We lived through the AIDS epidemic – which is more than we can say for some of our friends. We were in law school when people started dying. Throughout our careers as junior lawyers AIDS was a death sentence. We attended memorials. We walked in AIDS walks. We’ve seen the AIDS quilts. Ask Dr. Anthony Fauci, who was there:
In a 2016 interview, Fauci said the 15 years it then took researchers, many working in partnership with the NIH, to develop highly effective treatments for HIV “were the dark years of my life and my career, because almost every single one of my patients died. And that was a terrible feeling.”
If AIDS had been as communicable as COVID-19, or if COVID-19 had been as deadly as AIDS, civilization as we know it probably would have collapsed. But it wasn’t, and it didn’t. Instead, it turned into a 20th Century pharmaceutical success story:
Now, steady improvements in the care and treatment of people with HIV have expanded life expectancy of newly diagnosed 21-year-olds from an additional 12 years in the late 1980s to 56 years today . . . . Fauci said NIAID in particular “has been the major force in the development of drugs, in work toward the vaccine, in understanding the pathogenesis and the development of prevention modalities.” “And, of course, we’ve had all those innovations at a pace far faster than for any other medical condition, because [Dr. Fauci’s] urgency matches his rigor. . . .”
But now comes the revisionist history. We called it “hindsight” and “Monday morning quarterbacking” when allegations arose that the introduction of literally lifesaving AIDS drugs should have been postponed pending a potentially “safer” design in a case out of California, Holley v. Gilead Sciences, Inc., 379 F. Supp.3d 809 (N.D. Cal. 2019). Even taking those allegations at face value, even if a different drug introduced years later was easier on the kidneys, that wouldn’t help the tens of thousands that would have died of AIDS in the interim. That “hindsight-oriented opinion on hindsight claims alleging that first-generation drugs should not have even been submitted to the FDA because later treatments were safer” became our number seven worst – and worst trial-court-level – decision of 2019.
But now the same grotesque error has migrated east and can no longer be ascribed to California quirkiness. Thus, we condemn it again, in Gaetano v. Gilead Sciences, Inc., 2021 WL 1153193, at *1 (D.N.J. March 26, 2021). We note that, once again, these unprecedented “design defect” claims arise from a federal court purporting to predict state law, in stark violation of controlling Supreme Court and Third Circuit precedent that prohibit such novel predictions of state-law liability expansion.
Plaintiff Gaetano – who can thank his AIDS drugs for not being dead – alleges that the defendant put all of its effort into getting a particular AIDS drug approved in 2004. 2021 WL 115319, at *1. Since the defendant “had developed and sold other [similar] drugs in the years before marketing” the drug plaintiff attacked, it was allegedly aware that this class of drug “caused bone and kidney problems.” Id. A “safer” alternative allegedly exists. Id. Defendant developed it and received FDA approval in 2015. Id. “[I]t allegedly could have been approved years earlier if [defendant] had not forgone it in favor” of the earlier-approved drug. Id.
We can see where this is headed right now – this is as theory that is not just directed against one drug, but would allow similar attacks on every other drug in this class. It’s basic premise is that, whenever a “safer” alternative drug becomes available, all prior drugs are necessarily “defective.” And it’s not even true, not by a long shot. All prescription drugs have their own mix of risks and benefit. According to a respected AIDS newsletter:
[The drug plaintiff attacks] is generally safe and well tolerated, but it can cause kidney problems and bone loss in some people. [The supposed alternative] has less effect on the kidneys and bones. On the other hand, [the attacked drug] leads to lower cholesterol and triglyceride levels, which can lessen cardiovascular risk. [The claimed alternative] does not have the same beneficial effect on blood lipids, and it may be linked to greater weight gain. . . . Overall, research shows that both [drugs] are very effective for HIV treatment. . . . Because [both drugs] are both so effective, it is difficult to show whether one is statistically significantly better than the other.
The liability theory allowed in Gaetano, of course, focuses solely on the alleged risk that the plaintiff suffered – ignoring that, in other ways, the drug has its own relative safety benefits. Both drugs, of course, remain fully FDA approved, although the original drug may well be more affordable, since generics allegedly exist. 2021 WL 1153193, at *1.
To allow this unprecedented “design defect” theory to proceed, Gaetano has to reject or ignore precedent after precedent. That starts with the discussion of “three essential Supreme Court case” concerning preemption. Id. at *3. Thus, Gaetano ignores Merck Sharp & Dohme Corp. v. Albrecht, 139 S. Ct. 1668 (2019), and its requirement that preemption be treated as a legal issue.
Gaetano also has to avoid the “independence principle” recognized in PLIVA, Inc. v. Mensing, 564 U.S. 604 (2011): “[T]he question for ‘impossibility’ is whether the private party could independently do under federal law what state law requires of it.” Gaetano, 2021 WL 1153193, at *3 (quoting Mensing, 564 U.S. at 620). Plaintiff argued, as an “alternative design,” the other drug for which the defendant ultimately received FDA approval eleven years later. Id. “[Defendant] should have swapped in [the later drug] as the active ingredient and sought FDA approval for that . . . medication, instead of the less safe [actually approved] medication.” Id.
But the FDA would have to have approved this new, hypothetical submission, and that should fall afoul of the Mensing independence principle.
Gaetano got around that by allowing plaintiff to engage in rank speculation from the outset – the defendant “should have designed [the drug] differently . . . from the get-go.” 2021 WL 1153193, at *5. Maybe the FDA would have approved that, then, eleven years earlier.
Yes, and if wishes were horses that beggars would ride. . . .
How many levels of speculation does such a theory entail? First, one must presume that the defendant could compressed the eleven years of research that resulted in the alternative into one (plaintiff allegedly began taking the drug at issue in 2005, one year after its introduction). Second, the FDA would have granted rapid approval this hypothetical, now, presumably first-in-its-class, drug, in order for it to be available for plaintiff to take. Third, plaintiff’s physician would have had to prescribe this brand new drug, rather than any of those already on the market. Fourth, plaintiff would have to have agreed to take this brand new drug, rather than any other drug with a longer track record.
And if turnips were watches, I’d wear one by my side. . . .
Simply to enable this pile of inferences on speculation to proceed, Gaetano bought into the phony distinction between “pre-approval” and “post approval” design defects. Supposedly “there are no federal requirements dictating which compositions among available alternatives a manufacturer must submit for approval.” 2021 WL 1153193, at *5. That shouldn’t get around the independence principle, though, because no matter what was “submitted,” it would still require FDA approval. But so much for logic and precedent.
[Plaintiff] effectively claims that, under state law, a manufacturer has a duty to pursue a safe alternative if available. Pursuant to that state-law duty, [defendant] could have submitted an alternative design to the FDA without creating any conflict with its federal duties.
Id. (citing device, rather than drug, case). To Gaetano, the question was supposedly “whether a drug manufacturer can independently design a reasonably safe drug in compliance with its state-law duties before seeking FDA approval.” Id. at *6 (quoting Holley).
With all due respect, no it isn’t. No matter what is submitted, FDA must approve (not “clear” as misstated in Gaetano) it – so the Mensing independence principle cannot be evaded by this temporal sleight of hand. Even assuming “pre-approval design choices . . . were actions independent of the FDA,” 2021 WL 1153193, at *6, FDA approval itself, the next level of speculation, is not.
Gaetano next tries false equivalence with Wyeth v. Levine, 555 U.S. 555 (2009):
To be sure, once the alternative drug is submitted for approval, the FDA might reject it. But the same was true in [Levine]; where a brand-name manufacturer unilaterally changes a drug’s label, the FDA may later review and reject that change.
2021 WL 1153193, at *6.
Not so, either.
We repeat the full Mensing independence principle, as stated by the United States Supreme Court:
[I]t is enough to hold that when a party cannot satisfy its state duties without the Federal Government’s special permission and assistance, which is dependent on the exercise of judgment by a federal agency, that party cannot independently satisfy those state duties for pre-emption purposes.
564 U.S. at 624-24. Likewise, the next sentence in Mensing after the language quoted above from Gaetano, is to distinguish Levine – specifically, “See [Levine], 555 U.S., at 573 (finding no pre-emption where the defendant could “unilaterally” do what state law required). “Unilateral,” there’s the rub. Nothing about initial approval of a new drug is unilateral. Thus, drug approval is not analogous to the CBE regulation, where, a label change goes through unless the FDA affirmatively takes steps to disapprove it.
The attempted analogy between warnings and design in Gaetano, or in any other case, is false equivalence. As stated in Mensing, a “possibility of impossibility [is] not enough.” 564 U.S. at 625, n.8. The need for FDA approval of the hypothetical new drug in Gaetano is no mere possibility. It is the most fundamental thing that the FDA does.
But Gaetano is not really about the law. It is about philosophical preference. Mensing closed by instructing courts that preemption is a matter of supreme federal law, regardless of individualized judicial predilections:
[I]t is not this Court’s task to decide whether the statutory scheme established by Congress is unusual or even bizarre. . . . We will not distort the Supremacy Clause in order to create similar pre-emption across a dissimilar statutory scheme. As always, Congress and the FDA retain the authority to change the law and regulations if they so desire.
564 U.S. at 625-26. No such restraint is shown in Gaetano, instead the logic of preemption is not just ignored, but rejected:
[T]he sheer scope of [defendant’s] argument imperils both preemption doctrine and state police powers. [Defendant’s] argument carries the implication that a plaintiff could never bring a design-defect claim involving any drug that required FDA approval.
2021 WL 1153193, at *6. So what? Design defect claims against FDA-approved drugs are antithetical to FDA approval and should not exist. At least where, as here, the purported state-law claim is novel (see id. at *4 (finding no “Supreme Court or Third Circuit” precedent on point), it is not a court’s role to act as policy maker, as Gaetano purports to do. As Mensing wisely cautioned, that role is for “Congress and the FDA”). Too bad the PREP Act hasn’t been applied to AIDS.
This policy preference drives Gaetano’s willful disregard of any precedent standing in the way of a no-preemption result. First Gaetano declines to follow the only on-point appellate precedent. 2021 WL 1153193, at *7-8 (“declining to follow” Yates v. Ortho-McNeil-Janssen Pharmaceuticals, Inc., 808 F.3d 281 (6th Cir. 2015)). Next the decision rejects the reasoning of In re Celexa & Lexapro Marketing. & Sales Practices Litigation, 779 F.3d 34 (1st Cir. 2015), and Utts v. Bristol-Myers Squibb Co., 226 F. Supp.3d 166 (S.D.N.Y. 2016)). 2021 WL 1153193, at *9-10. Finally, Gaetano again rejects Celexa, along with Gibbons v. Bristol-Myers Squibb Co., 919 F.3d 699, 708 (2d Cir. 2019) – and, sub silentio, virtually all post-Albrecht precedent) to deny that “a plaintiff must plausibly allege newly acquired information.” 2021 WL 1153193, at *11 & n.12.
This last point warrants a little more discussion. Gaetano allows allegations that the defendant “should have amended the label post-approval,” id. at *10, escape preemption by invoking “Third Circuit precedent” that plaintiffs don’t have to plead around the “affirmative defense” of preemption. Id. at *11. Specifically, Gaetano held, “Affirmative defenses generally depend on extrinsic facts.” Id.
Facts.
In so doing Gaetano ignores that, at least as to preemption, that Third Circuit precedent fell by the wayside in Albrecht. That’s exactly what the Third Circuit held in In re Fosamax (Alendronate Sodium) Products Liability Litigation, 852 F.3d 268, 295 (3d Cir. 2017) (‘[i]mpossibility preemption is an affirmative defense”), vacated and remanded sub nom. Merck Sharp & Dohme Corp. v. Albrecht, 139 S. Ct. 1668, 203 L. Ed. 2d 822 (2019).
Albrecht specifically held, however, that preemption is not like other affirmative defenses:
We turn now to what is the determinative question before us: Is the question of agency disapproval primarily one of fact, normally for juries to decide, or is it a question of law, normally for a judge to decide without a jury? The complexity of the preceding discussion of the law helps to illustrate why we answer this question by concluding that the question is a legal one for the judge, not a jury.
139 S. Ct. at 1679.
Facts. Preemption-related facts are not for a jury to decide. No longer can a court kick the preemption can down the road (and greatly increase the nuisance value of a case) procedurally. After Albrecht, defendants (indeed, all parties) are entitled to rulings as a matter of law whether the pleaded facts support preemption, and those “facts” include the existence, or not, of newly acquired information. E.g., Knight v. Boehringer Ingelheim Pharmaceuticals, Inc., 984 F.3d 329, 339-40 (4th Cir. 2021). Of course, Gaetano would probably just ignore the Knight decision, too.
There is as darn good reason why design defect claims involving FDA-approved drugs are preempted. They amount to claims that the FDA should never have approved drugs that it did (and continues to) find safe and effective. Gaetano alleged that the FDA should have approved something else – something that took over a decade longer. Lest we forget, before these drugs tamed (but have yet to cure) AIDs, as many as 50,000 people annually in the United States alone died from AIDS. Make no mistake about it, the claim in Gaetano, no matter how it may be disguised or dissembled, is a claim that not just one, but an entire class, of effective drugs against this scourge should never have been sold at all. That kind of claim is, and should be, preempted. Mutual Pharmaceutical Co. v. Bartlett, 570 U.S. 472, 488 (2013) (the court “reasoned that [defendant] could escape the impossibility of complying with both its federal- and state-law duties by ‘choos[ing] not to make [sulindac] at all.’ We reject this ‘stop-selling’ rationale as incompatible with our pre-emption jurisprudence.”).
If Gaetano stands, the same logic would have plaintiffs alleging that all of the COVID-19 vaccines are “defective” because a version that hasn’t been invented yet was safer (thankfully, PREP Act immunity will prevent that from happening). We reject second-guessing of the FDA. And it’s personal:
I’ve been to the edge, an’ there I stood an’ looked down.
You know I lost a lot of friends there baby, I got no time to mess around.
Van Halen, Ain’t Talkin’ ‘Bout Love.