This picture makes me weep for humanity
Friday, April 18, 2008
Tuesday, April 8, 2008
Pre-Emption and Big Pharma
Drug makers may finally get what they want, a legal shield that will protect them from lawsuits when it comes to light that their drugs pose bigger risks to the public than previously thought. However, while the industry may look longingly at the prospect of a legal shield, it may just happen that they get what they want, and in the end, it will be their undoing.
A case that is currently in the Supreme Court may result in the legal shield that the drug industry wants. Pre-emption basically says that since the FDA approved the drug in the first place, the drug maker should be shielded from liability if things go bad. In the current case, Johnson & Johnson, the maker of the birth control patch, Ortho Evra, is being sued because the plaintiff's claim that the drug released more estrogen than the label claimed, injuring the plaintiffs.
"But because the Food and Drug Administration approved the patch, the company is arguing in court that it cannot be sued by women who claim that they were injured by the product — even though its old label inaccurately described the amount of estrogen it released."
The article goes on to tell the story of how the FDA knew of the problems with the patch in 1999 and 2003, but did not release the information to the public until November 2005. As a result, the drug maker, supported by the Bush Administration, argues that drug companies should have a legal shield to protect them since the FDA knew of the risks and approved the drugs.
"The Bush administration has argued strongly in favor of the doctrine, which holds that the F.D.A. is the only agency with enough expertise to regulate drug makers and that its decisions should not be second-guessed by courts."
While drug companies may welcome the idea of a wall protecting them from litigation, what they should be afraid of is losing billions of dollars in sales because the likely effect of such a legal shield is far more scrutiny from the FDA from any drug sent for approval. The FDA will now have an interest not to approve drugs that may be deemed too risky to the public. This could result in a more drawn out approval process, or even more rejections because the FDA no longer can pass the risk to the drug companies.
This will invariably have a negative impact on consumers who will have to wait longer for drugs that may help them, and will probably increase the price of drugs.
A case that is currently in the Supreme Court may result in the legal shield that the drug industry wants. Pre-emption basically says that since the FDA approved the drug in the first place, the drug maker should be shielded from liability if things go bad. In the current case, Johnson & Johnson, the maker of the birth control patch, Ortho Evra, is being sued because the plaintiff's claim that the drug released more estrogen than the label claimed, injuring the plaintiffs.
"But because the Food and Drug Administration approved the patch, the company is arguing in court that it cannot be sued by women who claim that they were injured by the product — even though its old label inaccurately described the amount of estrogen it released."
The article goes on to tell the story of how the FDA knew of the problems with the patch in 1999 and 2003, but did not release the information to the public until November 2005. As a result, the drug maker, supported by the Bush Administration, argues that drug companies should have a legal shield to protect them since the FDA knew of the risks and approved the drugs.
"The Bush administration has argued strongly in favor of the doctrine, which holds that the F.D.A. is the only agency with enough expertise to regulate drug makers and that its decisions should not be second-guessed by courts."
While drug companies may welcome the idea of a wall protecting them from litigation, what they should be afraid of is losing billions of dollars in sales because the likely effect of such a legal shield is far more scrutiny from the FDA from any drug sent for approval. The FDA will now have an interest not to approve drugs that may be deemed too risky to the public. This could result in a more drawn out approval process, or even more rejections because the FDA no longer can pass the risk to the drug companies.
This will invariably have a negative impact on consumers who will have to wait longer for drugs that may help them, and will probably increase the price of drugs.
Sunday, March 23, 2008
Monday, March 3, 2008
Free Trade And The Presdiential Politics
On the eve of the Ohio presidential primary, I want to reflect on a growing concern I have about Obama and Clinton concerning their stance on NAFTA and free trade. It seems that lately, as David Leonhardt points out in the New York Times, complaining about NAFTA and free trade is a rallying cry for democrats in the same vain as abortion is for Republicans. They love to complain about free trade but have yet to take any concrete steps to go the protectionist route, altogether.
Granted, being in Ohio, I have most likely heard such talk louder than others. The democratic candidates, for the past few weeks, have liked to point out that this state has been hit harder than most by the down economy. However, it is foolish to blame free trade. In fact, as a Wall Street Journal editorial points out, the likely culprit is protectionist policies, not free trade. "Ohio Governor Ted Strickland, a Democrat who supports Mrs. Clinton, blames his state's problems on President Bush. But Ohio's economy has been struggling for years, and most of its wounds are self-inflicted. Ohio now ranks 47th out of 50 in economic competitiveness, according to the American Legislative Exchange Council. Ohio politicians deplore plant closings even as they impose the third highest corporate income tax in the country (10.5%) and the sixth highest personal income tax (8.87%)."
It certainly does not appear that NAFTA and other such agreements hurt Ohio, as the column continues to point out that Texas, which is on the NAFTA front lines, has had enormous success, in no part thanks to staying competitive with taxes for individuals and corporations.
Does competition with other countries hurt Ohio's economy? Only so much as to glaringly point out Ohio's political deficiencies in competing on a domestic and global scale. However, it is also important to point out that this is no a problem only for democrats. After all, President Bill Clinton signed NAFTA, and Ohio is not exactly a blue state, with the previous governor being a Republican. However, free trade has turned into the cause célèbre of the democratic party.
Granted, being in Ohio, I have most likely heard such talk louder than others. The democratic candidates, for the past few weeks, have liked to point out that this state has been hit harder than most by the down economy. However, it is foolish to blame free trade. In fact, as a Wall Street Journal editorial points out, the likely culprit is protectionist policies, not free trade. "Ohio Governor Ted Strickland, a Democrat who supports Mrs. Clinton, blames his state's problems on President Bush. But Ohio's economy has been struggling for years, and most of its wounds are self-inflicted. Ohio now ranks 47th out of 50 in economic competitiveness, according to the American Legislative Exchange Council. Ohio politicians deplore plant closings even as they impose the third highest corporate income tax in the country (10.5%) and the sixth highest personal income tax (8.87%)."
It certainly does not appear that NAFTA and other such agreements hurt Ohio, as the column continues to point out that Texas, which is on the NAFTA front lines, has had enormous success, in no part thanks to staying competitive with taxes for individuals and corporations.
Does competition with other countries hurt Ohio's economy? Only so much as to glaringly point out Ohio's political deficiencies in competing on a domestic and global scale. However, it is also important to point out that this is no a problem only for democrats. After all, President Bill Clinton signed NAFTA, and Ohio is not exactly a blue state, with the previous governor being a Republican. However, free trade has turned into the cause célèbre of the democratic party.
Sunday, March 2, 2008
A debate amongst my friends deals with the ideal length of movies. I believe that the ideal movie length is 90 minutes. I also believe that this is a law of nature, just like the sun rises in the east, the sky is blue, and Ralph Nader will never be President. However, unlike the failure of the presidential aspirations of Ralph Nader, my movie rule is not absolute. A movie longer than 90 minutes is not, by default, a bad movie. Two movies that are still great, despite being 180 minutes or more are The Godfather and Lord of the Rings. It would have been hard for either movie to be as great as they were in only 90 minutes. In fact, it took two Godfather movies to tell the story in over 6 hours (no, I don't include the third movie) and it took 9 hours for the Lord of the Rings. However, these are examples of exceptions to the rule, and I stand by my 90 minute rule.
I am not going to make a list of movies that I feel should have been shorter or longer. Instead, I want the reader to think about recent movies they watched. Was it longer than 90 minutes? If so, could the movie have been just as good, or better than it was, if it was 90 minutes? Usually, the answer is yes. Losing a couple of unnecessary scenes or lines, or plot lines can go a long way to make a better story and a better movie. Unfortunately, directors feel that they need to include everything they shot into the final scene and editing is usually done to see what can be saved, not what should be cut.
I have told many friends about some of my laws of life, but I have decided to write them down so other may learn as well. My first law is related to movies. It is a simple formula, where the quality of a movie is directly proportional to the length of the movie. The ideal movie is 90 minutes long. That's it, any less and it most likely did not develop enough as a story or a movie. Any longer, and the film runs the risk of trying to do too much and be boring. That is not to say that any movie that is 90 minutes long is great nor am I saying that any movie longer than 90 minutes is crap. Some stories cannot be told in 90 minutes. However, the ideal is 90 minutes.
I am not going to make a list of movies that I feel should have been shorter or longer. Instead, I want the reader to think about recent movies they watched. Was it longer than 90 minutes? If so, could the movie have been just as good, or better than it was, if it was 90 minutes? Usually, the answer is yes. Losing a couple of unnecessary scenes or lines, or plot lines can go a long way to make a better story and a better movie. Unfortunately, directors feel that they need to include everything they shot into the final scene and editing is usually done to see what can be saved, not what should be cut.
I have told many friends about some of my laws of life, but I have decided to write them down so other may learn as well. My first law is related to movies. It is a simple formula, where the quality of a movie is directly proportional to the length of the movie. The ideal movie is 90 minutes long. That's it, any less and it most likely did not develop enough as a story or a movie. Any longer, and the film runs the risk of trying to do too much and be boring. That is not to say that any movie that is 90 minutes long is great nor am I saying that any movie longer than 90 minutes is crap. Some stories cannot be told in 90 minutes. However, the ideal is 90 minutes.
Tuesday, February 19, 2008
The future is now - Save my back edition!
I love books. I am getting that out of the way just so nobody misunderstands this post. I like to read. I read fiction, non-fiction, textbooks, newspapers, blogs, magazines, the back and sides of cereal boxes (lots of good reading on cardboard these days). What I don't like, is carrying three textbooks, a notebook, and a laptop around on my back. My back wants relief! And wouldn't you know it, but technology has provided a solution to a problem that apparently nobody besides myself wants solved. I am talking about ebooks and ebook readers.
Take, for example, the two most visible ebook readers, the Sony Reader and the Amazon Kindle. Both are amazing devices that simulate the real thing, reading on paper. The displays are designed to look exactly like paper and it really is amazing how good these devices are at doing so. I played with the Sony Reader (Never seen the Kindle in person, but it uses exactly the same display technology, e-ink) and I was blown away by how easy it is to read text on the e-ink display. It is not like reading on a computer screen, which can be difficult on the eyes, but more or less like reading text on paper. One has to see this technology in action to properly understand what I am talking about.
The promise of digital books and readers make me very excited. One device, the size of a book that can hold thousands of pages of reading. The Kindle is very neat, as it has a built in keyboard for taking notes, and an integrated wireless modem to get books, rss feeds, websites, magazines and newspapers without using a computer. Very nice!
But most important to my back is only carrying around one device that takes the place of all the books that I carry.
However, there are a number of drawbacks that keep me from taking the plunge into ebooks.
1. Price. The Sony and Amazon devices are expensive ($300 and $400) for what they are. a device to read books that you could individually own for $10 each. And since you have to buy all the books on top of buying the device, this suddenly becomes a very expensive proposition.
2. DRM. Right now, if you buy a reader from Sony or Amazon, you are stuck with them. Much like the iPod, and you want to get legal music, you are forced to use iTunes, Amazon forces you to buy books from them, and the same goes for Sony. This means that I cannot go to Borders and get the latest books and put them on my Kindle. And if I decide I don't like the Kindle and want the Sony Reader, I can't take my books with me. I like choice. Nice things about books is that it doesn't really matter where you get the book (Barnes & Nobles, Borders, the local bookstore), it is the same book everywhere. Not so with digital books. A kindle book is not the same as a Sony book. The text may be the same, but if I can't take the book with me when I buy a different reader, then it defeats the purpose in my mind.
3. While I don't like to mark up my books with notes, I'd like to and I know plenty of people who do. You can take notes on the iRex iLiad e-book reader, but you can't buy any books from Amazon or Sony which are the main places to get most books or periodicals. The Kindle has a keyboard to take notes with, but it's just not the same as handwriting notes in the margins. This is a necessity to some people, and something I would love to take advantage of (I just don't like to mark up paper)
4. There is a lack of a real selection. The killer application for this device would be to have textbooks for these devices. If I don't have to lug around three 1000 page boos on Constitutional Law or Torts, I'd be a very happy man. But right now, you will mostly find fiction and non-fiction for these devices.
5. I like my library. I like the look a bookcase full of books and I know I am not alone. A digital book negates this. But it doesn't have to. I think a great idea for Amazon or Sony would be to bundle books. I don't mind having a book at home that I can pick up and read, and then taking the digital copy with me when I leave the house. If I could go to a bookstore, pick up a book and bundled with it is a code for me to download the digital version, that would, in my opinion, take digital books into the mainstream and really make this a killer application.
Hopefully someone will make the perfect ebook reader and the infrastructure to make that happen. A man can dream
Judge Samuel B. Kent, saving Civil Procedure from pure boredom
While Civil Procedure certainly has its purposes, as a 1L, its only purpose is to bore me to death and lose precious brain cells. However, two cases have seemingly saved me from the grasps of a law coma, both written by the honorable Judge Samuel B. Kent who has written two of the funniest decisions I have read in my short legal career. Smith v. Colonial Penn Insurance Co and Bolivia v. Philip Morris are the cases I am referring to (I'm not including citations because, well, that would feel like writing a paper, and dammit, I'm not).
Clearly, Judge Kent is bored in the apparently non exciting legal world of Galveston, Texas because he makes his own excitement in writing decisions.
Excerpts from Bolivia v. Philip Morris, discussing why he is transferring jurisdiction to Washington DC:
"This is one of at least six similar actions brought by foreign governments in various courts throughout the United States. The governments of Guatemala, Panama, Nicaragua, Thailand, Venezuela, and Bolivia have filed suit in the geographically diverse locales of Washington, D.C., Puerto Rico, Texas, Louisiana, and Florida, in both state and federal courts. Why none of these countries seems to have a court system their own governments have confidence in is a mystery to this Court."
"the Court can hardly imagine why the Republic of Bolivia elected to file suit in the veritable hinterlands of Brazoria County, Texas. The Court seriously doubts whether Brazoria County has ever seen a live Bolivian ... even on the Discovery Channel. Though only here by removal, this humble Court by the sea is certainly flattered by what must be the worldwide renown of rural Texas courts for dispensing justice with unparalleled fairness and alacrity, apparently in common discussion even on the mountain peaks of Bolivia!"
Wait, there's more!
"Regardless of, and having nothing to do with, the outcome of Defendants' request for transfer and consolidation, it is the Court's opinion that the District of Columbia, located in this Nation's capital, is a much more logical venue for the parties and witnesses in this action because, among other things, Plaintiff has an embassy in Washington, D.C., and thus a physical presence and governmental representatives there, whereas there isn't even a Bolivian restaurant anywhere near here! Although the jurisdiction of this Court boasts no similar foreign offices, a somewhat dated globe is within its possession. While the Court does not therefrom profess to understand all of the political subtleties of the geographical transmogrifications ongoing in Eastern Europe, the Court is virtually certain that Bolivia is not within the four counties over which this Court presides, even though the words Bolivia and Brazoria are a lot alike and caused some real, initial confusion until the Court conferred with its law clerks."
While this is certainly not Chris Rock or Jerry Seinfeld funny, you have to appreciate the sarcasm spewing forth from Judge Kent's mouth in delivering this opinion. A legal scholar and writer, Judge Kent is not, but he definitely makes Civ Pro a lot more fun!
Clearly, Judge Kent is bored in the apparently non exciting legal world of Galveston, Texas because he makes his own excitement in writing decisions.
Excerpts from Bolivia v. Philip Morris, discussing why he is transferring jurisdiction to Washington DC:
"This is one of at least six similar actions brought by foreign governments in various courts throughout the United States. The governments of Guatemala, Panama, Nicaragua, Thailand, Venezuela, and Bolivia have filed suit in the geographically diverse locales of Washington, D.C., Puerto Rico, Texas, Louisiana, and Florida, in both state and federal courts. Why none of these countries seems to have a court system their own governments have confidence in is a mystery to this Court."
"the Court can hardly imagine why the Republic of Bolivia elected to file suit in the veritable hinterlands of Brazoria County, Texas. The Court seriously doubts whether Brazoria County has ever seen a live Bolivian ... even on the Discovery Channel. Though only here by removal, this humble Court by the sea is certainly flattered by what must be the worldwide renown of rural Texas courts for dispensing justice with unparalleled fairness and alacrity, apparently in common discussion even on the mountain peaks of Bolivia!"
Wait, there's more!
"Regardless of, and having nothing to do with, the outcome of Defendants' request for transfer and consolidation, it is the Court's opinion that the District of Columbia, located in this Nation's capital, is a much more logical venue for the parties and witnesses in this action because, among other things, Plaintiff has an embassy in Washington, D.C., and thus a physical presence and governmental representatives there, whereas there isn't even a Bolivian restaurant anywhere near here! Although the jurisdiction of this Court boasts no similar foreign offices, a somewhat dated globe is within its possession. While the Court does not therefrom profess to understand all of the political subtleties of the geographical transmogrifications ongoing in Eastern Europe, the Court is virtually certain that Bolivia is not within the four counties over which this Court presides, even though the words Bolivia and Brazoria are a lot alike and caused some real, initial confusion until the Court conferred with its law clerks."
While this is certainly not Chris Rock or Jerry Seinfeld funny, you have to appreciate the sarcasm spewing forth from Judge Kent's mouth in delivering this opinion. A legal scholar and writer, Judge Kent is not, but he definitely makes Civ Pro a lot more fun!
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