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In simpler times for those of us of a certain age, what we learned in elementary school was often supplemented during Saturday mornings watching cartoons.  While you could pick up some information watching Super Friends or Captain Caveman, the catchy songs and minimalist animation of Schoolhouse Rock! really helped to teach children a range of things they could use.  For instance, we learned the magic of the number three and the function of conjunctions.  As the U.S. Bicentennial approached, we were treated to a basic civics lesson in “I’m Just a Bill.”  In telling his tale, Bill described a basic part of the Constitution and separation of powers with a name that is not as well known, the Presentment Clause.  (Not to be confused with the term “presentment” that law students learn in their “Commercial Paper” class and usually forget soon after the final exam.)  The concept is simple:  a bill passed by both houses of Congress is not a law until the President signs it (after it is presented to him/her).  Among the obvious implications of this are that bills cannot become laws without the signature of the President and the President cannot make a law without Congress passing a bill first.  Like virtually every provision of the Constitution, there are Supreme Court decisions on the Presentment Clause, most notably in the post-Schoolhouse Rock! era, Clinton v. New York, 524 U.S. 417 (1998), concerning the Line Item Veto Act.  We had never seen the Presentment Clause raised in a drug or device case, however, at least one that had been august enough to merit a post or mention on these hallowed pages.

That changed with a recent decision of the MDL court in In re Gardasil Prods. Liab. Litig., No. 3:22-MD-03036, 2024 U.S. Dist. LEXIS 113839 (W.D.N.C. June 27, 2024).  We have discussed previously how the court had held most of the claims asserted by the bellwether plaintiffs were preempted.  (A similar decision was reached as to the same vaccine by another federal court before the MDL.)  We have also discussed how having a childhood vaccine MDL is peculiar.  Because it is an MDL trying to promote efficiency, the court invited other pending plaintiffs to move to avoid the application of the preemption ruling to their own substantially similar claims.  This was clearly not an invitation for a global re-do.  Yet a group of plaintiffs, implicitly conceding they had substantially similar claims and no basis to be treated differently than the bellwethers, offered the new argument that the application of the Vaccine Act to the particular vaccine at issue in the MDL violated the Presentment Clause.  Really, the argument applied equally to every vaccine now on the Vaccine Injury Table—we will explain that—that was not there when the National Childhood Vaccine Injury Act of 1986 was signed into law by President Reagan on November 14, 1986.  This is, legally speaking, a ludicrous argument.  Picking just one of the new ones, the seasonal influenza vaccine—i.e., the flu shot—has become part of the rhythm of life for school age children and their parents.  Were these plaintiffs correct, then children with anaphylaxis, shoulder injury related to vaccine administration, vasovagal syncope, and Guillain-Barre Syndrome, within a specified onset period for each, would be ineligible for participation in the Vaccine Injury Compensation Program without proof of causation.  Without speculating too much about the motivations for pursuing this novel argument in the context of a vaccine for human papillomavirus, we can say that a win for plaintiffs on this argument would frustrate the purpose of Congress, be bad for public health, and be good for plaintiff lawyers.  See here and here.  It also seems to fit with the disturbing pattern we have noted previously of litigation against medical products for women’s health, given the data on utilization by sex and the purpose of HPV vaccines.

Luckily, the Gardasil court shouldered aside the argument and stuck to its prior position.  The argument could have been rejected solely based on the procedural posture.

Although the broad constitutional question now raised by Plaintiffs is not the type of argument that the Court intended to invite in allowing other plaintiffs to raise individual issues after the resolution of [the bellwether plaintiffs’] motions, the Court will consider the merits of Plaintiffs’ constitutional challenge so as to put it to rest for all Plaintiffs.

Id. at *27.  The Presentment Clause argument was the procedure for adding covered new vaccines required action by the Secretary of Health and Human Services rather than a bill passed by Congress that was signed by the President.  This sole case support for the argument was a dissent in a 1999 case from the Federal Circuit.

Agreeing with this contention (which no court has ever accepted), would result in the effective removal from the Vaccine Act of all of the childhood vaccines developed in the nearly 40 years since its enactment in 1986, notwithstanding decades of vaccine table additions and the routine enforcement of the Act with respect to those “new” vaccines.

Id. at *30.  There is also more than a decade worth of vaccine preemption decisions since Bruesewitz v. Wyeth LLC, 562 U.S. 223 (2011).  While Bruesewitz involved the diphtheria, tetanus and pertussis vaccine, which was part of the original vaccine table, many of the decisions finding preemption since then have involved vaccines added to the table.  Implicit in every decision was that the addition was not invalid due to a constitutional infirmity or otherwise.  That nobody, as far as we know, had even raised the Presentment Clause in connection with litigating preemption based on the Vaccine Act says something.

A claimant under the Vaccine Injury Compensation Program has an easier route if he/she claims a “table injury.”  The Vaccine Act sets out a procedure for adding a new vaccine and specified injuries to the table.  Essentially, when the CDC recommends a new vaccine for routine administration to children, the Secretary of HHS adds it to the table within two years by promulgating a regulation.  Based on a 1993 amendment to the Vaccine Act, the addition takes effect only if/when Congress enacts an excise tax on the vaccine and the President signs the bill.  The test for an exercise of impermissible legislative power by the Executive branch—of which HHS is a part—comes from Field v. Clark, 143 U.S. 649 (1892), and the Vaccine Act’s application to HPV vaccines did not not come close to meeting it.  The addition of vaccines to the original table was based on future events—i.e., the development, approval, and acceptance of new vaccines—and was not discretionary for the Secretary of HHS.  2024 U.S. Dist. LEXIS 113839 at *38.  In addition, because of the requirement of an excise tax before the Secretary’s action has any real effect, Congress retains legislative authority.  That happened with the HPV vaccine expressly in the Tax Relief and Health Care Act of 2006, which was passed by Congress and signed by President G.W. Bush.  “Therefore, the Secretary’s inclusion of ‘Additional vaccines’ in accordance with the specific directions in the statute does not violate the Presentment Clause.”  Id.

That was more than enough.  However, even the dissent that plaintiffs cited had recognized that the process for adding new vaccines to the table through the Secretary’s rulemaking authority was constitutional.  Id. at *39 n.3 (citing Terran ex rel. Terran v Sec’y of Health & Hum. Servs., 195 F.3d 1302, 1321 (Fed. Cir. 1999) (Plager, J., dissenting)).  The Terran dissent took issue with a different provision of the Vaccine Act than the provision that authorized adding vaccines to the table.  Of course, because it was a dissent, the Terran majority had found otherwise:  “[W]e hold that the Vaccine Act does not violate either the Presentment Clause of the Constitution or the nondelegation doctrine that emanates from separation of powers principles.”  195 F.3d at 1317.  The Federal Circuit, of course, takes appeals from the Court of Federal Claims, which is responsible for challenges to a Special Master’s decisions on claims under the Vaccine Injury Compensation Program.  In other words, for the court with jurisdiction specific to the system set up by the Vaccine Act, the binding authority for twenty-five years was that the Vaccine Act did not violate the Presentment Clause.  Making the Gardasil plaintiffs’ argument in the Court of Federal Claims probably would have ventured in Rule 11 territory.  This brings us back to why an MDL on a childhood vaccine should exist at all.  It is a good thing that Bruesewitz’s preemption of design defect claims for covered vaccines is binding authority in the Western District of North Carolina, as in all other federal courts.  After the Presentment Clause detour, the court’s ruling preempting design claims now applies to every plaintiff in the Gardasil MDL, which is clearly correct.

As a bonus, here is the Schoolhouse Rock! episode on separation of powers and here is the episode on the nation’s anti-autocracy roots.  This one shows an injection of a medication, but presumably not a vaccine.