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For the past five years I have been writing about the perspective of factors that may drag down the US economy to near ruin, here, here, here, here, and here are just a few. All based on knowledge of the current parameters of the global economy. In simple term, data suggest that like the global system, the US financial system is severely top heavy with debt and our economy is dragging, stagnate and getting worse with each passing day. The sad thing is that the US government seems not to be telling the truth and wants to paint a rosy picture of all is getting better. But no matter what they are saying and no matter what the Federal Reserve Bank does, it won’t be enough to put Humpty back together again, or be able to avoid another major economic downturn. And even sadder is that these issues persist no matter which political party is in power.
My reason for thinking this has nothing to do with likes or dislikes of Obama or the GOP, or my purview of the Federal reserve, but rather that the specter of a tenable future of a "hyperinflationary depression” is real for the US Economy. Mine is the sort of logic that is more like mathematics or chess, and presented merely to explain what I mean.
Just last week, the associate Press, based on census figures for 2009 reported that the number of folk living in poverty, under President Obama’s leadership is approaching 1960s levels. Currently, more than 45 million Americans (1 in 7) were living at or below the poverty line. This represents an increase from 13.2% to 15%. – the highest single year increase since 1959 when the government first started keeping such statistics. One reason is stalled US economic growth. Although President Obama is saying things are getting better, facts are that there has been a complete collapse of the US retail sector in the world’s largest economy. Both republicans and democrats, via their plutocratic policies, have obviated wage-levels for U.S. workers on behalf of large corporations so they will be able to "compete" with the wages of cheap labor in Asia all in the name of globalization. With reduced wages, in an age in which our economy was based on consumer spending and house buying, financed via foreign debt from banks who as we have learned were way undercapitalized and shady (LIBOR, MF Global, JPMorgan Chase, Wells Fargo, Citibank & others).
As of 2007, US household debt was 133% of household income. Maybe this is why the according to AARP, 600,000 American homeowners that are 50 years of age or older are currently in foreclosure. Why, because the average American consumer today is poor, under employed and/or unemployed. In fact, over the past 40 years, wages for the average U.S. worker have fallen by more than 50% (levels equal to the Great Depression).
Appears that present US fiscal and economic policy is converting the Middle Class into the Working Poor although they orate otherwise. How can we be in a a"recovery" when as a nation, we continue to sell less goods to consumers with lower incomes and increasingly more debt? This for me is an indication that we are living in a time of incessant high inflation.
America’s economy will continue to get worse if our only solution is to print more paper money while food prices continue to increase and more people become under-employed, unemployed as our disability rolls grow exponentially. Our seems to be a nation that is very burdened with substantial debt, but also at the mercy of Wall Street and Banks and Corporations who would rather profit on the backs of the average consumer whether via fradulaent complex financial instrument money making schemes or risky gambling practices that the Federal government sanctions. Way I seee it, from this perspective, what is being called economic growth is more akin to a recesssion than growth at all.
13 Ekim 2012 Cumartesi
US should think twice about Attacking Iran
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Obama should think twice about IranMore and more each day appears that the US is inching its way closer to an armed conflict with Iran -- something I think will hurt the US more than Israel in the long term. All because the big bully on the block, Israel is purported to be “facing grave danger.” This is mainly being promoted by Zionist from everywhere this side of the Pecos River. My question is why do we have to defend Israel, a nation with the largest army and only nuclear arsenal in the region?
We all are well aware of the fact that Israel is no friend of Iran, or of any other Islamic and predominantly Arab state in the region. Thus, Israel is the one making trouble yet they want the present administration to decide to launch a pre-emptive war in what are probably the world’s most volatile environs.
If history is any guide, we should be very careful about deciding to attack Iran. Prior to WW 2 it was the Germans who convinced the "enlightened civilization" that it only wants to execute its rights. But one war led to another and country upon country was invaded including France, Belgium, Netherlands and other countries. Now it is Israel, and they will only be happy until all of the other Arab nations are not just a threat, but nonexistent for like Germany, their goal is not defensive but an aggressive offence to conquer the entirety of Middle East Asia.
True, it is hard to assess whether to “confront” or to “contain” Iran without examining more than 300 years of contemporary Iranian history, in concert with the history of conflict in the Middle East throughout modern times. Then we must decide and determine if possible what are we trying to prevent or contain them from doing? Otherwise we will formulate policy, which has become customary, based on anger, fear and hatred singularly. Even worse, one based on Israel must not be allowed to drive the world into chaos, just because it wants to. We need to protect AMERICA's interests, first, last, and always, and America's interests do not include shedding more blood for Israel or carrying their water for them. We lost too many American lives already to satisfy Israel's demands over Iraq. But, apparently, we have learned nothing from Iraq, and Israel doesn't care as long as they get their own way.
The only difference now is that the false flag of preventing a nation from self-determination in the form of developing nuclear capability is the issue. Albeit both the US and Israel have such capabilities and past history reveals that the US vowed that Pakistan or North Korea would never be allowed to possess Nuke. Why should it be different with Iran?
Factually, given our present quagmires in Iraq and Afghanistan and our bombing of our present alley Pakistan daily, a confrontation with Iran would also last for years and possibly crush America's economy – especially for the average American. Thus any form of military intervention at all in Iran means that the American taxpayer should be ready to pay $5 plus for a gallon if a war breaks out in the Strait of Hormuz. We are already in a recession at best and depression at worse and hyperinflation is everywhere we look.
Next, we must try and anticipate what will happen as a function if either side wins. After WW II, half of Europe ended up being given to the Soviets. Then due to our wasteful war effort in Iraq, in essence we have succeeded nearly half of this state to Iran. For both of these operation we as a nation have nothing really to show for it, except ending up in bed with the most treacherous leaders in modern times the likes of Mubarak, Pavlavi, House of Saud, Saddam Hussein, Khomeini, Assad and yes, the Likud.
The current administration still has Kool-Aid pumping through its veins. Sure, they went into Libya and are now selling wolf tickets about Syria; but the US needs to think about these actions and the global political consequences. We need to stop demanding that Syrian President Bashar al-Assad step down and cease the threats because it shows hypocrisy when we decide and shout to the world who we think should step down from the position of a head of a state, in particular when we aren’t prepared to remove that person. And talking about democracy when to suggest the aforementioned is in contradiction of our own values.
Also, who cares if Israel is our strongest ally in the region, forget a clear and strong commitment to the security of Israel: the US government should only have that strong of commitment to the US. If they don’t how we do our thing then stop giving them loot. We should stick to our guns that Netanyahu and Israel should use the 1967 borders should be a basis for negotiating of a Palestinian state. And for those who believe that Israel is our friend, they are not and only care about Israel first – even before the US unlike the US. In the past, they have attacked one of our naval ships, killed our sailors, spied on us, and treat us like a vassal state.
I say let’s us pack up the American Israel Public Affairs Committee, the most powerful pro-Israel lobby in Washington, and send them to Israel and let them fight their on war. If they do, and if Israel attacks, the United States may get drawn into a war that could set the Middle East further aflame and no telling how bad global markets will get.
Iran is a country of 80 million people, compared with about 30 million in Afghanistan or Iraq. Its territory of 1.65 million square kilometers, including deserts and rugged mountains, gives it impressive strategic depth compared to Israel, which exists on 20,000 square kilometers. Even to attack Iran by air, .Israel would have to strike Iran's four major nuclear sites. The most direct path to do so is across Jordan and Iraq. Will Jordan allow Israel to fly over? Then, Israeli pilots have to fly more than 1,600 kilometers refueling in the air, fighting off Iran's air defense, while attacking multiple underground sites at the same time.
Moreover, Iran is a major oil producer located right by the most critical petroleum and gas supply lines in the world, from the Strait of Hormuz in the south to the Caspian Sea in the north. I’m lost that military intervention is even being considered, because if it happens, it will introduce a whole new destabilizing reality into the Middle East.
And although the US will try not to have a land war, we can’t tell what will happen, or know the outcome. Will it be a war of attrition or an all-out invasion? We do know it will be long, money wasting, US war in the Middle East? We cannot forget that in Europe in 1914, a small and unexpected event began the First World War. Obama really needs to think carefully about this. The sad reality is if America and our national security and safety were placed first – we would not attack Iran. However, he has learned from Bush, who has had US in Iraq for more than 10 years and resulted in a sustained US military presence for 11 years an in Afghanistan as we speak.
We all are well aware of the fact that Israel is no friend of Iran, or of any other Islamic and predominantly Arab state in the region. Thus, Israel is the one making trouble yet they want the present administration to decide to launch a pre-emptive war in what are probably the world’s most volatile environs.
If history is any guide, we should be very careful about deciding to attack Iran. Prior to WW 2 it was the Germans who convinced the "enlightened civilization" that it only wants to execute its rights. But one war led to another and country upon country was invaded including France, Belgium, Netherlands and other countries. Now it is Israel, and they will only be happy until all of the other Arab nations are not just a threat, but nonexistent for like Germany, their goal is not defensive but an aggressive offence to conquer the entirety of Middle East Asia.
True, it is hard to assess whether to “confront” or to “contain” Iran without examining more than 300 years of contemporary Iranian history, in concert with the history of conflict in the Middle East throughout modern times. Then we must decide and determine if possible what are we trying to prevent or contain them from doing? Otherwise we will formulate policy, which has become customary, based on anger, fear and hatred singularly. Even worse, one based on Israel must not be allowed to drive the world into chaos, just because it wants to. We need to protect AMERICA's interests, first, last, and always, and America's interests do not include shedding more blood for Israel or carrying their water for them. We lost too many American lives already to satisfy Israel's demands over Iraq. But, apparently, we have learned nothing from Iraq, and Israel doesn't care as long as they get their own way.
The only difference now is that the false flag of preventing a nation from self-determination in the form of developing nuclear capability is the issue. Albeit both the US and Israel have such capabilities and past history reveals that the US vowed that Pakistan or North Korea would never be allowed to possess Nuke. Why should it be different with Iran?
Factually, given our present quagmires in Iraq and Afghanistan and our bombing of our present alley Pakistan daily, a confrontation with Iran would also last for years and possibly crush America's economy – especially for the average American. Thus any form of military intervention at all in Iran means that the American taxpayer should be ready to pay $5 plus for a gallon if a war breaks out in the Strait of Hormuz. We are already in a recession at best and depression at worse and hyperinflation is everywhere we look.
Next, we must try and anticipate what will happen as a function if either side wins. After WW II, half of Europe ended up being given to the Soviets. Then due to our wasteful war effort in Iraq, in essence we have succeeded nearly half of this state to Iran. For both of these operation we as a nation have nothing really to show for it, except ending up in bed with the most treacherous leaders in modern times the likes of Mubarak, Pavlavi, House of Saud, Saddam Hussein, Khomeini, Assad and yes, the Likud.
The current administration still has Kool-Aid pumping through its veins. Sure, they went into Libya and are now selling wolf tickets about Syria; but the US needs to think about these actions and the global political consequences. We need to stop demanding that Syrian President Bashar al-Assad step down and cease the threats because it shows hypocrisy when we decide and shout to the world who we think should step down from the position of a head of a state, in particular when we aren’t prepared to remove that person. And talking about democracy when to suggest the aforementioned is in contradiction of our own values.
Also, who cares if Israel is our strongest ally in the region, forget a clear and strong commitment to the security of Israel: the US government should only have that strong of commitment to the US. If they don’t how we do our thing then stop giving them loot. We should stick to our guns that Netanyahu and Israel should use the 1967 borders should be a basis for negotiating of a Palestinian state. And for those who believe that Israel is our friend, they are not and only care about Israel first – even before the US unlike the US. In the past, they have attacked one of our naval ships, killed our sailors, spied on us, and treat us like a vassal state.
I say let’s us pack up the American Israel Public Affairs Committee, the most powerful pro-Israel lobby in Washington, and send them to Israel and let them fight their on war. If they do, and if Israel attacks, the United States may get drawn into a war that could set the Middle East further aflame and no telling how bad global markets will get.
Iran is a country of 80 million people, compared with about 30 million in Afghanistan or Iraq. Its territory of 1.65 million square kilometers, including deserts and rugged mountains, gives it impressive strategic depth compared to Israel, which exists on 20,000 square kilometers. Even to attack Iran by air, .Israel would have to strike Iran's four major nuclear sites. The most direct path to do so is across Jordan and Iraq. Will Jordan allow Israel to fly over? Then, Israeli pilots have to fly more than 1,600 kilometers refueling in the air, fighting off Iran's air defense, while attacking multiple underground sites at the same time.
Moreover, Iran is a major oil producer located right by the most critical petroleum and gas supply lines in the world, from the Strait of Hormuz in the south to the Caspian Sea in the north. I’m lost that military intervention is even being considered, because if it happens, it will introduce a whole new destabilizing reality into the Middle East.
And although the US will try not to have a land war, we can’t tell what will happen, or know the outcome. Will it be a war of attrition or an all-out invasion? We do know it will be long, money wasting, US war in the Middle East? We cannot forget that in Europe in 1914, a small and unexpected event began the First World War. Obama really needs to think carefully about this. The sad reality is if America and our national security and safety were placed first – we would not attack Iran. However, he has learned from Bush, who has had US in Iraq for more than 10 years and resulted in a sustained US military presence for 11 years an in Afghanistan as we speak.
Black Progressive is An Oxymoron
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Seems it has become fashionable over the past four years for African Americans to consider themselves to be politically progressives as opposed to liberals. The way I have managed to understand progressivism, in simple terms is that it is a political ideology that states it desires better conditions in society that is rooted in early 20th century liberal philosophy. It is supposed to be a response to the impact of industrialization as well is a political philosophy in between the response taken by traditional conservatives and socialist to deal with social and economic issues. Naturally, it started in urban areas and was first championed by folk advocating egalitarian and liberal methods to reform socioeconomic policy.
Scholars have had a very difficult time defining Progressivism. Some have even grouped both Theodore Roosevelt and Woodrow Wilson as Progressives even absent of any common ideological ground between the two. They even add Lyndon Johnson and now, Barack Obama in scope and aim.
For some oddly coherently dissonant reason (historical and philosophical), I find it implausible and oxymoronic for any African American to call themselves progressives.
I would advance that most describe themselves as such either because of the aforementioned adumbrated definition, or because they support President Obama and white democrats call him progressive.In the past I have often had to disabuse politically, what I comprehended about the progressive political orientation. Specifically that it is rooted in the concept of liberal internationalism as implemented first via the foreign policy of Woodrow Wilson, the 28th President of the United States. Albeit not called such during the time of the imperialistic colonization of Africa, Wilson approach to the world (on behalf of the well-being of America) was immured to practices similar to what led to the enslavement of Africans and the subjugation of other world ethnic nationalities. This is the main reason I find African American progressive as a term, to be dysfunctional and improbable.
It assumes the false and contumelious Kantian Moral Imperative of exceptionalism that resulted in apartheid in South Africa and Nazism as well as the White Man’s Burden in Europe. The Progressive narrative in antithetical to the political philosophies of African Americans from a chronicled perspective and stresses a “muscular nationalism” designed to serve Americas well being only from a plutocrats perspective singularly internationally – meaning foreign policy is for the simple goal of protecting US national security (the wealthy). Ergo, the best national security involves advancing democracy abroad even by military force, regardless if nations desire such or not.
Back home, we have seen the pseud Darwinism of progressive politics from the attributing of race based cultural traits being antecedents for criminal behavior (Cesare Lombroso) and prior to that in the opinion of Chief Justice Roger B. Tanny who wrote in the Dred Scott ruling: that free blacks would always be “identified in the public [white folks] mind with the race which they belonged, and regarded as part of the slave population rather than free.”
True, Progressives began in response to political powers unwilling or unable to address the economic and social changes consequential of the industrial revolution in America; but somewhere it turned into a monster that overlooked liberty, self-determination, sovereignty and individual rights- all in complete contradiction of the struggles of African Americans from slavery to the civil rights movement. And just as then, Progressives today want the same things from safety to making sure that our political system is free from corruption. The problem is that they want all of this implemented by advancing American interests by a Hobbesian (warlordism) the internationalism that at the same time make positive-sum interactions almost impossible.
First progressives place America first and intentionally ignore that we live in a global world and not an isolated one. Thus they miss the bigger picture that most African Americans have traditionally observed, that declining living standards, weapons proliferation, deforestation and social injustice everywhere, especially when perpetrated by America, is a hazard and a danger to us all. This means that progressives applaud approaches put forth by men like Obama, Roosevelt, Truman and Wilson because simply put, their policy advocate that the United States knows what's right and what other should do -- all the US has to do insist that others snap into line. Thus both the left and right looks at other nations as objects of American foreign policy, rather than as being free agents themselves.
Now it seems in the age of Obama, even liberals support war under the cover of other attributes. The war in Libya was the progressive way to protect innocent civilians. President Obama is in many way similar to both Wilson and Roosevelt. This is why I assert that black and Progressive are incompatible just as freedom and ignorance, for progressives thrive and promulgate economic inequality for if it didn’t exist they would not be able to survive. This is the reason why the 99 percent exist, and why we find ourselves in wars in Libya, Yemen, Somalia and asking for one in Syria. The progressives do not send their kids off to war for a better life or struggle economically, they have it all, unlike most African Americans, even the ones who call themselves progressive.
Scholars have had a very difficult time defining Progressivism. Some have even grouped both Theodore Roosevelt and Woodrow Wilson as Progressives even absent of any common ideological ground between the two. They even add Lyndon Johnson and now, Barack Obama in scope and aim.
For some oddly coherently dissonant reason (historical and philosophical), I find it implausible and oxymoronic for any African American to call themselves progressives.
I would advance that most describe themselves as such either because of the aforementioned adumbrated definition, or because they support President Obama and white democrats call him progressive.In the past I have often had to disabuse politically, what I comprehended about the progressive political orientation. Specifically that it is rooted in the concept of liberal internationalism as implemented first via the foreign policy of Woodrow Wilson, the 28th President of the United States. Albeit not called such during the time of the imperialistic colonization of Africa, Wilson approach to the world (on behalf of the well-being of America) was immured to practices similar to what led to the enslavement of Africans and the subjugation of other world ethnic nationalities. This is the main reason I find African American progressive as a term, to be dysfunctional and improbable.
It assumes the false and contumelious Kantian Moral Imperative of exceptionalism that resulted in apartheid in South Africa and Nazism as well as the White Man’s Burden in Europe. The Progressive narrative in antithetical to the political philosophies of African Americans from a chronicled perspective and stresses a “muscular nationalism” designed to serve Americas well being only from a plutocrats perspective singularly internationally – meaning foreign policy is for the simple goal of protecting US national security (the wealthy). Ergo, the best national security involves advancing democracy abroad even by military force, regardless if nations desire such or not.
Back home, we have seen the pseud Darwinism of progressive politics from the attributing of race based cultural traits being antecedents for criminal behavior (Cesare Lombroso) and prior to that in the opinion of Chief Justice Roger B. Tanny who wrote in the Dred Scott ruling: that free blacks would always be “identified in the public [white folks] mind with the race which they belonged, and regarded as part of the slave population rather than free.”
True, Progressives began in response to political powers unwilling or unable to address the economic and social changes consequential of the industrial revolution in America; but somewhere it turned into a monster that overlooked liberty, self-determination, sovereignty and individual rights- all in complete contradiction of the struggles of African Americans from slavery to the civil rights movement. And just as then, Progressives today want the same things from safety to making sure that our political system is free from corruption. The problem is that they want all of this implemented by advancing American interests by a Hobbesian (warlordism) the internationalism that at the same time make positive-sum interactions almost impossible.
First progressives place America first and intentionally ignore that we live in a global world and not an isolated one. Thus they miss the bigger picture that most African Americans have traditionally observed, that declining living standards, weapons proliferation, deforestation and social injustice everywhere, especially when perpetrated by America, is a hazard and a danger to us all. This means that progressives applaud approaches put forth by men like Obama, Roosevelt, Truman and Wilson because simply put, their policy advocate that the United States knows what's right and what other should do -- all the US has to do insist that others snap into line. Thus both the left and right looks at other nations as objects of American foreign policy, rather than as being free agents themselves.
Now it seems in the age of Obama, even liberals support war under the cover of other attributes. The war in Libya was the progressive way to protect innocent civilians. President Obama is in many way similar to both Wilson and Roosevelt. This is why I assert that black and Progressive are incompatible just as freedom and ignorance, for progressives thrive and promulgate economic inequality for if it didn’t exist they would not be able to survive. This is the reason why the 99 percent exist, and why we find ourselves in wars in Libya, Yemen, Somalia and asking for one in Syria. The progressives do not send their kids off to war for a better life or struggle economically, they have it all, unlike most African Americans, even the ones who call themselves progressive.
An Answer to Moivory’s question on Paul Ryan
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It is more than evident thatthe diseases of misinformation as well as blatant disinformation have takencomplete control of Americans in pandemic proportions resulting in vertiginousoutcomes. This morning while in the truck I was listening to talk radio asusual. Given it was too late for NPR; I turned to WAOK, a radio station inAtlanta that only promotes talk radio programming. Unfortunately this episode was all talk,little fact and even less substance. Listening to the host, Mo Ivory, it wasreminiscent of something I had read by Daniel Foster. For listening to the hostramble on about Paul Ryan, Romney and President Obama was fit of hisdescription of being “a mélange of relentlessly provocative half-insightsgarbled by ponderous jargon…delivered by a narrator who seems to delight in[their] unreliability.” For as like Conservative Talk Radio, she too was allvenerate in her support of Obama as they are of Conservative stalwarts – sincethere was nothing said to inform an already dumbed down audience.
First there was the rant thatsuggested since Romney introduced Ryan as the next President, that it showed hewas not prepared and unfit to be President. Although several callers correctlyinformed her that Obama did the same thing, she asked that they show her proofcommenting that they are all hypotheticals and can’t back up what they withfacts. Next she attacked a caller who correctly discussed capitalism without apolitical slant and she cut him off saying that he was trying to make it arepublican and democratic issue (she has poor listening skills). After a fewstatements addressed to vilify Mr. Ryan, asserting that he had ran a state or abudget, another caller confronted her on this and indicated that neither hadObama, since he had not been a governor of a state or balanced a budget (bothjobs off the governor). He was attacked as well and here logic then morphedinto being in state politics.
None the less her question,which she never supported or answered was would Ryan be a benefit or liabilityfor the November 2012 election. So to assist her I will provide a substantiveargument to answer her query and suggest why Ryan will be a liability. I hopeif she reads this it will assist her in the future.
If President Obama had anybrains, Romney’s selection of Ryan as his running mate would be like a baseballset on a tee. First, his record or lack of record over a thirteen year careerin government would be the ball. During the bush years, Ryan voted for andhelped to pass Medicare part D (prescription drug benefit) which just happenedto be the largest entitlement since the days of FDR and added trillions to themassively underfunded Medicaid/Medicare system. He was also one of the twenty Republicans who voted for TARP and evenpleaded for others in the GOP to follow suit. Not only did he support the bailout of Wall Street but of the autoindustry as well.
During the Obamaadministration, many of the issues that most knowledgeable Americans which areso vehemently against and see as a threat to individual as I do – NDAA, ThePatriot Act and Funding for the Libyan war – he voted for and helped getpassed. Which reminds me that also under the Bush administration, he voted forthe war in Iraq without it being paid for as a supposed conservative fiscalhawk. These are actions that some in the Tea party will not forget or forgiveand will likely isolate a majority of independent voters.
Now some may say I am wrong,that his affiliation with the former senator Jack Kemp will do him somegood. I think it will work againsthim. See, I remember Jack Kemp, even rememberseeing him on Monday Night football playing quarterback for the Buffalo Billsand the LA Rams before that. He is thecomplete antithesis of Kemp. To startwith, It was Kemp who noted and informed conservative neocons that the war inIraq was unnecessary and would only serve to weaken America economically and bea major waste of our resources. UnlikeRyan, Kemp has been described by some as an “optimistic realist” who authoredand passed legislation for years in the congress. Ryan over his tenure in Washingtonas authored or passed any major legislation on his own. Not to mention I can’tever recall Jack Kemp ever voting for a tax increase then turn around and sayhe was against tax hikes – as Ryan’s record reveals. Plus Jack Kemp looked out for the poor firstand was inclusive of both the poor and minorities when authoring hislegislation.
Even staying on his budget maybe enough for Obama to pounce. I won’tdiscuss the stuff most talk about (Medicare/Medicaid, cuts in education, headstart and college aid), but will point out that it does include increasingPentagon spending by $20 billion and overall it is just a plan for facilitatinga plutocratic transfer of wealth. Onsecond thought maybe Obama should shy away from such since his economic proposalsdo the same? But if he does, he should attack his logic, for Ryan blames majorentitlement programs for our impending fiscal cliff and doesn’t even includethe cost of unfunded wars in Iraq and Afghanistan (if I take him from what hesaid in his speech to the Alexander Hamilton Society).
If Obama wanted to play dirty,he could use the Reverend Wright card and hit below the belt for Ryan’s firm beliefin the philosophical views of Ayn Rand. In her 1943 novel “The Fountain head”(if you all recall or ever read it), the in the end of the book the maincharacter blows up a home for mentally retarded orphans. If this is too low for Obama, then attack himon his profiting on insider information to avoid the 2008 crash. According to an article published in theRichmonder Newspaper, Ryan was part of a closed door meeting with FederalReserve Chairman Ben Bernanke, then Treasury Secretary Hank Paulson and othercongressional leaders on September 18, 2008 that informed the congress of theimpending economic collapse and to get them to pass the TARP legislation. The article continues: “on that very same dayPaul Ryan sold shares of stock he owned in several troubled banks, andreinvested the proceeds in Goldman Sachs, a bank that the meeting had disclosedwas not in trouble.” They even provide a link of PDF files of his transactions.
Now I could continue but insummary, the point is that Obama should have no problem dealing with aRomney-Ryan ticket if he has half a brain. Thus he being selected as Romney’srunning mate is more of a liability in the bigger picture than an asset.
First there was the rant thatsuggested since Romney introduced Ryan as the next President, that it showed hewas not prepared and unfit to be President. Although several callers correctlyinformed her that Obama did the same thing, she asked that they show her proofcommenting that they are all hypotheticals and can’t back up what they withfacts. Next she attacked a caller who correctly discussed capitalism without apolitical slant and she cut him off saying that he was trying to make it arepublican and democratic issue (she has poor listening skills). After a fewstatements addressed to vilify Mr. Ryan, asserting that he had ran a state or abudget, another caller confronted her on this and indicated that neither hadObama, since he had not been a governor of a state or balanced a budget (bothjobs off the governor). He was attacked as well and here logic then morphedinto being in state politics.
None the less her question,which she never supported or answered was would Ryan be a benefit or liabilityfor the November 2012 election. So to assist her I will provide a substantiveargument to answer her query and suggest why Ryan will be a liability. I hopeif she reads this it will assist her in the future.
If President Obama had anybrains, Romney’s selection of Ryan as his running mate would be like a baseballset on a tee. First, his record or lack of record over a thirteen year careerin government would be the ball. During the bush years, Ryan voted for andhelped to pass Medicare part D (prescription drug benefit) which just happenedto be the largest entitlement since the days of FDR and added trillions to themassively underfunded Medicaid/Medicare system. He was also one of the twenty Republicans who voted for TARP and evenpleaded for others in the GOP to follow suit. Not only did he support the bailout of Wall Street but of the autoindustry as well.
During the Obamaadministration, many of the issues that most knowledgeable Americans which areso vehemently against and see as a threat to individual as I do – NDAA, ThePatriot Act and Funding for the Libyan war – he voted for and helped getpassed. Which reminds me that also under the Bush administration, he voted forthe war in Iraq without it being paid for as a supposed conservative fiscalhawk. These are actions that some in the Tea party will not forget or forgiveand will likely isolate a majority of independent voters.
Now some may say I am wrong,that his affiliation with the former senator Jack Kemp will do him somegood. I think it will work againsthim. See, I remember Jack Kemp, even rememberseeing him on Monday Night football playing quarterback for the Buffalo Billsand the LA Rams before that. He is thecomplete antithesis of Kemp. To startwith, It was Kemp who noted and informed conservative neocons that the war inIraq was unnecessary and would only serve to weaken America economically and bea major waste of our resources. UnlikeRyan, Kemp has been described by some as an “optimistic realist” who authoredand passed legislation for years in the congress. Ryan over his tenure in Washingtonas authored or passed any major legislation on his own. Not to mention I can’tever recall Jack Kemp ever voting for a tax increase then turn around and sayhe was against tax hikes – as Ryan’s record reveals. Plus Jack Kemp looked out for the poor firstand was inclusive of both the poor and minorities when authoring hislegislation.
Even staying on his budget maybe enough for Obama to pounce. I won’tdiscuss the stuff most talk about (Medicare/Medicaid, cuts in education, headstart and college aid), but will point out that it does include increasingPentagon spending by $20 billion and overall it is just a plan for facilitatinga plutocratic transfer of wealth. Onsecond thought maybe Obama should shy away from such since his economic proposalsdo the same? But if he does, he should attack his logic, for Ryan blames majorentitlement programs for our impending fiscal cliff and doesn’t even includethe cost of unfunded wars in Iraq and Afghanistan (if I take him from what hesaid in his speech to the Alexander Hamilton Society).
If Obama wanted to play dirty,he could use the Reverend Wright card and hit below the belt for Ryan’s firm beliefin the philosophical views of Ayn Rand. In her 1943 novel “The Fountain head”(if you all recall or ever read it), the in the end of the book the maincharacter blows up a home for mentally retarded orphans. If this is too low for Obama, then attack himon his profiting on insider information to avoid the 2008 crash. According to an article published in theRichmonder Newspaper, Ryan was part of a closed door meeting with FederalReserve Chairman Ben Bernanke, then Treasury Secretary Hank Paulson and othercongressional leaders on September 18, 2008 that informed the congress of theimpending economic collapse and to get them to pass the TARP legislation. The article continues: “on that very same dayPaul Ryan sold shares of stock he owned in several troubled banks, andreinvested the proceeds in Goldman Sachs, a bank that the meeting had disclosedwas not in trouble.” They even provide a link of PDF files of his transactions.
Now I could continue but insummary, the point is that Obama should have no problem dealing with aRomney-Ryan ticket if he has half a brain. Thus he being selected as Romney’srunning mate is more of a liability in the bigger picture than an asset.
From Eisenhower to Obama: War is Money
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“We must use terror, assassination, intimidation, land confiscation, and the cutting of all social services to rid Galilee of its Arab population."
The above statement is attributed to David Ben-Gurion, the founding father of the State of Israel and First Israeli Prime Minister taken from Ben-Gurion, a Biography, by Michael Ben-Zohar (May 1948). I am not a historian, but such transgressions aside, it is not too farfetched to suggest that history often repeats itself. Especially when it pertains to presidential politics and nations like Israel, the United States, Syria, Turkey and Iran. Even considering smaller yet significant events ranging from the slaying of Crispus Attucks during the Boston Massacre in 1770 to the signing of the “Southern Manifesto” by Strom Thurman and a hundred plus democratic members of the house, to the operations run by Kermit Roosevelt that caused a coup in Iran in 1959; to even Eisenhower himself and his conundrum regarding Nasser of Egypt inclusive of France, Israel and the Aswan Damn.
This is a week or more after the first Presidential debate and I am willing to bet most black folk are still talking about it. Subsequently, given that most are caught up with that circus called the Presidential debate, truth be told it is immaterial and all that I mention prior are (albeit) past history more important than the debate when we look at the global predicament and war and our relationship with Israel. You see, although the US has laws that require foreign interests to register as foreign agents, these laws are not equally or always applied to all Israeli lobby groups, such as AIPAC.
Unless you have been behind a rock, you would know that besides the criminal industrial complex, the big industry money maker in America is war. Yes, war drives the economy and amounts to more than all of our allocated GDP spent when compared to all other programs in the United States that is if you don’t include international aid in the form of grants to nations like Israel, Egypt, Saudi Arabia, Pakistan and Afghanistan. Even as one reads this, Syria is being attacked inside by NATO funded Al Qaeda “Rebels,” China and japan are at each other throats, Shells fly each and every day in the Sudan and Mali is in the middle of a serious conflict.
For a while now, much has been made in political forums of addressing Iran and their quest to become nuclear sufficient (strangely enough by nations who have nuclear weapons - US and Israel). Meaning that regardless of what is being spoken in public, behind closed doors activities show how involved this issue is in both political and economic capital. The US, via NATO and the Saudi’s are funding dozens of training camps that have been set up to prepare for the fight against President Bashar al-Assad’s military. Both US and Saudi millions and Special Forces expertise are engaged covertly in training Al Qaeda terrorist (FSA Syria's rebels) into a disciplined military force. The FSA or “The Free Syrian Army” didn’t exist until Israel, NATO and the US decided that the powers that be needed a war, a major war, to make money and to topple the Syrian leader as well as the state bank of Syria. In fact the same ploy that is being used to break Iran and their independent state bank via the Libyan blue print for the same is being replicated in Syria.
Seems as if those of us in the West, limited by our ignorance and overshadowed by our obsessive ranting on freedom and democracy, cannot comprehend what democracy would mean to a non-Western world dominated by a belief in Islam. We look at what has happened in Libya and what is currently happening in Syria as being singularly about democracy and the development of a secular ideology that includes a pluralistic society run according to democratic principles while those on the ground see it about something completely different - espousing fundamentalism directed exclusive against western aggression and hegemony.
Another issue of concern is confounded when Middle Eastern Nations question the nationalistic approach of the West to their region. For example, the overt hypocrisy of US leadership under President Obama concerned about repression I Syria and Libya but not Bahrain and Saudi Arabia. They wonder how the US continue to evaluate all issues from state perspectives and a monolithic Islam versus Alawite, Sunni and ShÄ«'ah sects of Islam. On the one hand he supposedly is operating a multi-front war, in secrecy against Al Qaeda {Islamic fundamentalism}, particularly in Africa and the Middle East – as evident by the increase in size of the U.S. military's Special Forces Operation Command and the CIA's strike expansion capabilities in the region in places including Kenya, Uganda, the Central African Republic, Ethiopia, Djibouti, Mauritania, Burkina Faso and the Seychelles islands in the Indian Ocean off East Africa – while at the same time asserting that they do not desire a conflict with Islam. This albeit our policy pursues wars presently on three fronts: Syria, Lebanon and Iran, and Afghanistan.
We have seen this all before when President Gamal Abdel Nasser's, who had come to power in the 1953 nationalistic revolution in Egypt. Nasser's wanted to construction dam at Aswan, to form a massive lake that would aid to control the annual flooding of the Nile, crucial to Egypt's agriculture, as well as generating vast amounts of electricity. First he was offered economic support by Britain and US to finance the Aswan dam. But then the West backed out.
This led to Britain and France to build up their forces in the Mediterranean, with the secret understand that Israeli troops would move into the Sinai Peninsula. Trying to present a position of peace the European nations asked that both move away from the region and when Egypt disregarded, against the ruling of the UN Security Council and general assembly, Britain and France begin bombing Egyptian airfields. This was under Eisenhower, who although in the open refused to join Britain, France and Israel in an invasion of Egypt, had approved of and knew about such behind closed doors.
Yes the methods of Eisenhower are similar to the methods of Obama presently and well, the role of Israel as agent provocateur is the same – making up a threat that doesn’t exist because a nation attempts to exist in a self-determined fashion. Only difference is that then it was a damn in Egypt and now it is Nuclear power in Iran.
Another common denominator was economics. Then, it pertained to vital shipping routes today; it deals with the Middle East, West Africa as emerging vital oil-producing, mineral rich zones including arable farmland. Then after the US denied funding Egypt, they went to Russia for military support which was granted. Today, the same is happening in Syria, Iran and also Pakistan. In fact, Pakistan-Russia ties are growing under Russian President Vladimir Putin’s who is expected to make the first visit by a Russian president to Pakistan ever supposedly to sign multiple MOU’s (Memorandums of Understanding) on development and investment in the steel and energy sectors of Pakistan. Syria’s central role in the Arab gas pipeline is also a key to why Israel, NATO and the US wants Assad out, in addition to having a direct path to Iran (just as the Taliban in Afghanistan because they are in the way of the Unocal pipeline).
Guess what I am saying, to repeat myself is that without war, America’s economy would already be in the grave as opposed to on its death bed. War is good economics, no matter if it is in the Middle East, China, the Far East or Africa. The question is will we be able to make money before we realize we may not have the financial ability to carry out such efforts? As we speak, The United States military has secretly sent a task force of more than 150 specialists to Jordan be in place in case the turmoil in Syria expand into a wider conflict.
Unfortunately, it is a fallacy to think or believe that America can be taken out of economic crisis via more and more wars given that the most productive part of the US economy has been moved offshore in order to increase corporate profits and capital gains to equity owners. It is not the American people who are at the center of such policy efforts, like I said; historically it is the war machine and the oligarchy of private interests. More wars that we can only afford to pay with debt is trouble. It is just like having a gallon of gasoline, and pouring a half gallon of water into it doesn’t change the fact of how much gasoline remains. Borrowing more debt, quantitative easing, or printing more loot is the same thing as the above example. It is an invisible tax that just steals tax payer’s money through inflation. Simply because basic math wins out in the end and shows that because the act of printing money doesn’t create any more jobs than one already has.
Now, in light of Obama’s “neoliberalism, the federal government is just borrowing more loot from itself, loot it doesn’t have because the Federal Reserve can print as much as it wants and buy government bonds with the new money it has printed. Such practices in concert with America’s "Ad hoc global 'counter-terrorism' efforts that began under President George W. Bush. The way I think it, this means that what can be anticipated in the future is that either the Obama Administration or Romney Administration will in my estimation, by 2013, have the U.S. at war with Iran just because it is the penchant of Israel and its nuclear program will be used as a reason for this attack. Although it is well know that Iran doesn't have a nuclear weapon. We already see posturing visa via Turkey being used as a NATO proxy to get to Syria on a direct path to Iran. As well as evidence that the Egypt-Israel peace treaty is slowly evaporating before our eyes apart. Although we say we desire the impossible dream of secular Islamic or secular Islamic states all across the region that includes a pluralistic society run according to democratic principles, it won’t happen, now given what has manifested in Syria as I stated earlier.
For decades, the Americans indulged and propped up pro-Western dictators in the interests U.S. foreign policy in the Middle East. Over the last 18 months, four of these dictators have fallen to pro-democracy uprisings, leaving U.S. strategy cold war-esque. And since we broke and can’t make loot via cold war, we will continue to engage in efforts to spark wars around the world, for whatever reason even if they are as petty as what transpired in Egypt and France and Britain – even if we have to adopt the position of David Ben-Gurion, and use terror just to accomplish such.
The above statement is attributed to David Ben-Gurion, the founding father of the State of Israel and First Israeli Prime Minister taken from Ben-Gurion, a Biography, by Michael Ben-Zohar (May 1948). I am not a historian, but such transgressions aside, it is not too farfetched to suggest that history often repeats itself. Especially when it pertains to presidential politics and nations like Israel, the United States, Syria, Turkey and Iran. Even considering smaller yet significant events ranging from the slaying of Crispus Attucks during the Boston Massacre in 1770 to the signing of the “Southern Manifesto” by Strom Thurman and a hundred plus democratic members of the house, to the operations run by Kermit Roosevelt that caused a coup in Iran in 1959; to even Eisenhower himself and his conundrum regarding Nasser of Egypt inclusive of France, Israel and the Aswan Damn.
This is a week or more after the first Presidential debate and I am willing to bet most black folk are still talking about it. Subsequently, given that most are caught up with that circus called the Presidential debate, truth be told it is immaterial and all that I mention prior are (albeit) past history more important than the debate when we look at the global predicament and war and our relationship with Israel. You see, although the US has laws that require foreign interests to register as foreign agents, these laws are not equally or always applied to all Israeli lobby groups, such as AIPAC.
Unless you have been behind a rock, you would know that besides the criminal industrial complex, the big industry money maker in America is war. Yes, war drives the economy and amounts to more than all of our allocated GDP spent when compared to all other programs in the United States that is if you don’t include international aid in the form of grants to nations like Israel, Egypt, Saudi Arabia, Pakistan and Afghanistan. Even as one reads this, Syria is being attacked inside by NATO funded Al Qaeda “Rebels,” China and japan are at each other throats, Shells fly each and every day in the Sudan and Mali is in the middle of a serious conflict.
For a while now, much has been made in political forums of addressing Iran and their quest to become nuclear sufficient (strangely enough by nations who have nuclear weapons - US and Israel). Meaning that regardless of what is being spoken in public, behind closed doors activities show how involved this issue is in both political and economic capital. The US, via NATO and the Saudi’s are funding dozens of training camps that have been set up to prepare for the fight against President Bashar al-Assad’s military. Both US and Saudi millions and Special Forces expertise are engaged covertly in training Al Qaeda terrorist (FSA Syria's rebels) into a disciplined military force. The FSA or “The Free Syrian Army” didn’t exist until Israel, NATO and the US decided that the powers that be needed a war, a major war, to make money and to topple the Syrian leader as well as the state bank of Syria. In fact the same ploy that is being used to break Iran and their independent state bank via the Libyan blue print for the same is being replicated in Syria.
Seems as if those of us in the West, limited by our ignorance and overshadowed by our obsessive ranting on freedom and democracy, cannot comprehend what democracy would mean to a non-Western world dominated by a belief in Islam. We look at what has happened in Libya and what is currently happening in Syria as being singularly about democracy and the development of a secular ideology that includes a pluralistic society run according to democratic principles while those on the ground see it about something completely different - espousing fundamentalism directed exclusive against western aggression and hegemony.
Another issue of concern is confounded when Middle Eastern Nations question the nationalistic approach of the West to their region. For example, the overt hypocrisy of US leadership under President Obama concerned about repression I Syria and Libya but not Bahrain and Saudi Arabia. They wonder how the US continue to evaluate all issues from state perspectives and a monolithic Islam versus Alawite, Sunni and ShÄ«'ah sects of Islam. On the one hand he supposedly is operating a multi-front war, in secrecy against Al Qaeda {Islamic fundamentalism}, particularly in Africa and the Middle East – as evident by the increase in size of the U.S. military's Special Forces Operation Command and the CIA's strike expansion capabilities in the region in places including Kenya, Uganda, the Central African Republic, Ethiopia, Djibouti, Mauritania, Burkina Faso and the Seychelles islands in the Indian Ocean off East Africa – while at the same time asserting that they do not desire a conflict with Islam. This albeit our policy pursues wars presently on three fronts: Syria, Lebanon and Iran, and Afghanistan.
We have seen this all before when President Gamal Abdel Nasser's, who had come to power in the 1953 nationalistic revolution in Egypt. Nasser's wanted to construction dam at Aswan, to form a massive lake that would aid to control the annual flooding of the Nile, crucial to Egypt's agriculture, as well as generating vast amounts of electricity. First he was offered economic support by Britain and US to finance the Aswan dam. But then the West backed out.
This led to Britain and France to build up their forces in the Mediterranean, with the secret understand that Israeli troops would move into the Sinai Peninsula. Trying to present a position of peace the European nations asked that both move away from the region and when Egypt disregarded, against the ruling of the UN Security Council and general assembly, Britain and France begin bombing Egyptian airfields. This was under Eisenhower, who although in the open refused to join Britain, France and Israel in an invasion of Egypt, had approved of and knew about such behind closed doors.
Yes the methods of Eisenhower are similar to the methods of Obama presently and well, the role of Israel as agent provocateur is the same – making up a threat that doesn’t exist because a nation attempts to exist in a self-determined fashion. Only difference is that then it was a damn in Egypt and now it is Nuclear power in Iran.
Another common denominator was economics. Then, it pertained to vital shipping routes today; it deals with the Middle East, West Africa as emerging vital oil-producing, mineral rich zones including arable farmland. Then after the US denied funding Egypt, they went to Russia for military support which was granted. Today, the same is happening in Syria, Iran and also Pakistan. In fact, Pakistan-Russia ties are growing under Russian President Vladimir Putin’s who is expected to make the first visit by a Russian president to Pakistan ever supposedly to sign multiple MOU’s (Memorandums of Understanding) on development and investment in the steel and energy sectors of Pakistan. Syria’s central role in the Arab gas pipeline is also a key to why Israel, NATO and the US wants Assad out, in addition to having a direct path to Iran (just as the Taliban in Afghanistan because they are in the way of the Unocal pipeline).
Guess what I am saying, to repeat myself is that without war, America’s economy would already be in the grave as opposed to on its death bed. War is good economics, no matter if it is in the Middle East, China, the Far East or Africa. The question is will we be able to make money before we realize we may not have the financial ability to carry out such efforts? As we speak, The United States military has secretly sent a task force of more than 150 specialists to Jordan be in place in case the turmoil in Syria expand into a wider conflict.
Unfortunately, it is a fallacy to think or believe that America can be taken out of economic crisis via more and more wars given that the most productive part of the US economy has been moved offshore in order to increase corporate profits and capital gains to equity owners. It is not the American people who are at the center of such policy efforts, like I said; historically it is the war machine and the oligarchy of private interests. More wars that we can only afford to pay with debt is trouble. It is just like having a gallon of gasoline, and pouring a half gallon of water into it doesn’t change the fact of how much gasoline remains. Borrowing more debt, quantitative easing, or printing more loot is the same thing as the above example. It is an invisible tax that just steals tax payer’s money through inflation. Simply because basic math wins out in the end and shows that because the act of printing money doesn’t create any more jobs than one already has.
Now, in light of Obama’s “neoliberalism, the federal government is just borrowing more loot from itself, loot it doesn’t have because the Federal Reserve can print as much as it wants and buy government bonds with the new money it has printed. Such practices in concert with America’s "Ad hoc global 'counter-terrorism' efforts that began under President George W. Bush. The way I think it, this means that what can be anticipated in the future is that either the Obama Administration or Romney Administration will in my estimation, by 2013, have the U.S. at war with Iran just because it is the penchant of Israel and its nuclear program will be used as a reason for this attack. Although it is well know that Iran doesn't have a nuclear weapon. We already see posturing visa via Turkey being used as a NATO proxy to get to Syria on a direct path to Iran. As well as evidence that the Egypt-Israel peace treaty is slowly evaporating before our eyes apart. Although we say we desire the impossible dream of secular Islamic or secular Islamic states all across the region that includes a pluralistic society run according to democratic principles, it won’t happen, now given what has manifested in Syria as I stated earlier.
For decades, the Americans indulged and propped up pro-Western dictators in the interests U.S. foreign policy in the Middle East. Over the last 18 months, four of these dictators have fallen to pro-democracy uprisings, leaving U.S. strategy cold war-esque. And since we broke and can’t make loot via cold war, we will continue to engage in efforts to spark wars around the world, for whatever reason even if they are as petty as what transpired in Egypt and France and Britain – even if we have to adopt the position of David Ben-Gurion, and use terror just to accomplish such.
12 Ekim 2012 Cuma
Conviction on Defrauding Fen-phen Settlement
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I'm posting this at the behest of our DoJ readers. Congratulations are in order.
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Please congratulate Paul Shapiro, who, after a one-week trial, successfully prosecuted Dr. Abdur Razzak Tai, convicting him on all 13 counts of mail and wire fraud today. Tai is a physician who specializes in cardiology and who practices medicine in Florida. He was among a number of doctors who agreed to review echocardiogram test results to make determinations as to whether individuals who ingested the diet drug Fen-Phen suffered mitral valve damage to their heart, thereby qualifying them for settlements that averaged approximately $400,000 per person from the trust that had been established here in Philadelphia to pay claims and settle lawsuits from across the United States. Dr. Tai had sought to profit from the $3.5 billion class action settlement of the Fen-Phen litigation by submitting false medical reports attesting that claimants had suffered heart damage when they were, in fact, fine. Tai took the stand and insisted that his medical reports had been forged or altered by the mass-tort lawyer who had hired him and who had paid him on a contingency fee basis. Under cross-examination, the doctor was forced to admit that he had had previously lied under oath about his compensation scheme with the lawyer who had hired him. The jury did not buy his act, and returned its verdicts (and managed to eat lunch) in less than two hours.
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We would only add that the defendant's allegations about being as an expert on contingent fee are themselves serious. We consider the source, but one those allegations are not necessarily inconsistent with theconviction. We hope that they are being investigated by the approproate authorities.
*********************
Please congratulate Paul Shapiro, who, after a one-week trial, successfully prosecuted Dr. Abdur Razzak Tai, convicting him on all 13 counts of mail and wire fraud today. Tai is a physician who specializes in cardiology and who practices medicine in Florida. He was among a number of doctors who agreed to review echocardiogram test results to make determinations as to whether individuals who ingested the diet drug Fen-Phen suffered mitral valve damage to their heart, thereby qualifying them for settlements that averaged approximately $400,000 per person from the trust that had been established here in Philadelphia to pay claims and settle lawsuits from across the United States. Dr. Tai had sought to profit from the $3.5 billion class action settlement of the Fen-Phen litigation by submitting false medical reports attesting that claimants had suffered heart damage when they were, in fact, fine. Tai took the stand and insisted that his medical reports had been forged or altered by the mass-tort lawyer who had hired him and who had paid him on a contingency fee basis. Under cross-examination, the doctor was forced to admit that he had had previously lied under oath about his compensation scheme with the lawyer who had hired him. The jury did not buy his act, and returned its verdicts (and managed to eat lunch) in less than two hours.
*********************
We would only add that the defendant's allegations about being as an expert on contingent fee are themselves serious. We consider the source, but one those allegations are not necessarily inconsistent with theconviction. We hope that they are being investigated by the approproate authorities.
One Smelly Product, Two Defendants, and Two Different Results
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Out of Illinois comes a medical device case with odd and smelly facts. Smith v. Phoenix Seating Sys. LLC, 2012 U.S. Dist. LEXIS 127865 (S.D. Ill. Sep. 10, 2012). The medical device was a wheelchair armrest called the 312G. The plaintiffs bought it (and, earlier, the wheelchair) from the defendant, Apria Healthcare Group. Plaintiffs installed the armrest themselves. Id. at *2-3. But not right away. That’s the odd and smelly part. Plaintiffs claimed that when they first received the armrest in the mail and opened its box, it smelled. How bad? So bad that they put it out of the house. First they put it in the garage for a week. That didn’t work. It still smelled. So they moved it outside – to the patio – for another 3-4 days to air it out. While the opinion doesn’t make it seem as if this worked completely, it apparently worked enough for plaintiffs to install the armrest. Id. at *3-4. That didn’t go so well. Plaintiffs claimed that each of them then suffered injuries from a toxic combination created by a gel contained in the armrest and the gel’s surface material. Id. at *6, 17-18. They sued two defendants. One was Apria, whose role appeared to be that of the direct seller. Id. at *29, 30-31. Apria faced negligent failure to warn claims. The other defendant was Phoenix Seating Systems, who designed the armrest (the extent of their involvement in the design seemed to be in dispute), received the armrest from the manufacturer, repackaged it, applied some identifying labeling, and then sent it to Apria. Id. at *13-14. Phoenix faced various strict liability claims. Alright, so the facts are a little odd. But what about the summary judgment decision? Not odd at all. Phoenix wanted out because it wasn’t a manufacturer, because there couldn’t be a failure to warn plaintiffs who had such idiosyncratic reactions, and because medical device preemption applied. The court rejected all these arguments. Illinois product liability actions, according to the court, apply to “all persons in the distributive chain . . . including suppliers, distributors, wholesalers[,] and retailers.” Id. at *10 (quoting Hammond v. North Am. Asbestos Corp., 97 Ill. 2d 195 (Ill. 1983). So it didn’t matter that Phoenix wasn’t a manufacturer. The court also found a fact dispute as to whether the plaintiffs’ reactions were idiosyncratic. So that argument didn’t work. As to preemption – and take heed here -- the 312G armrest was cleared under §510(k). But current law is that preemption only applies to devices approved under the PMA process, not those cleared under §510(k). While we’ve argued here that it’s time for the Supreme Court to reconsider this, it hasn’t done so yet. So no preemption, and Phoenix stays in the case. The court saw Apria differently. There was insufficient evidence in the record to establish that Apria was involved in the manufacture or design of the armrest, or that Apria had reason to know of any problem that needed to be warned about:Apria alleges it did not manufacture the 312G, take any part in its design, have knowledge concerning the specific materials contained in the 312G, or have knowledge of complaints similar to plaintiffs’ instant grievances. . . . As plaintiffs’ response does not address Apria’s argument concerning its lack of knowledge, plaintiffs do not dispute such allegations. Moreover, plaintiffs’ complaint does not allege Apria had any role in the 312G’s design or manufacture, or knowledge of the 312G’s alleged defective design or manufacture. Similarly, plaintiffs have not instantly offered evidence demonstrating Apria was involved in the 312G’s manufacture or design, or that other complaints or reactions to the 312G have ever been reported.Id. at *29, *30-31 (record citations omitted). Plaintiffs had only negligent failure to warn claims against Apria, and those claims couldn’t survive summary judgment – not on this record. Now, just like Phoenix, Apria had a hiccup. It claimed to be exempt from liability under a “seller’s exception” to product liability claims, but the statute that contained that exception had been declared unconstitutional years earlier by the Illinois Supreme Court. Id. at *24-45. So that argument didn’t work. Fortunately for Apria, its other arguments did. No duty, no claim – regardless of how bad the armrest smelled. So Atria gets out of the case. Sometimes odd facts make for ordinary law.
The FDA On Warning Letters - They're Sure Not Final
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Remember that case about ear candles? Given the product, we had some fun with it in our earlier posts. Well, it turns out that the ear candling folks are nothing if not persistent. They appealed the second opinion, Holistic Candlers & Consumers Ass’n v. FDA, 664 F.3d 940 (D.C. Cir. 2012), to the Supreme Court. As our post indicated, this opinion turned (in part, but a large part) on the “finality” of an FDA warning letter.
The Supreme Court appeal has given the FDA the opportunity to state its formal opinion about how it views the “finality” of warning letters. See Brief for the Respondents [FDA] in Opposition, Holistic Candlers & Consumers Ass’n v. FDA, No. 11-1454, 2012 WL 3991471 (filed Sept. 11, 2012). To put it succinctly, they aren’t final at all.
Since it’s Friday and we’re lazy, we’ll simply quote for you some of the FDA’s reasoning on why its warning letters aren’t legal determinations of anything. Here’s what the FDA has told the United States Supreme Court:
If FDA believes that a person is violating the FDCA, the agency may issue a warning letter giving the person an opportunity to take voluntary corrective measures before the agency pursues enforcement action. Warning letters are “the agency’s principal means of achieving prompt voluntary compliance with the [FDCA].” FDA, Regulatory Procedures Manual, 4-1-1 (July 2012), http://www.fda.gov/downloads/ICECI/ComplianceManuals/RegulatoryProceduresManual/UCM074330.pdf A warning letter is “informal and advisory”; it “communicates the agency’s position on a matter” but “does not commit FDA to taking enforcement action.” Ibid.
FDA Holistic Candlers br. at *5.
[T]he warning letters here did not mark the consummation of FDA’s decisionmaking process. As FDA has explained, warning letters give “firms an opportunity to take voluntary and prompt corrective action before [FDA] initiates an enforcement action.” Regulatory Procedures Manual 4-1-1. An enforcement action - typically a seizure or an injunction - is not inevitable, and indeed, most warning letters do not result in enforcement action. See FDA, Enforcement Statistics Summary Fiscal Year 2011 (reporting 1720 Warning Letters, but only 15 seizures and 16 injunctions), http://www.fda.gov/downloads/ICECI/EnforcementActions/UCM285781.pdf. Violations identified in warning letters “may lead to enforcement action if not promptly and adequately corrected.” Regulatory Procedures Manual 4-1-1 (emphasis added). Consistent with the Regulatory Procedures Manual, the warning letters at issue here stated that “FDA will evaluate the information you submit and decide whether your product may be legally marketed.” Pet. App. 43 (quoting FDA warning letter) (emphasis and internal quotation marks omitted). Relatedly, the warning letters were not based on a formal and complete administrative record. At this stage, FDA’s statement that petitioners violated the FDCA was not “final and binding” on the agency or petitioners but rather remained “tentative [and] interlocutory [in] nature.”
Id. at *9-10 (emphasis original).
Nor did the warning letters finally determine the “rights or obligations” of petitioners with regard to the distribution of ear candles, or trigger “direct and appreciable legal consequences.” Bennett, 520 U.S. at 178. Rather, the letters “request[ed]” that petitioners “take prompt action to correct [the identified] deviations” from the FDCA, and cautioned that “[f]ailure to promptly correct these deviations may result in regulatory action.” Pet. App. 39. The letters served only to communicate FDA's position with regard to ear candles, and to warn recipients about the possibility of future enforcement action. See Regulatory Procedures Manual 4-1-1. The letters nonetheless remained “informal and advisory” and “[did] not commit FDA to taking enforcement action.” Ibid.
Id. at *10-11.
FDA warning letters trigger no legal consequences and are subject to further agency “evaluat[ion]” based on the recipient’s response. See Pet. App. 47. Such letters do not trigger any enlarged exposure to penalties for noncompliance with the FDCA, nor does their issuance preclude further agency consideration or review. Rather, the letters state FDA’s position on the facts available to it, encourage voluntary compliance with the FDCA, and alert the recipient of possible enforcement action by the FDA. If and when an enforcement action is brought, the agency’s claim is not that the recipient has “violated” the warning letter, but rather that it has violated the underlying requirements of the FDCA.
Id. at *14.
So there you have it, from the proverbial horse’s mouth. And what should be the consequences of the non-final nature of FDA warning letters. Here are a few − there may well be more, the more we think about this: (1) without enforcement they’re not admissible evidence, being considerably less than a bare criminal indictment; (2) any attempt to give a warning letter binding collateral estoppel effect would be a violation of Due Process, since such letters are not appealable; (3) warning letters are nothing like the enforcement actions mentioned in the concurrence in Buckman Co. v. Plaintiffs Legal Committee, 531 U.S. 341 (2001), (4) as warning letters are not legally enforceable, they shouldn’t be the basis of an negligence per se action; and (5) being tentative and subject to change at any time, a warning letter should not be the type of evidence reasonably relied upon by experts in the field (assuming there is a “field” as to which expert testimony is permissible in the first instance).
The Supreme Court appeal has given the FDA the opportunity to state its formal opinion about how it views the “finality” of warning letters. See Brief for the Respondents [FDA] in Opposition, Holistic Candlers & Consumers Ass’n v. FDA, No. 11-1454, 2012 WL 3991471 (filed Sept. 11, 2012). To put it succinctly, they aren’t final at all.
Since it’s Friday and we’re lazy, we’ll simply quote for you some of the FDA’s reasoning on why its warning letters aren’t legal determinations of anything. Here’s what the FDA has told the United States Supreme Court:
If FDA believes that a person is violating the FDCA, the agency may issue a warning letter giving the person an opportunity to take voluntary corrective measures before the agency pursues enforcement action. Warning letters are “the agency’s principal means of achieving prompt voluntary compliance with the [FDCA].” FDA, Regulatory Procedures Manual, 4-1-1 (July 2012), http://www.fda.gov/downloads/ICECI/ComplianceManuals/RegulatoryProceduresManual/UCM074330.pdf A warning letter is “informal and advisory”; it “communicates the agency’s position on a matter” but “does not commit FDA to taking enforcement action.” Ibid.
FDA Holistic Candlers br. at *5.
[T]he warning letters here did not mark the consummation of FDA’s decisionmaking process. As FDA has explained, warning letters give “firms an opportunity to take voluntary and prompt corrective action before [FDA] initiates an enforcement action.” Regulatory Procedures Manual 4-1-1. An enforcement action - typically a seizure or an injunction - is not inevitable, and indeed, most warning letters do not result in enforcement action. See FDA, Enforcement Statistics Summary Fiscal Year 2011 (reporting 1720 Warning Letters, but only 15 seizures and 16 injunctions), http://www.fda.gov/downloads/ICECI/EnforcementActions/UCM285781.pdf. Violations identified in warning letters “may lead to enforcement action if not promptly and adequately corrected.” Regulatory Procedures Manual 4-1-1 (emphasis added). Consistent with the Regulatory Procedures Manual, the warning letters at issue here stated that “FDA will evaluate the information you submit and decide whether your product may be legally marketed.” Pet. App. 43 (quoting FDA warning letter) (emphasis and internal quotation marks omitted). Relatedly, the warning letters were not based on a formal and complete administrative record. At this stage, FDA’s statement that petitioners violated the FDCA was not “final and binding” on the agency or petitioners but rather remained “tentative [and] interlocutory [in] nature.”
Id. at *9-10 (emphasis original).
Nor did the warning letters finally determine the “rights or obligations” of petitioners with regard to the distribution of ear candles, or trigger “direct and appreciable legal consequences.” Bennett, 520 U.S. at 178. Rather, the letters “request[ed]” that petitioners “take prompt action to correct [the identified] deviations” from the FDCA, and cautioned that “[f]ailure to promptly correct these deviations may result in regulatory action.” Pet. App. 39. The letters served only to communicate FDA's position with regard to ear candles, and to warn recipients about the possibility of future enforcement action. See Regulatory Procedures Manual 4-1-1. The letters nonetheless remained “informal and advisory” and “[did] not commit FDA to taking enforcement action.” Ibid.
Id. at *10-11.
FDA warning letters trigger no legal consequences and are subject to further agency “evaluat[ion]” based on the recipient’s response. See Pet. App. 47. Such letters do not trigger any enlarged exposure to penalties for noncompliance with the FDCA, nor does their issuance preclude further agency consideration or review. Rather, the letters state FDA’s position on the facts available to it, encourage voluntary compliance with the FDCA, and alert the recipient of possible enforcement action by the FDA. If and when an enforcement action is brought, the agency’s claim is not that the recipient has “violated” the warning letter, but rather that it has violated the underlying requirements of the FDCA.
Id. at *14.
So there you have it, from the proverbial horse’s mouth. And what should be the consequences of the non-final nature of FDA warning letters. Here are a few − there may well be more, the more we think about this: (1) without enforcement they’re not admissible evidence, being considerably less than a bare criminal indictment; (2) any attempt to give a warning letter binding collateral estoppel effect would be a violation of Due Process, since such letters are not appealable; (3) warning letters are nothing like the enforcement actions mentioned in the concurrence in Buckman Co. v. Plaintiffs Legal Committee, 531 U.S. 341 (2001), (4) as warning letters are not legally enforceable, they shouldn’t be the basis of an negligence per se action; and (5) being tentative and subject to change at any time, a warning letter should not be the type of evidence reasonably relied upon by experts in the field (assuming there is a “field” as to which expert testimony is permissible in the first instance).
Basile v. H&R Block - It's Finally Over (and That's a Good Thing)
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Today's guest post is by Jim Sargent, of Lamb McErlane, who was one of the winning attorneys in the Basile v. H&R Block decision his post discusses. Way to go Jim (and everybody else on the team)! Bexis and Jim go back a ways, since Bexis wrote PLAC amicus briefs in the Samuel-Bassett case that Jim mentions in this post. As always, the guest blogger gets all the credit/shoulders all the blame for his post (unless the links don't work - that would be Bexis' fault).
Basile, although not a drug/device opinion, is an important class certification decision in Pennsylvania.
*******************
The Pennsylvania Supreme Court’s most recent decision on class actions is in Basile v. H&R Block, Inc., ___ A.3d ___, 2012 WL 3871504, slip op. (Pa. Sept. 7, 2012) ("Basile III"). Basile was a putative class action commenced way back in 1993, claiming that the defendant breached a fiduciary duty to its customers by not sufficiently disclosing that its “rapid refunds” of federal taxes actually were high interest consumer loans. Plaintiffs claimed that the defendant was a "fiduciary" as a way of avoiding reliance and individualized issues that prevent certification of this sort of claim.
The class was certified in 1997 by the late Judge Bernard Avellino, based on a “presumption” that an agency relationship existed between the defendant and some 600,000 customers. Over the next 15 years there then ensued 9 separate appeals – the case was before the Superior Court 5 (twice before the court en banc) times and the Supreme Court 4 times – which well may make it the longest appellate record in Pennsylvania history.
On the first appeal, the Supreme Court rejected the notion that any agency relationship supported Plaintiffs’ claim that a fiduciary duty existed between the defendant and the class. Basile v. H & R Block, Inc., 761 A. 2d 1115 (Pa. 2000) ("Basile I"). In its September 7, 2012 opinion the Court reiterated that it meant what it said the first time, rejecting the contention that a “confidential relationship” (the “fiduciary” claim under another name) existed, thus knocking out the remaining foundation for Plaintiffs’ claim.
In the course of the 19 year history in Basile, the Supreme Court clarified the law of agency, Basile I, supra, 761 A. 2d 1115, the aggrieved party doctrine (after some Superior Court funny business with appellate issues), Basile v. H & R Block, Inc., 973 A. 2d 417 (Pa. 2009) ("Basile II"), and now, in this latest opinion, the “confidential relationship” doctrine.
Probably most important in the long term, though, is what the Court had to say about the principles governing class certification. .
Its September 7 Basile III opinion reversed the Superior Court and affirmed the trial court decertification order. Think about what the Superior Court had done. It had held that that this class had to be certified; that decertification was an abuse of discretion. Writing in a 6-0 decision (Justice Orie-Melvin attended argument but is now suspended from the Court), Justice Saylor disposed of some eighty-year-old dictum, and held that a “confidential relationship” sufficient to give rise to a fiduciary duty is “‘intensely fact-specific,’” 2012 WL 3871504, at *7-8, and not suited to class-certification. The Court therefore held that the class was properly decertified.
Justice Saylor’s rulings on class action procedure and his reflections generally on the class action mechanism bear taking specific note. Speaking for a unanimous court, he rejected the Superior Court’s attempt to flip the burden of proof on class certification. Evidence sufficient to defeat summary judgment (where all inferences benefit the plaintiff), does not create grounds for certification of a class (where the plaintiff bears the burden). To support class certification facts must be “properly determined . . . not assumed.” 2012 WL 3871504, at *6. “[D]eferring close consideration of class certification to the time when facts are determined by a jury at trial (namely, in connection with the verdict) is incompatible with the governing procedural rules.” Id.
Towards the end − after once describing class actions as “collectivized treatment,” id. at *6 − the opinion returns to this theme, stating: “We are cognizant of the tendency toward sanctioning the use of class actions as a convenience to address colorably meritorious claims in an aggregate fashion, where these might not otherwise be capable of being redressed practically on an individual basis.” Id. at *8. However, the Court rejected this temptation, holding that the approach to class treatment reflected in Pennsylvania’s class action rules “stems from limitations inherent in the judicial rulemaking process, the impact of collectivized treatment of individual claims on defendants’ substantive rights,” and “the limited policymaking role of the courts (as compared with the legislative branch) in terms of manipulating substantive law.” Id.
[Editor's note: On this blog, we refer to the "tendency" that Court rejected in Basile III "judicial triumphalism."]
The Court’s rejection of Plaintiffs’ invitation to fashion a judicial solution to a legislative problem should be applauded. In contrast, 9 months earlier in Samuel-Bassett v. Kia Motors America, Inc., 34 A.3d 1 (Pa. 2011), the same Court approved certification of a class of automobile owners on claims of out-of-pocket expense for brake repairs under an express warranty, where there was no proof that each class member had sustained any (let alone similar) repair expenses. The Court stated: “…a certification proceeding is a preliminary inquiry whose purpose is to establish who the parties to the class action are ‘and nothing more.’” 34 A.3d at 21-22 (quoting Pa. R.C.P. No. 1707 cmt). That plaintiff was not required to prove anything about the defendant’s liability at the certification stage and the trial court was prohibited from factoring the perceived adequacy of the “underlying merits of the class’s claims into the certification decision.” Id. at 22. The Court continued: “By the same token, pre-trial class certification proceedings do not require a mini-trial; the class is not obligated to establish liability during the class certification phase.” Id. (citations omitted). The Court then discounted the importance of individual proof of out-of-pocket costs for each class member: “As our previous analysis shows, [plaintiff] and the class adduced sufficient evidence during certification proceedings to show a common source of liability. Any question regarding individual expenditures resulting from varying attempts to repair the defect was not a ground to reject the commonality found on other issues, to defeat the predominance of common issues and, ultimately, to deny certification of the class at the preliminary stages of trial.” Id. at 28.
But less than a year later, the Court is rejecting, unanimously, “assumed facts” and requiring “close consideration of class certification”in the name of “limitations inherent in the judicial rulemaking process” and “the limited policymaking role of the courts” in Basile III.
There is no easy explanation for the differences between Samuel-Bassett and Basile III. It may be significant that Samuel-Bassett languished with the Court for 3 1/2 years after argument (during which time Basile II author Justice Greenspan left the bench), whereas Basile III was decided with lightening speed for the Court (4 months from May 8 argument to September 7 decision).
Some will always say, most particularly Plaintiff's counsel in Samuel-Bassett, that the two decisions can be distinguished purely on the grounds of "waiver," since the Samuel-Bassett Court concluded that defense trial counsel had waived objection to the molded verdict after trial. But Justice Saylor’s strong dissent in Samuel-Bassett argued that there was no waiver and that Samuel-Bassett would not be cited as a waiver case in the future. 34 A.3d at 64. Moreover, "waiver" usually gives appellate judges a quick exit, and yet Chief Justice Castille wrote an 80-page opinion in Samuel-Bassett that labored hard to justify the result, which certainly didn't conserve judicial resources, and is not convincing.
Others will say that the two decisions can't be reconciled. After all, Justice Saylor, who vehemently dissented in Samuel-Bassett, wrote for the unanimous court in Basile III. They will say there are now two alternative sets of policies in Pennsylvania: the "class actions are favored" rationale and acceptance of collectivized proof in Samuel-Bassett and the proscription against using procedural vehicles to change substantive law in Basile III – the second of which appears to line up better with the evolving federal standards articulated in Hydrogen Peroxide and Dukes.
It may be that, Justice Saylor, who is next in line to be Chief, will usher in a new era. Or perhaps the Court is slowly awakening to the misuse of the class action mechanism in circumstances where the effect is to relieve plaintiffs of the burden of proving all elements of their claims. Philadelphia has earned a reputation nationally for favoring plaintiffs in class actions that might not fly in other jurisdictions. See The City of Unbrotherly Torts, Wall St. J., Dec. 3, 2011 (noting that Philadelphia state court is a “destination of choice” for plaintiff classes due to fewer settlements and higher verdicts); see also Am. Tort Reform Found., Judicial Hellholes 2011-2012, at 3–8 (2011) (listing Philadelphia as the number one “judicial hellhole”); id. at 2 (“Judicial Hellholes have been considered places where judges systematically apply laws and court procedures in an unfair and unbalanced manner.”) (emphasis omitted); id. at 3 (“Of greatest concern is the Complex Litigation Center (CLC) in Philadelphia, where judges have actively sought to attract personal injury lawyers from across the state and the country.”). In Daniel v. Wyeth, Nos. 63-64 EDA 2011, before the Supreme Court from the decision of a panel of the Superior Court overturning the trial court's JNOV on punitive damages, Justice Castille was reported to have remarked that sustaining the award would result in Pennsylvania being labeled a "judicial hellhole." Legal Intelligencer, 9/12/12. Perhaps the Court finally has gotten the message.
Basile, although not a drug/device opinion, is an important class certification decision in Pennsylvania.
*******************
The Pennsylvania Supreme Court’s most recent decision on class actions is in Basile v. H&R Block, Inc., ___ A.3d ___, 2012 WL 3871504, slip op. (Pa. Sept. 7, 2012) ("Basile III"). Basile was a putative class action commenced way back in 1993, claiming that the defendant breached a fiduciary duty to its customers by not sufficiently disclosing that its “rapid refunds” of federal taxes actually were high interest consumer loans. Plaintiffs claimed that the defendant was a "fiduciary" as a way of avoiding reliance and individualized issues that prevent certification of this sort of claim.
The class was certified in 1997 by the late Judge Bernard Avellino, based on a “presumption” that an agency relationship existed between the defendant and some 600,000 customers. Over the next 15 years there then ensued 9 separate appeals – the case was before the Superior Court 5 (twice before the court en banc) times and the Supreme Court 4 times – which well may make it the longest appellate record in Pennsylvania history.
On the first appeal, the Supreme Court rejected the notion that any agency relationship supported Plaintiffs’ claim that a fiduciary duty existed between the defendant and the class. Basile v. H & R Block, Inc., 761 A. 2d 1115 (Pa. 2000) ("Basile I"). In its September 7, 2012 opinion the Court reiterated that it meant what it said the first time, rejecting the contention that a “confidential relationship” (the “fiduciary” claim under another name) existed, thus knocking out the remaining foundation for Plaintiffs’ claim.
In the course of the 19 year history in Basile, the Supreme Court clarified the law of agency, Basile I, supra, 761 A. 2d 1115, the aggrieved party doctrine (after some Superior Court funny business with appellate issues), Basile v. H & R Block, Inc., 973 A. 2d 417 (Pa. 2009) ("Basile II"), and now, in this latest opinion, the “confidential relationship” doctrine.
Probably most important in the long term, though, is what the Court had to say about the principles governing class certification. .
Its September 7 Basile III opinion reversed the Superior Court and affirmed the trial court decertification order. Think about what the Superior Court had done. It had held that that this class had to be certified; that decertification was an abuse of discretion. Writing in a 6-0 decision (Justice Orie-Melvin attended argument but is now suspended from the Court), Justice Saylor disposed of some eighty-year-old dictum, and held that a “confidential relationship” sufficient to give rise to a fiduciary duty is “‘intensely fact-specific,’” 2012 WL 3871504, at *7-8, and not suited to class-certification. The Court therefore held that the class was properly decertified.
Justice Saylor’s rulings on class action procedure and his reflections generally on the class action mechanism bear taking specific note. Speaking for a unanimous court, he rejected the Superior Court’s attempt to flip the burden of proof on class certification. Evidence sufficient to defeat summary judgment (where all inferences benefit the plaintiff), does not create grounds for certification of a class (where the plaintiff bears the burden). To support class certification facts must be “properly determined . . . not assumed.” 2012 WL 3871504, at *6. “[D]eferring close consideration of class certification to the time when facts are determined by a jury at trial (namely, in connection with the verdict) is incompatible with the governing procedural rules.” Id.
Towards the end − after once describing class actions as “collectivized treatment,” id. at *6 − the opinion returns to this theme, stating: “We are cognizant of the tendency toward sanctioning the use of class actions as a convenience to address colorably meritorious claims in an aggregate fashion, where these might not otherwise be capable of being redressed practically on an individual basis.” Id. at *8. However, the Court rejected this temptation, holding that the approach to class treatment reflected in Pennsylvania’s class action rules “stems from limitations inherent in the judicial rulemaking process, the impact of collectivized treatment of individual claims on defendants’ substantive rights,” and “the limited policymaking role of the courts (as compared with the legislative branch) in terms of manipulating substantive law.” Id.
[Editor's note: On this blog, we refer to the "tendency" that Court rejected in Basile III "judicial triumphalism."]
The Court’s rejection of Plaintiffs’ invitation to fashion a judicial solution to a legislative problem should be applauded. In contrast, 9 months earlier in Samuel-Bassett v. Kia Motors America, Inc., 34 A.3d 1 (Pa. 2011), the same Court approved certification of a class of automobile owners on claims of out-of-pocket expense for brake repairs under an express warranty, where there was no proof that each class member had sustained any (let alone similar) repair expenses. The Court stated: “…a certification proceeding is a preliminary inquiry whose purpose is to establish who the parties to the class action are ‘and nothing more.’” 34 A.3d at 21-22 (quoting Pa. R.C.P. No. 1707 cmt). That plaintiff was not required to prove anything about the defendant’s liability at the certification stage and the trial court was prohibited from factoring the perceived adequacy of the “underlying merits of the class’s claims into the certification decision.” Id. at 22. The Court continued: “By the same token, pre-trial class certification proceedings do not require a mini-trial; the class is not obligated to establish liability during the class certification phase.” Id. (citations omitted). The Court then discounted the importance of individual proof of out-of-pocket costs for each class member: “As our previous analysis shows, [plaintiff] and the class adduced sufficient evidence during certification proceedings to show a common source of liability. Any question regarding individual expenditures resulting from varying attempts to repair the defect was not a ground to reject the commonality found on other issues, to defeat the predominance of common issues and, ultimately, to deny certification of the class at the preliminary stages of trial.” Id. at 28.
But less than a year later, the Court is rejecting, unanimously, “assumed facts” and requiring “close consideration of class certification”in the name of “limitations inherent in the judicial rulemaking process” and “the limited policymaking role of the courts” in Basile III.
There is no easy explanation for the differences between Samuel-Bassett and Basile III. It may be significant that Samuel-Bassett languished with the Court for 3 1/2 years after argument (during which time Basile II author Justice Greenspan left the bench), whereas Basile III was decided with lightening speed for the Court (4 months from May 8 argument to September 7 decision).
Some will always say, most particularly Plaintiff's counsel in Samuel-Bassett, that the two decisions can be distinguished purely on the grounds of "waiver," since the Samuel-Bassett Court concluded that defense trial counsel had waived objection to the molded verdict after trial. But Justice Saylor’s strong dissent in Samuel-Bassett argued that there was no waiver and that Samuel-Bassett would not be cited as a waiver case in the future. 34 A.3d at 64. Moreover, "waiver" usually gives appellate judges a quick exit, and yet Chief Justice Castille wrote an 80-page opinion in Samuel-Bassett that labored hard to justify the result, which certainly didn't conserve judicial resources, and is not convincing.
Others will say that the two decisions can't be reconciled. After all, Justice Saylor, who vehemently dissented in Samuel-Bassett, wrote for the unanimous court in Basile III. They will say there are now two alternative sets of policies in Pennsylvania: the "class actions are favored" rationale and acceptance of collectivized proof in Samuel-Bassett and the proscription against using procedural vehicles to change substantive law in Basile III – the second of which appears to line up better with the evolving federal standards articulated in Hydrogen Peroxide and Dukes.
It may be that, Justice Saylor, who is next in line to be Chief, will usher in a new era. Or perhaps the Court is slowly awakening to the misuse of the class action mechanism in circumstances where the effect is to relieve plaintiffs of the burden of proving all elements of their claims. Philadelphia has earned a reputation nationally for favoring plaintiffs in class actions that might not fly in other jurisdictions. See The City of Unbrotherly Torts, Wall St. J., Dec. 3, 2011 (noting that Philadelphia state court is a “destination of choice” for plaintiff classes due to fewer settlements and higher verdicts); see also Am. Tort Reform Found., Judicial Hellholes 2011-2012, at 3–8 (2011) (listing Philadelphia as the number one “judicial hellhole”); id. at 2 (“Judicial Hellholes have been considered places where judges systematically apply laws and court procedures in an unfair and unbalanced manner.”) (emphasis omitted); id. at 3 (“Of greatest concern is the Complex Litigation Center (CLC) in Philadelphia, where judges have actively sought to attract personal injury lawyers from across the state and the country.”). In Daniel v. Wyeth, Nos. 63-64 EDA 2011, before the Supreme Court from the decision of a panel of the Superior Court overturning the trial court's JNOV on punitive damages, Justice Castille was reported to have remarked that sustaining the award would result in Pennsylvania being labeled a "judicial hellhole." Legal Intelligencer, 9/12/12. Perhaps the Court finally has gotten the message.
Interesting Mensing Application
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We saw the 360 blurb this morning on In reDarvocet, Darvon & Propoxyphene Products Liability Litigation, MDLDocket No. 2226, slip op. (E.D. Ky. Oct. 10, 2012), and we thought we’d be content just adding it to ourbranded-in-generic (that is to say Conte) scorecard. After all – we’re pleased to say – there havebeen a lot of similar decisions lately.
But there’s more to this Darvocet opinion –which we’ll henceforth call “AAIPharma” because there are now so many Darvocets− than meets 360’s eye (at least until you get to the 12th paragraph). Specifically, we found an application of theimplied preemption rationale in PLIVA v. Mensing, 131 S. Ct. 2567(2011), to a branded manufacturer. That’s worthy of a post.
Here’s what happened. Only one of 50 cases in AAIPharma survivedthe product identification requirements of state law, involving a plaintiff Lopez. As to that case, the court found a sufficientTwIqbal allegation of product identification, specifically:
The plaintiffs in Lopez, however, do specificallyallege the ingestion of a . . . product manufactured by the AAIDefendants. [They] assert[] that PlaintiffMark Lopez ingested “[t]hree prescriptions for Darvocet N-100 from OldenPharmacy, which lists the manufacturers as AAI Pharma, LLC . . . fromAugust 2005 to October 2006.” Thesealleged ingestion dates occurred after the AAI Defendants transferred the NewDrug Application (“NDA”) for Darvocet to Xanodyne Pharmaceuticals.
Slip op. at 5 (record citations omitted). The court held that this was enough, at thejudgment on the pleadings stage, to avoid dismissal.
However, the court did not stop there. It went on to consider preemption under Mensing. Slip op. at 5. That’s notable because the opinion specifies that the defendants inquestion are branded manufacturers. SeeId. at 3 n.2 (identifying moving defendants as “Brand defendants”). We consider the application of Mensingimplied preemption to branded manufacturers as one of the frontiers ofpreemption at the moment. So where does Mensingleave off and the benighted domain of Wyeth v. Levine, 555 U.S. 555(2009), begin? The court in AAIPharmafixed the boundary at the point where the branded manufacturer lost the abilityto do what the Levine decision turned upon – unilaterally change itswarnings. As mentioned in the blockquote above, the plaintiff in Lopez only ingested that particularbranded product after thedefendant had sold its NDA to somebody else. At that point, because it was no longer the NDA holder, the defendantcould no longer file a unilateral CBE label change to its warnings:
Because the AAI Defendants did not have the power tochange the label after May 2005, Lopez’s failure-to-warn claims against the AAIDefendants are preempted under [Mensing].
Slip op. at 5. Thus, the Lopez plaintiffs’ warning claims were preempted. The court did not preempt design-relatedclaims because at the time of manufacture the defendant was still the NDAholder, and thus not subject to any such limitations. Id. at 5-6. So it’s a warning-only decision, but then in most prescription drugcases warnings are the major battleground.
Thus, the important point in AAIPharma remains: Mensing’s impossibility preemptionapplies, and bars warning-related claims, whenever the facts support it. Those facts are the distinction that the Mensingcourt drew against Levine – the ability of the defendant tochange/strengthen its warnings unilaterally, without needing the priorinvolvement of the FDA. Thus, while Levineand its “clear evidence” of likely FDA rejection standard eliminated a lot ofpreemption in litigation involving branded drugs (clear evidence being foundonly in a handful of cases), it did not eliminate all of it. As AAIPharma demonstrates, there arecertain situations (transfer of the NDA) as well as certain types of defendants(non-NDA holders that can’t use the CBE process at all) where the impliedpreemption defense can succeed even where the product in question is a brandeddrug.
While Mensing is by no means an antidote to theexecrable Levine decision, it’s something to remember if you happen tobe representing a branded defendant in one of these peculiar situations.
We saw the 360 blurb this morning on In reDarvocet, Darvon & Propoxyphene Products Liability Litigation, MDLDocket No. 2226, slip op. (E.D. Ky. Oct. 10, 2012), and we thought we’d be content just adding it to ourbranded-in-generic (that is to say Conte) scorecard. After all – we’re pleased to say – there havebeen a lot of similar decisions lately.
But there’s more to this Darvocet opinion –which we’ll henceforth call “AAIPharma” because there are now so many Darvocets− than meets 360’s eye (at least until you get to the 12th paragraph). Specifically, we found an application of theimplied preemption rationale in PLIVA v. Mensing, 131 S. Ct. 2567(2011), to a branded manufacturer. That’s worthy of a post.
Here’s what happened. Only one of 50 cases in AAIPharma survivedthe product identification requirements of state law, involving a plaintiff Lopez. As to that case, the court found a sufficientTwIqbal allegation of product identification, specifically:
The plaintiffs in Lopez, however, do specificallyallege the ingestion of a . . . product manufactured by the AAIDefendants. [They] assert[] that PlaintiffMark Lopez ingested “[t]hree prescriptions for Darvocet N-100 from OldenPharmacy, which lists the manufacturers as AAI Pharma, LLC . . . fromAugust 2005 to October 2006.” Thesealleged ingestion dates occurred after the AAI Defendants transferred the NewDrug Application (“NDA”) for Darvocet to Xanodyne Pharmaceuticals.
Slip op. at 5 (record citations omitted). The court held that this was enough, at thejudgment on the pleadings stage, to avoid dismissal.
However, the court did not stop there. It went on to consider preemption under Mensing. Slip op. at 5. That’s notable because the opinion specifies that the defendants inquestion are branded manufacturers. SeeId. at 3 n.2 (identifying moving defendants as “Brand defendants”). We consider the application of Mensingimplied preemption to branded manufacturers as one of the frontiers ofpreemption at the moment. So where does Mensingleave off and the benighted domain of Wyeth v. Levine, 555 U.S. 555(2009), begin? The court in AAIPharmafixed the boundary at the point where the branded manufacturer lost the abilityto do what the Levine decision turned upon – unilaterally change itswarnings. As mentioned in the blockquote above, the plaintiff in Lopez only ingested that particularbranded product after thedefendant had sold its NDA to somebody else. At that point, because it was no longer the NDA holder, the defendantcould no longer file a unilateral CBE label change to its warnings:
Because the AAI Defendants did not have the power tochange the label after May 2005, Lopez’s failure-to-warn claims against the AAIDefendants are preempted under [Mensing].
Slip op. at 5. Thus, the Lopez plaintiffs’ warning claims were preempted. The court did not preempt design-relatedclaims because at the time of manufacture the defendant was still the NDAholder, and thus not subject to any such limitations. Id. at 5-6. So it’s a warning-only decision, but then in most prescription drugcases warnings are the major battleground.
Thus, the important point in AAIPharma remains: Mensing’s impossibility preemptionapplies, and bars warning-related claims, whenever the facts support it. Those facts are the distinction that the Mensingcourt drew against Levine – the ability of the defendant tochange/strengthen its warnings unilaterally, without needing the priorinvolvement of the FDA. Thus, while Levineand its “clear evidence” of likely FDA rejection standard eliminated a lot ofpreemption in litigation involving branded drugs (clear evidence being foundonly in a handful of cases), it did not eliminate all of it. As AAIPharma demonstrates, there arecertain situations (transfer of the NDA) as well as certain types of defendants(non-NDA holders that can’t use the CBE process at all) where the impliedpreemption defense can succeed even where the product in question is a brandeddrug.
While Mensing is by no means an antidote to theexecrable Levine decision, it’s something to remember if you happen tobe representing a branded defendant in one of these peculiar situations.
11 Ekim 2012 Perşembe
School Ban On Student Distribution of Proselytizing Messages Is Viewpoint Discrimination
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In Gillio v. School Board of Hillsborough County, Florida, (MD FL, Oct. 5, 2012), a Florida federal magistrate judge recommended issuance of a preliminary injunction to allow a 4th grade student to distribute invitations to a church organized Easter egg hunt to fellow classmates. The invitation indicated that the purpose of the event was "To have fun and learn the true meaning of Easter." According to the court:
Board Policy 9700 bans the distribution of materials from religious institutions or organizations that “contain a proselytizing message (i.e., promote the benefits of the specific religion).” The policy also states that school officials shall use the criteria in Board Policy 5722 to determine whether materials are suitable for distribution at school. In turn, one provision in Board Policy 5722 explains that materials are not appropriate if they “[s]eek to establish the supremacy of a particular religious denomination, sect, or point of view over any other religious denomination, sect, or point of view[.]”...
As applied to J.G.’s invitations, the contested provisions ... permit viewpoint discrimination because they target proselytizing messages solely from a religious perspective.... Board Policy 9700 applies only to religious institutions and organizations – not secular groups. The policy also defines “proselytizing messages” exclusively in relation to religious speech, or messages that “promote the benefits of the specific religion.” But proselytizing also has a broader meaning, such as “recruit[ing] members for an institution, team, or group.”... Although the School Board asserts that the policies are viewpoint neutral because they apply equally to all religions, regardless of the underlying theology, this argument is not persuasive.Student Press Law Center reports on the decision.
Another Suit Filed Challenging ACA Contraceptive Coverage Mandate
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New suits continue to be filed challenging the mandate under the Affordable Care Act requiring that most insurance policies cover contraceptive services. The latest is Korte v. U.S. Department of Health and Human Services, (SD IL, filed 10/9/2012) (full text of complaint) in which the two controlling shareholders of a family-owned construction firm with 90 employees allege that complying with the Mandate would require them to violate their Catholic religious beliefs. Plaintiffs also filed a Memorandum of Law in support of their motion for partial summary judgment and a Memorandum of Law in support of their motion for a preliminary injunction. In a press release, the American Center for Law and Justice announced the filing of the lawsuit.
Denial of Loan Guarantee for Faith-Based Group Remanded For Consideration of Constitutional Issues
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In Care Net Pregnancy Center of Windham County v. U.S. Department of Agriculture, (D DC, Oct. 10, 2012), a Christian pregnancy resource center in Brattleboro, Vermont challenged the Department of Agriculture's denial to it of a loan guarantee under the agency's Community Facilities Loan Program. The agency sought to purchase and renovate property for it to use as its permanent facility. While faith-based organizations are eligible to participate in the program, inherently religious activities cannot be supported. Part of Care Net's program included Bible study or Bible centered teaching. The USDA's Appeals Division Hearing Officer concluded that:
Due to the fluctuating nature of [Care Net’s] program and due to a lack of reliable classroom information provided by [Care Net], [the USDA] is unable to realistically separate the eligible activities from the inherently religious activities either by time or space, thereby creating an excessive entanglement between Government and religion.... [Care Net] has not satisfactorily shown that the amount of direct USDA assistance requested does not exceed the cost of the proposed acquisition and renovation attributable to eligible program activities.The court concluded that this was a reasonable interpretation of the agency's regulations. However the court remanded the case to the USDA's Appeals Division for it to consider Care Net’s claims under the Free Speech and Equal Protection Clauses, the USDA’s defense under the Establishment Clause, and Care Net’s Fair Housing Act claim.
Trespass Conviction of Church Member Reversed
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In a 2-1 decision in Semenick v. State of Indiana, (IN App., Oct. 9, 2012), and Indiana appellate court reversed the criminal trespass conviction of a long-time church member who was evicted from church services by an off-duty police officer acting as a security guard after the church member complained that a volunteer greeter was speaking too loudly with others during the service. The majority held that the church member had a right to be on church premises and there was no evidence that the off-duty police officer had authority to take sides in a dispute between members and ask one of them to leave. Judge Mathias dissenting argued that defendant's conduct during services was disruptive. The jury, he argued, could reasonably conclude that defendant did not have a contractual interest in the property at issue, and knowingly or intentionally refused to leave the Church after having been asked to do so by an agent of the Church. 
German Court Refuses To Excuse Muslim Girl From Co-Ed School Swimming Classes
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Gatestone Institute reports on a Sept. 28 decision by the Hessian Administrative Court in Germany refusing to excuse a 12-year old Muslim girl from co-ed swimming lessons in her school. The court, emphasizing that religious minorities must avoid segregating themselves, said that the girl's religious beliefs could be accommodated by her wearing a full-body swimsuit (also known as a "burkini"), as do several other Muslim girls at her school. The girl's lawyer said the 12-year old does not want to wear a burkini because it makes her look ugly, and seeing other boys and girls in short clothes violates her modesty. Because of the importance of the case, the court is asking the Federal Administrative Court to review the decision.
10 Ekim 2012 Çarşamba
The FDA On Warning Letters - They're Sure Not Final
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Remember that case about ear candles? Given the product, we had some fun with it in our earlier posts. Well, it turns out that the ear candling folks are nothing if not persistent. They appealed the second opinion, Holistic Candlers & Consumers Ass’n v. FDA, 664 F.3d 940 (D.C. Cir. 2012), to the Supreme Court. As our post indicated, this opinion turned (in part, but a large part) on the “finality” of an FDA warning letter.
The Supreme Court appeal has given the FDA the opportunity to state its formal opinion about how it views the “finality” of warning letters. See Brief for the Respondents [FDA] in Opposition, Holistic Candlers & Consumers Ass’n v. FDA, No. 11-1454, 2012 WL 3991471 (filed Sept. 11, 2012). To put it succinctly, they aren’t final at all.
Since it’s Friday and we’re lazy, we’ll simply quote for you some of the FDA’s reasoning on why its warning letters aren’t legal determinations of anything. Here’s what the FDA has told the United States Supreme Court:
If FDA believes that a person is violating the FDCA, the agency may issue a warning letter giving the person an opportunity to take voluntary corrective measures before the agency pursues enforcement action. Warning letters are “the agency’s principal means of achieving prompt voluntary compliance with the [FDCA].” FDA, Regulatory Procedures Manual, 4-1-1 (July 2012), http://www.fda.gov/downloads/ICECI/ComplianceManuals/RegulatoryProceduresManual/UCM074330.pdf A warning letter is “informal and advisory”; it “communicates the agency’s position on a matter” but “does not commit FDA to taking enforcement action.” Ibid.
FDA Holistic Candlers br. at *5.
[T]he warning letters here did not mark the consummation of FDA’s decisionmaking process. As FDA has explained, warning letters give “firms an opportunity to take voluntary and prompt corrective action before [FDA] initiates an enforcement action.” Regulatory Procedures Manual 4-1-1. An enforcement action - typically a seizure or an injunction - is not inevitable, and indeed, most warning letters do not result in enforcement action. See FDA, Enforcement Statistics Summary Fiscal Year 2011 (reporting 1720 Warning Letters, but only 15 seizures and 16 injunctions), http://www.fda.gov/downloads/ICECI/EnforcementActions/UCM285781.pdf. Violations identified in warning letters “may lead to enforcement action if not promptly and adequately corrected.” Regulatory Procedures Manual 4-1-1 (emphasis added). Consistent with the Regulatory Procedures Manual, the warning letters at issue here stated that “FDA will evaluate the information you submit and decide whether your product may be legally marketed.” Pet. App. 43 (quoting FDA warning letter) (emphasis and internal quotation marks omitted). Relatedly, the warning letters were not based on a formal and complete administrative record. At this stage, FDA’s statement that petitioners violated the FDCA was not “final and binding” on the agency or petitioners but rather remained “tentative [and] interlocutory [in] nature.”
Id. at *9-10 (emphasis original).
Nor did the warning letters finally determine the “rights or obligations” of petitioners with regard to the distribution of ear candles, or trigger “direct and appreciable legal consequences.” Bennett, 520 U.S. at 178. Rather, the letters “request[ed]” that petitioners “take prompt action to correct [the identified] deviations” from the FDCA, and cautioned that “[f]ailure to promptly correct these deviations may result in regulatory action.” Pet. App. 39. The letters served only to communicate FDA's position with regard to ear candles, and to warn recipients about the possibility of future enforcement action. See Regulatory Procedures Manual 4-1-1. The letters nonetheless remained “informal and advisory” and “[did] not commit FDA to taking enforcement action.” Ibid.
Id. at *10-11.
FDA warning letters trigger no legal consequences and are subject to further agency “evaluat[ion]” based on the recipient’s response. See Pet. App. 47. Such letters do not trigger any enlarged exposure to penalties for noncompliance with the FDCA, nor does their issuance preclude further agency consideration or review. Rather, the letters state FDA’s position on the facts available to it, encourage voluntary compliance with the FDCA, and alert the recipient of possible enforcement action by the FDA. If and when an enforcement action is brought, the agency’s claim is not that the recipient has “violated” the warning letter, but rather that it has violated the underlying requirements of the FDCA.
Id. at *14.
So there you have it, from the proverbial horse’s mouth. And what should be the consequences of the non-final nature of FDA warning letters. Here are a few − there may well be more, the more we think about this: (1) without enforcement they’re not admissible evidence, being considerably less than a bare criminal indictment; (2) any attempt to give a warning letter binding collateral estoppel effect would be a violation of Due Process, since such letters are not appealable; (3) warning letters are nothing like the enforcement actions mentioned in the concurrence in Buckman Co. v. Plaintiffs Legal Committee, 531 U.S. 341 (2001), (4) as warning letters are not legally enforceable, they shouldn’t be the basis of an negligence per se action; and (5) being tentative and subject to change at any time, a warning letter should not be the type of evidence reasonably relied upon by experts in the field (assuming there is a “field” as to which expert testimony is permissible in the first instance).
The Supreme Court appeal has given the FDA the opportunity to state its formal opinion about how it views the “finality” of warning letters. See Brief for the Respondents [FDA] in Opposition, Holistic Candlers & Consumers Ass’n v. FDA, No. 11-1454, 2012 WL 3991471 (filed Sept. 11, 2012). To put it succinctly, they aren’t final at all.
Since it’s Friday and we’re lazy, we’ll simply quote for you some of the FDA’s reasoning on why its warning letters aren’t legal determinations of anything. Here’s what the FDA has told the United States Supreme Court:
If FDA believes that a person is violating the FDCA, the agency may issue a warning letter giving the person an opportunity to take voluntary corrective measures before the agency pursues enforcement action. Warning letters are “the agency’s principal means of achieving prompt voluntary compliance with the [FDCA].” FDA, Regulatory Procedures Manual, 4-1-1 (July 2012), http://www.fda.gov/downloads/ICECI/ComplianceManuals/RegulatoryProceduresManual/UCM074330.pdf A warning letter is “informal and advisory”; it “communicates the agency’s position on a matter” but “does not commit FDA to taking enforcement action.” Ibid.
FDA Holistic Candlers br. at *5.
[T]he warning letters here did not mark the consummation of FDA’s decisionmaking process. As FDA has explained, warning letters give “firms an opportunity to take voluntary and prompt corrective action before [FDA] initiates an enforcement action.” Regulatory Procedures Manual 4-1-1. An enforcement action - typically a seizure or an injunction - is not inevitable, and indeed, most warning letters do not result in enforcement action. See FDA, Enforcement Statistics Summary Fiscal Year 2011 (reporting 1720 Warning Letters, but only 15 seizures and 16 injunctions), http://www.fda.gov/downloads/ICECI/EnforcementActions/UCM285781.pdf. Violations identified in warning letters “may lead to enforcement action if not promptly and adequately corrected.” Regulatory Procedures Manual 4-1-1 (emphasis added). Consistent with the Regulatory Procedures Manual, the warning letters at issue here stated that “FDA will evaluate the information you submit and decide whether your product may be legally marketed.” Pet. App. 43 (quoting FDA warning letter) (emphasis and internal quotation marks omitted). Relatedly, the warning letters were not based on a formal and complete administrative record. At this stage, FDA’s statement that petitioners violated the FDCA was not “final and binding” on the agency or petitioners but rather remained “tentative [and] interlocutory [in] nature.”
Id. at *9-10 (emphasis original).
Nor did the warning letters finally determine the “rights or obligations” of petitioners with regard to the distribution of ear candles, or trigger “direct and appreciable legal consequences.” Bennett, 520 U.S. at 178. Rather, the letters “request[ed]” that petitioners “take prompt action to correct [the identified] deviations” from the FDCA, and cautioned that “[f]ailure to promptly correct these deviations may result in regulatory action.” Pet. App. 39. The letters served only to communicate FDA's position with regard to ear candles, and to warn recipients about the possibility of future enforcement action. See Regulatory Procedures Manual 4-1-1. The letters nonetheless remained “informal and advisory” and “[did] not commit FDA to taking enforcement action.” Ibid.
Id. at *10-11.
FDA warning letters trigger no legal consequences and are subject to further agency “evaluat[ion]” based on the recipient’s response. See Pet. App. 47. Such letters do not trigger any enlarged exposure to penalties for noncompliance with the FDCA, nor does their issuance preclude further agency consideration or review. Rather, the letters state FDA’s position on the facts available to it, encourage voluntary compliance with the FDCA, and alert the recipient of possible enforcement action by the FDA. If and when an enforcement action is brought, the agency’s claim is not that the recipient has “violated” the warning letter, but rather that it has violated the underlying requirements of the FDCA.
Id. at *14.
So there you have it, from the proverbial horse’s mouth. And what should be the consequences of the non-final nature of FDA warning letters. Here are a few − there may well be more, the more we think about this: (1) without enforcement they’re not admissible evidence, being considerably less than a bare criminal indictment; (2) any attempt to give a warning letter binding collateral estoppel effect would be a violation of Due Process, since such letters are not appealable; (3) warning letters are nothing like the enforcement actions mentioned in the concurrence in Buckman Co. v. Plaintiffs Legal Committee, 531 U.S. 341 (2001), (4) as warning letters are not legally enforceable, they shouldn’t be the basis of an negligence per se action; and (5) being tentative and subject to change at any time, a warning letter should not be the type of evidence reasonably relied upon by experts in the field (assuming there is a “field” as to which expert testimony is permissible in the first instance).
FDA Regulatory Muscles: Ripped and Oiled
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Here's a shocker: your average drug and device law lawyer seldom hoists more weight at any one time than 22 ounces of F.3d or three ounces of The Glenlivet. There is usually a long, nerdy history behind this state of indolence. For example, when we were in high school, we got a varsity letter for being a "Mathlete." Take that in for a moment. That's right, we were on the Math team. The true jocks snickered. But it was not entirely funny to them. They thought we pencil-necked geeks were devaluing their football and track letters. They were probably right. They were also - let's be honest about this - thoroughly repulsed by the more academic types.
Let's say two things about that (now that we have the big megaphone of the blog and now that those mesomorphs can no longer menace us at our locker):
(1) Who has the last laugh now? When she was in high school, we used to tell the Drug and Device Law Daughter that she should befriend the wonks because some day they might flower into a Bill Gates or Marc Zuckerberg. Did she listen? She did not. And what do you suppose will happen to the hockey player and Goth who captured her young heart? The closest they will come to Microsoft or Facebook will be inputting customer data at a bad retail job or posting a bong as their profile picture. Now she is in college and dating an engineering student. Maybe there's hope. Maybe some day money will flow toward us, not away from us. Maybe we won't have to eat cat food in our dotage. Maybe we should veer away from this digression.
(2) That repulsion went both ways. The wrestlers went around on match days incessantly spitting into a cup (kind of like a Texas plaintiff lawyer during a deposition). One guy in our class got into bodybuilding quite early. The movie Pumping Iron came out around this time. It was Arnold Schwarzenegger's break-through. Schwarzenegger was remarkable for more than his trolley-car sized biceps. He was also inordinately clever at getting into his competitors' heads. He would give them "the wrong advices" (a preview of Schwarzenegger's charming battles with the English language) whilst crushing their egos. Our classmate emulated Schwarzenegger by carrying a can of protein powder around and occasionally disrobing in class to display his "guns" and "pythons". He is now a self-help maven on the Internet and claims he can uncover your past lives and make them "work for you". Perhaps he takes control over those past lives the same way he took control over things back in 1977: with threats and headlocks.
One might have thought that after four years of a fine liberal arts education and then three years of that hazing ritual known as law school, that we would cease to have very much to do with the bodybuilding cult. One would be wrong. We spent a year on a case defending a nutraceutical company accused of making a bad product and phony claims. These folks operate on a wholly different level from companies that manufacture prescription drugs or class III devices. The word "aggressive" does not begin to do them justice. One of our key company witnesses was a champion body-builder who had some sort of Ph.D. We can not remember what the Ph.D was for, but this guy clearly knew a few things. He had taken a hearty dislike of the plaintiff's lawyer. The night before he was to be deposed, he downed a concoction of herbs and other goodies that would render his breath toxic and his gastrointestinal system explosive. It worked. The deposition was extremely unpleasant for the plaintiff lawyer. (As it was for everyone there except, perhaps, the witness.) The deposition did not last very long.
As we said, nutraceuticals are different from pharmaceuticals. But they are both regulated by the FDA. And therein lies the tale of today's case, Cytosport, Inc. v. Vital Pharmaceuticals, Inc., 2012 U.S. Dist. LEXIS 126976 (E.D. Cal. Sept. 6, 2012). Cytosport makes Muscle Milk, a ready-to-drink protein shake in an octagonal bottle. Vital Pharmaceuticals makes Muscle Power, a ready-to-drink protein shake in an octagonal bottle. Cytosport sued Vital under the Lanham Act, claiming that the Muscle Power product infringed on its trademark and trade dress for Muscle Milk. Vital counterclaimed, arguing that the Muscle Milk trademark was invalid and deceptive because Muscle Milk contains not a drop of milk. Thus, this is a case concerning intellectual property. Linger on the richness of that. Much of the back-and-forth in the case involves competing surveys, with competing experts opining as to whether consumers were confused. You don't want our opinion on that, do you?
Anyway, you ask, what does any of this have to do with drug and device law? First, we don't like your tone of impatience one little bit. This sort of 'roid rage does not become you. Frankly, you're scaring us. Second, relax. The Cytosport case is fun. No heavy lifting required. Vital's counterclaim cited a warning letter sent from the FDA to Cytosport taking issue with the use of the word "Milk." According to Vital, the FDA warning letter should prompt the court to find the "Muscle Milk" trademark to be deceptive and, hence, invalid under 15 U.S.C. section 1125(a). If all this sounds vaguely reminiscent of Pom Wonderful, LLC v. Coca-Cola Co., 679 F.3d 1170 (9th Cir. 2012), it should. The Cytosport court leaned heavily on the Pom Wonderful case, which it characterized as follows: "When the FDA extensively regulates a certain area and does not act to enforce its regulations, the Lanham Act may not be used by a private party to 'usurp, preempt, or undermine FDA authority.'" Cytosport, 2012 U.S. Dist., LEXIS 126976 at *17, quoting Pom Wonderful, 679 F.3d at 1176. Which way does Pom Wonderful cut in this Muscle contest? The Cytosport court says that Pom is not wonderful news for the Vital counterclaim, because "the FDA regulates the use of the term 'milk' on food labels. The FDA is aware of Cytosport's labeling and has not acted." Id.
But wait a minute, what about the FDA warning latter? And here, we encounter the same point that we blogged about yesterday. A warning letter is not a final action. It does not mean anything until it culminates in some final action by the FDA. A warning letter is an invitation to dialogue and compliance. It is almost like that semi-surprising notion in first-year Contracts class about how an advertisement is not in itself an offer, but merely an invitation to the customer to make an offer. Here is how the Cytosport court dealt with the FDA warning letter: "The fact that the FDA sent a warning letter to Cytosport concerning its labeling does not require a different finding. FDA warning letters are informal and advisory, and do not amount to an FDA action." Id. Vital then offered a back-up position: "the Court should defer granting judgment until the FDA issues a final decision on Cytosport's use of 'Muscle Milk.'" Id. at *18. Nice try. The Cytosport refused to defer. The FDA's final decision might end up supporting Cytosport, supporting Vital, or falling somewhere in between. But "the Pom holding is clear that the claims are barred until the FDA issues its decision, not that they are stayed or deferred." Id.
That is the part of the case that matters to us. Once again, private causes of action cannot muscle in on the FDA's turf. That is good news for all of us high-minded defense hacks. We put the "clean" in the clean-and-jerk. (Guess who puts in the other part.) Further, an FDA warning is tentative, incomplete, and - ta da - meaningless. More good news. Where it counts, the Cytosport opinion is a strong one for us. Use it. Hold it up. Flex with it. Feel the burn.
There are other bits that do not matter as much to us or that we don't understand. For example, Vital also brought "two state law claims which reference the FDA regulations to show that Cytosport's use of the term 'Milk' is inconsistent with FDA regulations." Id. The court holds that these state law claims "are not barred by the ruling in Pom because the FDA specifically permits states to create labeling requirements that are identical to the FDA's and establish independent causes of action for those claims." Id. Sounds like more "parallel claim" Hell to our ears. Also, the court upholds Muscle Power's advertising assertion that it has "600% less sugar and 187% less fat than Muscle Milk." Id. at *37. We agree with Cytosport that there is something mathematically nonsensical about saying that something has "600%" less of something.
Once a mathlete, always a mathlete.
Let's say two things about that (now that we have the big megaphone of the blog and now that those mesomorphs can no longer menace us at our locker):
(1) Who has the last laugh now? When she was in high school, we used to tell the Drug and Device Law Daughter that she should befriend the wonks because some day they might flower into a Bill Gates or Marc Zuckerberg. Did she listen? She did not. And what do you suppose will happen to the hockey player and Goth who captured her young heart? The closest they will come to Microsoft or Facebook will be inputting customer data at a bad retail job or posting a bong as their profile picture. Now she is in college and dating an engineering student. Maybe there's hope. Maybe some day money will flow toward us, not away from us. Maybe we won't have to eat cat food in our dotage. Maybe we should veer away from this digression.
(2) That repulsion went both ways. The wrestlers went around on match days incessantly spitting into a cup (kind of like a Texas plaintiff lawyer during a deposition). One guy in our class got into bodybuilding quite early. The movie Pumping Iron came out around this time. It was Arnold Schwarzenegger's break-through. Schwarzenegger was remarkable for more than his trolley-car sized biceps. He was also inordinately clever at getting into his competitors' heads. He would give them "the wrong advices" (a preview of Schwarzenegger's charming battles with the English language) whilst crushing their egos. Our classmate emulated Schwarzenegger by carrying a can of protein powder around and occasionally disrobing in class to display his "guns" and "pythons". He is now a self-help maven on the Internet and claims he can uncover your past lives and make them "work for you". Perhaps he takes control over those past lives the same way he took control over things back in 1977: with threats and headlocks.
One might have thought that after four years of a fine liberal arts education and then three years of that hazing ritual known as law school, that we would cease to have very much to do with the bodybuilding cult. One would be wrong. We spent a year on a case defending a nutraceutical company accused of making a bad product and phony claims. These folks operate on a wholly different level from companies that manufacture prescription drugs or class III devices. The word "aggressive" does not begin to do them justice. One of our key company witnesses was a champion body-builder who had some sort of Ph.D. We can not remember what the Ph.D was for, but this guy clearly knew a few things. He had taken a hearty dislike of the plaintiff's lawyer. The night before he was to be deposed, he downed a concoction of herbs and other goodies that would render his breath toxic and his gastrointestinal system explosive. It worked. The deposition was extremely unpleasant for the plaintiff lawyer. (As it was for everyone there except, perhaps, the witness.) The deposition did not last very long.
As we said, nutraceuticals are different from pharmaceuticals. But they are both regulated by the FDA. And therein lies the tale of today's case, Cytosport, Inc. v. Vital Pharmaceuticals, Inc., 2012 U.S. Dist. LEXIS 126976 (E.D. Cal. Sept. 6, 2012). Cytosport makes Muscle Milk, a ready-to-drink protein shake in an octagonal bottle. Vital Pharmaceuticals makes Muscle Power, a ready-to-drink protein shake in an octagonal bottle. Cytosport sued Vital under the Lanham Act, claiming that the Muscle Power product infringed on its trademark and trade dress for Muscle Milk. Vital counterclaimed, arguing that the Muscle Milk trademark was invalid and deceptive because Muscle Milk contains not a drop of milk. Thus, this is a case concerning intellectual property. Linger on the richness of that. Much of the back-and-forth in the case involves competing surveys, with competing experts opining as to whether consumers were confused. You don't want our opinion on that, do you?
Anyway, you ask, what does any of this have to do with drug and device law? First, we don't like your tone of impatience one little bit. This sort of 'roid rage does not become you. Frankly, you're scaring us. Second, relax. The Cytosport case is fun. No heavy lifting required. Vital's counterclaim cited a warning letter sent from the FDA to Cytosport taking issue with the use of the word "Milk." According to Vital, the FDA warning letter should prompt the court to find the "Muscle Milk" trademark to be deceptive and, hence, invalid under 15 U.S.C. section 1125(a). If all this sounds vaguely reminiscent of Pom Wonderful, LLC v. Coca-Cola Co., 679 F.3d 1170 (9th Cir. 2012), it should. The Cytosport court leaned heavily on the Pom Wonderful case, which it characterized as follows: "When the FDA extensively regulates a certain area and does not act to enforce its regulations, the Lanham Act may not be used by a private party to 'usurp, preempt, or undermine FDA authority.'" Cytosport, 2012 U.S. Dist., LEXIS 126976 at *17, quoting Pom Wonderful, 679 F.3d at 1176. Which way does Pom Wonderful cut in this Muscle contest? The Cytosport court says that Pom is not wonderful news for the Vital counterclaim, because "the FDA regulates the use of the term 'milk' on food labels. The FDA is aware of Cytosport's labeling and has not acted." Id.
But wait a minute, what about the FDA warning latter? And here, we encounter the same point that we blogged about yesterday. A warning letter is not a final action. It does not mean anything until it culminates in some final action by the FDA. A warning letter is an invitation to dialogue and compliance. It is almost like that semi-surprising notion in first-year Contracts class about how an advertisement is not in itself an offer, but merely an invitation to the customer to make an offer. Here is how the Cytosport court dealt with the FDA warning letter: "The fact that the FDA sent a warning letter to Cytosport concerning its labeling does not require a different finding. FDA warning letters are informal and advisory, and do not amount to an FDA action." Id. Vital then offered a back-up position: "the Court should defer granting judgment until the FDA issues a final decision on Cytosport's use of 'Muscle Milk.'" Id. at *18. Nice try. The Cytosport refused to defer. The FDA's final decision might end up supporting Cytosport, supporting Vital, or falling somewhere in between. But "the Pom holding is clear that the claims are barred until the FDA issues its decision, not that they are stayed or deferred." Id.
That is the part of the case that matters to us. Once again, private causes of action cannot muscle in on the FDA's turf. That is good news for all of us high-minded defense hacks. We put the "clean" in the clean-and-jerk. (Guess who puts in the other part.) Further, an FDA warning is tentative, incomplete, and - ta da - meaningless. More good news. Where it counts, the Cytosport opinion is a strong one for us. Use it. Hold it up. Flex with it. Feel the burn.
There are other bits that do not matter as much to us or that we don't understand. For example, Vital also brought "two state law claims which reference the FDA regulations to show that Cytosport's use of the term 'Milk' is inconsistent with FDA regulations." Id. The court holds that these state law claims "are not barred by the ruling in Pom because the FDA specifically permits states to create labeling requirements that are identical to the FDA's and establish independent causes of action for those claims." Id. Sounds like more "parallel claim" Hell to our ears. Also, the court upholds Muscle Power's advertising assertion that it has "600% less sugar and 187% less fat than Muscle Milk." Id. at *37. We agree with Cytosport that there is something mathematically nonsensical about saying that something has "600%" less of something.
Once a mathlete, always a mathlete.
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