Earlier this week a district court dismissed claims brought against the manufacturer and the distributor of a generic drug, holding that all of the claims were preempted by federal law and the several also failed under Florida law. The decision, Hernandez v. Aurobindo Pharma USA, Inc., 2022 WL 204401 (M.D. Fla. 2022), is long and does not break any new ground, but its conclusions are spot-on.
The claims were asserted by the daughter of a woman who died shortly after taking Losartan HCTZ, a generic drug that treats high blood pressure. The plaintiff brought five claims against the drug’s manufacturer and three against the pharmacy that dispensed the drug.
The court found that four of the five claims asserted against the manufacturer were at bottom failure-to-warn claims, including the plaintiff’s negligence and wrongful-death claims. Applying PLIVA, Inc. v. Mensing, 564 U.S. 604 (2011), the court easily concluded that the failure-to-warn claims were preempted because federal law requires that generic drugs to carry the same label as their brand-name equivalents and thus prevented the manufacturer from complying with the purported state-law duty to warn. 2022 WL 204401, at *7–10.
The court treated the fifth claim against the drug manufacturer—a claim for breach of the implied warranty of merchantability—slightly differently but ultimately reached the same conclusion. The plaintiff’s warranty claim, said the court, was effectively a design-defect claim that would hold the manufacturer liable for not having changed the drug’s composition. Quoting Mutual Pharmaceuticals Co., Inc. v. Bartlett, 570 U.S. 472 (2013) and citing a slew of other cases, the court found the claim preempted because federal law “requires a generic drug to have the same active ingredients … as the brand-name drug upon which it is based.” 2022 WL 204401, at *11.
The plaintiff’s claims against the dispensing pharmacy fared no better.
Inasmuch as the claims against the pharmacy were based on an alleged failure to warn, the court held that they were preempted because the pharmacy had no authority under federal law to alter the drug’s label. The court further held that the claims also failed under Florida law, both because “Florida law does not recognize a claim sounding in strict liability against a pharmacy” and because “it is well settled under Florida law” that the “duty to warn of the dangerousness of [a] drug … is not extended to retail prescription pharmacists.” 2022 WL 204401, at *12–14.
Finally, the court dismissed the wrongful-death claim asserted against the pharmacy because, to the extent it was not a preempted failure-to-warn claim, it was a preempted design-defect claim. As the court observed, federal law prevented the pharmacy from “alter[ing] the drug’s composition” and from thus fulfilling its purported state-law duty because the pharmacy “does not hold an NDA”—an approved New Drug Application—for the drug. Consequently, “federal law preempts” the claim. 2022 WL 204401, at *14.
Chalk one up for the good guys.