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It's Not Good-bye. It's Onward!
Friends--Now that our beloved Ed Silverman and Pharmalot have returned, Pharmalittle will refine its focus.
Of course, we never imagined we could be more than a small stop-over for a few people. We are glad that we have been that and had some fun along the way. That will continue. But, beginning today, we will devote the lion's share of our reporting and commentary to the issues of accountability in the medical device and drug industries--both nationally and, for drugs, especially in Michigan. That means the issues of FDA preemption and civil liability, of course. But it also includes FDA regulation, Department of Justice actions, incentives for integrity, and examples of self-regulation that we view as terrific.
We expect to discuss these issues in detail--not only the law, but the politics, the spin, the tactics, the money, and more. We will connect the dots. And we will do so as advocates. No surprise there.
We are also what we have always been--a group of people representing both major political parties, healthcare professionals, academics, folks from industry (yes, that's true), patient advocates, and--above all--concerned citizens.
Our discussions will be linked directly to the combined organizations, Americans for Drug and Device Accountability / Justice in Michigan.
http://pharmaccountability.org/index.html
Whatever our own positions, we fervently hope that this space will serve as a forum for discussion and debate. In our view, the greatest travesty of all is that most people know nothing about these issues, or what they think they know is simply false.
For those who represent perspectives we oppose: If we think you knowingly lied, we will call you a liar, and we will say why. If we think you are arguing sincerely, you will maintain our respect, and we will tell you so. Count on both.
Let's hash it out. Let's tell the truth. Let's see what just and rational policy dictates.
Onward!
Showing posts with label Michigan. Show all posts
Showing posts with label Michigan. Show all posts
Sunday, October 18, 2009
Sunday, April 19, 2009
UNITED AGAINST FDA PREEMPTION
Two Groups Join Forces Against Device Preemption and Michigan's Shield Law
(yes, an issue dear to some of our hearts....)
Two Anti-preemption Groups Unite
For release, April 20. 2009
Americans for Drug and Device Accountability (ADDA) and Justice in Michigan (JIM) have announced their consolidation into a single organization dedicated to fighting FDA preemption in the drug and device arenas, and on both the state and national levels. Their updated website is http://pharmaccountability.org/.
ADDA was formed one year ago and consists of business people, patient advocates, healthcare professionals, and concerned citizens. Members represent the full political spectrum—from conservative Republicans to liberal Democrats. They also include current and former employees of the pharmaceutical industry who agree that FDA preemption is bad policy—a disaster for patient rights, public health, and industry accountability. A petition initiated last year quickly gathered nearly 1,000 signatures and comments, including those of Dr. David Graham of FDA, Dr. Joel Lexchin, Dr. Doug Bremner, Dr. Howard Brody, Vera Sharav, Tom Lamb, and many more.
JIM was formed four years ago, primarily by social scientists, policy analysts, and bioethicists in Michigan. Along with issues of healthcare and social justice generally, the organization’s focus has been on Michigan’s unique drug industry shield law, passed in 1996, that fully bars Michigan citizens from bringing suit over drugs approved by the FDA. Michigan’s law is the most draconian in the nation. Courts have ruled that even the most egregious negligence or fraud would not open the courthouse to Michigan citizens. That is thirteen years of justice denied.
Both ADDA and JIM believe that it will take legislative action to restore justice. On the national level, this means the Medical Device Safety Act which would restore the right of citizens to bring suit in the medical device arena. In Michigan, it means rescinding drug industry immunity. The Michigan House has already voted twice to do so. But the bills have been killed by a small number of immunity supporters in the Michigan Senate.
The national and state levels of these issues reinforce each other. Across both parties, and across this land, citizens are recognizing that the days of special interest legislation—along with the era of government arrogance and irresponsibility—are drawing to a close. Before long, we will look back at this time as a nightmare from which we will be thankful to have awakened. In the meantime, Americans for Drug and Device Accountability and Justice in Michigan fight toward that dawn.
Join us.
http://pharmaccountability.org/
(yes, an issue dear to some of our hearts....)
Two Anti-preemption Groups Unite
For release, April 20. 2009
Americans for Drug and Device Accountability (ADDA) and Justice in Michigan (JIM) have announced their consolidation into a single organization dedicated to fighting FDA preemption in the drug and device arenas, and on both the state and national levels. Their updated website is http://pharmaccountability.org/.
ADDA was formed one year ago and consists of business people, patient advocates, healthcare professionals, and concerned citizens. Members represent the full political spectrum—from conservative Republicans to liberal Democrats. They also include current and former employees of the pharmaceutical industry who agree that FDA preemption is bad policy—a disaster for patient rights, public health, and industry accountability. A petition initiated last year quickly gathered nearly 1,000 signatures and comments, including those of Dr. David Graham of FDA, Dr. Joel Lexchin, Dr. Doug Bremner, Dr. Howard Brody, Vera Sharav, Tom Lamb, and many more.
JIM was formed four years ago, primarily by social scientists, policy analysts, and bioethicists in Michigan. Along with issues of healthcare and social justice generally, the organization’s focus has been on Michigan’s unique drug industry shield law, passed in 1996, that fully bars Michigan citizens from bringing suit over drugs approved by the FDA. Michigan’s law is the most draconian in the nation. Courts have ruled that even the most egregious negligence or fraud would not open the courthouse to Michigan citizens. That is thirteen years of justice denied.
Both ADDA and JIM believe that it will take legislative action to restore justice. On the national level, this means the Medical Device Safety Act which would restore the right of citizens to bring suit in the medical device arena. In Michigan, it means rescinding drug industry immunity. The Michigan House has already voted twice to do so. But the bills have been killed by a small number of immunity supporters in the Michigan Senate.
The national and state levels of these issues reinforce each other. Across both parties, and across this land, citizens are recognizing that the days of special interest legislation—along with the era of government arrogance and irresponsibility—are drawing to a close. Before long, we will look back at this time as a nightmare from which we will be thankful to have awakened. In the meantime, Americans for Drug and Device Accountability and Justice in Michigan fight toward that dawn.
Join us.
http://pharmaccountability.org/
Wednesday, April 15, 2009
WE WON!
David Vladeck to FTC
When Dan Troy left his role as FDA Chief Counsel in 2004, he had only a few comments to the press. One was his reflection, "We won," referring the the 2004 Bush reelection and perhaps more.
Troy continued to impact matters FDA and the superstructure of rule-making--the 2006 preamble, the CBE changes, etc.--all of which were to be part of the yellow brick road to preemption.
Of course, as it turned out, the road was a house of cards. It was whisked away as "meritless" in the Levine majority and essentially ignored in the dissent. It turned out that nothing was won after all, at least not on that front.
So, with relevant perspective, we can celebrate a bit here after learning of the appointment of David Vladeck to FTC. (Hat tip to Pharmalot in exile and various links along the line). Most here will know Vladeck through his writings against preemption that, it turns out, were cited at significant points in the majority opinion in Levine.
So there are still battles to fight: Device preemption as represented by the Riegel decision; Michigan's odious shield law which is on another legal planet even relative to the dissent in Levine. But there should always be a moment when we can kick back, check in on a link,
http://www.democraticmedia.org/jcblog/?p=791
open a brewsky, and say--with relevant satisfaction--"We won."
And they didn't.
When Dan Troy left his role as FDA Chief Counsel in 2004, he had only a few comments to the press. One was his reflection, "We won," referring the the 2004 Bush reelection and perhaps more.
Troy continued to impact matters FDA and the superstructure of rule-making--the 2006 preamble, the CBE changes, etc.--all of which were to be part of the yellow brick road to preemption.
Of course, as it turned out, the road was a house of cards. It was whisked away as "meritless" in the Levine majority and essentially ignored in the dissent. It turned out that nothing was won after all, at least not on that front.
So, with relevant perspective, we can celebrate a bit here after learning of the appointment of David Vladeck to FTC. (Hat tip to Pharmalot in exile and various links along the line). Most here will know Vladeck through his writings against preemption that, it turns out, were cited at significant points in the majority opinion in Levine.
So there are still battles to fight: Device preemption as represented by the Riegel decision; Michigan's odious shield law which is on another legal planet even relative to the dissent in Levine. But there should always be a moment when we can kick back, check in on a link,
http://www.democraticmedia.org/jcblog/?p=791
open a brewsky, and say--with relevant satisfaction--"We won."
And they didn't.
Thursday, March 26, 2009
MICHIGAN HOUSE RESCINDS FDA PREEMPTION LAW....AGAIN
Make Sense to You?
Today, the Michigan House voted to rescind (i.e., repeal) the state's thirteen-year-old drug industry immunity law....again. In 2007, the House voted similarly, but the bill was killed in the state Senate which has a thin majority favoring the 1996 statute. A difference this year is that a number of the Senators who favor Michigan's full preemption will be running for reelection in 2010. The issue made a significant difference in the 2006 and 2008 state elections.
The Michigan statute is unique, providing a full shield to any drug that is FDA approved. This is a far broader immunity than even the dissent imagined in Wyeth v. Levine. Justice Alito wrote in that dissent:
"To be sure, 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."
The operative phrase is "this case"--the particular circumstances of the Levine case in which, the dissent argued, the FDA had fully reviewed the particular risk in question. In order to make that argument, the dissent itself fully reviewed the history of FDA's considerations of the Phenergan label. So the issue in Levine was not what was, or was not, on the label. It was the regulatory history of how it got there. (Indeed, writing for the majority in Levine, Justice Stevens wryly noted that the dissenting Justices had done a far more thorough job reviewing Phenergan's risks and benefits than the FDA ever did.)
In Michigan, the sheer fact that a drug and its label are "FDA-approved" is, in and of itself, the only criterion necessary to provide a full shield. Thus, in Michigan, there are _no_ situations in which tort suits "can peacefully coexist with the FDA's labeling regime." The fact that they "have done so for decades" is either entirely ignored or dismissed as a mistake.
Today, the Michigan House voted to rescind (i.e., repeal) the state's thirteen-year-old drug industry immunity law....again. In 2007, the House voted similarly, but the bill was killed in the state Senate which has a thin majority favoring the 1996 statute. A difference this year is that a number of the Senators who favor Michigan's full preemption will be running for reelection in 2010. The issue made a significant difference in the 2006 and 2008 state elections.
The Michigan statute is unique, providing a full shield to any drug that is FDA approved. This is a far broader immunity than even the dissent imagined in Wyeth v. Levine. Justice Alito wrote in that dissent:
"To be sure, 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."
The operative phrase is "this case"--the particular circumstances of the Levine case in which, the dissent argued, the FDA had fully reviewed the particular risk in question. In order to make that argument, the dissent itself fully reviewed the history of FDA's considerations of the Phenergan label. So the issue in Levine was not what was, or was not, on the label. It was the regulatory history of how it got there. (Indeed, writing for the majority in Levine, Justice Stevens wryly noted that the dissenting Justices had done a far more thorough job reviewing Phenergan's risks and benefits than the FDA ever did.)
In Michigan, the sheer fact that a drug and its label are "FDA-approved" is, in and of itself, the only criterion necessary to provide a full shield. Thus, in Michigan, there are _no_ situations in which tort suits "can peacefully coexist with the FDA's labeling regime." The fact that they "have done so for decades" is either entirely ignored or dismissed as a mistake.
Thursday, March 19, 2009
MICHIGAN PREEMPTION SAVING MILLIONS!!!!
America's Bantustan: Michigan Ready to Fall on Spear to Save Nation
Yesterday, there was a hearing at our state capital concerning Michigan's unique drug industry immunity law. Michigan is alone among the fifty states in having a full preemption law--no exceptions, even if the company commits felony fraud. In the U.S., such fraud is considered the moral equivalent of rape in public polls. In Sweden, it is considered the moral equivalent of murder (not manslaughter). We have had that law since 1996.
Thus, a vote against repeal is a vote favoring no accountability for rape or murder.
At yesterday's hearing, PhRMA put together a series of "talking points" for the state legislators opposed to rescinding our law. (In earlier votes, repeal was supported by most Dems and about one-third of the Republican representatives).
PhRMA's document was interesting. Among the highlights:
"Repealing this FDA lawsuit abuse law would keep millions of patients waiting unncessarily for medicines to save their lives or to improve the quality of their lives."
Most citizens in Michigans had not realized that they were performing combat-level sacrifice in order to save millions of lives. But we are patriotic state. And now that PhRMA has told us how much benefit derives from our legal apartheid, we are ready to do our duty.
Bless us.
Lord save us.
Yesterday, there was a hearing at our state capital concerning Michigan's unique drug industry immunity law. Michigan is alone among the fifty states in having a full preemption law--no exceptions, even if the company commits felony fraud. In the U.S., such fraud is considered the moral equivalent of rape in public polls. In Sweden, it is considered the moral equivalent of murder (not manslaughter). We have had that law since 1996.
Thus, a vote against repeal is a vote favoring no accountability for rape or murder.
At yesterday's hearing, PhRMA put together a series of "talking points" for the state legislators opposed to rescinding our law. (In earlier votes, repeal was supported by most Dems and about one-third of the Republican representatives).
PhRMA's document was interesting. Among the highlights:
"Repealing this FDA lawsuit abuse law would keep millions of patients waiting unncessarily for medicines to save their lives or to improve the quality of their lives."
Most citizens in Michigans had not realized that they were performing combat-level sacrifice in order to save millions of lives. But we are patriotic state. And now that PhRMA has told us how much benefit derives from our legal apartheid, we are ready to do our duty.
Bless us.
Lord save us.
Saturday, March 7, 2009
Wary
With the lonely exception of the great state of Michigan, America, for now, has been saved from FDA preemption. However, I find it hard to believe the idea will simply dry up and blow away. Levine won, but the bad guys are still out there, waiting for their chance to pounce.
We need laws that protect citizens from un-American notions like FDA preemption. Michigan’s 1996 Drug Immunity Law--that gave drug makers total immunity from product liability--has been in existence for 14 years. Then governor John Engler asserted the Michigan model was intended to be the law of the land. America missed that bullet, but what about the next time? What loop hole made it possible that an industry had the right to strip citizens of legal redress?
I don’t feel that assured about the future. And, Michigan still has a stinky law.
Please tell us your thoughts. Thanks.
See: ThePopTort: Drug Company Immunity Remains Status Quo in Michigan Unless Legislature Acts
We need laws that protect citizens from un-American notions like FDA preemption. Michigan’s 1996 Drug Immunity Law--that gave drug makers total immunity from product liability--has been in existence for 14 years. Then governor John Engler asserted the Michigan model was intended to be the law of the land. America missed that bullet, but what about the next time? What loop hole made it possible that an industry had the right to strip citizens of legal redress?
I don’t feel that assured about the future. And, Michigan still has a stinky law.
Please tell us your thoughts. Thanks.
See: ThePopTort: Drug Company Immunity Remains Status Quo in Michigan Unless Legislature Acts
Friday, February 20, 2009
THE MIDNIGHT TRAIN FOR PREEMPTION
Georgia Rejects "Michigan Model" Preemption
According to reports (which will be updated), a key legislative committee in Georgia has voted _not_ to vote a "Michigan model" preemption bill out of committee. This was a stinging rejection both of the Governor, who has been lobbying for the bill, and for many of the same people involved in creating and defending Michigan's 1995 Ground Zero FDA Preemption law. (They have been actively lobbying in Georgia in recent weeks.)
It is reported that an overwhelming bi-partisan majority of the Republican-dominated committee supported the rejection of the bill. And that even hardened "tort reformers" chose not to support a law which they viewed as bad for Georgia, bad for consumers' rights, and ultimately bad for the industry itself.
More info as it arrives.
According to reports (which will be updated), a key legislative committee in Georgia has voted _not_ to vote a "Michigan model" preemption bill out of committee. This was a stinging rejection both of the Governor, who has been lobbying for the bill, and for many of the same people involved in creating and defending Michigan's 1995 Ground Zero FDA Preemption law. (They have been actively lobbying in Georgia in recent weeks.)
It is reported that an overwhelming bi-partisan majority of the Republican-dominated committee supported the rejection of the bill. And that even hardened "tort reformers" chose not to support a law which they viewed as bad for Georgia, bad for consumers' rights, and ultimately bad for the industry itself.
More info as it arrives.
Wednesday, February 18, 2009
HERE WE GO AGAIN!
FDA Preemption Ground Zero
Once again, the great State of Michigan will attempt to repeal it's full FDA preemption law which goes back t0 1995. Except for a few flukey instances, no Michigan citizens have been able to file suit against drug companies if their drug has been FDA approved and is in compliance. There are, de facto, no exceptions because of related higher court decisions. That includes a company having committed fraud in the approval or post-approval process.
Two years ago, three bills to repeal our preemption law were passed in the state House by a vote of 70-39, with most but not all Democrats joined by one-third of the Republicans voting against preemption. That parallels state polls, which suggest about 70% of Michiganders are in favor of repealing our preemption law.
The state Senate, which is controlled by a small pro-preemption majority (about 2 votes) killed the bill in committee.
So now we begin again. Below a trio of bills introduced to rescind Michigan's preemption law. A difference between now and 2007 is that many of the pro-preemption Senators will be running for office. You can be certain, whatever the Levine decision, that there will be a great deal of noise coming from the Mitten State on this issue. Keep your ears open.
HB 4316 of 2009 (Lisa Brown) Torts; product liability; limitation on liability for drugs that have been approved by federal food and drug administration; rescind.Last Action: 2/17/2009 referred to Committee on Judiciary
http://www.legislature.mi.gov/(S(saebng3lgufg24ar3be0wlbt))/mileg.aspx?page=getobject&objectname=2009-HB-4316
HB 4317 of 2009 (Deb Kennedy) Civil procedure; statute of limitations; drug product liability cases previously prohibited because of FDA approval defense; allow to be commenced within 3 years after repeal of the defense. TIE BAR WITH: HB 4316'09Last Action: 2/17/2009 referred to Committee on Judiciary
http://www.legislature.mi.gov/(S(saebng3lgufg24ar3be0wlbt))/mileg.aspx?page=getobject&objectname=2009-HB-4317
HB 4318 of 2009 (Dian Slavens) Consumer protection; unfair trade practices; liability for inaccurate representations concerning risks of certain drugs, medications, and supplements; clarify.Last Action: 2/17/2009 referred to Committee on Judiciary
http://www.legislature.mi.gov/(S(al3eexiy0lqc3uim0jb0pdis))/mileg.aspx?page=getobject&objectname=2009-HB-4318
Once again, the great State of Michigan will attempt to repeal it's full FDA preemption law which goes back t0 1995. Except for a few flukey instances, no Michigan citizens have been able to file suit against drug companies if their drug has been FDA approved and is in compliance. There are, de facto, no exceptions because of related higher court decisions. That includes a company having committed fraud in the approval or post-approval process.
Two years ago, three bills to repeal our preemption law were passed in the state House by a vote of 70-39, with most but not all Democrats joined by one-third of the Republicans voting against preemption. That parallels state polls, which suggest about 70% of Michiganders are in favor of repealing our preemption law.
The state Senate, which is controlled by a small pro-preemption majority (about 2 votes) killed the bill in committee.
So now we begin again. Below a trio of bills introduced to rescind Michigan's preemption law. A difference between now and 2007 is that many of the pro-preemption Senators will be running for office. You can be certain, whatever the Levine decision, that there will be a great deal of noise coming from the Mitten State on this issue. Keep your ears open.
HB 4316 of 2009 (Lisa Brown) Torts; product liability; limitation on liability for drugs that have been approved by federal food and drug administration; rescind.Last Action: 2/17/2009 referred to Committee on Judiciary
http://www.legislature.mi.gov/(S(saebng3lgufg24ar3be0wlbt))/mileg.aspx?page=getobject&objectname=2009-HB-4316
HB 4317 of 2009 (Deb Kennedy) Civil procedure; statute of limitations; drug product liability cases previously prohibited because of FDA approval defense; allow to be commenced within 3 years after repeal of the defense. TIE BAR WITH: HB 4316'09Last Action: 2/17/2009 referred to Committee on Judiciary
http://www.legislature.mi.gov/(S(saebng3lgufg24ar3be0wlbt))/mileg.aspx?page=getobject&objectname=2009-HB-4317
HB 4318 of 2009 (Dian Slavens) Consumer protection; unfair trade practices; liability for inaccurate representations concerning risks of certain drugs, medications, and supplements; clarify.Last Action: 2/17/2009 referred to Committee on Judiciary
http://www.legislature.mi.gov/(S(al3eexiy0lqc3uim0jb0pdis))/mileg.aspx?page=getobject&objectname=2009-HB-4318
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