Every time we read an order about “pre-approval” defects in prescription drugs, we stop to scratch our heads.  It is not because we are easily confused, at least not on most days.  No, we pause to ponder what exactly a “pre-approval” defect is and how a company can be held to answer for an alleged defect in a product’s design or in its warnings before the product is approved, let alone marketed and used to treat a patient. 

“Pre-approval” defect is a legal construct invented by plaintiffs’ lawyers to dodge federal preemption.  When it comes to design defect, the signpost is Mutual Pharma v. Bartlett, where the Supreme Court held that federal law preempts state law design defect claims involving a generic drug because the manufacturer could not have changed the design without the FDA’s pre-approval.  That makes it impossible to comply with state and federal requirements at the same time—thus preemption.  Cases like the Sixth Circuit’s opinion in Yates v. Ortho-McNeil extended that to innovator products, on the ironclad reasoning that a manufacturer of an innovator product cannot change the product’s design without FDA approval any more than a generic manufacturer can. 

The latest plaintiffs to use claims of “pre-approval” defect to avoid preemption (successfully, for now) are the plaintiffs in the Suboxone Film MDL, where they allege that suboxone film which dissolves under the tongue caused dental issues.  Under Bartlett, federal law should preempt any design defect claim, since the defendant could not have altered the product design without FDA approval.  To get around that, though, the plaintiffs argued that federal law did not prevent the defendant from proposing a different design before FDA approval.  In re Suboxone Film Prods. Liab. Litig., No. 24-md-3092, 2024 WL 5264278, at *8 (N.D. Ohio Dec. 31, 2024).  As an example of how the defendant could have designed a safer product, the plaintiffs cited a drug with the same active ingredient, but as an injectable gel—i.e., a different product.  Id. at *11. 

This is a “pre-approval” defect claim, and you can see why it makes no sense.  This “pre-approval” claim is merely a claim that, under state law, the manufacturer should never have sold the product in its approved form.  But, the FDA, under federal law, said that it could. 

State law should have given way.  But it didn’t, at least not for now.  The district court dedicated an entire section of its order to the presumption against preemption (you can see the smoke coming out of Bexis’ ears now).  It also rejected Yates as precedent because the Yates opinion noted that results “might differ ‘in some circumstances’” and because the court found older opinions that Yates left untouched to be more persuasive.  Id. at *9-*10.  The district court also said that no other circuit has followed Yates, an assertion that we have not verified.  Regardless, we reported just over a year ago that preemption of “pre-approval” design defect claims was a majority position.  We doubt that has changed. 

The district court therefore denied the defendant’s motion to dismiss on pre-approval design defect, but it granted the motion on “post-approval” design, under which the plaintiffs alleged that the product’s design was defective after the FDA approved the product.  This of course is a claim that the defendant should “stop selling” a federally approved drug in order to comply with state law, which is obviously preempted under Bartlett.  The district court correctly so held.  Id. at *11. 

That brings us to the plaintiff’s warnings based claims, where they alleged that the defendant did not adequately warn of adverse dental effects until a label change in June 2022.  If you thought “pre-approval” design defect claims were questionable, then “pre-approval” failure-to-warn claims are downright nonsense.  There is no duty to warn of risks in products that are not yet being sold, and the FDA is the final arbiter of what prescription drug labeling can and cannot say once products enter the market.  Under Supreme Court precedent (in Levine v. Wyeth, Pliva v. Mensing, Mutual Pharma v. Bartlett, and Merck v. Albrecht), there is only one exception to federal preemption under these circumstances—when the plaintiff can show that “newly acquired information” would have allowed the defendant to unilaterally strengthen its label under the FDA’s Changes Being Effected (or “CBE”) regulation. 

And the CBE regulation does not apply pre-approval.  So how can there be a “pre-approval” failure to warn claim?  There can’t be. 

This district court could have said that, but instead it wrote that because the plaintiff did not use the product “before its approval,” the court “need not address whether FDA approval of the label forecloses any warning claim arising before then.”  Id. at *12.  We are not sure why the court felt compelled to say this.  No one used the product before it was approved, and no failure-to-warn claim could have arisen before approval. 

The real controversy was on the garden-variety, “post-approval” failure-to-warn claim under which the plaintiffs argued that a December 2022 publication provided “newly acquired information” on adverse dental effects that could have supported a unilateral label change, thus avoiding preemption.  The defendant countered that it had already updated the label to include adverse dental effects in June 2022 and that the December publication revealed nothing new.  The district court, however, ruled that the plaintiffs had alleged newly acquired information sufficient to survive a motion to dismiss.  Perhaps the outcome will be different on a more-developed record. 

The concept of “pre-approval” claims still makes our heads hurt, but we have written so much on them by now that our views are firm.  A “pre-approval” design defect claim is just a claim that the defendant never should have sold the approved product.  And a “pre-approval” failure-to-warn claim is merely a claim that the drug labeling, as approved by the FDA, was not adequate.  No mental gymnastics are required to find such claims preempted.