FROM: Alan S. Goldberg, JD, LLM (Tax), Mod'r, HIT listserv, AHLA Past Pres. & Inaug. Fellow, Alan@GoldbergLawyer.com
6845 Elm St., Suite 205, McLean, Virginia 22101, http://www.healthlawyer.com
Adj. Prof. of Health Law, George Mason University - Admitted VA NY DC FL MA - This email is neither legal nor tax advice and cannot be used by anyone to avoid penalties under the Internal Revenue Code of 1986, as amended; please retain a competent attorney for legal or tax advice.
Query how the PL 111-005 provisions relative to certification quoted below are to be construed in light of the decision of the USSCT referenced below (and regardless, this decision is a fascinating performance by the Justices providing much to consider, ponder, and reflect upon regarding preemption and federal-state relationships in matters of health care regulation):
`(c) Duties of the National Coordinator-
`(1) STANDARDS- The National Coordinator shall--
`(A) review and determine whether to endorse each standard, implementation specification, and certification criterion for the electronic exchange and use of health information that is recommended by the HIT Standards Committee under section 3003 for purposes of adoption under section 3004;
`(B) make such determinations under subparagraph (A), and report to the Secretary such determinations, not later than 45 days after the date the recommendation is received by the Coordinator; and
`(C) review Federal health information technology investments to ensure that Federal health information technology programs are meeting the objectives of the strategic plan published under paragraph (3).
`(5) CERTIFICATION-
`(A) IN GENERAL- The National Coordinator, in consultation with the Director of the National Institute of Standards and Technology, shall keep or recognize a program or programs for the voluntary certification of health information technology as being in compliance with applicable certification criteria adopted under this subtitle. Such program shall include, as appropriate, testing of the technology in accordance with section 13201(b) of the Health Information Technology for Economic and Clinical Health Act.
`(B) CERTIFICATION CRITERIA DESCRIBED- In this title, the term `certification criteria' means, with respect to standards and implementation specifications for health information technology, criteria to establish that the technology meets such standards and implementation specifications.
WYETH, PETITIONER v. DIANA LEVINE
quote
The Supreme Court ruled yesterday in favor of a woman who had her arm amputated after an improper injection of an anti-nausea medication and said drugmakers could not rely on federal regulation to shield them from lawsuits brought under state consumer protection laws.
The 6 to 3 vote in the court's most anticipated business decision of the term was a rejection of Bush administration policy and a major setback to pharmaceutical companies, which face thousands of lawsuits in state courts from patients who allege that drugs have harmed them.
http://www.washingtonpost.com/wp-dyn/content/article/2009/03/04/AR2009030401407.html
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http://www.supremecourtus.gov/opinions/08pdf/06-1249.pdf
WYETH, PETITIONER v. DIANA LEVINE
...Our answer to that question must be guided by two cornerstones of our pre-emption jurisprudence. First, “the purpose of Congress is the ultimate touchstone in everypre-emption case.” Medtronic, Inc. v. Lohr, 518 U. S. 470, 485 (1996) (internal quotation marks omitted); see Retail Clerks v. Schermerhorn, 375 U. S. 96, 103 (1963). Second, “[i]n all pre-emption cases, and particularly in those inwhich Congress has ‘legislated . . . in a field which the States have traditionally occupied,’ . . . we ‘start with theassumption that the historic police powers of the States were not to be superseded by the Federal Act unless thatwas the clear and manifest purpose of Congress.’” Lohr, 518 U. S., at 485 (quoting Rice v. Santa Fe Elevator Corp., 331 U. S. 218, 230 (1947)).
In order to identify the “purpose of Congress,” it is appropriate to briefly review the history of federal regulation of drugs and drug labeling. In 1906, Congress enacted itsfirst significant public health law, the Federal Food andDrugs Act, ch. 3915, 34 Stat. 768. The Act, which prohibited the manufacture or interstate shipment of adulterated or misbranded drugs, supplemented the protection for consumers already provided by state regulation and common-law liability. In the 1930’s, Congress becameincreasingly concerned about unsafe drugs and fraudulent marketing, and it enacted the Federal Food, Drug, and Cosmetic Act (FDCA), ch. 675, 52 Stat. 1040, as amended,21 U. S. C. §301 et seq. The Act’s most substantial innovation was its provision for premarket approval of new drugs.
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JUSTICE ALITO, with whom THE CHIEF JUSTICE and JUSTICE SCALIA join, dissenting.
This case illustrates that tragic facts make bad law. The Court holds that a state tort jury, rather than the Food and Drug Administration (FDA), is ultimately responsible for regulating warning labels for prescription drugs. That result cannot be reconciled with Geier v. American Honda Motor Co., 529 U. S. 861 (2000), or general principles of conflict pre-emption. I respectfully dissent.
I The Court frames the question presented as a “narro[w]” one—namely, whether Wyeth has a duty to provide “an adequate warning about using the IV-push method” toadminister Phenergan. Ante, at 8. But that ignores the antecedent question of who—the FDA or a jury in Vermont—has the authority and responsibility for determining the “adequacy” of Phenergan’s warnings. Moreover, it is unclear how a “stronger” warning could ....
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