6 Şubat 2013 Çarşamba

Got 99 Problems – Owning an Assault Rifle Isn’t One

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As it has been presented, the Obama Administration has indicated that he is ready for serious gun reform. He has pledged to put his “full weight” behind a legislative package for containing gun violence offered by Senator Dianne Feinstein. The bill aims to “stop the sale, transfer, importation and manufacturing of military-style assault weapons and high capacity ammunition feeding devises.” It will ban 120 specifically named weapons, including handguns and shotguns, and strengthen the 1994 Assault Weapons Ban, which expired in 2004.

Now I am against violence of any form, but I don’t see why an assault rifle should be the focus of his political venom- guns do not kill people, people do. To focus on the tool misses the problem.

I have owned several SKS since 1990. If you don’t know what an SKS, see the image in this post of me on the book cover of my last book. No it is not a prop is is real and one of several. I like it because it fires the 7.62 x 39 (AK47/SKS) slug. Now for most this is an assult rifle, for me it’s just a rifle.

Some ask why I want or need an assault rifle like an SKS? My answer is based on two things: the second amendment and prospects of Tyranny. The second amendment says “A well-regulated militia, being necessary to the security of a free state, the right of the people to keep and bear arms, shall not be infringed” (keyword being regulated not maintained). There was no standing militia in the colonies. In fact they did not get together until 1774 (the Coercive Acts) when the British implemented gun control measures via an import ban on firearms and gunpowder;” the 1774-75 confiscations of firearms and gunpowder; and the use of violence to effectuate the confiscations. History is complete with examples of gun control and the results. Whether in Turkey where in 1911 when1 .5 million Armenians, unable to defend themselves, were exterminated between 1915 and 1917, or even in modern times when in 1964, Guatemala established gun control allowing the government to kill 100,000 Mayan Indians between - From 1964 to 1981. I won’t even mention Nazi Germany, who killed 13 million weaponless Jews, gypsies, and homosexuals after established gun control in 1938.

The aforementioned represents Tyranny which refers to the arbitrary or unrestrained exercise of power and/or the despotic abuse of authority or oppressive or unjustly severe government on the part of any ruler. Fact is, according to the FBI homicide data, hammers, clubs and knives are responsible for more homicides than rifles In fact; the FBI concluded that rifles of all types are the least-used guns when crimes are committed. Not to mention that  most firearm murders (about11,400), are gang related, how many would you guess had legally purchased or registered weapons?

Now many would suggest that tyranny on behalf of the US government with it’s first black President is outrageous: maybe or maybe not but looking at the facts sughgest that anything is possible. Take the National Weather Service, who like the Department of Homeland Security in securing large quantities of ammo. Back in March,Homeland Security purchased 450 million rounds of .40-caliber hollow point bullets that are designed to expand upon entry and cause maximum organ damage. The NWS ordered 46,000 rounds of hollow point bullets and I don’t think they are for predicting tornadoes. Then there was the solicitation posted by the the Social Security Administration for for contractors to supply 174,000 rounds of “.357 Sig 125 grain bonded jacketed hollow point pistol ammunition.”

The point is technology, if there is tyranny, then what good is a handgun against weaponized drones, Tanks and body armor? None. But I can rest assured that the 7.62 of the SKS can go through all and that makes me comfortable for I have 99 problems – owning an assault rifle isn’t one of them. For the fact of the matter is, when only the military and police have guns, it is called a police state.

Obama and Rice Only Black Global Leaders against Palestine Statehood

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Obama and Rice Only Black Global Leaders to Vote against Palestine StatehoodOver the past four years, the Obama Administration in concert with his present U.S. ambassador to the United Nations, Susan Rice have been speaking of the importance and the need for America and his administration to show world leadership on the importance of democracy to flourish around the globe. Both have spoken vehemently on the importance of supporting democracy in Syria, Libya and Egypt among other nations hit by the Arab protest earlier this year. However, the word democracy is never used by the world’s leading Black global leaders with respect to Palestine.

Case in point, the overwhelming U.N. vote to elevate the status of Palestine at the world body saw the United States via Ambassador Rice on the request of President Obama, vote against the resolution.

Moreover, it showed how the Administration’s policy in the Middle East outs of touch with the rest of the globe.Canada, Panama, the Czech Republic and four tiny Pacific island states were the only ones in the 193-member U.N. General Assembly siding with the U.S. against the Palestinian Authority’s request for nonmember observer state status in a losing effort resulting in a 138-9 vote, with 41 abstentions in support of the measure. France, Italy, Spain, Norway, Denmark and Turkey were among the U.S. allies voting in support of the resolution.The blatant hypocrisy of this vote on behalf of the United States was made even more political when Ambassador Rice indicated that they were against the motion because it would disrupt the peace process (albeit Obama has not had any success nor made any effort to negotiate a serious peace between Israel and the Palestinians). The issue of Palestinian statehood and self determination has been festering for 65 years regarding mostly territory and sovereignty.

However, it should not be surprising, given the Obama administration sides with Israel as US foreign policy in the region has done historically, making no real effort t support a two state solution. Not to mention the Israeli government can do what it pleases to violate civil rights and the Obama Administration will look away. To date the Obama Administration and Ambassador Rice have yet to speak against Israel’s treatment of African Immigrants and refugees – burning and closing their stores, rounding them up like Apartied South Africa and holding them in detention centers as Hilter once did the Jews.

Speaking of Africans, Prime Minister Benjamin Netanyahu suggest that African immigrants threaten the Jewish character of Israel and that all Blacks will on arrival be placed immediately in the many detention centers and containment camps to house tens of thousands. One opinion poll showed 52 percent of Israelis agree that the Africans are "a cancer".

Obama and Rice will never speak out against Israel although not doing so shows their selective views on democracy, especially as the only two major world leaders not to side by Palestinian statehood and self-determination. In many respects, it as if they support Apartied over the rights and liberties of the people.

Gold Digging: Will Mali be Obama’s Afghanistan?

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When I think of Mali, or any part of West Africa, I often say to myself, I had a ball when I was there in 1992 and 1993. At the time I was living in Owerri, in Southeastern Nigeria. And if you have ever seen the Sahel, what sticks out from a geo-political locution is that it runs from the Atlantic Ocean to the Red Sea.

But the country, inclusive of the history of the Dogon and those who inhabit the Mopti river region of that great historic place, may be the location of America’s next war of western imperialism and neocolonial fervor. To top it all off, it will be carried out via the instruction of the first African America President in the history of the United States.

It seems that Obama drone wars will have to find a new country to target since the US will be ending its occupation of Afghanistan soon. And since the Administration’s war on terror has not ended, the obvious next place to send US and UN troops is Africa, specifically Mali. Now I know we have US troops in the Congo, Uganda, Somalia and several other nations, but I have an inclination that Obama will be in this West African nation soon.

All of this would have been unnecessary if the administration had not taken the actions via the UN it did in Libya. In fact, Mali was a stable democracy for the last few decades until we destabilized. Not only did it lead to arms from Libya flooding the northern region of the nation, it also leads to the influx of al-Qaeda affiliated Islamists in the North.

Some would say that I am making this entire up. However, I would say that they have not been reading or paying attention or worse, they do know evaluate historical actions that would make the suggestion that the Obama Administration would be supportive of Western military forces in Mali. The US in concert with the UN has conducted armed interventions (with support from Obama). We saw such in Libya where via the UN; Obama although in direct violation of the US constitution, never consulted congress to overthrow the leader of a sovereign nation. Even though it required supporting militarily, Islamic fundamentalist militants and Al Qaeda and resulted in the — ethnic cleansing and lynchings of thousands black Africans.

We also saw such when the Obama Administration and the UN aided in the violent overthrow of the President of the Ivory Coast although the nations highest court that he had won the election. He was subsequently replaced by a UN hand-picked Muslim central banker. This too resulted in the death of thousands most of which were Christians.

We are already hearing the administration and UN drop little hints about al Qaeda having set up in northern Mali, right next to Boko Haram in Nigeria. Not to mention the Islamic Maghreb, al Shabab in East Africa. Especially if the story is being laid out by Robert Fowler of the UN. In addition, Last year the UN Security Council unanimously adopted a resolution “determining that the situation in Mali constitutes a threat to international peace and security.” The resolution also noted that the UN was ready to deploy an “international military force” to invade the country if such is seemed necessary.

Stranger is that this is all coming from the urging really, of the Obama State Department – that is the ideal of invading Mali - to prop up the interim government. The Obama administration has also been increasing military aid to leaders of ruling countries around Mali in preparation for the upcoming intervention. Not to mention that last year, President Obama ended all of Mali’s trade privileges with the US, citing backtracking from democracy in the annual assessment of benefits conferred by the Africa Growth and Opportunity Act (AGOA) program. Funny, the way I see it, taking the limited benefits they had under the prior arrangements will only punch prospects for democracy farther away. Especially given he approved such with the South Sudan, who is in conflict with Sudan. Mali only exported about $7 million from precious stones, gold, art and antiques, while imports from the U.S. exceeded $40 million. But that’s right; the South Sudan has the plentiful Abyei oil region.

Funny, Mali used to be Africa’s democratic success stories, now it may be the next Somalia, or even worse – Afghanistan. If the President does involve US military forces in Mali, it will be a tacit confession that his actions in Libya failed and really served to undermine international peace and security., It will reveal to history that his Libyan interventionist policy was his biggest foreign policy mistake and that helping Africa is the farthest thing from his policy perspectives when compared to the old imperialistic agenda of raping the continent of all its natural resources while killing million via war, starvation, poverty and drought in the process.Yes Mali may be Obama's Afghanistan and all because there is gold in them their hills. Afterall, Mali is Africa's third largest gold producer after South Africa and Ghana. Mali produced 53,7 t of gold in 2009.

A Nation of Pet Rocks Governed and Schooled By Bricks

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I have always said to my closets folk that the problem with America, in particularly Black America is that we do know or understand that there is a difference from education and schooling: that there is a chasm between being educated and being schooled. Although my folk get it I hesitantly accept that the vast majority do not and will not. Now I will try and describe this in an historical context making use of the current political discussion of gun control as well as an event recently that occurred in a faculty meeting last week.

For many of us, fact and reason and logic and thought has nothing to do with what we believe, agree with and or select to accept as truth, albeit what we accept as truth is mainly dogma. I came to this conclusion again recently when in a faculty meeting. I was asked not to work problems on the board as much and use the technology available. It was their suggestion that doing such was not in concert with the mission of integrating technology in the classroom. I retorted that use of technology is not the same as integrating technology in the class room. I received a bunch of sneers and false assertions until I made the argument mathematically. I suggested use and integration are not even synonyms and that I could prove such mathematically if the faculty asserting the argument that they were, were mathematically inclined.

As I explained, in calculus integrating complex functions shows us how use and integration are not even close to being the same things, even if in its simplest form it pertains to the use of technology in the class room. First of all, the integral of a complex function is always defined by the integral of a complex-valued function of a real variable and are generally evaluated by finding the ant derivatives of that real variable. Such processes always evince that many times extra effort is required to make the right side equal to the life; which means such entails much more than just stating such is the truth. Which takes me to the second example of gun control.

If I take the same methods of integrating complex functions to the extent of asserting mathematically more gun control will equal less gun deaths, then I must accept the premise that a singular variables can only define an implied integral of a complex function by defining the integral of a complex-valued function of the real variables gun death and gun control. I could in semantic terms say that if gun control works (what Obama presently is proposing with the exception of mental health back ground checks is already in effect in Chicago) then Chicago should be the safest city in America – but it is not. Plus, it is more fun to using the dialectics of calculus to prove my point.

First, one would have to ask if saving lives is the central important issue here. Calculus suggest it is not, for if it were maybe more laws on swimming pools would be needed or sticking with gun control (especially among children), hand guns should be targeted. Why, well according to the CDC, cars, poisonings and even swimming account for annual deaths those deaths by fire arms, in particular when it applies to children. In fact less than 70 deaths for kids under age of 15 were due to accidental firearm use and when will look at all firearm deaths for children, the date proves more die from accidental drowning than being killed by an fire arm. Now I know the focus is on assault rifles, but this true is feculent.

What is confusing is that more than 66% of all gun deaths in the US are suicides – this according to the UN, CDC and FBI. Secondly, although there are more than 200 million rifles and shot guns owned by American citizens, 75 percent of the murders in Americas (suicides not included) are committed with hand guns with 4 percent and 5 percent being committed with rifles and shotguns respectively. These are FBI and Justice Department figures aggregated from state and local police affiliates. And I won't say that the FBI also notes that more people are killed by bats and that rifles combined.

Thus complex mathematics would assert that the singular variable of gun control, in particular if it targets large ammo magazines and assault rifles will not do much if anything to save lives. This is if saving lives is paramount to controlling guns.

Now what does this have to do with education and schooling? Well a lot. To start with, going to school don’t mean you are being educated, it just means you learn to go to a building in a class with a group of folks the same age being trained by a single individual. So much for socialization, since in the real world folks interact with people of all ages and persuasions. Unfortunately it is this mentality that has people, who in many cases behave like pet rocks, believe and accept anything they hear if it comes from TV or even worse someone they select to be their savior – a President Obama for lack of a better example.

Yes rocks and even worse rocks run by bricks. Who know maybe they will try to ban the word “gun next.” After all it was just reported that Elementary School Girl Threatened Wit
h Arrest over ‘Paper Gun’ and that of a Pennsylvania kindergartner suspended from school for talking about a soap bubble toy gun. Then there was the six year old boy earlier this year who was suspended for making a gun with his fingers and saying POW. Our irrational acceptance of things regardless of fact is scary to me. It is as if we would prefer to let emotion dictate our thoughts over, logic, fact and/or reason. We already allow politicians to persuade us that a war can even be waged over emotion (terror).

People say there is no gun control movement in Washington but I suggest there is. They want to target assault weapons but as I noted hand guns are involved in more deaths that rifles or shot guns. Not to mention as I noted, 66% of all gun deaths are suicides and if safety was concerned, swimming pools and automobiles would be the focus of attention but they are not. Watch, they will try to target more than assault rifle – whoops, that’s right, California Democrat Dianne Feinstein just did today.

Maybe I’m more like Carl Philipp Gottfried von Clausewitz than the average person. I think his book was the first I read, in high school on war – Vom Kriege (On War). Or even worse, more like Joseph T. Chew who said: Expecting a carjacker or rapist or drug pusher to care that his possession or use of a gun is unlawful is like expecting a terrorist to care that his car bomb is taking up two parking spaces.

Desiderius Erasmus was correct, "In the country of the blind the one-eyed man is king.

The Problem is Darkness

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As a people, in particular a nation – we some dumb folk. I really wanted to use another word that conjoins a female parent with the act of copulation, but that is beside the point. I know I have been harping on the inadequacy of the general populous in concert with what is supposed to be leadership, especially as it pertains to legislation implemented for show in the perverse attempt to protect folk from themselves via the impossible act of legislating morality, just so happen this time it deals with gun control, assault weapons ban and across the board registration requirements.

Now, all this reminds me of something I heard Dr. Martin Luther King, Jr. say on a talk show once when I was a kid. I think I was in Kindergarten at the time. Back then TV and television watching was a social event and when Dr. King was on, everybody in the household watched. Otherwise, if I was inside and not playing outside and had to watch TV, all who knocked on my door asking for me to come outside, and I said I couldn’t, that I was watching TV, knew I was on punishment. Back then you only stayed in to watch TV when you were on punishment.

On the show, the two tortoise-shelled rim glasses wearing white cats asked Dr. King if those who rioted in America who were black took away from his cause and his message of non-violence. He quoted Victor Hugo and stated: “Where there is darkness crimes will be committed. The guilty one is not merely he who commits the crime but he who caused the darkness.”

Now it seems to me the weight in which I look at Dr. King’s mental prowess is like a ton to an ounce when I compare it to the likes of a Barack Obama or a Rahm Emanuel. It seems that the latter two gentlemen are so caught up on the propaganda (and banning guns), more than the root causes of the ailments of our social predicament, or saving lives. Fact is when the gun laws are put in place (and I doubt if they will be) the social ills that precipitate our violent oriented society will still remain. First it is not the tool, for we see around the world car and suicide bombs can and do as much damage as assault rifles. Second, the darkness which the metaphorically inclined Hugo made and Dr. King referenced is still going undealt with. The darkness that produces crime is a historic occurrence based in the economic deprived citizenry of our nation who just so happen mainly to be folk the same color as I. It is this loss of opportunity, or really, the lack of opportunity that facilitates the “I will get mine even at the expense of yours mentality. It is not guns but the reality of the environmental circumstances in which we see 25% of blacks in poverty – a rate which is at its highest in the past 60 years and snow-balled downhill just by chance when America has its first African American President.

Yes, TV watchers watch the subscribed and pre-prepared news broadcast and say the economy is getting better but outside of make-believe facts do not support this. Truth be told, thanks to our declining economy, poverty is ravaging out city like some exotic parasitic infection. Add to that the millions of young folk, who only watch TV, play video games and self-medicate in our materialistic culture, and whom are unemployed, do not even have the prospects of long-term or temporary employment for that fact. In Detroit for example, more than 60% of folk fewer than 18 years of age live in poverty – an increase of 40 percent since 2009. And this is one reason why 80% of the murders in Detroit or a Chicago are gang-related. These numbers are staggering, especially in urban areas from New York, to Oakland, to Memphis to New Orleans. Across America, more than 150 million folks live in poverty. Not to mention more than 1 million US school children are homeless. This is the darkness the aforementioned spoke of. Where there is darkness there will be crime. But no, to accept such requires logic and reason, two things that are severely lacking in modern American culture. Our status quo instead is to accept what is being told without query and let the government deal with it, since the government is the only solution and only folk with the answers (albeit their track record suggest otherwise).

Even if you go to college it doesn’t translate in to success or economic stability. One recent study published by the Center for College Affordability and Productivity revealed that Almost half of college educated workers are over qualified for the jobs that they do have.

And we black folk go along with everything being feed us as if we were still expecting master to drop some chittlings on our plates. Because if gun control do pass, we gone be stuck with the same thing we got with mandatory minimums and three strike laws – more black men in prison. Yep, I said it; I can add that the man who Obama asked to work out something on guns, Joseph Biden, is the same cat who came up with the Violent Crime Control and Law Enforcement Act. If I must remind you, the Violent Crime Control and Law Enforcement Act, H.R. 3355, Pub.L. 103–322, (commonly referred to as the Assault Weapons Ban) was originally written by Senator Joe Biden of Delaware, passed by Congress and signed into law by President Bill Clinton. In the Bill, Biden as a lawyer mandated that people in prison were not to be allowed to get an education in the form of a high school diploma or a college degree and also created the 3 strike law, which sent a lot of black people to prison for life. Democrat Bill Clinton sign this into law in 1994. Biden’s law also made many new provisions to be considered as capital offenses including but not limited to gang membership, and created several new federal death penalty offenses, including murders related to drug dealing, and drive-by shooting murders. And this new bill, well it will be the same, just a disproportionate number of black men being incarcerated.

I write this to suggest that most politicians and Americans (especially African Americans are lost, misguided and lack the critical thinking required to both problem solve and address what is wrong within our communities. It is we who are the problem and as such only we can proffer answers and solutions to deal with such. It is darkness that creates the crime and the folk who create the problem are just as much as fault as the tools of criminals. I can honestly say that before Obama 32 million Americans were on food stamps. Today, more than 47 million Americans are on food stamps. That the Median household income in America has fallen for four consecutive years, which means it has fallen even more for the average African American. And it will only get worse with America losing half a million jobs to China every single year and with a future that will have robots working in fast food restaurants and the service industry. Again, our problem is not guns it is darkness and no one can see the light.

5 Şubat 2013 Salı

Silver Linings Casebook: Getting Happy with a Bad Discovery Ruling

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You have to hand it to the Academy of Motion Pictures. Byexpanding the number of Best Picture nominees, it ended up selling lots moretickets. Like many people we know, we try to see all the Best Picture nomineesso as to earn the right to grouse about the Academy’s inevitable injustices(e.g., Oliver! over 2001?! Gandhi over ET?!! Art Carney over Jack Nicholson, Al Pacino, and Dustin Hoffman?!!!). In past years, that meant seeing fivefilms. This year, we need to see nine. So that's almost twice as many movietickets, popcorns, nachos, snowcaps, and slushees.  Last weekend we sawSilver Linings Playbook.  It is weird that it took us so long,considering the Philly-centric nature of the story. Brad Cooper plays a bipolarpatient who has trouble coping with life, especially the disintegration of hismarriage. He keeps telling himself that he needs to find the silver linings intough situations. His father seems to have a serious case of OCD, especiallywhen it comes to rooting for and betting on the Philadelphia Eagles. (If onewants to make the point that the enterprise of life is rescuing the good bitsfrom a failure pile, it’s hard to come up with a better metaphor thancheering for a Philadelphia sports team.) A psychiatrist tells the Coopercharacter that he needs a “strategy” (presumably that is the “Playbook” of thetitle) to pluck out the glories from the dismal parade of life's indignities.Nevertheless, it’s not clear what sort of strategy would work – beyond, maybe,just being open to the possibility of happiness.
 
A week ago, we were watching one of our favorite sitcoms,Modern Family. For the first twenty or so minutes, it seemed like a whole lotof nothing. The episode was disappointing.  It was flat.  But itturned out that it was setting us up for a concluding couple of minutes thatare as brilliant as anything we’ve seen in a while. Levitan et al served up aparody of the conclusion of The Godfather. See it for yourself here. More thana few of our lawyer buddies have a running gag about how the most valuablelessons for life and litigation are contained in The Godfather. What welearned from the Modern Family reenactment of The Godfather is that humancleverness is endless, a long set-up can prepare the way for a sublime punchline, that even in our dotage we can laugh ourselves to tears, and that TyBurrell (again) can make us giddy with stonefaced genius.  It soundsoverblown and frivolous, but a tv show managed to amplify our delight in being alive.  
 
For some reason, that excellent television show andexcellent movie put us in mind of a New Yorker article we read many years agoabout a corporate coach named Marshall Goldsmith.  Companies invitedGoldsmith to help executives who were smart, driven, and completely successful,save for the fact that they were utterly obnoxious.  Goldsmith applied hismodified Zen Buddhism to organizational dynamics and emerged with threerules:  (1) Life is Good; (2) Be Happy Now; and (3) Let it Go.  Hewas convinced that those three rules are the key to happiness.  Stopcomplaining and, instead,  appreciate how gorgeous existence is.  Donot play the game of 'I'll be happy when' [e.g., when I get that promotion,when I make enough money, when I get that certain someone to love meback].  And if something wrong is done to you, or, perhaps moreimportantly, if you have done something you regret, learn from it, and thenstop obsessing over it.  To this day, we think more about that New Yorkerarticle than any other we've read over the past (gulp) 35 years.
 
Armed with this wisdom and joy and openness, let's dance in the rain of dodgy legal analysis.  The case is from the Pradaxa MDL, Inre Pradaxa, 2013 U.S. Dist. LEXIS 7979 (S.D. Illinois January 18, 2013).  Theplaintiffs brought a product liability claim against Boehringer IngelheimPharmaceuticals, Inc. ("BIPI") relating to Pradaxa.  As we all know, discovery inmass tort cases is a grim slog. There are way too manycustodial files, way too many databases, and way too many things to do with this stuff, including reviews for responsiveness, privilege, and confidentiality. Even then, we haven't scratched the surface of tasks associated with thismountain of documents and terabytes.  (De-duplication, anyone?) Responding to this discovery costs a company more money than most civillitigation defendants must pay after being found liable -- yet when we talkabout mass tort defendants responding to discovery, we are talking aboutdefendants who have not yet been found liable for anything.  The Americandiscovery regime is, not to put too fine a point on it, insane.
 
Now consider how much more insane it gets when the plaintiffasks for documents relating to drugs that are not at issue in thelitigation.  The Pradaxa MDL plaintiffs asked for documents relating toany lawsuit alleging that BIPI engaged in off-label promotion of any medicineor that BIPI paid kickbacks to induce doctors to prescribe any BIPImedicine.  The plaintiffs also asked BIPI to identify witnesses relatingto such lawsuits, and employees who participated in the alleged wrongfulactivities.  When the plaintiffs inquired about earlier lawsuits, theywere focusing on a qui tam suit alleging off-label marketing of four products, none of them Pradaxa.  As part of thesettlement of that qui tam action, BIPI entered into a Corporate IntegrityAgreement ("CIA").  That CIA governed BIPI's conduct as itrelates to all of BIPI's drugs, including Pradaxa. 
 
BIPI objected to the non-Pradaxa discovery requests ongrounds of relevance and burden.  That is not surprising in theleast.  Nor are the grounds asserted by BIPI surprising:  (a) Pradaxais the only drug at issue in the Pradaxa MDL; (b) the sought-for discovery mostly antedates the conduct atissue in the Pradaxa litigation; and (c) obtaining the non-Pradaxa informationwould "impose a great expense and an undue burden."  2013 U.S.Dist. LEXIS 7979 at *9.  The plaintiffs, you will be shocked to learn,disagreed.  They argued that the non-Pradaxa materials might lead toother acts evidence admissible under Fed. R. Evid. 404(b), that impeachment ammo might surface,and that evidence of improper conduct would be relevant on the issue ofpunitive damages. 
 
We are displeased to report that Chief Judge Herndon bought more arguments from theplaintiffs than the defendant.  The court begins by observing how"federal discovery rules are liberal in order to assist in the preparationfor trial and settlement of litigated disputes."  Id. at *11-12.  Sometimes the beginning gives you a clear idea of the end. Think of Reservoir Dogs.  Or Citizen Kane.  Sometimes you just knowyou're not headed for a happy ending.  In this case, the unhappy ending is the virtual disappearance of any notion ofproportionality in discovery.  Okay, so the rules ofdiscovery are liberal.  Boy,  are they ever liberal.  But theyare not limitless ... are they?  The court cites Fed. R. 26(b)(1). Remember that. 
 
The court reads the Pradaxa MDL complaint to assert"allegations related to the manner in which Pradaxa wasmarketed."  Id. at * 13.  Then here's the kicker:  "Itis entirely possible that the marketing policies and strategies at issue in thequi tam action extended to BIPI's marketing of Pradaxa."  Id. at *15.  Later, in addressing the issue of undue burden, the court ... well,the court does not really seem to care about that issue very much.  First,the court "finds that this evidence is extremely probative." Id. at *19.  Really?  That information the relevance of which is "entirelypossible"?  Anyway, that is not a burden point.  What the courtdoes say about burden is that the "identity of witnesses and documentationsought is not that extensive in relative terms."  Id.  Sorry,but that conclusion (and it really is nothing more than a conclusion; there isn’teven a smidgen of factual support) seems profoundly wrong. The information relating to the earlier lawsuit may be, as the courtsays, "obtainable," but we'd make a wager bigger than any wager theDeNiro character makes in Silver Linings Playbook that production of thosematerials will be massive and expensive.  What are the "relativeterms" that the court alludes to? Relative to an ordinary case? Relative to the rest of the massive production in the case?  Relative toall the paper and data in the world?  Relative to our nation’s GDP?
 
Remember when we mentioned how the court mentioned Rule26(b)(1)?  What about 26(b)(2) (Limitations on Frequency and Extent) or26(g)(1)(B)(iii) (signing a request for discovery is a certification that thediscovery sought is "neither unreasonable nor unduly burdensome orexpensive, considering the needs of the case, prior discovery in the case, theamount in controversy, and the importance of the issues at stake in theaction")?  We do not see how the non-Pradaxa discovery requestssatisfy a rigorous application of the benefit vs. burden balancing test. Yes, as any former federal prosecutor will tell you, Rule 404(b) is a rule ofinclusion not exclusion.  But "other acts" evidence is usuallyfairly unnecessary, tangential stuff and it is still hemmed in by Rule 403(undue prejudice).  Accordingly, if production of the 404(b) materialinvolves significant time, effort, and expense (and please do not ignore theexpense issue just because the defendant is a large corporation, because thatis not part of the balancing test nor should it be), then we think the sideshowof other acts evidence should be shut down.
 
There is a scene in Silver Linings Playbook where Cooper,disgusted with the unhappy ending in A Farewell to Arms, heaves the bookthrough the bedroom window.  Hemingway's book streaks through the nightand plops on the middle of an Upper Darby street.  It lays there, no doubtstunned at the insult.  Poor thing.  It’s not such a bad book. We were tempted to treat the Pradaxa opinion with similar belligerence. But it is only six pages long, so it would merely bounce off our officewindow.  Then we thought about Silver Linings.  And we thought aboutlaughter.  And we thought about Marshall Goldsmith and his threerules.  Is there a way to fend off our unhappy feelings about the battydiscovery ruling in Pradaxa?
 
There are a couple of things.  We've been on panelswith Chief Judge Herndon and we like and respect him.  He has a good senseof humor.  We are not saying that the Pradaxa opinion is a joke (wishfulthinking, that), but we should pay attention to the nice parts of the opinion,especially understanding how difficult and enervating it is to resolvediscovery disputes.  There are some things in the opinion you might evenwant to cite in the face of overreaching plaintiffs.  In seeking aprotective order, BIPI attached a sealed document. Ever the opportunists, theplaintiffs requested that the document be unsealed.  The court denied theplaintiffs' motion without breaking a sweat.  Id. at * 12.  The courtalso narrowed the non-Pradaxa discovery by timeframe -- it had to be 1990 orlater.  Not great, but it's something.  The court also did not get tothe plaintiffs' punitive damages justification for the discovery, so we dodgeda bad law bullet there.
 
Life is still good.  In our experience, when plaintiffsget broad-ranging, additional discovery of things that should not matter, thethings discovered seldom help their case much.  Meanwhile,plaintiff-specific discovery inevitably reveals that a huge chunk of the MDL inventory ispure, unmitigated junk.  Can we be happy now?  Of course we can(though we are still grieving over that last episode of Downton Abbey).  Abad discovery ruling does not diminish the delight we experience from a jobthat surrounds us with smart, engaging people, or from the Drug and Device LawSon bringing home an A on his latest French test, or from a praline dessert wecannot stop thinking about.  Can we let the Pradaxa ruling go?  Sure. It is annoying and wrong, but it is, “in relative terms,” a minorskirmish.  There is more day to dawn.   We look forward toreporting on the silver lining.     
 
                   

Spherical Error Revisited

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Every now and then we run into a decision that wethink is wrong in so many different ways that we call it an example of“spherical error” – that is, error no matter how one looks at it.  We only do that rarely.  Back in May, 2010 we first applied that descriptionto In re Gadolinium-Based Contrast Agents Products Liability Litigation,2010 WL 1796334 (N.D. Ohio May 4, 2010). Then in September of that year we likewise identifiedspherical error in Sheet Metal Workers Local 441 Health & Welfare Planv. GlaxoSmithKline, PLC, 737 F. Supp.2d 380 (E.D. Pa. 2010) – or at leastthe Pennsylvania part of it, which dealt with the law we knew best.
That’s it – two cases earned that sobriquet in theblog’s six-plus years of existence.
Make that three.
The recent decision in Arters v. Sandoz Inc.,2013 WL 308768 (S.D. Ohio Jan. 25 2013), likewise bollixed up the law in somany different ways that we think it rises (falls?) to the level of sphericalerror.
Arters involved a question that a lot of courtshave considered lately with almost (but not quite) uniformly good results –preemption in the context of generic drugs following PLIVA v. Mensing, 131 S. Ct. 2567 (2011).  As in many generic preemption cases, thedefendant sought to have the case dismissed under Rule 12.
That – Rule 12 – is the first error in Arters.  The decision states:
A motion for judgment on the pleadings pursuant to Rule12(c) should not be granted “unless it appears beyond doubt that the plaintiffcan prove no set of facts in support of his claim which would entitle him torelief.”  Conley v. Gibson, 355U.S. 41, 45–46, 78 S.Ct. 99, 2 L.Ed.2d 80 (1957).
Arters, 2013 WL 308768, at *1.
Umm….  No.
Someone must have been the second coming of Rip VanWinkle and slept through the last five years. In a rather well-publicized decision, back in 2007, the Supreme Courtexpressly overruled Conley on specifically this “no set of facts”point.  See Bell Atlantic Corp.v. Twombly, 550 U.S. 544, 561-63 (2007). Twombly?  Maybe you’veheard of it.  If so, you’re already oneup on Arters.  Anyway, the SupremeCourt in Twombly explicitly “retired” the Conley standard reliedupon in Arters:
On such a focused and literal reading of Conley’s“no set of facts,” a wholly conclusory statement of claim would survive amotion to dismiss whenever the pleadings left open the possibility that aplaintiff might later establish some set of undisclosed facts to supportrecovery. . . .  It seemsfair to say that this approach to pleading would dispense with any showing of areasonably founded hope that a plaintiff would be able to make a case; Mr.Micawber’s optimism would be enough.
Seeing this, a good many judges and commentators havebalked at taking the literal terms of the Conley passage as a pleadingstandard.  [many citations omitted]  We could go on, but there is no need to pileup further citations to show that Conley’s“no set of facts” language has been questioned, criticized, and explained awaylong enough. . . . [A]fter puzzling the profession for 50 years, this famous observationhas earned its retirement.  The phrase isbest forgotten as an incomplete, negative gloss on an accepted pleadingstandard.
Twombly, 550 U.S. at 561-63 (emphasisadded).  Then, a couple of years later,the Court made clear that Twombly’s interrment of the Conleylanguage cited in Arters applies across the board to all types of cases.  See Ashcroft v. Iqbal, 556 U.S.662, 684 (2009).
So that’s where the spherical error in Artersgets rolling.  The opinion starts offwith the wrong basic standard for review.
And it’s downhill from there.  Spherical error keeps rolling.
As we mentioned, Arters is a preemptioncase.  So where does the decision gonext?  Why, straight to that old saw, thepurported “presumption against preemption”:
In considering whether these claims are preempted by theFDCA, some deference to state law is appropriate:  “[I]n all preemption cases, and particularlyin those in which Congress has legislated in a field which the States havetraditionally occupied, we start with the assumption that the historic policepowers of the States were not to be superseded by the Federal Act unless thatwas the clear and manifest purpose of Congress.”  Levine, 555 U.S. at 565 (internalquotations omitted).
Arters, 2013 WL 308768, at *4.
Wrong again. Arters is a generic drug case – it’s governed by Mensing,not Levine.  And it’s safe to saythat the presumption against preemption was a major bone of contention in Mensing– and a 5-4 majority of the Court chose not to apply any such presumption.  Four justices in Mensing went fullbore the other direction:  rejecting anysuch presumption and expressing the opposite view, that the Supremacy clause issomething called a “non obstante” provision, and consequently, if anything,there should be a presumption in favor of preemption:
[T]he provision suggests that courts should not strain to find ways to reconcilefederal law with seemingly conflicting state law. . . .  A non obstante provision thus was a usefulway for legislatures to specify that they didnot want courts distorting the new law to accommodate the old.
Mensing, 131 S. Ct. at 2580 (emphasisadded) (plurality opinion).  Now, this piece of Mensingwasn’t a majority opinion (Justice Kennedy did not join this section), but onlyfour justices wanted to apply a positive presumption against preemption of thesort invoked in Arters – and that’s a minority.
So, before we even get to the merits, Artershas directly contradicted three controlling Supreme Court opinions – taking anerroneous pro-plaintiff position as to each.
Why are we not surprised that the merits aren’t anybetter?
The plaintiff in Arters asserted a “designdefect”/“remove from the market” claim à la Bartlett v. MutualPharmaceutical Co., 678 F.3d 30 (3d Cir.), cert. granted, 133 S.Ct.694 (U.S. 2012).  2013 WL 308768, at*4.  Of course, the vast majority ofprecedent is to the contrary.  AnotherOhio case, Fulgenzi v. PLIVA, Inc., 867 F. Supp.2d 966 (N.D. Ohio 2012),held, first, that design defect claims were improperly pleaded under the OhioProduct Liability Act (“OPLA”), id. at 972-73, and further that plaintiffcouldn’t replead because there was no way to construct an unpreempted “designdefect” claim:
Even if the pleading deficiencies could be remedied,dismissal of these claims would still be appropriate because, regardless of howPlaintiff attempts to cast these claims, they are, at the core, failure-to-warnclaims that are clearly preempted. . . .  [A] generic pharmaceutical product must bethe same as the referenced listed drug in active ingredients, safety and efficacyand hence, as was the case with labeling, federal law pre-empts state laws imposingthe duty to change a drug’s design upon generic manufacturers.
867 F. Supp.2d at 973-74 (citations and quotationmarks omitted).  Fulgenziexemplifies decisions reached by many other courts.  See Demahy v. Schwarz Pharma, Inc.,702 F.3d 177, 186 (5th Cir. 2012) (design defect claims are “failure-to-warnclaims under different names” and preempted) (applying Louisiana law); Frazierv. Mylan Inc., ___ F. Supp.2d ___, 2012 WL 6641626, at *5-6 (N.D. Ga. Dec.18, 2012) (“a generic drug is designed to be a copy of a reference listed drugand it must be identical in active ingredients and efficacy” rejecting Bartlettbecause generic “was not free to unilaterally pursue a safer alternative design. . . to comply with state law while also being in compliance withfederal law”); Strayhorn v. Wyeth Pharmaceuticals, Inc.,  ___ F. Supp.2d ___, 2012 WL 3261377, at *10,12 9-10 (W.D. Tenn. Aug. 8, 2012) (“design claim is “at [its] core” a warningclaim; Bartlett “offered little explanation for accepting the failure towithdraw theory”); Lashley v. Pfizer, Inc., 877 F. Supp.2d 466, 478, 480(S.D. Miss. 2012) (design defect claim without alternative design is really apreempted warning claim; Bartlett “unpersuasive and not a proper basisfor relief”); Metz v. Wyeth, 872 F. Supp.2d 1335, 1341 (M.D. Fla. 2012)(generic drug “was required to be the bioequivalent to the reference listeddrug”); Eckhardt v. Qualitest Pharmaceuticals, Inc., 858 F. Supp.2d 792,801 (S.D. Tex. 2012) (“Generics were required to produce a drug that wasequivalent to the brand-name drug and were not free to unilaterally pursue asafer alternative design in order to comply with state law”); In rePamidronate Products Liability Litigation, 842 F. Supp. 2d 479, 484(E.D.N.Y. 2012) (“the federal duty of ‘sameness’’’ also applies in the contextof generic drug design, and federal law preempts state laws imposing a duty tochange a drug’s design on generic drug manufacturers”); Jacobsen v. Wyeth,LLC, 2012 WL 3575293, at *9 (E.D. La. Aug. 20, 2012) (“federal law requiresa generic drug to be of the same design as its brand name counterpart”); Inre: Accutane Products Liability Litigation, 2012 WL 3194952, at *2 (M.D.Fla. Aug. 7, 2012) (“defective design claims are similarly preempted underMensing because the generic drug was required to be the bioequivalent to thereference listed drug”); Aucoin v. Amneal Pharmaceuticals, LLC, 2012 WL2990697, at *8-9 (E.D. La. July 20, 2012) (“federal law requires a generic drugto be of the same design as its brand name counterpart”); Fullington v.PLIVA, Inc., 2012 WL 1893749, at *5 (E.D. Ark. May 23, 2012) (design defectclaim based on inherent risk really a preempted warning claim); Johnson v.Teva Pharmaceuticals USA, Inc., 2012 WL 1866839, at *4 (W.D. La. May 21,2012) (design defect claims preempted because plaintiff “cannot show that analternative drug design was available to the Generic Defendants”); Cooper v.Wyeth, Inc., 2012 WL 733846, at *6 (M.D. La. March 6, 2012) (“if state lawcould require a generic drug manufacturer to wholly withdraw from the marketbased on the unreasonable danger of the product . . . it necessarilymust repudiate the label approved by the FDA”); In re Darvocet, Darvon &Propoxyphene Products Liability Litigation, 2012 WL 718618, at *3 (E.D. Ky.March 5, 2012) (failure to withdraw claim was “based on the allegedly defectivedesign of the drug, which the Generic Defendants, bound by their ‘ongoingfederal duty of sameness,’ were powerless to change”); Lyman v. Pfizer, Inc.,2012 WL 368675, at *4 (D. Vt. Feb. 3, 2012) (design defect claims “arepreempted as well by Mensing’s logic,” since the “ ‘federal duty ofsameness’ . . . applies to the design or composition of the drug aswell as to its labeling”); In re Fosamax (Alendronate Sodium) ProductsLiability Litigation, 2011 WL 5903623, at *6 (D.N.J. Nov. 21, 2011) (“FDArequires generic Fosamax to have the same active ingredient as Fosamax”); Stevensv. PLIVA, Inc., 2011 WL 6224569, at *2 (Mag. W.D. La. Nov. 15, 2011) (“genericpharmaceutical product must be the same as the referenced listed drug . . .in active ingredients”), adopted, 2011 WL 6224556 (W.D. La. Dec. 2,2011).
Arters’ response to this massive opposing precedent?  First, they’re not binding, so theycan be ignored.  2013 WL 308768, at *5(“[n]one of the cases . . . bind this Court on the issue of whetherdesign defect claims are preempted by the FDCA”).  Second, if it’s not a failure to warnclaim, it’s distinguishable.  Id.(“other district courts within the Sixth Circuit have reached the oppositeconclusion. . . .  TheseCourts have considered different state laws and different factual situations.Here, plaintiffs' design-defect claim rests on the alleged violation of anentirely different duty than their failure to warn claim”).
Well, although the first is true, one would expect Artersat least to address the other courts’ reasoning – that bioequivalence means the“same” design as well as warnings – but no, not one word about how there isn’t“sameness” in design claims.  As for thesecond, that’s just false.  While someother Sixth Circuit district courts (Strayhorn (Tennessee) and Darvocet(Kentucky)), were under other states’ laws, Fulgenzi – which Artersnotably fails to cite – simply isn’t.  Fulgenzianalyzed the identical question under identical state law.  Arters sweeps the mostdirectly-on-point precedent silently under the rug.
But the scope of the error in Arters is evenworse than ignoring uncomfortable precedent. Rather, Arters should never have been out on that limb, and thusruling contrary to both Mensing and the great weight of precedent, in the firstplace.  The decision puts the cart beforethe horse.  There has to be a state lawclaim first – before it can be preempted. See Purvis v. Teva Pharmaceuticals, USA, Inc., ___ F.Supp.2d ___, 2012 WL 5364392, at *4 (M.D. La. Oct. 30, 2012) (design defectclaim without alternative design not viable; Bartlett not persuasive); Grinagev. Mylan Pharmaceuticals, Inc., 840 F. Supp.2d 862, 870 (D. Md. 2011)(plaintiff failed to allege a proper design defect claim under state law; noneed to reach preemption); Fisher v. Pelstring, 817 F. Supp.2d 791, 817-18(D.S.C. 2011) (design defect failed when plaintiff failed to demonstrate analternative feasible design).  This iswhat “failure to state a claim” is all about.
Unlike Bartlett, where (non-drug) NewHampshire law could at least be plausibly read as allowing a “design defect”based on pure risk/utility balancing without an alternative design, Artersarose under Ohio law.  2013 WL 308768, at *5.  Ohio simply does not recognize a designdefect without a feasible alternative design:
A product is notdefective in design or formulation if,at the time the product left the control of its manufacturer, a practical and technically feasiblealternative design or formulation was not available that would haveprevented the harm for which the claimant seeks to recover compensatory damageswithout substantially impairing the usefulness or intended purpose of theproduct.
Ohio Rev. Code §2307.75(F) (emphasis added).  That goes double for prescription medicalproducts:
An ethical drug or ethical medical device is not defective in design orformulation because some aspect of it is unavoidablyunsafe, if the manufacturer of the ethical drug or ethical medicaldevice provides adequate warning and instruction . . . concerningthat unavoidably unsafe aspect.
Ohio Rev. Code §2307.75(D) (emphasis added).  While Arters cites §2307.75 generally,2013 WL 308768, at *5, it inexplicably ignores the two most directly on-pointsubsections that establish the unavailability of an OPLA design defect cause ofaction in the absence of any alternative design.  Nor is there any conceivable otheravenue open in Arters.  OPLA is “intendedto abrogate all common law product liability claims or causes of action.”  Ohio Rev.Code §2307.71(B).
In short, the “design defect” claim purportedly atissue in Arters does not exist under relevant state law.  A “design defect” claim absolutely, bystatute, requires an alternative design in Ohio.  Plaintiff cannot assert an Ohio claim that aproduct – particularly a prescription medical product – can simply be removedfrom the market.  Because there is no Bartlettrationale under Ohio law, it was error for Arters even to consider preemptionof that claim.  “[W]e do not ordinarilydecide constitutional issues if a case can be resolved on non-constitutionalgrounds.”  Sistrunk v. City ofStrongsville, 99 F.3d 194, 197 (6th Cir. 1996).
In reaching and resolving this constitutional issue, theDistrict Court ignored the basic and longstanding rule of construction thatwhen two questions are raised, and resolution of the non-constitutionalquestion makes unnecessary a decision on the constitutional question, only thenon-constitutional question should be decided.
Nagy v. Farmers Insurance Exchange, 758 F.2d189, 192 (6th Cir. 1985).
And that’s not the end of it.  Arters goes on to hold that somethingit calls “off-label promotion” also survives preemption.  2013 WL 308768, at *6.  Arters states that there’s some sortof “duty not to promote a dangerous use of [the drug] that is inconsistent withthe FDA-approved label.”  Id.  Where does this novel duty come from?  Arter cites no law at all, statingonly that the defendant allegedly “promoted a use of [the drug] that was inviolation of Ohio law.”  Id.
Wrong again.
Off-label use isn’t illegal in Ohio.  The only off-label use ever banned in Ohiohas to do with (you guessed it) abortion. See Planned Parenthood Southwest Ohio Region v. DeWine,696 F.3d 490, 496 (6th Cir. 2012) (discussing Ohio Rev. Code §2919.123(A)).  Otherwise, off-label use is perfectly legalunder Ohio common law.
[A]lthough the FDA regulates, among other things, drugsand medical devices, the FDA does not regulate the practice of medicine. . . .  [C]ourts addressing issues of FDA-regulateddrugs have determined that physicians are permitted to use federally approveddrugs as they, in their medical judgment, see fit. . . .  FDA approved indications were not intended tolimit or interfere with the practice of medicine nor to preclude physiciansfrom using their best judgment in the interest of the patient  The Food, Drug and Cosmetic Act does notlimit the manner in which a physician may use an approved drug.  Once a product has been approved formarketing, a physician may prescribe it for uses or in treatment regimens orpatient populations that are not included in approved labeling.  Thus, the decision whether to use a drug foran off-label purpose is a matter of medical judgment, not of regulatoryapproval.
Klein v. Biscup, 673 N.E.2d 225, 231 (OhioApp.) (citations and quotation marks omitted), review denied, 667 N.E.2d987 (Ohio 1996).
It is well established that the U.S. Food and Drug Administrationneither regulates the practice of medication nor restricts uses of those of the“official” approval, but merely approves or disapproves the use and marketingof medical devices and drugs.  The OhioState Medical Association has taken the position that “off-label use” isneither “experimental” nor “investigational.” The off-label use of a medical device is merely a matter of medicaljudgment . . . is not barred by the U.S. Food and Drug Administration.
State ex rel. Bax Global, Inc. v. Industrial Com’n,2007 WL 512529,  at *5 (Ohio App. Feb. 20,2007).
So if not off-label use itself, what could be a“violation” of the law?  Off-labelpromotion?  For one thing, no federalstatute or regulation prohibits that, as the Second Circuit pointed out  recently in United States  v. Caronia, ___ F.3d ___, 2012 WL 5992141,at *3 (2d Cir. Dec. 3, 2012) (“[t]he FDCA and its accompanying regulations donot expressly prohibit the 'promotion' or 'marketing' of drugs for off-labeluse”).  For another, assuming a plaintiffcould nonetheless tease a “plausible” violation out of various FDA regulations:  (1) off-label promotion is not inherentlyfalse or fraudulent, as we discussed at length here; and (2) there’s not a scrap of Ohio precedent holding that off-labelpromotion also somehow violates state tort law. It’s not the role of federal courts sitting in diversity to dream up newstate-law tort claims.
[F]ederal courts must proceed with caution when makingpronouncements about state law.  Sittingin diversity, we are not commissioned to take a position regarding theadvisability or fairness of the state rule to be applied, but must determinethe issue as would the highest court of the state.  This Court’s proper reluctance to speculateon any trends of state law applies with special force to a plaintiff in adiversity case. . . .  Whengiven a choice between an interpretation of state law which reasonablyrestricts liability, and one which greatly expands liability, we should choosethe narrower and more reasonable path.
Combs v. International Insurance Co., 354 F.3d568, 577 (6th Cir. 2004) (citations and quotation marks omitted); see Ventas, Inc. v. HCP, Inc., 647 F.3d291, 328 n.15 (6th Cir. 2011 (quoting and following Combs); Kurczi v. Eli Lilly & Co., 113F.3d 1426, 1429 (6th Cir. 1997) (“A federal court in a diversity case is notfree to engraft onto ... state rules exceptions or modifications which maycommend themselves to the federal court, but which have not commendedthemselves to the State in which the federal court sits”) (quoting Day &Zimmermann, Inc. v. Challoner, 423 U.S. 3, 4 (1975)).
Moreover, there’s another United States SupremeCourt case holding, in the specific context of off-label use, that supposed state-law claims asserting FDA regulatoryviolations are in fact nothing more than improperattempts to sue over alleged violations of a statutory scheme that doesn’tpermit private enforcement.  See21 U.S.C. §337(a) (reserving FDCA enforcement exclusively to the federalgovernment).  However far Buckman Co.v. Plaintiffs Legal Committee, 531 U.S. 341 (2001), might or might nototherwise extend, it forbids state-law claims such as those in Artersthat allege improprieties involving off-label use:
[Plaintiff’s claims would ] delay health careprofessionals’ ability to prescribe appropriate off-label uses. . . . [I]t is clear that the [Lohr]claims arose from the manufacturer’s alleged failure to use reasonable care inthe production of the product, not solely from the violation of FDCArequirements.  In the present case,however, the [plaintiffs’] fraud claims exist solely by virtue of the FDCAdisclosure requirements. . . . [W]ere plaintiffs to maintain their fraud-on-the-agency claims here,they would not be relying on traditional state tort law which had predated thefederal enactments in questions.  On thecontrary, the existence of these federal enactments is a critical element intheir case.
531 U.S. at 351-53 (numerous citations omitted).  Without the FDA-approved label, there’s nosuch thing as “off-label” use – let alone “promotion” – which is anotherregulatory term.  Thus, a tort claim for“off-label promotion” as discused in Arters necessarily runs afoul of Buckman’s“critical element” test.
If that weren’t enough, the Ohio Supreme Court hasalso banned this sort of disguised statutory enforcement claim where, as withthe FDCA, the statute in question bars private enforcement.  In Hernandez v. Martin Chevrolet, Inc.,649 N.E.2d 1215 (Ohio 1995), the court considered the effect of a claimedviolation of OSHA, a federal statute that, like the FDCA, explicitly barred itsuse (the so-called “disclaimer”) in private civil litigation.  The court, in a rare unanimous decision, said“no” to the claim:
This statutory disclaimer clearly indicates thatCongress did not intend OSHA to affect the duties of employers owed to thoseinjured during the course of their employment. . . .  Negligence per se decreases the elements thata plaintiff must prove in a negligence action.  Thus, a plaintiff's case is significantlyaided if negligence per se is established.  If we held that a violation of OSHAconstitutes negligence per se, we would allow OSHA to affect the duties owed byindividuals to those injured in the course of their employment. Such a holdingwould be contrary to the intent of the legislation. Accordingly, we hold that aviolation of OSHA does not constitute negligence per se.
Id. at 1216-17 (citations omitted).  As for "intent" in the FDCA context, as Buckman held, §337(a) is “clearevidence that Congress intended that the MDA be enforced exclusively by theFederal Government.”  531 U.S. at352. And finally, while it only makesthe rubble of Arters bounce, as Caronia, supra, pointed out, there is nothing in the FDCA itself aboutoff-label promotion (or, indeed, off-label use).  Ohio law also prohibits violations of meregovernmental regulations from being the basis of an negligence per se claim.  See Chambers v. St. Mary’s School,697 N.E.2d 198, 203 (Ohio 1998) (“we hold that the violation of anadministrative rule does not constitute negligence per se”).
Spherical error. In one relatively short opinion (seven Westlaw pages), the Artersdecision manages to:
(1)        employa “retired” standard for deciding a rule 12 motion, directly contrary to two ofthe most-widely cited Supreme Court decisions in recent years;
(2)        applya presumption against preemption directly contrary to the holding in a third controllingSupreme Court decision;
(3)        holdthat a design defect/failure to withdraw claim was not preempted when thatclaim cannot possibly exist under the controlling state (OPLA) statute;
(4)        holdthat a design defect/failure to withdraw claim was not preempted ignoring (andin some cases not even acknowledging) the reasoning of the vast weight ofcontrary precedent;
(5)        holdthat an off-label promotion claim is not preempted, directly contrary to theholding of a fourth controlling Supreme Court decision;
(6)        entertainan off-label promotion claim that no Ohio court has permitted, contrary to thecourt’s limited role when sitting in diversity; and
(7)        entertainan off-label promotion claim that’s barred by two Ohio Supreme Court decisionsthat limit the scope of negligence per se claim under controlling state law.