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Thirteen years litigating the same case is a looooong time.  Absurdly long.  Long enough for an attorney working on the case to go from an associate learning to coax a newborn to sleep, to a partner juggling teen school and soccer commitments.  Long enough for lawyers to migrate from Blackberrys and voicemail, to smart phones and instant messages.  Long enough for new judges to be appointed by multiple presidential administrations, while erstwhile stalwarts of the bench take senior status or retire.  Circle of life.  You get the picture.

Perhaps the biggest downside of litigation lasting so long is cost.  Litigation is ridiculously expensive, and spending more than a decade litigating one case must really, really add up.  But apparently there can be an upside to a slow pace too:  With that much time, new evidence can materialize that improves the liability picture. 

We saw that happen in the Zofran litigation.  Zofran initially was approved as an anti-nausea medication for chemotherapy patients.  As it became widely used off-label for morning sickness, the FDA considered, but did not require, pregnancy-related labeling. 

Litigation began over alleged birth defects in 2015 and whether the manufacturer should have added warnings about that issue.  Then, over the next several years, both sides brought the plaintiffs’ allegations/evidence to the FDA’s attention, and the FDA rejected multiple proposed labeling changes regarding birth defects.  Eventually, in 2021, it allowed a label change—but not one the plaintiff wanted.  Instead, the new label merely stated that current data precluded an assessment of teratogenic risk.  See Perham v. GlaxoSmithKline LLC (In re Zofran Ondansetron Prods. Liab. Litig.), 57 F.4th 327 (1st Cir. 2023). 

In Zofran, the passage of time helped crystalize the FDA’s regulatory stance about the proposed birth defect warning.  Events that took place years after the lawsuit started led the court to eventually agree that there was “clear evidence” the manufacturer had “fully informed the FDA of the justifications for the warning . . . and that the FDA, in turn, informed the drug manufacturer that the FDA would not approve changing the drug’s label to include that warning.”  Id. at 341.  With clear evidence the FDA would not allow the warning the plaintiff said should have been given, the entire MDL was deemed preempted, pursuant to Merck Sharp & Dohme Corp. v. Albrecht, 139 S. Ct. 1668 (2019)and Wyeth v. Levine, 555 U.S. 555 (2009).  A good result, but a long time coming.

The same dynamic that resulted in a win in Zofran now has resulted in a win in a False Claims Act case, United States ex rel. Krahling v. Merck & Co., 2023 U.S. Dist. LEXIS 135853 (E.D. Pa. July 27, 2023). 

In Khraling, two qui tam relators contended that false claims were submitted to the federal Center for Disease Control and Prevention (CDC), which purchases mumps vaccines for its “Vaccines for Children” program.  Mumps is a once-prevalent childhood disease that can cause meningitis, encephalitis, sudden onset deafness, and even death. 

Starting with the initial mumps vaccine approval in 1967, the FDA extensively regulated the vaccines’ labeling.  This oversight included a mid-1990’s review of labeling—driven by the National Childhood Vaccine Injury Act, 42 U.S.C. § § 300aa-1-34—regarding the potency of the mumps portion of the MMR-II vaccine (a vaccine for measles, mumps, and rubella).  The Khraling relators nevertheless filed their false claim lawsuit in 2010 alleging that the manufacturer misled the CDC about the potency of its mumps vaccines. 

“Years of discovery” then followed.  Nine, to be exact.  Years of summary judgment practice followed that.  Over three, apparently.  With the case reassigned to a new judge in the middle.

So, after all that, was there evidence the federal government was misled about the potency of the mumps vaccines it purchased?  No, of course not.  Not only had the FDA evaluated the mumps potency issue before the lawsuit was filed, Khraling, 2023 U.S. Dist. LEXIS 135853 at *45, the government’s post-filing conduct also confirmed it was not misled.

First, the filing of the qui tam action led the government to investigate the claims and, after it did so, the DOJ declined to intervene in the case, suggesting it did not see a problem with the vaccine purchases.  Second, even after the court authorized the relators’ expert (Dr. Kessler) to submit his opinions and evidence about the mumps vaccine potency issue to the FDA and CDC, the CDC continued to purchase the mumps vaccines, and the FDA did not take any action either.  In other words, the government’s (lack of) response to the relators’ false claims allegations meant that the information just wasn’t material to the CDC’s decision to buy the vaccine.  Id. at *58.  No materiality means no false claims, and thus thirteen years of litigation ends with summary judgment in the defendants’ favor. Another good result, but again, a long time coming.

The Krahling opinion provides a good reminder that the regulatory history for an on-market pharmaceutical, device, or vaccine is not static.  With a bit of time (preferably not too much), regulatory events might even develop, post-litigation, in a way that strengthens your factual position and preemption arguments.