
Finally, Wyeth closes the way it opened, with a ringing policy-based defense of preemption based upon the critical importance of vaccines to the public health. Discussing the massive, but scientifically baseless, thimerosal/autism attack on vaccines, Wyeth lets the Court know that, without the strong preemption included by Congress in the Vaccine Act, what happened in the 1980s could well recur:
Were this Court to hold that the Vaccine Act does not preempt design-defect claims, claimants in the [thimerosal] omnibus proceeding could be emboldened to pursue a flood of civil actions. As the American Academy of Pediatrics has explained, the consequences of such litigation for the vaccine supply (and ultimately for public health) could be devastating.
Wyeth br. at 56-57 (citations omitted).
If anybody needs an authoritative description of the Vaccine Act – both generally and with respect to its alternative administrative compensation scheme, the government’s Bruesewitz brief is a good place to start. See U.S. br. at 2-6, 25-29. The government put a lot of work into this part of its brief, and has created an excellent resource.
Thankfully, in stark comparison to the frequently anti-preemption stance of the Obama administration, the federal government has consistently supported preemption of design defect claims under the Vaccine Act. But we were looking for the caveat that would allow the administration to take anti-preemption positions against other FDA-regulated products, and we found it on page 19: “The federal government has a unique policy governing childhood vaccines, and that policy differs from those governing most pharmaceuticals and medical devices.” So this brief is strictly one-off.
The government makes essentially the same textual and comment k based arguments as Wyeth. But on certain points it goes farther – particularly in emphasizing the speculative nature of design defect claims:
[F]or the plaintiff to prove the existence of a safer alternative vaccine, would the alternative vaccine simply have to be available in a lab somewhere? Or would it have to be available for sale? Must it have been licensed by FDA? . . . A particular side effect might have been avoided by using an unlicensed, untested vaccine of unknown potency that exists only in a laboratory. Yet no one suggests the possibility of that kind of avoidance would be reason to hold a vaccine manufacturer liable.
U.S. br. at 11. Thus the government argues that the relevant state of the art is limited to the universe of FDA-approved products. Since the FDA is the government, that’s hardly surprising.
Then the government makes an argument about statutory construction that echoes the complaints that defense lawyers raise about inadequate warning claims – that in hindsight it’s always possible to suggest “better” language:
Petitioners further suggest that if Congress had intended to bar all liability based on vaccine design, it could have said so more clearly or in different words. But it is always possible to construct through hindsight an alternate structure for a statute with alternative wording that would render it more clear.
U.S. br. at 12. Glad to see the government with us on that point.
Unlike Wyeth, the government doesn’t wait very long before playing the legislative history card – since the 1986 contemporaneous history is so favorable.
The 1986 Report states that the Committee “intends that the principle in Comment K regarding ‘unavoidably unsafe’ products . . . apply to the vaccines covered in the bill and that such products not be the subject of liability in the tort system.” 1986 Report 26. In other words, vaccines covered by the Act are categorically deemed “unavoidably unsafe products,” if properly prepared and labeled, and thus not subject to design-defect claims. . . . [T]he 1986 Report explains that “the principle . . . regarding ‘unavoidably unsafe’ products” – the principle of non-liability – should always apply if the vaccine has been properly manufactured and labeled.
U.S. br. at 14. It points out another illogical aspect of the plaintiffs’ case-by-case argument:
[N]o State in 1986 left vaccine manufacturers without even the prospect of invoking Comment k case-by-case. Thus, on petitioners’ view, Congress achieved nothing in Section 22(b)(1) because it preempts liability only for conduct that state tort law would never have held tortious in the first place.
Id. at 15 (emphasis original). Plaintiffs thus argue that, while giving defendants no greater protection than existing law, the Vaccine Act affirmatively forbade the states from doing so. “That is irreconcilable with Congress’s overriding concern about instability and unpredictability of the childhood vaccine market.” Id. (citation and quotation marks omitted).
The government also compares at some length the Vaccine Act’s approval process to the “rigorous” PMA system for devices at issue in Riegel v. Medtronic, Inc., 552 U.S. 312 (2008). U.S. br. at 20-21. We have to note that the same could be said about prescription drugs, however. Conversely, it contrasts vaccine design criteria with the warnings at issue in Wyeth v. Levine, 129 S. Ct. 1187 (2009):
[T]he Vaccine Act . . . required prior FDA approval of any “[i]mportant proposed changes,” which included any design changes. Congress therefore could not have expected vaccine manufacturers to alter the designs of their vaccines unilaterally. The situation here thus differs materially from [Levine], in which this Court concluded that the drug manufacturer could have unilaterally remedied a labeling defect.
U.S. br. at 21. The Act’s joint public-private partnership is thus sufficient in the government’s view to ensure vaccine safety. “Tort litigation play[s] no role.” Id. at 24 (discussing rotavirus vaccine example). Indeed, product liability can be counterproductive:
[S]uch liability could, perversely, stall innovations in safety. As noted above, the side effects of childhood vaccines can be so rare that they are not evident until millions of doses have been administered, meaning that a manufacturer may be unable realistically to assess its potential liability before marketing a vaccine. Public health would be undermined if manufacturers reacted by foregoing research and development of new vaccines.
Id. at 25. The government closes with a cogent debunking of the Japanese experience with DTP – why, far from being a model that this country should follow, that was a public health disaster, involving a scientifically baseless panic; a preventable pertussis epidemic that sickened thousands, and killed scores, of babies; and the substitution of an unproven vaccine that “fortunately” turned out to work. Id. at 32-33.
Finally, as if to prove the point that it’s always interesting to read the government’s amicus briefs, we’ve found something else of interest that has nothing to do with preemption. The government’s brief makes a point that we’ve made elsewhere about why voluntarily submitted adverse events aren’t probative of causation. After pointing out how the Act “mandates stringent post-licensing monitoring by requiring that both vaccine manufacturers and health care providers report side effects,” br. at 21, the government goes on to state that “voluntary” adverse event reports “alone” simply aren’t enough to establish anything:
Because VAERS [the Vaccine Adverse Event Reporting System] depends on self-reporting, however, its data alone are not sufficient for sound public health policy decisions. VAERS data are instead used to trigger further investigation….
U.S. br. at 21-22. We’ll remember that.
The three other major US vaccine manufacturers – GlaxoSmithKline, Merck, Sharp & Dohme, and Sanofi-Aventis – filed their own amicus brief. It’s primarily a historical and policy document, giving a detailed history of the vaccine industry leading to the tort liability crisis of the 1980s, and how, even today, most vaccines are made by only one or two suppliers. G/M/S br. at 7-9. This brief details the financial realities of the vaccine industry: the high costs, problematic product development, limited duration use, and restricted profit opportunities for products sold primarily in bulk to governmental agencies. Id. at 9-12.
All these economic strains reached a boiling point in the “product liability crisis” of the 1980s – the backdrop for Congress’s enactment of the Vaccine Act. Vaccine companies faced unprecedented exposure to tort liability, culminating in a rash of market departures and vaccine supply shortages. In 1985 alone, 219 lawsuits were filed against vaccine manufacturers seeking over three billion dollars in damages for injuries alleged to have been caused by [DTP] – a figure over 30 times greater than the market value of all DTP vaccine sales that year.
Id. at 13. If Congress had not acted, all the remaining companies were preparing to stop making vaccines. Id. at 14. All in all, the brief is a compelling testament to the harm that product liability can cause to society as a whole.
Vaccines are administered to apparently healthy children at very young ages. Thus they’re a convenient scapegoat for anything that might start going wrong during the early years covered by mandatory immunization schedules:
When an apparently healthy child experiences a serious condition in the wake of vaccination, parents naturally have the instinct to search for something to blame . . . even though many diseases and developmental disorders naturally and independently manifest themselves during childhood, coincidentally during the same time period vaccines are administered.
G/M/S br. at 16-17. The Vaccine Act was a measured response to the tort liability crisis, as it “applies only to vaccines that the government has recommended for all children.” Id. at 18.
Even more than Wyeth, the G/M/S brief delves into the current thimerosal mass tort, based upon claims that are even more scientifically bogus than those brought against DTP:
Every government public health agency and reputable scientific body to address the question has rejected the hypothesis that thimerosal-containing pediatric vaccines ever caused or contributed to autism. . . . As of 2008, at least eight major studies had examined the effect of reductions or removal of thimerosal as a preservative from vaccines, and all demonstrated that autism rates failed to decline despite the removal of thimerosal.
Id. at 20-21. Still, over 5000 utterly meritless thimerosal claims, including some 350 civil suits, persist in our legal system. Id. at 22. But even what’s in this brief is understated. Unmentioned is the fact that what little support ever existed for thimerosal/autism claims has proven to be academically fraudulent, as we discussed here.
In an extraordinary show of support by medicine for industry (and in vivid contrast to the pro-plaintiff attitude of the New England Journal of Medicine) no fewer than 22 medical societies led by the American Academy of Pediatrics joined forces to support preemption in the case of childhood vaccines.
Heck, it takes almost one-third (9 of 29 pages) just to describe all these organizations.
Why did they do this? First, because health care professionals know that vaccines work – they see it every day of their professional lives:
The public health benefits of childhood vaccines cannot be overstated. Because of vaccines, a number of debilitating and life-threatening infectious diseases have been eliminated or virtually eliminated in this country, thereby not only enhancing the length and quality of life of countless children, but also providing significant savings in direct and indirect costs. It is no wonder that Congress has declared that the availability and use of vaccines to prevent childhood diseases is among the Nation’s top public health priorities.
Societies br. at 10. If anybody ever needs a richly cited paean to the value of vaccinations, look no further. Id. at 12-15.
Second, because product liability litigation almost destroyed childhood vaccination in this country once, and given the chance, would do it again:
In the mid-1980s, the number of vaccine-related lawsuits filed against vaccine manufacturers rose sharply. . . . [T]he flood of vaccine-related litigation overwhelmed vaccine manufacturers. A genuine threat to the public health emerged as manufacturers abandoned or considered abandoning the vaccine market. . . . [A]doption of petitioners’ interpretation of the Act could precipitate the same crisis that Congress sought to avert in passing the Vaccine Act: the very real possibility of vaccine shortages, and, in turn increasing numbers of unimmunized children, and, perhaps, a resurgence of preventable diseases.
Societies br. at 10-11. See Id. at 16-19, 23-26. Litigation drove up the prices of some vaccines by 900% before the manufacturers began dropping out of the market altogether. Id. at 17. “Case by case” analysis is just a stalking horse for universal litigation, as “every design defect claim is subject to evaluation by a court” in each case. Id. at 24 (emphasis original).
Third, umm … who needs a third point when the first two are that strong?
Our kindred spirits over at the Washington Legal Foundation also filed an amicus brief in Bruesewitz largely to protect what may well be the most comprehensive and successful piece of federal tort reform legislation ever from being gutted after a quarter century of successful operation:
The contrary interpretation of the Vaccine Act urged by [petitioners] would completely undermine one of the principal policy considerations that influenced Congress’s decision to pass the Vaccine Act. Allowing a disappointed vaccine claimant who lost in the Vaccine Court to then seek compensation for design defects via civil tort litigation would exacerbate, not remedy, the burden of litigation and the threat of large and unpredictable jury awards against vaccine manufacturers. Nor would it do anything to help to control the skyrocketing costs that would result from extravagant civil jury awards.
WLF br. at 8-9. WLF might not like federal regulations very much, but it likes regulation by litigation even less.
Most of the WLF’s brief is pure policy – which underscores something that defendants have going for them in this case. Vaccines are a public good. They’re responsible for probably at least 20 of the 30 year expansion in life expectancy in the US in the Twentieth Century. If ever there’s a product that it will be hard for the other side to vilify before the Supreme Court, childhood vaccines are it.
Scientists’ Amicus Brief
Making the policy-related rubble bounce, a group of eleven scientists also filed a brief in support of preemption and vaccination. Like the associations, their CVs (in extremely abbreviated form, no doubt) take up a third of the brief. Among them is James Watson, the co-discover of DNA.
The scientists’ brief expressly devotes itself to public health implications, rather than strictly legal arguments. Scientists’ br. at 7. It is notable for citing only two cases other than the decision below – the most recent of which is from 1922. Since we’re lawyers, not scientists, there’s not a great deal that we can report about this brief other than it’s another excellent discussion of the public policies in favor of universal vaccination.
But with us, they’re preaching to the choir.
That’s all the pro-defense briefs listed on the ABA’s site. If we missed any, let us know.