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April 27, 2016 Top Story

Federal Preemption Precludes Challenge to FDA-Approved Drug

Impossibility preemption precludes drug manufacturer from changing FDA-approved formulation

Adam E. Lyons

For the first time, a circuit court has taken the U.S. Supreme Court’s invitation and extended impossibility preemption to preclude a claim against a name-brand pharmaceutical manufacturer. Yates v. Ortho-McNeil-Janssen Pharmaceuticals, Inc. Impossibility preemption is the principle that state law cannot require a drug manufacturer to take an act that the drug’s federal approval precludes. ABA Section of Litigation leaders say the decision now forces plaintiffs to develop “safer alternative” type proof to defeat future state-law design defect claims whenever the challenged formulation was approved by the FDA.

Impossibility Preemption Applies to Name Brands

In Mutual Pharmaceutical Co. v. Bartlett, the Supreme Court had applied impossibility preemption to prohibit a design-defect claim against a generic drug manufacturer. The plaintiff’s claim was that the generic drug’s FDA-approved label was insufficient as a matter of state law. The Court disagreed, ruling that it was impossible for the generic drug manufacturer to make the proposed changes, even before FDA-approval, because a generic drug is required to have “the same active ingredients, route of administration, dosage form, strength, and labepling as the brand-name drug on which it is based.” Bartlett explicitly identified this pre-approval impossibility preemption as applying to “a drug—whether generic or brand-name.”

However, earlier Supreme Court precedent, in Pliva, Inc. v. Mensing, had noted that regulation of generic and brand-name drugs was different, which could “lead to different preemption results.” Because Bartlett dealt with a generic drug and because name-brand drug manufacturers can change their drug preapproval, it was therefore unclear to what extent impossibility preemption applied to name-brand drugs, in light of Mensing. “Supreme Court cases had left people pretty puzzled because it looked like generics had more protection than name brands,” explains Maura K. Monaghan, New York, NY, cochair of the Section of Litigation’s Products Liability Committee.

The Yates case, from the U.S. Court of Appeals for the Sixth Circuit, addresses a teenager’s claim for damages due to a stroke she suffered after taking ORTHO EVRA®, a drug approved by the U.S. Food and Drug Administration. The plaintiff’s claim was that the manufacturer should have designed a safer drug. In making that argument, the plaintiff acknowledged the precedent on impossibility preemption, but argued that reading Bartlett and Mensing together showed that preemption was limited to claims involving generic drugs. The Yates court acknowledged the basis of the plaintiff’s argument: “Important to the preemption findings in Bartlett and Mensing is the fact that generic drug manufacturers are prohibited from making any unilateral changes to the drug’s composition or label, which is known as the ‘sameness’ requirement.” In addition, the court noted that “the Bartlett Court did not reach the sweeping conclusion that all design defect claims are preempted by federal law.”

Nonetheless, the court found, 

Yates’s argument regarding defendants’ preapproval duty is too attenuated. To imagine such a preapproval duty exists, we would have to speculate that had defendants designed ORTHO EVRA® differently, the FDA would have approved the alternate design. Next, we would have to assume that Yates would have selected this method of birth control. Further yet, we would have to suppose that this alternate design would not have caused Yates to suffer a stroke. This is several steps too far.

New Turns for Preemption Cases

While Yates affirmatively applied impossibility preemption to a name-brand drug, the decision will likely lead to a change in tactics rather than an end to defect claims. “Sometimes I think there is an overreaction to preemption, with people claiming it is either the end of the world as we know it or the savior of mankind,” Monaghan quips. “Keep in mind this preemption ruling only dealt with the state-law claim that the drug was defectively designed. This decision did not address preemption of state-law claims based on other theories like failure to warn,” notes Samuel L. Felker, Nashville, TN, cochair of the Section’s Products Liability Committee.

However, Felker expects that “drug manufacturers now have another arrow in their quiver and will be citing Yates to defeat product design defect claims where the FDA approved the formulation challenged by plaintiff.” Thus, “drug manufacturers will cite Yates to defeat state-law design defect claims, whenever the challenged formulation was approved by the FDA,” he states. “Plaintiffs must try to gather proof that the FDA would have approved ‘the safer formulation’ to take the approval process out of the realm of speculation, but that is an uphill battle,” Felker adds.

The Decision’s Potential Reach

While the court’s reasoning appears sound, there is a subtext in the opinion that may curtail its impact. The Yates court was “wary of creating an artful pleading standard” under which the plaintiffs could avoid preemption by ignoring post-approval events and framing their claim entirely on pre-approval, Monaghan notes. Allowing that approach would, in Monaghan’s view, have undermined the FDA’s regulatory scheme.

Accordingly, courts going forward will likely “look at the facts of each claim, and the level of freedom the FDA gives to the manufacturer in each instance to decide whether preemption will apply,” Monaghan says. That suggests a more case-by-case approach in which it is only where “there isn’t any freedom that preemption will be found to apply,” she opines. The decision, and others that may follow, has “more to do with people’s daily lives than they might otherwise think. There is almost no one it will not touch,” Monaghan concludes.

Adam E. Lyons is a contributing editor for Litigation News.

Keywords: impossibility preemption, FDA, Yates, preapproval

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