Court Opinion

ID: 9723100
Source: CourtListenerOpinion
Date Created: 2023-08-26 10:02:25.485323+00
Date Added: 2024-06-11T18:24:44.793439
License: Public Domain

FRIEDLANDER, Judge,
dissenting.
I believe that Purepae was entitled to summary judgment on Lollar’s “failure to warn” claim, and therefore respectfully dissent from the majority’s holding to the contrary.
In a nutshell, the majority holds today that Purepae could fully comply with applicable FDA requirements with respect to warning labels, yet still be liable for negligence under Indiana common law. In the majority’s view, preemption is not an issue because the FDA regulations concerning warning labels are merely minimum standards established by Congress, which the states are free to supplement with more stringent requirements of their own. We are by no means writing on a clean slate on this question. Although no Indiana court has yet rendered a decision on this precise issue, courts in other jurisdictions have grappled with substantially similar questions. In so doing, the arguments on both sides have been ably laid out and need not be rehashed here at length. Thus, I write briefly to express and explain my view that the majority has come down on the wrong side of the question, and that applicable FDA regulations have indeed preempted Indiana common law with respect to the content of warning labels on drugs.
The majority dismisses as precedent any cases concerning the Medical Devices Amendments of 1976(MDA) “[bjecause drugs and devices are defined and treated differently,” Slip op. at 8, and because the MDA contains an express preemption provision, whereas the Federal Food, Drug, and Cosmetic Act (FDCA) does not. The lack of a preemption clause is by no means conclusive proof that preemption was not *856intended. Rather, in such cases, courts must determine whether preemption applies.
When there is no preemption clause, courts are guided first and foremost by the principle that “the purpose of Congress is the ultimate touchstone.” Philip Morris Inc. v. Harshbarger, 122 F.3d 58, 67 (1st Cir.1997). Implied preemption will be found where the pervasiveness of the federal regulations in question or the dominance of the federal interest in a particular area of legislative activity permits an implication that Congress intended to occupy the field. Massachusetts Ass’n of Health Maint. Orgs. v. Ruthardt, 194 F.3d 176 (1st Cir.1999). “[A] congressional determination to effect a nationally uniform standard presents ‘a situation similar in practical effect to that of federal occupation of a field.’” Philip Morris, Inc. v. Harshbarger, 122 F.3d at 85 n. 41 (quoting Laurence H. Tribe, American Constitutional Law, § 6-29, p. 510 (2d ed.1988)). I believe the FDCA labeling scheme represents a nationally uniform standard. Moreover, the sheer volume and specificity of the scheme set out in the FDCA is sufficient in my view to evince a Congressional intent to “occupy the field” within the meaning of Ruthardt, and understandably so. In what is inarguably a national market, one can readily perceive the near impossibility of a pharmaceutical company’s task of navigating through the quagmire of what would amount to fifty-one different standards (FDCA regulations plus the respective common-law requirements of the fifty states). Yet, that is precisely the situation created by today’s decision.
21 CFR Ch. 1 § 314.94(a)(8)(iv), the FDCA provision in question, provides:
A side-by-side comparison of the applicant’s proposed labeling including, if applicable, any Medication Guide required under part 208 of this chapter with the approved labeling for the reference listed drug with all differences annotated and explained. Labeling (including the container label, package insert, and, if applicable, Medication Guide) proposed for the drug product must be the same as the labeling approved for the reference listed drug, except for changes required because of differences approved under a petition filed under § 314.93 or because the drug product and the reference listed drug are produced or distributed by different manufacturers. Such differences between the applicant’s proposed labeling and labeling approved for the reference listed drug may include differences in expiration date, formulation, bioavailability, or pharmakonetics, labeling revisions made to comply with current FDA labeling guidelines or other guidance, or omission of an indication or other aspect of labeling protected by patent or accorded exclusivity under section 505(j)(4)(D) of the act.
(Emphasis supplied.) The above provision is part of a comprehensive regulatory scheme requiring that a proposed drug’s label must be the same as that of its reference drug, with limited and well defined exceptions. None of those exceptions (e.g., approved differences, different manufacturer, etc.) apply here. Thus, as I read the FDCA, Purepac’s label in this case was required by FDCA regulations to be identical to that of the reference drug. It follows that any duties not embodied in the FDCA’s regulatory scheme would necessarily be additional duties imposed by Indiana common law.
In Medtronic, Inc. v. Lohr, 518 U.S. 470, 116 S.Ct. 2240, 135 L.Ed.2d 700 (1996), the United States Supreme Court determined that, with respect to drug package labeling, duties arising solely under state common law—and not arising under the *857MDA—constitute requirements different from, or in addition to, FDA requirements. In the face of an MDA provision forbidding a state from establishing requirements that differ from those established in the MDA, the Court concluded that state common law was preempted in that area. Although we are concerned in the instant case with the FDCA and not the MDA, the principle in Medtronic applies here as well. State common law may not impose requirements different from or in addition to requirements set out in the FDCA concerning labeling, because Congress has expressed its intent to preempt that area, as explained above.
Applying these principles here, Lollar seeks to impose liability on Purepac based upon a claim of inadequate warning labels. Because Purepac’s label complied with FDCA requirements, liability could be premised only upon Indiana state common law principles. In my view, those would constitute forbidden additional requirements in an area that has been preempted by the FDCA. I would enter summary judgment in favor of Purepac.