“Don’t major in minor things.” A wise professor once shared those words and they’ve always stuck. As a general approach to life, it makes a lot of sense. Learning to let go of the small stuff is easer said than done, but it is usually well worth the effort. But the same does not generally apply to the DDL blog. We pride ourselves in collecting the major, the minor, and everything in between. That’s because there is value in knowing that yet another court dismissed pharmaceutical design defect claims as preempted. So, Ortega v. Merck & Co., Inc., — F. Supp. 3d –, 2023 WL 35358 (D. Mass. Jan. 4, 2023) may not break new ground, but we will add it to the pile of “minor” decisions that make up a “major” area of positive preemption law.
Singulair was approved by the FDA in 1998 and its active ingredient is montelukast. Plaintiff was prescribed and took Singulair to treat his asthma from 2000 to 2009 and alleges he now suffers from depression and social anxiety as a result. Plaintiff’s lawsuit makes two design defect claims – strict liability and negligence. Plaintiff claims that the drug was defectively designed because defendant could have either modified the montelukast or modified the Singulair to make it less likely to contribute to adverse neuropsychiatric events. Id. at *3.
But federal law requires “major changes” to a drug product to be submitted to the FDA for approval prior to distribution. Therefore, applying First Circuit precedent that we discussed here, the court found that “a pharmaceutical company cannot unilaterally implement ‘major changes’ to the chemical formulation of a medication that the FDA has previously approved.” Id. Because plaintiff’s proposed changes are “major changes” to Singulair, plaintiff’s design defect claims are preempted. While the court did not directly address Mensing, it is Mensing impossibility preemption that is being applied. As the Mensing Court explained, “[t]he question for ‘impossibility’ is whether the private party could independently do under federal law what state law requires of it.” PLIVA v. Mensing, 564 U.S. 604, 620 (2011). When the answer to that question is no, the claim is preempted.
That’s it. Claim dismissed with prejudice as any amendment would be futile. Just a minor decision in an otherwise major area of the law that pushes forward favorable Supreme Court and First Circuit precedent. Maybe not so minor after all.