GREGORY L. FROST, District Judge.
This matter is before the Court for consideration of the following filings: a motion to dismiss (ECF No. 8) filed by Defendants Valeant Pharmaceuticals North America LLC, sanofiaventis U.S. LLC, and Aventis Pharmaceuticals Inc.; a memorandum in opposition (ECF No. 19) filed by Plaintiff, Dominique Brooks; and a reply memorandum (ECF No. 24) filed by Defendants Valeant Pharmaceuticals North America LLC, sanofi-aventis U.S. LLC, and Aventis Pharmaceuticals Inc. The Court
Injectable poly-L-lactic acid is classified as a prescription medical device that is used for cosmetic injections. It is sold under the trade names Sculptra and Sculptra Aesthetic. The Food and Drug Administration ("FDA") approved the former for use in treating patients with the human immunodeficiency virus ("HIV") who suffered from facial depressions or deficits. The FDA subsequently approved the latter for cosmetic use in non-HIV patients.
Beginning in August 2012 and continuing until sometime in June 2013, Plaintiff, Dominique Brooks, received a series of prescribed injections of either Sculptra or Sculptra Aesthetic while under the care of her physician.
In June 2014, Plaintiff filed a complaint in the Court of Common Pleas in Franklin County, Ohio, against the companies purportedly involved in developing, manufacturing, marketing, and distributing Sculptra and Sculptra Aesthetic: Valeant Pharmaceuticals North America LLC, sanofi-aventis U.S. LLC, and Aventis Pharmaceuticals Inc.
Defendants move for dismissal on the grounds that Plaintiff has failed to assert claims upon which this Court can grant relief. This Federal Rule of Civil Procedure 12(b)(6) argument requires the Court to construe the complaint in Plaintiff's favor, accept the factual allegations contained in that pleading as true, and determine whether the factual allegations present any plausible claim. See Bell Atlantic Corp. v. Twombly, 550 U.S. 554, 570 (2007). The United States Supreme Court has explained, however, that "the tenet that a court must accept as true all of the allegations contained in a complaint is inapplicable to legal conclusions." Ashcroft v. Iqbal, 556 U.S. 662, 678 (2009). Thus, "[t]hreadbare recitals of the elements of a cause of action, supported by mere conclusory statements, do not suffice." Id. Consequently, "[d]etermining whether a complaint states a plausible claim for relief will . . . be a context-specific task that requires the reviewing court to draw on its judicial experience and common sense." Id. at 679.
To be considered plausible, a claim must be more than merely conceivable. Twombly, 550 U.S. at 556; Ass'n of Cleveland Fire Fighters v. City of Cleveland, Ohio, 502 F.3d 545, 548 (6th Cir. 2007). What this means is that "[a] claim has facial plausibility when the plaintiff pleads factual content that allows the court to draw the reasonable inference that the defendant is liable for the misconduct alleged." Iqbal, 556 U.S. at 678. The factual allegations of a pleading "must be enough to raise a right to relief above the speculative level. . . ." Twombly, 550 U.S. at 555. See also Sensations, Inc. v. City of Grand Rapids, 526 F.3d 291, 295 (6th Cir. 2008).
Despite the briefing, Defendants' argument for dismissal is simple: federal law preempts Plaintiff's state law claims.
In addressing the PMA process, the United States Supreme Court has explained that "the FDA requires a device that has received premarket approval to be made with almost no deviations from the specifications in its approval application, for the reason that the FDA has determined that the approved form provides a reasonable assurance of safety and effectiveness." Riegel v. Medtronic, Inc., 552 U.S. 312, 323 (2008). A consequence of this rationale and the statutory scheme presented by the Medical Device Amendments of 1976 ("MDA") to the Federal Food, Drug, and Cosmetic Act is that the MDA expressly preempts state claims that impose requirements that are different from, or in addition to, these federal requirements. Riegel, 552 U.S. at 321; see also 21 U.S.C. § 360(k)(a).
Plaintiff argues that dismissal is not appropriate because her claims fall outside the scope of the MDA's preemption clause. This is possible. The Supreme Court noted in Riegel that "[s]tate requirements are pre-empted under the MDA only to the extent that they are `different from, or in addition to' the requirements imposed by federal law. 552 at 330 (quoting 21 U.S.C. § 360(k)(a)(1)). Thus, parallel state claims-claims premised on a violation of an FDA requirement-indeed evade preemption. Id. Plaintiff therefore characterizes Defendants' motion as premature and asks this Court to permit discovery that would enable her to provide a detailed statement of the specific bases for her claims-in other words, to uncover the facts that would enable her to assert that her claims parallel to the federal requirements.
Some courts follow this approach. For example, in Bausch v. Stryker Corp., 630 F.3d 546 (7th Cir. 2010), the Seventh Circuit Court of Appeals addressed the problem of how to plead in Class III medical device cases in light of the plausibility standard of Iqbal and Twombly. The Seventh Circuit explained:
Id. at 558. Accordingly, the court of appeals concluded that a district court had erred by dismissing a plaintiff's original complaint and by denying that plaintiff leave to file an amend complaint. Id. Notably, the Court reasoned as follows:
Id. at 560-61.
Bausch makes sense to this Court. Defendants seek to distinguish that case on grounds that are inconsequential to its core rationale. The point is that the Seventh Circuit's measured approach logically avoids the harsh result seen in those cases that find preemption based only on notice pleading. It would impose an illogical pleading burden on Plaintiff to require her complaint to point to specific federal requirements in order to establish that her state law claims are parallel and thus not preempted. It also would require too much to demand that Plaintiff allege specific defects that violate the FDA standards when such information is not necessarily within her control.
Discovery would thus afford Plaintiff the fair opportunity to evade preemption if such evasion is warranted, and, as Plaintiff concedes, summary judgment affords Defendants the mechanism through which they might ultimately prevail in this lawsuit if preemption applies. To decide the issue against Plaintiff here on the understandably limited context of an initial complaint would perhaps not only require more than Plaintiff could reasonably be expected to give, but also would impose more stringent requirements than notice pleading under Federal Rule of Civil Procedure 8 demands. Therefore, even setting aside the parties' various debates over issues such as off-label use, dismissal is not appropriate at this time on the parallel claim basis.
The Court
Second, in a footnote in their reply memorandum, Defendants contend that Plaintiff has conceded various arguments for dismissal that are independent from the federal preemption argument. (ECF No. 24, at Page ID # 309 n.7.) The reply memorandum footnote then directs this Court to three footnotes contained in the memorandum in support of Defendant's motion to dismiss, each of which contains one or more one- to two-sentence arguments for dismissal with string citations. See ECF No. 8, at Page ID # 128 n.6, Page ID # 133 n.7, Page ID # 134 n.8. This essentially perfunctory method of briefing fails to constitute developed arguments that this Court will consider adequately presented for disposition. See Embassy Realty Investments, Inc. v. City of Cleveland, 976 F.Supp.2d 931, 944 (N.D. Ohio 2013) (rejecting an argument presented "in the most skeletal way, leaving the court to . . . put flesh on its bones"); cf. Kuhn v. Washtenaw Cnty., 709 F.3d 612, 624 (6th Cir. 2013) (declining to consider arguments briefed in only a perfunctory manner). The Court expresses no opinion on the merits of these potential arguments, which Defendants may raise in a future motion.