Thursday, March 05, 2009

federal courts - standing - organizational standing

SUPREME COURT OF THE UNITED STATES
SUMMERS ET AL. v. EARTH ISLAND INSTITUTE ET AL.
CERTIORARI TO THE UNITED STATES COURT OF APPEALS FOR THE NINTH CIRCUIT
No. 07–463. Argued October 8, 2008—Decided March 3, 2009

After the U. S. Forest Service approved the Burnt Ridge Project, a salvage sale of timber on 238 acres of fire-damaged federal land, respondent environmentalist organizations filed suit to enjoin the Service from applying its regulations exempting such small sales fromthe notice, comment, and appeal process it uses for more significant land management decisions, and to challenge other regulations thatdid not apply to Burnt Ridge. The District Court granted a preliminary injunction against the sale, and the parties then settled theirdispute as to Burnt Ridge. Although concluding that the sale was no longer at issue, and despite the Government’s argument that respondents therefore lacked standing to challenge the regulations, thecourt nevertheless proceeded to adjudicate the merits of their challenges, invalidating several regulations, including the notice and comment and the appeal provisions. Among its rulings, the NinthCircuit affirmed the determination that the latter regulations, which were applicable to Burnt Ridge, were contrary to law, but held that challenges to other regulations not at issue in that project were not ripe for adjudication.

Held: Respondents lack standing to challenge the regulations still atissue absent a live dispute over a concrete application of those regulations. Pp. 4–12.

(a) In limiting the judicial power to "Cases" and "Controversies," Article III restricts it to redressing or preventing actual or imminently threatened injury to persons caused by violation of law. See, e.g., Lujan v. Defenders of Wildlife, 504 U. S. 555, 559–560. The standing doctrine reflects this fundamental limitation, requiring that "the plaintiff . . . ‘alleg[e] such a personal stake in the outcome of thecontroversy’ as to warrant his invocation of federal-court jurisdiction," Warth v. Seldin, 422 U. S. 490, 498–499. Here, respondentscan demonstrate standing only if application of the regulations will affect them in such a manner. Pp. 4–5.

(b) As organizations, respondents can assert their members’ standing. Harm to their members’ recreational, or even their mere esthetic, interests in the National Forests will suffice to establish the requisite concrete and particularized injury, see Sierra Club v. Morton, 405 U. S. 727, 734–736, but generalized harm to the forest or the environment will not alone suffice. Respondents have identified noapplication of the invalidated regulations that threatens imminentand concrete harm to their members’ interests. Respondents’ argument that they have standing based on Burnt Ridge fails because, after voluntarily settling the portion of their lawsuit relevant to Burnt Ridge, respondents and their members are no longer under threat of injury from that project. The remaining affidavit submitted in support of standing fails to establish that any member has concrete plans to visit a site where the challenged regulations are being applied in a manner that will harm that member’s concrete interests. Additional affidavits purporting to establish standing were submitted after judgment had already been entered and notice of appeal filed,and are thus untimely. Pp. 5–8.

(c) Respondents’ argument that they have standing because they have suffered procedural injury—i.e., they have been denied the ability to file comments on some Forest Service actions and will continueto be so denied—fails because such a deprivation without some concrete interest affected thereby is insufficient to create Article III standing. See, e.g., Defenders of Wildlife, supra, at 572, n. 7. Pp. 8–9.

(d) The dissent’s objections are addressed and rejected. Pp. 9–12. 490 F. 3d 687, reversed in part and affirmed in part.

SCALIA, J., delivered the opinion of the Court, in which ROBERTS, C. J., and KENNEDY, THOMAS, and ALITO, JJ., joined. KENNEDY, J., filed a concurring opinion. BREYER, J., filed a dissenting opinion, in which STEVENS, SOUTER, and GINSBURG, JJ., joined.

federal courts - pre-emption - drug warnings

SUPREME COURT OF THE UNITED STATES - WYETH v. LEVINE
CERTIORARI TO THE SUPREME COURT OF VERMONT
No. 06–1249. Argued November 3, 2008—Decided March 4, 2009

Petitioner Wyeth manufactures the antinausea drug Phenergan. After a clinician injected respondent Levine with Phenergan by the "IVpush" method, whereby a drug is injected directly into a patient’s vein, the drug entered Levine’s artery, she developed gangrene, and doctors amputated her forearm. Levine brought a state-law damages action, alleging, inter alia, that Wyeth had failed to provide an adequate warning about the significant risks of administering Phenergan by the IV-push method. The Vermont jury determined that Levine’s injury would not have occurred if Phenergan’s label includedan adequate warning, and it awarded damages for her pain and suffering, substantial medical expenses, and loss of her livelihood as aprofessional musician. Declining to overturn the verdict, the trial court rejected Wyeth’s argument that Levine’s failure-to-warn claimswere pre-empted by federal law because Phenergan’s labeling hadbeen approved by the federal Food and Drug Administration (FDA). The Vermont Supreme Court affirmed.

Held: Federal law does not pre-empt Levine’s claim that Phenergan’slabel did not contain an adequate warning about the IV-push method of administration. Pp. 6–25.

(a) The argument that Levine’s state-law claims are pre-empted because it is impossible for Wyeth to comply with both the state-law duties underlying those claims and its federal labeling duties is rejected. Although a manufacturer generally may change a drug labelonly after the FDA approves a supplemental application, the agency’s"changes being effected" (CBE) regulation permits certain preapproval labeling changes that add or strengthen a warning to improve drug safety. Pursuant to the CBE regulation, Wyeth could have unilaterally added a stronger warning about IV-push administration,and there is no evidence that the FDA would ultimately have rejected such a labeling change. Wyeth’s cramped reading of the CBE regulation and its broad assertion that unilaterally changing the Phenerganlabel would have violated federal law governing unauthorized distribution and misbranding of drugs are based on the fundamental misunderstanding that the FDA, rather than the manufacturer, bearsprimary responsibility for drug labeling. It is a central premise of theFood, Drug, and Cosmetic Act (FDCA) and the FDA’s regulationsthat the manufacturer bears responsibility for the content of its label at all times. Pp. 11–16.

(b) Wyeth’s argument that requiring it to comply with a state-law duty to provide a stronger warning would interfere with Congress’ purpose of entrusting an expert agency with drug labeling decisions is meritless because it relies on an untenable interpretation of congressional intent and an overbroad view of an agency’s power to preempt state law. The history of the FDCA shows that Congress didnot intend to pre-empt state-law failure-to-warn actions. In advancing the argument that the FDA must be presumed to have established a specific labeling standard that leaves no room for different state-law judgments, Wyeth relies not on any statement by Congress but on the preamble to a 2006 FDA regulation declaring that statelaw failure-to-warn claims threaten the FDA’s statutorily prescribed role. Although an agency regulation with the force of law can preempt conflicting state requirements, this case involves no such regulation but merely an agency’s assertion that state law is an obstacleto achieving its statutory objectives. Where, as here, Congress has not authorized a federal agency to pre-empt state law directly, theweight this Court accords the agency’s explanation of state law’s impact on the federal scheme depends on its thoroughness, consistency,and persuasiveness. Cf., e.g., Skidmore v. Swift & Co., 323 U. S. 134. Under this standard, the FDA’s 2006 preamble does not merit deference: It is inherently suspect in light of the FDA’s failure to offer interested parties notice or opportunity for comment on the preemption question; it is at odds with the available evidence of Congress’ purposes; and it reverses the FDA’s own longstanding positionthat state law is a complementary form of drug regulation without providing a reasoned explanation. Geier v. American Honda Motor Co., 529 U. S. 861, is distinguished. Pp. 17–25.
___ Vt. ___, 944 A. 2d 179, affirmed.

STEVENS, J., delivered the opinion of the Court, in which KENNEDY, SOUTER, GINSBURG, and BREYER, JJ., joined. BREYER, J., filed a concurring opinion. THOMAS, J., filed an opinion concurring in the judgment. ALITO, J., filed a dissenting opinion, in which ROBERTS, C. J., and SCALIA, J., joined.

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