Photo of Michelle Yeary

This post is from the non-Reed Smith side of the blog.

It may be early November, but halls (more like malls) are being decked; trees are being trimmed; 24-7 Christmas carol radio stations are in full swing; and there’s some internet-created controversy over whether Starbucks’ cups will have snowflakes and reindeer on them???  Anyway, it’s hard not to start thinking about the holidays when the signs and symbols are everywhere you look.  One of this blogger’s favorite holiday traditions is to read Yes, Virginia.  For those who may be unfamiliar, it is the account of eight-year-old Virginia O’Hanlon’s letter to the editor of The Sun in 1897.  Little Virginia is dismayed by her friends’ lack of belief in Santa Claus.  Her father tells her to write to the The Sun because “if you see it in Sun, it’s so.”  So Virginia simply asks “is there a Santa Claus?”  The response was of course — Yes, Virginia.  He is real.  “He lives and he lives forever.  A thousand years from now, Virginia, nay, ten times ten thousand years from now, he will continue to make glad the heart of childhood.”

Well, we don’t know about a thousand years from now, but as for today and the foreseeable future – preemption makes glad the heart of defense lawyers.  We gave you the link to the decision in In re Incretin-Based Therapies Products Liability Litigation, slip op.  (S.D. Cal. Nov. 9, 2015) this morning. It’s a lot to read, but it’s worth it. The bottom line is the court granted defendants’ motion for summary judgement dismissing all failure to warn claims that had accrued as of October 15, 2015 based on clear evidence that the FDA would have rejected any change to the drugs’ labeling regarding the risk of pancreatic cancer.  Slip op. at 2.  Let’s get you to the highlights of this lengthy decision.

First, the facts.  The litigation involves a class of drugs used to treat diabetes. Plaintiffs allege the drug labels should have included a warning about the risk of pancreatic cancer.   Id. at 3.  As the opinion sets forth, on numerous occasions between 2009 and 2014, the FDA took the position that “a causal risk between the drugs and pancreatic cancer was indeterminate.” Id. at 17 (the detailed discussion of all of the FDA assessments on pancreatic cancer are found at pages 16-19).

Next, the law.  If you ever have to brief the Wyeth v. Levine clear evidence standard, I recommend you go back to pages 6-13 of this opinion.  The court sets out a fulsome discussion of the most important decisions to have dealt with the issue.  What the Supreme Court said in Levine was that “absent clear evidence that the FDA would not have approved a change to [the] label,” there is no impossibility preemption.  That is the preemption standard.  The rest of the cases cited in In re Incretin deal with how to define what constitutes clear evidence.  We’re not going to go through them all here. What seems clear, however, is that it is a very fact intensive standard.

It is against that precedential framework that the court had to analyze the facts of this case.  As noted above, the court started with a recitation of all the times the FDA assessed the pancreatic cancer risk.  While most of that discussion is case-specific, it is worth noting that this court, like others, acknowledged the “limited value” of adverse event reports in assessing causation.  Slip op.  at 18n.13.   If you read all the facts, we think you’ll find it hard to argue with the court’s conclusion that not only had the FDA “considered pancreatic cancer risk, the specific issue Plaintiffs allege Defendants should have warned of,” id. at 19, but “the FDA has also consistently concluded that a causal association between the drugs and pancreatic cancer is indeterminate.”  Id. at 20.  And “indeterminate” “falls below the science-based regulatory standards that govern what must be included in product labeling.”  Id.

In this case there was significantly more clear evidence then just inaction on the part of the FDA, but inaction was part of the analysis:

The FDA has also not required any of the Defendants to add a pancreatic cancer warning, or required the inclusion of a warning in newly approved incretin-based therapies. While FDA inaction is insufficient on its own to establish preemption, it is highly persuasive given the FDA’s comprehensive review of pancreatic safety and ability to mandate a label change if it concluded the regulatory standards were satisfied.


It appears plaintiffs made four arguments against preemption. First, there cannot be conflict preemption “absent express rejection of a proposed labeling change.”  Id. at 21.  In other words, the clear evidence standard would only be met if defendants had submitted a proposed labeling change (a CBE or PAS) and the FDA rejected it.  Id.  Not so said the court.  After all, in Levine, the Supreme Court said the defendant had to demonstrate the FDA “would” have rejected a label change, not that they “did.”  Id. at 22.  Moreover, “Plaintiffs do not establish the FDA’s substantial review of pancreatic safety was different from what the FDA would have done in response to a CBE.”  Id. at 23.  The extensive review done by the FDA was actually likely more comprehensive then a CBE review, making the plaintiffs’ argument one of form over function. Id.

Second, statements by FDA staff members don’t have preemptive effect because they are not “official” FDA positions.  Id. at 24.  While that may be accurate, it didn’t apply to the various positions taken by the FDA in relation to incretin-based therapies and pancreatic cancer.  Here, the review of pancreatic safety data “falls squarely within the FDA’s congressionally delegated authority to regulate the safety of prescription drugs.”  Id. at 25.  For instance, the Assessment prepared by four FDA officials was identified as coming from the FDA’s Office of New Drugs, Center for Drug Evaluation and Research. Id.  Likewise, responding to a citizen petition is within the FDA’s regulatory authority. Id.  

Third, there is no preemption where the FDA has not reached a final conclusion. Id. at 26.  Wrong again. Plaintiffs allege that because the FDA has left open the pancreatic cancer safety signal that provides a basis for a causal connection.  The open signal was hardly enough to “undermine the FDA’s previously articulated conclusions.” Id. at 27.  A safety signal is a “might be,” not evidence of a causal connection between a drug and an adverse event.  Id.  We like what the court said next enough to quote:

To warrant inclusion in product labeling the FDA must conclude, at a minimum, that there is some basis to believe there is a causal relationship between the drug and the adverse reaction. The existence of a hypothetical causal association is insufficient to satisfy this standard.  . . .

Additionally, the Court finds the FDA’s ongoing review of pancreatic safety more indicative of the evolving nature of drug surveillance, than of the existence of a causal association.  . . . The potential for the FDA to reach a different conclusion in the future in light of new scientific evidence or development does not preclude a finding of preemption now.

Id. at 27-28.  This is the marriage between the FDA’s labeling standards and its safety obligations and the legal standard that a manufacturer has a duty to warn only of those risks of which it knew or reasonably should have known.  Science may change what we know in the future, but now is what matters.

And finally, plaintiffs try to avoid Levine impossibility preemption by making a fraud-on-the-FDA argument – which leads them directly into Buckman preemption.  Plaintiffs allege that defendants misrepresented and/or under-represented data related to pancreatic cancer to the FDA.  Id. at 29.  Plaintiffs should have seen where this was heading when the court denied them preemption discovery based on fraud-on-the-FDA allegations last year.  Id. at 30.  While Buckman may not apply to plaintiffs’ failure to warn claims, the court found it did apply to plaintiffs’ defense to the clear evidence standard:

Under Plaintiffs’ reasoning, a plaintiff could always cite to a particular piece of data, presumably unconsidered by the FDA, and overcome conflict preemption.  A reevaluation of scientific data or a judicial challenge to the accuracy of the FDA’s conclusion would disrupt the “delicate balance of statutory objectives” the Buckman court sought to preserve.

Id. at 32.   Also, Levine “does not mandate which data the FDA must consider,” only that the FDA did consider the “safety concern challenged by a plaintiff.”  Id.  What the FDA considers is best left to the discretion of the FDA, id. at 33, and the court was not willing “to substitute Plaintiffs’ evaluation of scientific data for that of the FDA’s.”  Id. at 34.

Finally, we note that oral argument on this motion was held jointly with the incretin cases pending in state court in California.  We did some poking around and understand that the state court is going to come out the same way as the federal court.  Kudos to federal-state coordination.

Like the editor said to Virginia, so the court said to plaintiffs:  “your little friends are wrong.”  Santa Claus exists “as certainly as love and generosity and devotion exist.”  And conflict preemption exists as certainly as there is clear evidence of FDA consideration of the risk at issue.