Good law from tragic facts--Congress, the FDA, and preemption

Good law from tragic facts--Congress, the FDA, and preemption.
Annas GJ.
N Engl J Med. 2009 Sep 17;361(12):1206-11. No abstract available.
PMID: 19759383 [PubMed - indexed for MEDLINE]
Related Articles


The New York Times heralded "A Win for Injured Patients,"¹ while the Wall Street Journal said that the U.S. Supreme Court was "Pre-empting Drug Innovation."² To the New York Times, the Court's decision in Wyeth v. Levine was "wise and surprising."¹ To the Wall Street Journal, it was a "defeat for drug innovation and public health"²; the editorial expressed surprise because the Supreme Court had earlier ruled that Congress had preempted state civil lawsuits alleging device misbranding, and many persons thought that the Court had turned relentlessly pro-business and would therefore also rule that civil lawsuits alleging drug misbranding . . . [Full Text of this Article]
The Facts in Wyeth
The Law of Preemption
"Tragic Facts"
Preemption after Wyeth

Source Information
From the Department of Health Law, Bioethics, and Human Rights, Boston University School of Public Health, Boston.
References

1. A win for injured patients. New York Times. March 5, 2009. 
2. Pre-empting drug innovation. Wall Street Journal. March 5, 2009:A16.
3. Rosen J. Supreme Court, Inc. New York Times Magazine. March 16, 2008.
4. Wyeth v. Levine, 129 U.S. 1187 (2009).
5. Curfman GD, Morrissey S, Drazen JM. Why doctors should worry about preemption. N Engl J Med 2008;359:1-3. [Free Full Text]
6. Northern Securities v. United States, 193 U.S. 197, 400 (1904).
7. Glantz LH, Annas GJ. The FDA, preemption, and the Supreme Court. N Engl J Med 2008;358:1883-1885. [Free Full Text]
8. Kennedy D. Misbegotten preemptions. Science 2008;320:585-585. [Free Full Text]
9. Warning signs. Nature 2008;452:254-254. [Medline]
10. Committee on the Assessment of the US Drug-Safety System. The future of drug safety: promoting and protecting the health of the public. Washington, DC: National Academies Press, 2007.
11. Psaty BM, Burke SP. Protecting the health of the public -- Institute of Medicine recommendations on drug safety. N Engl J Med 2006;355:1753-1755. [Free Full Text]
12. Gilhooley M. Drug preemption and the need to reform the FDA consultation process. Am J Law Med 2008;34:539-561. [Web of Science][Medline]
13. Wyeth v. Levine, 944 A.2d 179 (Vt. 2006).
14. Riegel v. Medtronic, 128 U.S. 999 (2008).
15. 71 C.F.R. 3922 (2006).
16. Geier v. American Honda Motor Co., 529 U.S. 861 (2000).
17. Curfman GD, Morrissey S, Drazen JM. The Medical Device Safety Act of 2009. N Engl J Med 2009;360:1550-1551. [Free Full Text]
18. Obama B. Memorandum for the heads of executive departments and agencies: preemption. Washington, DC: White House, May 20, 2009. (Accessed August 27, 2009, at http://www.whitehouse.gov/the_press_office/Presidential-Memorandum-Regarding-Preemption/.)

Kimberly McCallum Files Suit Against Billy Graham Evangelistic Association

Black Woman Files Suit Against Billy Graham Evangelistic Association

Friday, September 4, 2009

(RNS) The Billy Graham Evangelistic Association has denied the claims of a black former employee who filed suit, alleging she was fired after expressing concern that the ministry was not sufficiently reaching out to African-American churches.
The racial discrimination lawsuit by Kimberly McCallum was moved Wednesday (Sept. 2) from a local court to a federal court, the Associated Press reported.
In response, the association issued a statement confirming the suit and saying it works to be inclusive.
"We cannot discuss the specifics of the pending case, except to state that we disagree with the allegations in the lawsuit," said the association, which is based in Charlotte, N.C. "The BGEA provides equal employment opportunities to people of all races. The organization continues to be inclusive of all people regardless of race, gender or nationality in all of the ministry's activities worldwide."
The suit was filed in June in a Mecklenburg County (N.C.) court, but was moved to a U.S. District Court in Charlotte.
According to the AP, the suit says McCallum complained that a list of 635 prospective congregations for a BGEA program included only three that were predominantly black.  She said she was fired a week later due to downsizing.  She seeks back pay, damages, and job reinstatement.
"Subsequent to her discharge, plaintiff learned that the global offices had not been downsized and that the only job that was eliminated there was the one occupied by the plaintiff," the suit reads.
Adelle M. Banks
Copyright 2009 Religion News Service. All rights reserved. No part of this transmission may be distributed or reproduced without written permission.

Comments (6)

posted by Michael Consoli @ 4:34pm Permalink Email This Add to »

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Tom

September 4, 2009 11:33 PM

But anyone who has seen him has seen the father :-)
This is a new wrinkle. Allegedly, she wasn't fired for her race per say. She was fired for 'rocking the boat' regarding outreach to people of her race. Does she have a case? Can the court determine that religious orgs that don't reach out enough to save souls of minority races are 'racist'? I'm very interested to see how this pans out. Granting her a judgment can have serious implications on church & state issues

nnmns

September 5, 2009 12:04 AM

It sounds to me, based only on this RNS article, like she has a case. If they tell her they are down-sizing but only down-size her, and that after she rocked a boat that probably hates rocking, that's some evidence. But I'm no lawyer.

cknuck

September 5, 2009 12:54 AM

I disagree Tom when you see Franklin you don't see Billy. I agree with you nnmns I think she does have a case if upon suggesting outreach to more Black churches they "downsized" her only with that cover up in mind. Here's the deal, her lawyer probably knows they will settle to avoid the negative publicity. Franklin has had to do bad decision damage control before.

Tom

September 5, 2009 9:08 AM

I agree that there's a wrongful termination case, given the minimal "downsizing". If it is, in fact, a racial discrimination suit, it would likely be necessary to prove that the "layoff" was significantly related to race and not solely because of her speaking out. But this article is very sketchy, which makes educated guessing next to impossible (and like nnmns, I'm no lawyer, but I play one in beliefnet comboxes ;-).

pagansister

September 5, 2009 8:46 PM

Adding here to the idea that she seems to have a case. I hope she wins it. The leadership will have some fancy stepping to do to get out of this one.

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