We haven’t see too many of these. The reason for that is the gadolinium litigation is practically a textbook example of where federal law ought to preempt state-law product liability claims of all kinds—including both design defect claims and failure-to-warn claims. Just search gadolinium on the blog and you’ll find plenty of cases dismissed on the pleadings based on preemption. Given that, all we can really say about Gremo v. Bayer Corp., 2020 WL 3496917 (D.N.J. Jun. 29, 2020) is that is a model of how to kick the can down the road. If you follow this court’s model, as long as plaintiff has satisfied TwIqbal minimally, everything else is for a later day.
Based on the court’s briefest description of plaintiff’s allegations, it appears this case is nearly identical to the others we have discussed. Plaintiff was given gadolinium during MRIs on several occasions. Plaintiff has normal kidney function. Plaintiff alleges as a result of her gadolinium exposure she has sustained a list of varied side effects. Id. at *3. Plaintiff brought claims for failure to warn and design defect under the New Jersey Products Liability Act, as well as claims for breach of warranty and punitive damages. Defendants moved to dismiss all claims on numerous grounds, chief among them preemption.
The court’s discussion of the failure to warn claim is like a giant back swing with no follow through. It talks about impossibility preemption, clear evidence, CBEs based on newly acquired information, and the need for evidence of a causal connection to make a label change. Id. at *5. But it applies none of that to the facts about gadolinium. Facts that have featured prominently in other decisions such as – that the FDA has itself determined that it cannot establish a causal association between gadolinium and adverse side effects in patients with normal kidney function. Rather the court finds that the preemption question is “not properly before [it] to answer at this time,” because defendants did not “constrain” themselves to the allegations of the complaint or to documents on which plaintiff’s claims are based. Id. at *6. Certainly the court could have taken judicial notice of the FDA’s own findings and then reached a substantive decision instead of forcing the parties into discovery on a claim that is also as certainly preempted.
Moving onto to design defect the court’s analysis does not get any better. It distinguishes Bartlett on the grounds that under New Hampshire law because the drug was “chemically incapable of being redesigned,” defendant’s only recourse was to change the drug’s warning which it could not do because it was a generic drug. Id. at *8. In New Jersey, design defect claims largely live or die based on whether plaintiff can prove the existence of a safer, feasible alternative design. Id. at *7. Plaintiff here alleges that different gadolinium products with a macrocyclic structure, made by other manufacturers, pose less of a risk than defendants’ linear product and that therefore defendants should have made macrocyclic not linear drugs. Id. at *9. What plaintiff is really arguing is that these defendants should have stopped selling their FDA-approved product and made a different FDA-approved product. An argument that has been rejected by Bartlett and a host of courts to hear the issue since. But in Gremo, the court twists the defendants’ stop-selling preemption defense to an absurd extreme contending that any time a re-design is proposed, implementing the re-design means the manufacturer stops selling the original product. The court’s missing a key fact – prescription drugs are not refrigerators. We aren’t talking about making a water line out of thicker rubber to prevent a leak. For plaintiff to prevail on its design defect claim, a jury would have to decide that the defendants should have made an entirely different product than the one the FDA-approved. That’s the core of impossibility preemption. Moreover, nowhere does the court even mention that the type of design change suggested by plaintiff would require FDA pre-approval. That’s why Bartlett is applicable equally to innovator drugs and generic drugs. In both scenarios, defendants cannot make the change required by state law.
On breach of warranty the court does little analysis. Plaintiff alleges defendants’ labeling made certain representations, the product did not live up to those representations, and that breach caused plaintiff’s injuries. Id. at *10. The court presumed reliance with no real discussion, id., and determined that the question of whether plaintiff had timely notified defendants of her warranty claims was an issue for the jury. Id. at *13 n.12.
Finally, defendants moved to dismiss plaintiff’s punitive damages claim based on New Jersey’s bar on such claims where the drug at issue was approved by the FDA. Id. at *10. There is an exception to that prohibition if information was withheld from or misrepresented to the FDA – in other words, there is a fraud-on-the-FDA exception. Id. But the New Jersey Appellate Court, relying on Buckman, has held that the exception is impliedly preempted and therefore “effectively invalid”. But rather than rely on that holding, the Gremo court cites the New Jersey Supreme Court decision to not hear the appeal in light of the ruling in Wyeth v. Levine and then goes on to quote Levine about the lack of express FDA preemption and the role of state law claims in monitoring prescription drugs. Id. at *12. What any of that has to do with fraud-on-the-FDA, implied preemption and New Jersey’s ban on punitive damages for approved prescription drugs is frankly beyond us. We view it as just the final effort by the court to delay any substantive decision that would have narrowed, if not completely dismissed, plaintiff’s claims. That’s in nobody’s best interest. Not defendants who now have to defend non-meritorious claims at great expense. And not plaintiffs for whom settlement seems less likely with increased litigation costs. And not the court who is likely just going to have to re-hear all these arguments on summary judgment. We’ve said it before and we’ll say it again, a trimmed back case helps everyone. Kicking the can doesn’t get the job done.