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Levine Appears Vindicated
The NY Times reports that the FDA will require stronger warnings about administering Phenergan via IV push:
http://www.nytimes.com/2009/09/19/health/19drug.html?_r=1
Needless to say, this is a fascinating sequel to the Wyeth v. Levine case. The new warnings will apparently be what Diana Levine argued should have been on the label in the first place. The FDA reports the change is based on the number of cases it has received in which IV push administration led to gangrene and amputation--precisely what happened to Levine.
There is no suggestion that the label change was based on "new information" per se, but rather a few additional cases along with rethinking the older warning. The Vermont juries that twice upheld Levine agreed with her argument that Wyeth knew enough at the time of her injury, and had the authority, to make precisely such a change on its own (under the "Changes Being Effected" rules). While FDA would have had to agree, there are virtually no instances when it has not under such circumstances.
In an interesting closing, Gardiner Harris writes that this change may lend support to FDA's older position--pre-Bush administration--that civil liability and FDA regulation are overlapping, generally complementary, systems of consumer protection.
Friday, September 18, 2009
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As many here will know, preemptors will argue (as they do re: changed warnings on SSRI) that none of this impacts Levine, or should if that case (in their dreams!) were heard again.
ReplyDeleteEvery one of these arguments was rejected by the Supreme Court, btw, not only 6-3, but 9-0.
1. Wyeth could not have changed the label without "misbranding" the drug and thus being in legal jeopardy with FDA.
2. The _only_ relevant fact is the label in place at the time, which should be preemptive simply because it existed.
3. Wyeth could not have changed the label unless there was truly "new" information.
4. Civil liability "second guesses" the FDA, which will lead to dangerous overw-warning, a "chaos of conflicting standards," dissolution of the pharmaceutical industry, and the end of life on earth.
Was Diana Levine the sacrificial lamb? If it had not been for her valiant fight would FDA preemption for drugs have “slipped” into law like it did in Michigan?
ReplyDeleteWho in the media is going to pick up the ball for Michigan where thousands of Americans have been denied their civil right of due process; a state where drug companies have gotten off scot-free for over 13 years after harming and killing its citizens?
What is it going to take before laws against preemption are written? George Bush losing his arms and legs, John Engler dying from anti-psychotic drugs, Daniel Troy paralyzed from the mouth down from vaccines?
Or do they receive a “heads-up” on meds and devices?
Just to the first part, it seems unlikely to me that FDA would have changed the label--at least so quickly--if the Levine case did not focus attention on the Phenergan label. The same could be said for cases involving Vioxx, SSRIs, Baycol, etc.. In many such instances, civil cases--and the information they uncover--contributes to FDA's mission.
ReplyDeleteAs for Michigan.....the fight goes on. In that case, it will take the next state elections.
p.s. As already posted, I am afraid the health-care debate and O's adoption of some of the "tort reform" proposal will make it less likely that Congress will act to reverse Riegel, and thus device preemption.
ReplyDelete"When people live in a culture defined by corporate values, common sense evaporates"
ReplyDeletewww.poclad.org
Anon--Is it "corporate values" or corporate power? Or are those two sides of the same thing?
ReplyDeleteIn the meantime, what do you see as the best alternative ground for values?
Sorry - missed the second question. Best alternative ground for values? How about Precautionary Principle?
ReplyDeleteI'd agree two sides of same thing -- however not my quote. came from the poclad site
ReplyDeleteHi!
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Federal preemption --perversely backed by conservatives-- remains among the most unconservative of doctrines. Stripping private citizens of Constitutional rights, allowing elected lawmakers and judged to abdicate their responsibility for the public good, and cedeing those rights and responsibilities to a huge 'big government' administrative bueracracy. Leave out the specific facts and present that pattern to most people and they'd assume you were talking about some far-left socialist plan. Ironic as well as sad.
ReplyDeleteThat's why Clarence Thomas voted against Wyeth in the Levine case. Whatever else, he's consistent!
ReplyDeleteThank-you Angelina. We will fly our flag proudly.
ReplyDeleteAnonymous
ReplyDeleteThe Conservatives may claim to be the anti-Federalist Party and the the champion of State Rights but nothing could be further from the truth.
Whenever a Conservative politician says they are opposed to Big Government you must remember it is their definition of Big Government. Under the Conservative philosopy "Big Government" is defined as those programs that are designed to assist those less fortunate. In their twisted outlook "Big Government" is designed to protect the free market interests of Corporate America. One need look no further then the State of Georgia where one of these so called Fiscally Conservative anti-government Congressman went out of his way to receive federal funding for a Fighter Plane that even the Pentagon did not want. Apparently a bloated Military does not constitute Big Government.
However, with the increasing domination at the State Level of Conservative ideals much of the Federal Government's intrusion into State issues is becoming moot. A number of States are making it increasingly difficult to bring Class Action suits in their quest to attract Big Business to their States. Besides the oft-cited Michigan we have, as an example, the State of North Carolina where the Doctrine of "Strict Liability" has been eliminated from their code. The majority of its citizens would have no idea of the implications of this change and would happily endorse a change that is designed to eliminate those "frivolous lawsuits" and keep from enriching those money hungry bottom feeders known as lawyers.