[Drug and Device Law] Breaking News - Reinforcement For Buckman
We’ve been watching for Armstrong v. Exceptional Child Center, Inc., ___ U.S. ___, 2015 WL 14194231 (U.S. Mar. 31, 2015), ever since we spotted an intriguing footnote mentioning the certiorari grant in Ouellette v. Mills, ___ F. Supp.3d ___, 2015 WL 751760 (D. Me. Feb. 23, 2015) (other aspects of Ouellette discussed here). Ouellette noted:
The State also asserts that where the Plaintiffs have no private right of action under the FDCA, the Supremacy Clause does not create one. This Court has already resolved that issue in favor of the Plaintiffs in light of Pharmaceutical Research and Manufacturers of America v. Concannon, 249 F.3d 66, 73-74 (1st Cir. 2001). However, the Supreme Court has granted certiorari on a similar, potentially dispositive question. See Armstrong v. Exceptional Child Ctr., Inc., 567 Fed. Appx. 496 (9th Cir. 2014), cert. granted, 83 U.S.L.W. 3077 (U.S. Oct. 2, 2014) (No. 14-15) (“Does the Supremacy Clause give Medicaid providers a private right of action to enforce § 1396a(a)(30)(A) against a state where Congress chose not to create enforceable rights under that statute?”). . . .
Id. at *3 n.5.
Any time courts mention private rights under the FDCA, we think back to Supreme Court’s implied preemption reasoning in Buckman Co. v. Plaintiffs Legal Committee, 531 U.S. 341 (2001), specifically:
The FDCA leaves no doubt that it is the Federal Government rather than private litigants who are authorized to file suit for noncompliance with the medical device provisions: “[A]ll such proceedings for the enforcement, or to restrain violations, of this chapter shall be by and in the name of the United States.” 21 U.S.C. § 337(a).
Id. at 349 n.4, and:
In the present case, by contrast, we have clear evidence that Congress intended that the MDA be enforced exclusively by the Federal Government. 21 U.S.C. § 337(a).
Id. at 352 (distinguishing Silkwood v. Kerr-McGee Corp., 464 U.S. 238 (1984)).
Thus, we were wondering whether, when the Supreme Court decided Armstrong, it would have anything to say about respecting Congressional decisions, such as the FDCA’s §337(a), by precluding private enforcement of other statutes that also bear such “clear evidence” of congressional intent.
Armstrong was decided today. We were not disappointed.
In Armstrong, a health care provider paid by Medicaid funds sued the state of Idaho over allegedly illegal underpayment, asserting that the Supremacy Clause gave it the right to enforce its interpretation of what it considered to be the federal Medicaid payment scheme. Not only did the Court reject private enforcement, but it relied in part on its “preemption precedent” to do so. 2015 WL 14194231, at *4.
To say that the Supremacy Clause does not confer a right of action is not to diminish the significant role that courts play in assuring the supremacy of federal law. For once a case or controversy properly comes before a court, judges are bound by federal law. Thus, a court may not convict a criminal defendant of violating a state law that federal law prohibits. Similarly, a court may not hold a civil defendant liable under state law for conduct federal law requires.
Id. (citing, inter alia, Mutual Pharmaceutical Co. v. Bartlett, 133 S. Ct. 2466 (2013)) (emphasis added).
Specifically as to congressional intent, the Court in Armstrong held that the plaintiff could not bring an “equitable” action to enforce its view of the Medicaid statute. Congress did not grant such a right. “In our view the Medicaid Act implicitly precludes private enforcement . . ., and respondents cannot, by invoking our equitable powers, circumvent Congress’s exclusion of private enforcement.” Id. at *5. That sounds a lot like Buckman’s implied preemption rationale based on §337(a).
So do the Court’s two statutorily-based reasons in Armstrong. First, as in Buckman, Congress simply did not allow private enforcement:
[T]he sole remedy Congress provided for a State’s failure to comply with Medicaid’s requirements . . . is the withholding of Medicaid funds by the [government]. As we have elsewhere explained, the express provision of one method of enforcing a substantive rule suggests that Congress intended to preclude others.
Armstrong, 2015 WL 14194231, at *5 (citation and quotation marks omitted) (emphasis added). Ditto, Buckman – indeed, the explicit text of §337(a)’s prohibition of prvate enforcement is a fortiori from Armstrong, under the same reasoning.
The Court’s second reason is why medical device plaintiffs shouldn’t be allowed to enforce vague FDA Current Good Manufacturing Practices that do nothing more than state that the defendant should adopt some sort of process for doing X, Y, or Z: Such vague standards are “judicially administrable”:
[I]t does so when combined with the judicially unadministrable nature of [the Medicare statute’s] text. It is difficult to imagine a requirement broader and less specific than [the] mandate that state plans provide for payments that are “consistent with efficiency, economy, and quality of care,” all the while “safeguard[ing] against unnecessary utilization of . . . care and services.” Explicitly conferring enforcement of this judgment-laden standard upon the Secretary alone establishes, we think, that Congress wanted to make the agency remedy that it provided exclusive, thereby achieving the expertise, uniformity, widespread consultation, and resulting administrative guidance that can accompany agency decisionmaking, and avoiding the comparative risk of inconsistent interpretations and misincentives that can arise out of an occasional inappropriate application of the statute in a private action.
Id. (citations and quotation marks omitted) (emphasis added). Many of the FDA regulations that we see plaintiffs trying to advance as supposed “parallel claims” are equally vague. Combined with the express prohibition on private enforcement in §337(a), everything that the Court found preclusive of private enforcement in Armstrong also should be preclusive in medical device preemption cases. “The sheer complexity associated with enforcing [the vague statutory provision] coupled with the express provision of an administrative remedy . . ., shows that the [statute] precludes private enforcement of [that provision] in the courts.” Id.
As we see it, Buckman just received some timely reinforcement. It does not escape our notice that the court that Armstrong smacked back into line – the Ninth Circuit – was also the source of Stengel v. Medtronic Inc., 704 F.3d 1224 (9th Cir. 2013) (en banc), which similarly ignored Buckman in this respect.
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Posted By Bexis to Drug and Device Law at 3/31/2015 02:45:00 PM --
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