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)

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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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Stella Zhou Joins Brighter Green as an Associate 7/20/2009

Harvard Public Health graduate student Stella Zhou becomes a Brighter Green Associate. Stella's interests include population-level bioethics, animal rights, and the relationship between public health and diet. A Chinese citizen, Stella hopes to use her degree to reinvigorate the bioethics curricula used in Chinese Universities. Brighter Green looks forward to working with Stella and gaining from her fresh insights.

China: Animal Welfare on the Legal Docket

by Stella Zhou

July 26, 2009 8:58pm

Filed under:

• Rights

In future, a different destiny?

China has drafted it first Animal Protection Law. At present, Chinese animal law covers wildlife only. A team of experts headed by Chang Jiwen, director of the Chinese Academy of Social Sciences’ Social Law Research Department, is looking to change this. On June 15, 2009, state media reported that the team finished drafting China’s first Animal Protection Law. According to the draft, severe cases of animal abuse, such as the hauling of cats from all over China to Guangdong Province for a Cantonese delicacy of shui zhu huo mao or water-boiled live cats, can result in the jailing of violators. Lighter punishments include fines of up to 6,000 yuan ($877.50) and detention periods of 15 days or less. The draft also proposes implanting data chips in pets as a means of controlling stray populations, and improving farm animal welfare through the adoption of humane breeding, transportation, and slaughter practices.

In August, the draft law will be published to solicit public opinion and will be submitted to various government departments by year-end. Repeated accounts of animal abuse reported by the Chinese media have spurred on the legal drafting team’s work. In 2002 for example, a student from Tsinghua University poured sulphuric acid into the mouths of Beijing zoo’s black bears. In 2005, a graduate student from Fudan University abused 30 stray cats, gouging out their eyes and eventually killing them. More recently, in 2006, a group of teenage girls in high heels trampled a number of cats to death, supposedly for fun. An Internet uproar ensued and the events sparked off heated ethical debates.

While China’s animal lovers responded eagerly to news of the draft law, critical voices were also heard. “We’re unable even to take care of the numerous poor, let alone animals. Let’s talk about human rights first!” was a common public response. Some went further, accusing the scholars and activists of blindly emulating the West and pointing out the hypocrisy of “animal welfare,” as the animals are ultimately killed regardless of how humane the slaughter.

In an interview with CCTV, Professor Chang, head of the drafting team, responded to such criticisms. He stressed that the team sought to craft the law in accord with the actual conditions for animals in China, with anti-abuse (that is, punishing the infliction of unnecessary pain on nonhuman animals) forming the basis of the law. Professor Chang admitted that it while it is currently unrealistic for China to mirror Western standards of animal welfare, he detailed step-by-step measures to improve Chinese animal welfare that can be implemented within the next two decades.

A final version of the draft law will have to go through the State Council, China's highest executive organ, and undergo three readings at the National People’s Congress (China's national legislature) before taking effect. Every change in life presents its own set of challenges. Such difficulties are inevitable, but are never reason enough to avoid action. This draft presents the Chinese people with a plan detailing not only better animal treatment, but also reforms to industrial animal agriculture systems and rural labor. The "humane" path will encounter roadblocks in China, but it is an important route to the future.