If we were to recap briefly our reactions to the Levine decision and ten years of decisions attempting to apply it, then we might say something like this. The Court’s creation of a clear evidence standard for conflict preemption in the context of warnings claims for branded drugs was both novel and misguided. The Court

The toughest thing about defending product liability cases is the occasional immersion in human misery.  Securities and antitrust cases pose intellectual challenges but they are, in the end, pretty much about money.  By contrast, the plaintiffs in our cases are claiming injuries to their bodies, not just their wallets.  Sometimes those alleged injuries are phony

Recently Rudy Giuliani was broiled for saying that the truth isn’t the truth.  Denying a tautology won’t typically earn one high marks for logic.  Add in the callback to Pontius Pilate’s “What is truth” question, and it sounds like bad epistemology in service of bad morality.  But we’re not here to talk politics.  Nor are

Last year’s list of the Ten Worst DDL cases was remarkable because all ten decisions came from appellate courts.  Yikes.  And it is not as if the bad appellate decisions were spread around.  Two came from our home circuit, the Third.  Two came from the reliably problematic Ninth Circuit.  But the ‘winner’ was the Eleventh

There are plenty of f-words in this post, but fear not, for they are all fully capable of traveling in polite company. Most are even family-friendly. The most tasty f-word here is the “F” in FDA: food. While we focus on drug and device cases in this blog, we frequently find that food cases furnish

We’ve come to expect top-flight work product from the Product Liability Advisory Council (PLAC), even when it isn’t Bexis pushing the pen or pecking at the keyboard (as he has done so many times on so many important issues). PLAC’s amicus brief in support of the petition for certiorari regarding the Third Circuit Fosamax case

Last week we were going through the regulatory record of a drug that is now the subject of mass tort litigation.  This effort is central to assembling, per the SCOTUS Wyeth v. Levine case, “clear evidence” that the FDA would not have approved whatever label change the plaintiffs are advocating.  Then we remembered something.  It

It is quite unusual for a state trial court to depart from that state’s highest court precedent.  But consider that old Hebrew National frankfurter advertising campaign: “We answer to a higher authority.”  If the United States Supreme Court comes out with a case that renders your state supreme court’s opinion null, void, or wrong, you

Not that our readers are dying for a glimpse behind the curtain into the making of the sausage (and mixed metaphors) of the blog, but we do try to first figure out what decisions may be blogworthy before we start writing up the posts each week. We cannot say how blogworthiness relates to spongeworthiness, but we do know that the former involves asking a few questions, one of which is “is this just the same old same old?” In other words, even if the decision comes from a product liability case with a drug or device and addresses something that we think matters, we will not write about it if it adds nothing more than being another decision like we have seen many times before. Maybe it will be added to some cheat sheet or other compilation post, but it will not be worthy of its own post on this illustrious blog. (So illustrious are we that have noticed other blogs trying to rip off our name in the hopes that they will confuse search engines into directing traffic their way.)

When Levine came out with its misreading of the CBE regulation and novel “clear evidence” standard for impossibility preemption, we certainly did not think it would become so commonplace for prescription drug manufacturers—branded, in particular, although the liability of generics was not much of a concern then—to win warnings claims based on preemption. We are not yet there, but we can envisage a day where wins like in Seufert v. Merck Sharp & Dohme Corp., No. 13cv2928, 2016 WL 3369512 (S.D. Cal. May 11, 2016), just end up in our handy-dandy Levine cheat sheet For now, Seufert is still blogworthy.

Here are the basic facts. Plaintiffs sued over allegedly inadequate (absent) warnings on a purported risk of pancreatic cancer with two anti-diabetes drugs—the same compound is in each, with one adding metformin—within a class of drugs called incretin mimetics or incretin-based therapies. There are a number of approved drugs in this class, including one with its active ingredient derived from Gila monster venom. The two at issue were approved in 2009 and 2010 and there has been some degree of attention by FDA to a proposed risk of pancreatic cancer since they came on the market. It is not clear if plaintiffs contended that there was pre-marketing evidence of a pancreatic cancer risk specific to these two drugs, but we assume they did not have much if anything. In 2009, FDA reviewed adverse event data for the class of drugs and concluded “a causal association . . . is indeterminate as this time.” In 2013, FDA issued a “Drug Safety Communication” stating that it was analyzing the issue of pancreatitis and pancreatic cancer with the class of drugs, but that “it had not reached a new conclusion regarding whether incretin mimetics cause pancreatic cancer, and advised health care professionals to continue following the prescribing recommendations in the drug labeling”—which did not mention pancreatic cancer. Based on the plaintiffs’ case numbers, it looks like this Communication started them suing.


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