The phrase may be biblical in origin, coming from the story of Cain and Abel, but its meaning certainly persists and has relevance today. Being both a sibling and a parent of siblings, this blogger doesn't want to give the impression that her family is every person for themselves. But, let's face it in those teen years, just how helpful does an older brother want to be? Or how quick is an older sister to sell out her not-yet-licensed brother when parents find the car is missing. I'm not my brother's keeper. Now these are significantly less brutal examples than the original where Cain is trying to cover up having murdered his brother. And by today's standards, the phrase has become less associated with fratricide and more akin to not wanting to be held responsible for someone else's actions. No matter how closely related you may be.
And that brings us to today's case – Smith v. Teva Pharms. USA, Inc., 2020 U.S. Dist. LEXIS 20405 (S.D. Fla. Feb. 4, 2020). As you may have guessed, one about related companies. Plaintiff filed suit alleging injuries sustained from taking two oral contraceptives – one branded and one generic. The branded drug was approved by the FDA in 2006 and defendant is the grandparent-company of the drug's NDA holder (defendant owns a company that owns the NDA holder). Defendant is also the manufacturer of the generic drug and a distributor of the brand name drug. Id. at *2-3.
Defendant moved for summary judgment on the grounds of conflict preemption under PLIVA, Inc. v. Mensing, 564 U.S. 604 (2011). The decision contains a nice discussion of the statutory framework for who and how one can change a drug's label. Id. at *6-8. The who essentially boils down to the person who submitted the NDA, submitted an amendment or a supplement to an NDA, or who owns an NDA. Id. at *7. Oh, and the Secretary of Health and Human Services. The how depends on the what. Major changes require pre-approval by the FDA. Id. But, if merely adding or strengthening a warning (based on newly acquired information (not mentioned in the decision but we don't want you to forget that part)), a manufacturer can use the "changes being effected" (CBE) process. That allows a manufacturer to make the change at the same time as filing its supplemental NDA. Id. at *8.
The court look at each drug separately. As to the generic drug, PLIVA controls and requires dismissal based on preemption. Generic labels are required to be the same as their branded counterpart's labels. There was no dispute that the generic labeling matched the branded labeling at all relevant times. Therefore, the "duty of sameness" makes it impossible for the defendant to comply with that federal requirement and change its label in response to state duties. Id. at *10.
Defendant did not stop its PLIVA argument there. Because defendant is only the distributor of the branded drug, it argued plaintiff's brand claims against it were also barred by PLIVA. Plaintiff's first argument was that PLIVA only applies to generic drugs. "Not so." Id. PLIVA applies "with equal force" to brand name drugs "preempt[ing] state claims against parties that are unable to unilaterally effectuate label changes." Id. This brings us back to the question of "who" can change a drug's label. Defendant did not submit either the NDA or any supplement/amendment to the NDA. Defendant was never the owner of the NDA. Nor was defendant the Secretary of Health and Human Services. Id. at *11. What was the defendant – a distributor.
Plaintiff's next argued that all of foregoing aside, PLIVA shouldn't apply because defendant is the parent of the parent of the NDA holder. However, "[t]he FDA's regulations nowhere contemplate a distributor of a brand drug, albeit a distributor closely affiliated with the NDA holder, initiating changes to an approved NDA." Id. at *12. I'm not my brother's keeper. Plaintiff ignored the "wealth of authority" holding that non-NDA holders are "powerless to submit label changes to the FDA." Id. at *12-13. Rather, plaintiff argued that precedent shouldn't control because the companies are "intertwined" and defendant promotes the drug and handles its pharmacovigilance. "That is not the inquiry." Id. at *14. The CBE regulations make clear who can submit and effect a labeling change – and it's not the distributor or the parent of the parent of the NDA holder. I'm not my brother's keeper.
Plaintiff's last ditch effort was to point out, in supplemental briefing, that in 2003 the parent of the NDA holder submitted a CBE on behalf of the NDA holder for a different oral contraceptive. Plaintiff argued this was proof that defendant "could, in theory, have submitted a CBE" in this instance. Id. at *14 n.6. But the regulations still control and they state that a labeling change can be made by someone who actually submits an NDA or NDA supplement/amendment. Not someone who can theoretically submit one. It was too large a leap for the court to "assume that parent companies can submit CBEs for their subsidiaries." Id. I'm not my brother's keeper.
Finally, plaintiff asked for permission to amend her complaint to add the NDA holder as a defendant. However, because "[p]laintiff has failed to explain her undue delay in adding [the NDA holder] as a defendant when its involvement was known early on," the request was denied. Case dismissed. If you're not the NDA holder, you're also not the NDA holder's keeper.
This article is presented for informational purposes only and is not intended to constitute legal advice.