We reported two weeks ago on an order favoring implied preemption in an innovator prescription drug case coming out of the Eliquis MDL in New York. One week after that order, the Ninth Circuit filed an unpublished opinion reversing an order from the In re Incretin-Based Therapies MDL in the Southern District of California that similarly favored implied preemption. With these recent events, it is tempting to construct an east-versus-west narrative around federal preemption, but the cases don't really line up that way (see, e.g., the very eastern Fosamax opinion from the Third Circuit, discussed in detail here, here, and here). Still, when we saw the recent preemption juxtaposition of California against New York, we could not help but think of the 1977 World Series, with Reggie Jackson hitting home runs by the handful to lead the Yankees over the Dodgers. You have the Brooklyn Bridge versus the Golden Gate. Broadway versus Hollywood. Letterman versus Leno. We are told that the Los Angeles Kings recently played the New York Rangers in the ice hockey Stanley Cup finals, but if that actually occurred, we overlooked it.
Of course, one thing that New York and California have in common is that they both cast their electoral votes in the 2016 presidential election for a candidate that did not win. At least New York has the consolation that both major-party candidates hailed from New York, a situation that has not occurred since Franklin Roosevelt defeated Manhattan attorney Thomas Dewey in 1944. We do not believe there has ever been a New York versus California presidential election, but we have not looked it up. Bexis points out that one of FDR's general election opponents was Herbert Hoover, who relocated from Iowa to California, so we guess that counts. California Governor Ronald Reagan and New York Senator Robert Kennedy both sought their parties' nominations in 1968, but neither prevailed. We can only imagine what kind of general election that would have been.
When it comes to federal preemption, we would not have cast our vote for the Ninth Circuit's unpublished opinion in In re Incretin-Based Therapies Products Liability Litigation, No. 15-56997, 2017 WL 6030735 (9th Cir. Dec. 6, 2017). The plaintiffs in In re Incretin claim that the defendants did not adequately warn about the risk of pancreatic cancer in connection with their prescription diabetes drugs. The FDA, however, has said on multiple occasions that a causal association between the drugs and pancreatic cancer is indeterminate. The district court therefore granted summary judgment on the basis that the defendants had presented "clear evidence" under Wyeth v. Levine that the FDA would not have approved a change to the drug labeling regarding that particular risk. We reported on that order here and its California state-court counterpart here.
Well, the Ninth Circuit has undone the district court's order, at least for now. Maybe the most important part of the opinion is what the Ninth Circuit did not do, which is rule on whether the defendants had or had not satisfied the "clear evidence" standard. Instead, the Ninth Circuit reversed and remanded because the district court (1) improperly limited discovery and (2) did not consider certain "newly discovered evidence" when it granted summary judgment. In re Incretin, at *1.
Here is how it played out. On the discovery issue, the plaintiffs sought additional discovery into adverse event source documents and databases. The district court, however, denied that request because adverse event reporting, including what was reported to the FDA and what was not, was irrelevant under Buckman Co. v. Plaintiffs' Legal Committee, 531 U.S. 341 (2001). See In re Incretin, at *1. As our readers know, Buckman held that federal law impliedly preempts any claim for "fraud on the FDA."
The Ninth Circuit saw it differently and held that the plaintiffs were not seeking discovery under a "fraud on the FDA" theory, but instead were pursuing a routine state-law failure-to-warn claim such as in Stengel. That's the case where the Ninth Circuit held that a plaintiff could plead a non-preempted "parallel claim" based on allegations that the defendant failed to report adverse events to the FDA, an opinion that came in second on our "Worst Ten" list for 2013. According to the Ninth Circuit, the sought-after information was relevant to whether there was a causal connection between the products and pancreatic cancer, and preemption could not be determined "without knowing what information was available to the defendants." Id. at *2.
The purported "newly discovered evidence" was an assessment completed by Canadian regulators and "evidence from animal studies and clinical trials" somehow involving pancreatic cancer. Id. at *3. The Ninth Circuit held that the district court had improperly failed to consider this evidence, even after acknowledging that it remained "unclear whether the FDA considered this information, and if it did not, whether this data would have altered the FDA's conclusion." Id. (quoting district court's order). In the Ninth Circuit's view, uncertainty on whether the "newly discovered evidence" would have been material to the FDA's opinion on pancreatic cancer should have prevented summary judgment on the defendant's implied preemption defense. Id.
So the case is headed back to the district court for litigation on the scope of discovery and presumably another motion for summary judgment. Because the Ninth Circuit left undisturbed the district court's core ruling under the "clear evidence" standard, the result on remand could very well be the same.
Be that as it may, we find the Ninth Circuit's opinion questionable. For one thing, the whole thing underplays Buckman and overplays Stengel. Of course, any play on Stengel is an overplay because the opinion was wrongly decided. A state-law duty to inform physicians of the known and knowable risks of prescription drugs does not equate to a state-law duty to report information to a federal government agency. And without the latter duty, it is beyond us how a claim for failing to report adverse event information to the FDA does not exist solely by virtue of a federal enactment. That is Buckman preemption, yet the Ninth Circuit has again invoked a supposed "duty to report" to allow not only a claim, but now discovery.
We also question the Ninth Circuit's reasoning on the "newly discovered evidence" and the purported disputes of fact. The FDA's position on incretin-based therapies and pancreatic cancer was undisputed—the causal connection was indeterminate. The potential dispute apparently is over whether the FDA considered the plaintiffs' information and whether it would have altered the FDA's opinion. But if that dispute exists, is it really material? If defendant can present "clear evidence" that the FDA would not approve the plaintiffs' proposed warning based on the FDA's own statements and actions, are we now in the business of second-guessing the FDA's judgment by sifting through what the FDA has considered and what it has not? Are juries to engage in that review process based on the opinions of dueling regulatory experts? That is the main problem with the Third Circuit's opinion in Fosamax, which takes a legal issue (preemption) and the Supreme Court's "clear evidence" standard and converts them into factual issues for juries to decide under a "clear and convincing evidence" standard never before enunciated in this context.
Most pointedly, there typically is no discovery directly into the FDA's decision making process. As a result, when the Ninth Circuit suggests that the district court should have considered "whether the FDA considered this information" and whether it "would have altered" anything, the court is really asking by proxy whether the defendants made the information available to the FDA for consideration in the first place. In other words, the Incretin plaintiffs were seeking to undermine the FDA's stated position by questioning, at least in part, what the defendants did and did not submit to the FDA. That comes full circle to Buckman, and the district court had a valid point when it ruled that a "reevaluation of scientific data or a judicial challenge to the accuracy of the FDA's conclusions would disrupt the 'delicate balance of statutory objectives' the Buckman Court sought to preserve." In re Incretin-Based Therapies Prods. Liab. Litig., 142 F. Supp. 3d 1108, 1130 (S.D. Cal. 2015) (quoting Buckman, 531 U.S. at 351), rev'd.
As we mentioned at the outset, the summary judgment order is reversed for now, but the result in the end could be the same. As fans of California, let's hope that is the case. As every sports fan has said at some point in his or her life, there is always next year.
This article is presented for informational purposes only and is not intended to constitute legal advice.
