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Wyeth's Hired Hands
As James notes in the thread below, there is an unusually detailed article in today's NYT about the extent of ghost-written articles used to promote the use of Prempro, including numerous meta-analyses, etc. Nothing new about ghostwriting. But what seems unusual (but may not be) here is the extent of it, creating the illusion of medical consensus, as well as the role of the journals themselves and their publisher in all of this.
http://www.nytimes.com/2009/08/05/health/research/05ghost.html?_r=1&emc=tnt&tntemail1=y
Showing posts with label Wyeth. Show all posts
Showing posts with label Wyeth. Show all posts
Wednesday, August 5, 2009
Wednesday, July 29, 2009
Orders For Wyeth (Or better yet, “No more orders for Wyeth”)
As reported by the Chicago Tribune, U.S. District Judge Bill Wilson has ordered that thousands of pages of Wyeth documents be unsealed. At issue is Wyeth’s marketing practices and the safety of their hormone replacement therapy drugs, Prempro and Premarin. The release request was made by The New York Times and the biomedical journal Public Library of Science (PLoS).
The data is relevant in a case involving 8,000 combined lawsuits which will be heard by Judge Wilson. Of interest is whether Wyeth properly reported the risks of breast cancer from hormone therapy.
As described in a Decwember 12, 2008, New York Times article, Wyeth had relinquished the documents to Sen. Grassley for use in a Congressional investigation regarding the pharmaceutical industry’s influence on doctors.
“Wyeth, the pharmaceutical company, paid ghostwriters to produce medical journal articles favorable to its female hormone replacement therapy Prempro, according to Congressional letters seeking more information about the company’s involvement in medical ghostwriting.” See: Wyeth’s Use of Medical Ghostwriters Questioned - NYTimes.com
Although shown to a jury, the documents have been under a confidential seal and not made available to the public. However, on June 17, 2009, the Times joined PLoS in their attempt to have the documents released.
“‘These documents will educate the public and allow them to better understand materials they use every day in making their often life-depending health care decisions,’ said Little Rock attorney Gerry Schulze, who represented the Times.’”
Questions: If Wyeth is found to have hid and embellished medical data, who is the most guilty?
A. Wyeth?
B. The doctors who signed or allowed their names to be used in published articles?
C. Our legal system for allowing such information to be kept from the public?
D. All of the above
What should be done to protect the public?
To read all about it, see: Judge orders Wyeth papers unsealed -- chicagotribune.com, Associated Press, July 25, 2009
The data is relevant in a case involving 8,000 combined lawsuits which will be heard by Judge Wilson. Of interest is whether Wyeth properly reported the risks of breast cancer from hormone therapy.
As described in a Decwember 12, 2008, New York Times article, Wyeth had relinquished the documents to Sen. Grassley for use in a Congressional investigation regarding the pharmaceutical industry’s influence on doctors.
“Wyeth, the pharmaceutical company, paid ghostwriters to produce medical journal articles favorable to its female hormone replacement therapy Prempro, according to Congressional letters seeking more information about the company’s involvement in medical ghostwriting.” See: Wyeth’s Use of Medical Ghostwriters Questioned - NYTimes.com
Although shown to a jury, the documents have been under a confidential seal and not made available to the public. However, on June 17, 2009, the Times joined PLoS in their attempt to have the documents released.
“‘These documents will educate the public and allow them to better understand materials they use every day in making their often life-depending health care decisions,’ said Little Rock attorney Gerry Schulze, who represented the Times.’”
Questions: If Wyeth is found to have hid and embellished medical data, who is the most guilty?
A. Wyeth?
B. The doctors who signed or allowed their names to be used in published articles?
C. Our legal system for allowing such information to be kept from the public?
D. All of the above
What should be done to protect the public?
To read all about it, see: Judge orders Wyeth papers unsealed -- chicagotribune.com, Associated Press, July 25, 2009
Wednesday, May 20, 2009
OBAMA ON PREEMPTION
Memo on Overall Policy
In what I believe is the first general policy statement on federal agency preemption, the Obama administration directly rejects what had been the pattern of the past eight years. In particular, note is made of agency preambles which insert preemption language (or presumption) without basis in statutory law. The Troy-era FDA "preemption preamble" will be the most obvious example to people here.
The UPI story on the policy memo is here:
http://www.upi.com/Top_News/2009/05/20/Obama-issues-memo-on-pre-emption-regs/UPI-19211242855063/
In some respects, the Troy-era position was already dissolved. In Wyeth v. Levine, even the dissent paid essentially no attention to it. The majority blew it aside as irrelevant.
Editorial opinion: ding, dong the witch is dead.
In what I believe is the first general policy statement on federal agency preemption, the Obama administration directly rejects what had been the pattern of the past eight years. In particular, note is made of agency preambles which insert preemption language (or presumption) without basis in statutory law. The Troy-era FDA "preemption preamble" will be the most obvious example to people here.
The UPI story on the policy memo is here:
http://www.upi.com/Top_News/2009/05/20/Obama-issues-memo-on-pre-emption-regs/UPI-19211242855063/
In some respects, the Troy-era position was already dissolved. In Wyeth v. Levine, even the dissent paid essentially no attention to it. The majority blew it aside as irrelevant.
Editorial opinion: ding, dong the witch is dead.
Sunday, March 8, 2009
FURTHER THOUGHTS ON WYETH V. LEVINE
Supreme Court Rejects FDA Preemption—Nine to Nothing.
I have now read the complete set of opinions in Wyeth v. Levine. While I cannot claim to have followed every nuance, and I’m sure I’ve missed much, certain conclusions seem warranted.
The most important one is this: None of the opinions, neither the majority finding nor the dissents, support anything remotely like the kind of broad preemption that has been argued in most of the pro-preemption positions—whether in amici, white papers, or in the Bush FDA’s own pronouncements. Indeed, the entire structure that the FDA put together to justify preemption—most specifically, the 2006 preamble and the 2008 CBE redefinitions—are missing from Justice Alito’s dissent (in which he was joined by Chief Justice Roberts and Justice Scalia). In this regard, the dissent is also strikingly unlike a number lower court decisions which did turn on these FDA assertions. Here, what is striking is that nothing turns on them at all. They are windblown leaves; the scattered remnants of a house of cards.
Instead, the dissent is framed quite narrowly. It makes the very specific argument that FDA extensively considered the risks of IV push injection of Phenergan, established considered and appropriate warnings, and that—given those specific facts and their similarity to other precedents (the Geier case is noted most prominently)—preemption should prevail in this instance. Again, this is a far more narrow support of preemption than almost everything that we have heard from preemption’s advocates. And that narrowness is made explicit in Justice Alito’s conclusion, which itself merits close attention:
“To be sure, state tort suits can peacefully coexist with the FDA’s labeling regime, and they have done so for decades. But this case is far from peaceful coexistence.” (26)
The operative language, it seems to me, is “this case.” To those who yearn for the day when FDA approval, in and of itself, inherently preempts failure-to-warn suits, they will find no comfort from Justice Alito. Instead, they will find definitive rebuttal. That, to me, is extraordinary. And it means that the Supreme Court has unanimously rejected FDA preemption in the form in which we have most often heard it articulated.
If the dissent is this narrow on preemption, the majority opinion and concurrences are devastating. Taking a strong federalist view, Justice Thomas asserts that FDA preemption is little less than tyranny. He quotes an 1869 case that “the preservation of the States, and the maintenance of their governments, are as much within the design and care of the Constitution as the preservation of the Union and the maintenance of the National Government.”(3) Later, invoking Justice Story in 1831, he asserts that such “invasions” from the center are “merely acts of usurpation, and will deserve to be treated as such.” (5) Justice Thomas makes no mention of the fact that only Michigan has an FDA preemption law based on precisely the doctrine that he calls "usurpation." And while he does not call on Michigan citizens to dump their tea in the harbor, the text certainly evokes such imagery.
Regarding FDA preemption specifically, Justice Thomas is definitive:
“Initial approval of a label amounts to a finding by the FDA that the label is safe for the purposes of gaining federal approval to market the drug. It does not represent a finding that the drug, as labeled, can never be deemed unsafe by later federal action, or as in this case, the application of state law.” (11)
And further:
“Nothing in the text of the statutory or regulatory scheme necessarily insulates Wyeth from liability under state law simply because the FDA has approved a particular label.” (12)
It is hard to be more clear than that. Or more rejecting of the preemption argument as we have heard it during the past seven years.
Not surprisingly, Justice Thomas also makes no mention of the recent preamble or CBE changes. They are, in his opinion, of no consequence. By contrast, they do appear in the majority opinion—as presumptions entirely without merit and worthy of no deference. Here, there is no reason to go into detail. In a rolling series of arguments and citations, the majority asserts that preemption, as we have heard it asserted in recent years, is little more than an aberration, fully out of touch with the past seventy years of both the FDA’s own understanding of its authority relative to tort law and Congressional intent on the same question. For those of us who agree with that view, the opinion is a treasure trove of relevant citations. But there is no need to reiterate those here.
So I return to my initial conclusion. At core, Wyeth v. Levine was not a 6-3 decision. With regard to the preemption defense as we have most often heard it articulated, it was a 9-0 rejection.
Send in the brooms.
I have now read the complete set of opinions in Wyeth v. Levine. While I cannot claim to have followed every nuance, and I’m sure I’ve missed much, certain conclusions seem warranted.
The most important one is this: None of the opinions, neither the majority finding nor the dissents, support anything remotely like the kind of broad preemption that has been argued in most of the pro-preemption positions—whether in amici, white papers, or in the Bush FDA’s own pronouncements. Indeed, the entire structure that the FDA put together to justify preemption—most specifically, the 2006 preamble and the 2008 CBE redefinitions—are missing from Justice Alito’s dissent (in which he was joined by Chief Justice Roberts and Justice Scalia). In this regard, the dissent is also strikingly unlike a number lower court decisions which did turn on these FDA assertions. Here, what is striking is that nothing turns on them at all. They are windblown leaves; the scattered remnants of a house of cards.
Instead, the dissent is framed quite narrowly. It makes the very specific argument that FDA extensively considered the risks of IV push injection of Phenergan, established considered and appropriate warnings, and that—given those specific facts and their similarity to other precedents (the Geier case is noted most prominently)—preemption should prevail in this instance. Again, this is a far more narrow support of preemption than almost everything that we have heard from preemption’s advocates. And that narrowness is made explicit in Justice Alito’s conclusion, which itself merits close attention:
“To be sure, state tort suits can peacefully coexist with the FDA’s labeling regime, and they have done so for decades. But this case is far from peaceful coexistence.” (26)
The operative language, it seems to me, is “this case.” To those who yearn for the day when FDA approval, in and of itself, inherently preempts failure-to-warn suits, they will find no comfort from Justice Alito. Instead, they will find definitive rebuttal. That, to me, is extraordinary. And it means that the Supreme Court has unanimously rejected FDA preemption in the form in which we have most often heard it articulated.
If the dissent is this narrow on preemption, the majority opinion and concurrences are devastating. Taking a strong federalist view, Justice Thomas asserts that FDA preemption is little less than tyranny. He quotes an 1869 case that “the preservation of the States, and the maintenance of their governments, are as much within the design and care of the Constitution as the preservation of the Union and the maintenance of the National Government.”(3) Later, invoking Justice Story in 1831, he asserts that such “invasions” from the center are “merely acts of usurpation, and will deserve to be treated as such.” (5) Justice Thomas makes no mention of the fact that only Michigan has an FDA preemption law based on precisely the doctrine that he calls "usurpation." And while he does not call on Michigan citizens to dump their tea in the harbor, the text certainly evokes such imagery.
Regarding FDA preemption specifically, Justice Thomas is definitive:
“Initial approval of a label amounts to a finding by the FDA that the label is safe for the purposes of gaining federal approval to market the drug. It does not represent a finding that the drug, as labeled, can never be deemed unsafe by later federal action, or as in this case, the application of state law.” (11)
And further:
“Nothing in the text of the statutory or regulatory scheme necessarily insulates Wyeth from liability under state law simply because the FDA has approved a particular label.” (12)
It is hard to be more clear than that. Or more rejecting of the preemption argument as we have heard it during the past seven years.
Not surprisingly, Justice Thomas also makes no mention of the recent preamble or CBE changes. They are, in his opinion, of no consequence. By contrast, they do appear in the majority opinion—as presumptions entirely without merit and worthy of no deference. Here, there is no reason to go into detail. In a rolling series of arguments and citations, the majority asserts that preemption, as we have heard it asserted in recent years, is little more than an aberration, fully out of touch with the past seventy years of both the FDA’s own understanding of its authority relative to tort law and Congressional intent on the same question. For those of us who agree with that view, the opinion is a treasure trove of relevant citations. But there is no need to reiterate those here.
So I return to my initial conclusion. At core, Wyeth v. Levine was not a 6-3 decision. With regard to the preemption defense as we have most often heard it articulated, it was a 9-0 rejection.
Send in the brooms.
Wednesday, March 4, 2009
PREEMPTION DEFEATED IN LEVINE CASE
Supreme Court Sides With Plaintiff and Vermont, 6-3
The above is a headline I never thought I would be writing, at least not this decade. I have not had time to read beyond the overall summary. But it does appear that every major pro-preemption argument was rejected by the 6-3 majority, including the capacity of Wyeth to have independently warned and the intent of Congress that FDA regulations _not_ preempt state tort law. The opinion below:
http://www.supremecourtus.gov/opinions/08pdf/06-1249.pdf
No doubt, there will be more to say later--just got this ten minutes ago.
The above is a headline I never thought I would be writing, at least not this decade. I have not had time to read beyond the overall summary. But it does appear that every major pro-preemption argument was rejected by the 6-3 majority, including the capacity of Wyeth to have independently warned and the intent of Congress that FDA regulations _not_ preempt state tort law. The opinion below:
http://www.supremecourtus.gov/opinions/08pdf/06-1249.pdf
No doubt, there will be more to say later--just got this ten minutes ago.
Monday, February 9, 2009
Will Chief Justice Roberts Recuse in Wyeth v. Levine?
Is Roberts Recusal Possible?
Anne PME, one of our crack field reporters, raises the above question, linked to a post that can be found at:
http://legaltimes.typepad.com/blt/2009/02/should-cj-roberts-recuse-in-landmark-wyeth-case.html
(But if you don't want to link, the whole post is in our "drop box" thread. Just don't tell anybody.)
The logic would be that, now that Pfizer and Wyeth are to be wed (or at least become domestic partners), would Roberts' holding of stock in Pfizer lead to his deciding to recuse in the Levine case. Some of you will recall he did so in Warner-Lambert v. Kent (Warner-Lambert, of course, now being part of Pfizer) leading to a 4-4 non-decision. Most folks believe that, had Roberts voted, it would have been on the side of WL, and thus have given the company a 5-4 victory. The Kent case concerned our own (not beloved by all) Michigan law which, on paper, has a "fraud exception" for preemption. WL claimed, however, that that exception was itself preempted, since--based on the Buckman precedent--only the FDA can find fraud against itself. (Even though it essentially never does in such contexts.) And, argued the FDA/DOJ in Kent, even if FDA _did_ find fraud, that should not open the door to private lawsuits.
Confused? The short lesson here is that, according to the FDA/DOJ, there are NO conditions--including FDA's finding that a company committed felony fraud in the pre- or post-approval processl--that would allow lawsuits against that or any other company. None. Nada. Zilch. That's broad preemption, folks. And that's why DDL and others are clear about their goal of prescription drug litigation "vanishing from the face of the earth" (DDL, 11/6/08). And next time you hear preemptors tell us differently--and preemptors try to tell us differently almost every day--don't believe them.
In any event, I think it extremely unlikely Justice Roberts will recuse. As the article points out, a simple strategy would be simply to sell his Pfizer stock. Given the importance of Levine, that would seem his most likely course of action. It might also be argued that the new company--Pfyzeth--would not be the same as Pfizer. And/or that it will not exist until after a decision in Levine anyway.
Whatever. I say he sells the stock.
Anne PME, one of our crack field reporters, raises the above question, linked to a post that can be found at:
http://legaltimes.typepad.com/blt/2009/02/should-cj-roberts-recuse-in-landmark-wyeth-case.html
(But if you don't want to link, the whole post is in our "drop box" thread. Just don't tell anybody.)
The logic would be that, now that Pfizer and Wyeth are to be wed (or at least become domestic partners), would Roberts' holding of stock in Pfizer lead to his deciding to recuse in the Levine case. Some of you will recall he did so in Warner-Lambert v. Kent (Warner-Lambert, of course, now being part of Pfizer) leading to a 4-4 non-decision. Most folks believe that, had Roberts voted, it would have been on the side of WL, and thus have given the company a 5-4 victory. The Kent case concerned our own (not beloved by all) Michigan law which, on paper, has a "fraud exception" for preemption. WL claimed, however, that that exception was itself preempted, since--based on the Buckman precedent--only the FDA can find fraud against itself. (Even though it essentially never does in such contexts.) And, argued the FDA/DOJ in Kent, even if FDA _did_ find fraud, that should not open the door to private lawsuits.
Confused? The short lesson here is that, according to the FDA/DOJ, there are NO conditions--including FDA's finding that a company committed felony fraud in the pre- or post-approval processl--that would allow lawsuits against that or any other company. None. Nada. Zilch. That's broad preemption, folks. And that's why DDL and others are clear about their goal of prescription drug litigation "vanishing from the face of the earth" (DDL, 11/6/08). And next time you hear preemptors tell us differently--and preemptors try to tell us differently almost every day--don't believe them.
In any event, I think it extremely unlikely Justice Roberts will recuse. As the article points out, a simple strategy would be simply to sell his Pfizer stock. Given the importance of Levine, that would seem his most likely course of action. It might also be argued that the new company--Pfyzeth--would not be the same as Pfizer. And/or that it will not exist until after a decision in Levine anyway.
Whatever. I say he sells the stock.
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