Wyeth v. Levine – Are we in for a world of ubiquitous black box warnings?

The Supreme Court’s recent decision in Wyeth v. Levine held that FDA approval of a drug’s labeling does not preempt a state law tort claim for inadequate labeling.  So what do you do if you’re counsel to a pharmaceutical company making physician-administered drugs?  Put the biggest, scariest black box warning you can on every prescription drug you sell.  There’s no downside!  Physicians frequently don’t read labeling, relying instead on prior experience with the drug, or what they learn from pharmaceutical reps and colleagues.  Patients rarely even see these labels, and instead hear only the doctor’s summary of risks.  This course of action would provide a complete defense for the drug manufacturer so that tort liability will stop with the administering physician.

This seems absurd and counterintuitive; shouldn’t drug warning labels communicate actual dangers and not just be a proxy for a tort defense?  FDA needs to step in and address this before physicians and patients have no way of knowing the actual dangers of these drugs.

Pfizer Buys Wyeth, Industry Consolidates, IP Lawyers Rejoice

Pfizer’s purchase of Wyeth is big news for the pharmaceutical industry, and for big business in general.  Because its blockbuster cholesterol drug Lipitor comes off patent in 2010, probably ceding much of its $12.6 billion market to generics, Pfizer went looking to boost its pipeline in search of the next blockbuster drug.

Despite the generally gloomy outlook on Pfizer’s own pipeline, it still has a number of blockbuster drugs that remain on patent (based on rough projected global sales for 2008): rheumatoid arthritis drug Celebrex ($2.5 billion, on patent until 2014), Xalatan for glaucoma ($1.8 billion, on patent until 2011), Detrol for overactive bladder ($1.2 billion, on patent until 2012), antibacterial drug Zyvox ($1.1 billion, on patent until 2021) and schizophrenia drug Geodon ($1.0 billion, on patent until 2012).  The company still makes money from off-patent drugs, such as erectile dysfunction treatment Viagra ($2 billion, off patent since 2000), but sales generally drop off dramatically as patents expire and exclusivity ends.  See high blood pressure medication Norvasc ($2.2 billion, but down from $4.9 billion in 2006 since it came off patent in 2007), antidepressant Zoloft ($142 million, but down from $3.3 billion in 2005, off patent since 2006) and antibacterial Zithromax ($121 million, but down from $2 billion in its patent expiration year of 2005).

Pfizer acquires a major player in Wyeth, with blockbuster drugs including antidepressant Effexor ($3.9 billion, off patent in 2010), children’s vaccine Prevnar ($2.7 billion , off patent in 2007 in the US, but extended to 2012 in Europe), arthritis drug Enbrel ($3.8 billion, off patent in 2009), antibiotic Zosyn ($1.3 billion, off patent in 2007) and sales from nutritionals, vitamins and Advil totaling $3.0 billion in 2008.

This represents a trend in the pharmaceutical industry towards consolidation, in the hope of producing the next Lipitor, a drug which can net a company tens of billions of dollars each year.  Of course, monopoly profits only come with exclusivity, so I’m guessing patent lawyers and IP litigators will continue to find themselves very busy, even in the down economy.

A win for end users: Apple (finally) goes DRM-free

On January 6th, Apple announced that it will offer music from all four major music labels (Universal, BMG, Warner Bros. and EMI) for the first time as DRM-free downloads.  This is a huge step for iTunes, finally catching up with the method Amazon MP3 has used since its inception.  This represents a policy shift towards allowing users to freely transfer songs between their computers and mp3 players, something previously made extremely difficult and awkward by Apple’s DRM scheme.  Though iTunes allowed authorization of up to 5 computers to play content purchased from its iTunes Store, this always seemed like an artificial and arbitrary restriction to place on its users (not to mention the fact that DRM protected content couldn’t be played on other mp3 players).  Apple of course was well within their legal rights to negotiate licensing however they pleased and to implement their DRM scheme, but this decision marks a clear statement that it was a failed policy as a business decision.

Even though iTunes clearly maintains the content advantage over Amazon MP3 (10 million songs versus only 6 million), I will continue to use Amazon MP3 exclusively, and recommend my friends do the same, both because of the universality of the mp3 format, and my general disdain for Apple products (don’t get me started on the pathetic quality of iTunes as a music player/manager).

More generally, this marks a business trend towards a new method of dissuading piracy: Give users the autonomy to view and use content in the way they please, and they will be more likely to legitimately purchase copyrighted material, and less likely to resort to illegal copying and dissemination.  This move by Apple, along with the free streaming video content offered by Hulu (a collaboration between NBC, Fox, MGM, Sony, Warner Bros. and more), and most other major networks making their shows available streaming for free on their websites, represents a win for end users, freed from arbitrary and cumbersome restrictions on the use and enjoyment of the growing variety of digital content becoming available on the web.

A Shoveler’s Manifesto: Can I Lay Claim To That Parking Space?

Should I have a property right in the parking space I laboriously shoveled out after yet another New England winter storm?  Can I lay any legal claim to that space when I leave it, such as by placing a marker of some kind in it?  Should I be entitled to slash the tires or break the windows of a car that takes the space I shoveled out?

I’m sure these thoughts seem absurd (especially to those outside of urban areas in New England), but I can’t help but ponder them when I spend hours trying to find, clear out and keep a parking spot on my street in Somerville, MA (New England’s most densely populated city).  It doesn’t help matters when the city declares a snow emergency, towing cars parked on the even side of the street and cutting the number of available parking spaces in half.

The visceral notion that “I shoveled it, I should get to keep it,” rings true in a classic Lockean way: the labor of your body and the work of your hands is properly yours.  See John Locke, Second Treatise of Civil Government, Chapter 5, §27.  But from a modern legal standpoint, it would seem impossible for a private citizen to obtain any kind of property right in what is certainly government property.  It’s not the wild west, you can’t stake a claim to a piece of pavement simply because you surveyed it, dusted it off and tied your horse up there.  Methods other than simply staking your claim don’t look promising.  Generally, adverse possession is not an option, as most States explicitly exempt public roadways from adverse possession by statute.  See, e.g., Colo. Rev. Stat. § 38-41-101(2) (2008).  Notably, Massachusetts is an exception to this rule, only disallowing adverse possession against the commonwealth and its political subdivisions except in connection with land used for certain environmental purposes.  See Mass. Gen. L. Ch. 260, §31; Lawrence v. Concord, 439 Mass. 416 (2003).  Still, because of the unlikelihood of occupying a city parking space for 20 years in any urban area of the Commonwealth without someone breaking the continuity, adverse possession isn’t a realistic option, even in Massachusetts.

Nonetheless, a longstanding snowstorm practice, especially in South Boston, is to put lawn furniture, traffic cones, trash cans, cinderblocks and any other large object in resident-cleared parking spaces in order to reserve them.  These rights are vigorously defended in that neighborhood, resulting in the aforementioned slashed tires, broken windows, and even the occasional assault.  This is a place where you simply do NOT want to take someone’s clearly marked space.

Despite the questionable legality of this process, it has been sanctioned by Boston mayor Thomas M. Menino, to a limited extent.  In 2003, in response to some South Boston residents reserving spaces for three weeks after a two-inch snowfall, Menino put in place a 48-hour cap on the reservation of shoveled out spaces, implicitly endorsing the practice.  A long battle between Menino’s garbage crews (who pick up the milk crates, barrels and shopping carts used to save spaces) and South Boston residents have ensued, epitomized by South Boston city councilor James M. Kelly’s declaration to Menino that “I’ve got more barrels than he’s got trucks.”

It’s questionable whether Menino even has the authority to allow the private reservation of public property, even for a limited time, but only in the most academic sense.  The fact is that parking spaces will continue to be reserved in South Boston and other urban areas of Massachusetts, whether legally or not, and municipalities will implement their own policies to prevent, curtail or begrudgingly accept the practice for practicality’s sake.  So as I continue to battle the relentlessly falling snow, increasingly discolored by salt, sand and cat litter, I will consider the prospect of defending the product of my labor as John Locke would say I should… and probably just look for another parking space.

The Game of E-Discovery

An entertaining and informative piece on the “game book” for conducting e-discovery, using the metaphor of a basketball game. Practical and specific points and tips for anyone interested in the new world of electronic discovery.  

“[I]f you play hide the ball in e-discovery, and get caught, you may not only lose the case, but you may lose your job, and maybe even your license. … Instead, an e-Discovery Team plays a series of games that culminates in throwing the ball to the other side, not hiding it.”

Another Criticism on the Demise of OiNK (and the Problems of Class and Indie Rock)

Great post from marathonpacks (via fluxblog) on the demise of OiNK:

Yet what these people don’t understand, or at least won’t admit to understanding publicly, is that OiNK was a symbolic subcultural mirror of exactly everything they profess to hate about their vision of mainstream culture. You can’t deny that OiNK was itself a culture: it was private and elite, it had clearly elaborated and lengthy rules for membership that included an annoyingly audiophilic standard for musical “quality” and sanctions for not tithing as much as you took. It had forums where people discussed meta-level issues about its functionality. OiNK clearly had its own set of ideologies, and they were far from liberatory. While it’s only a symbolic gesture, I’m glad to see OiNK disappear for the same reasons I’m so glad to not be part of a music “scene” anymore; I don’t miss blue-blooded conservativism masquerading as originality and protest.

Also, included for free, support of the much-needed criticism of “Sasha Frere-Jones’ New Yorker article discussing race and indie rock.”

Fittingly, the most popular forms of “indie” music today—formerly accessible on OiNK by sorting in order of popularity—reflect its generic status as not one decided by instrumentation or miscegenation as much as social position. And, sad as it might be, that will probably (hopefully) be OiNK’s legacy 20 years from now: a cultural snapshot of music fandom and/of 00s indie rock as the express domain of the parochial and privileged.

Maybe places like this should take notice of the dangerousness of closed, elite communities.

Choosing Strong Passwords

Not quite a “law hack,” barely a “life hack,” maybe just a “memory hack.” But in response to this Lifehacker mention of an algorithm to create answers to “dumb” security questions, I decided to throw out my method of making memorable, strong passwords.

As time passes, password systems are requiring stronger passwords. Needs to be at least six characters wrong, mix up capital and lower case characters, has to have non-alphabetical characters, or even non-alphanumeric characters. Can’t have any words or names. And so on.

My method takes a line of a memorable song, using the naturally mnemonic nature of setting words to catchy music, and then uses the lyrics and the rhythm of the song to make the password sequence easier to remember.

What I do is choose a memorable phrase from one of my favorite songs. Let’s say I’m going to use the “Hey! Ho! Let’s go!” phrase in the Ramone’s “Blitzkrieg Pop.” (Just for the record, I’m not detailing any of my actual passwords.)

First, just take the first letter of each word: h-h-l-g. In the song, they shout this out twice in a row: h-h-l-g-h-h-l-g. Now, maybe there’s some emphasis on the first “Hey!” and “Ho!” and let’s put the exclamation point at the end of each verse: H-H-l-g-!-H-H-L-G-!

And there we go, a pretty strong password: HHlg!HHLG! Try it. Tap it out to the rhythm of the song while you’re singing the lyrics in your head. It works. HHlg!HHLG!

That’s the basic system. But you can get fancier by throwing in a word or two and just flashing it up a bit more:

WBTC,WBTCORARoll! (“We built this city on rock and roll!”)

ComWWS1TBPWYRD! (“Carry on my way-ward son…”)

1ggHiHntoaYC$ (“It’s getting hot in here…”)

Law Hacks

The ABA Journal online published a list of “law hacks” this past summer. They group these “hacks” under E-mail, Your PC, Time Management, Phones, the Web, Software, Low Tech, Your Brain, Your Money, Hardware, and more. (If you’re unfamiliar with the world of “hacks” or more properly “life hacks,” then they’re generally tidbits of advice to streamline your productivity. See Lifehacker for your daily dose.)

It’s pretty much a list scarfed from Lifehacker posts over the years. Only a few of them cater specifically to legal work. But nonetheless it’s a decent summary for people who are too busy to read through Lifehacker archives.

Instead of merely criticizing, here’s me putting my money where my mouth is and starting my own list of law hacks, some replicative of the ABA, others not. (You can read a snippet of my criticisms at the end of the list.)

1. Google Desktop Search (“GDS”) (or Spotlight in Mac OS). This is essential. Whenever I use a case, I save the PDF version in a folder for each client/project. And I allow GDS to catalog the contents. Then if I know I ran across a case about something, I don’t have to dig around—all I do is search. It’s that easy.
2. Name your files usefully. So I have a folder for every client/project. But files often float around independently. If I have a motion to dismiss document for client Smith, then it doesn’t help if the filename is “mot dismiss.doc,” especially if I e-mail it to someone or to myself to work on remotely. Name it usefully. I’ll use “Smith.MtD pers juris.111707.doc.” I won’t even explain what my abbreviations are for. It should be that easy.
3. Add short descriptions to case filenames. Even with GDS, sometimes you do find yourself digging around in folders and files looking for cases. When you’re reading cases, you’re usually looking for one main point of law from each one. So when you read through a case, name the file with the point it’s useful for. For example, “Smith v. Kim (1st Cir. 1992) neg op turn signals.pdf.”
4. Use a wiki or blog as a to-do list and notepad. I use a wiki to keep a running to-do list of short- and long-term tasks. I also have a list of “notepads” linked from the home page of long-term projects or just places to jot down important numbers and passwords, etc. Blogs are sometimes better for to-do lists because every day is a new to-do list and you can track your progress (or lack thereof) by replicating your existing to-do list every day. And keep them password-protected for security.
5. Use del.icio.us (or another bookmark manager). Organize and store all your bookmarks remotely so you can access them from any computer. Check out my bookmarks on rules: http://del.icio.us/pham/rules. Enough said.
6. Keep track of your time daily. Each summer, I had a small notebook for my to-do list that I would check off of and re-create at the end of each day—planning the next day’s work. I would have another small notebook where I’d write down the current project name, the time I started, and the time I stopped. Then at the end of the day or first thing the next day, I’d enter my time. I actually “experimented” by trying to account for time at the end of a week—it was impossible. And I didn’t feel right “fudging” the time, and in the end I’m sure I lost minutes which added up to hours, etc.
7. Use paper wisely—print double-sided and purge or re-use paper. It takes a few seconds to set your default printer to print double-sided. It just makes sense to do it. You’ll cut your paper usage approximately in half. I also think it’s easier to read; it’s more natural, like reading a book. Then, when you’re done with a project, purge as much paper as you can. Get it out of your office and into the recycling bin. Also, if you have to print on one-side, re-use it as scrap paper, put a staple into it and use it as a notebook, or take it home and use it in your inkjet. If you hand-write important annotations on cases, consider using something like Skim (Mac OS) to electronically annotate PDFs.
8. Keep your inbox slim. I talk about this below. You don’t need to empty your inbox every day; just keep it slim. It’s satisfying—or at least not overwhelming—to have a slim inbox. It doesn’t take much. When you get an e-mail, read it immediately and then file it away. If something needs to be taken care of, take care of it ASAP. If you can’t, then keep it in your inbox until you can, but make sure you get to it.
9. Practice voice mail etiquette—keep your greeting short, leave informative messages, use e-mail, text, or IM. Voice mail greetings don’t have to say much—hey, know you’re number, that’s why they’re calling you. “You’re reached [name]. Please leave a message.” And then when you’re leaving a message, don’t just say, “Call me back.” Tell me why. Compel me. Otherwise, you’ve wasted everybody’s time. Or just e-mail me or IM me. Voice mails are passive communications (just like e-mail or IM) that I can’t skim, that I have to work to get to.
10. Use IM. I think IM can be so useful in a work environment. It’s a quick, passive, unobtrusive way to get in touch with people. There’s also the fantastically helpful status message—you can, at a glance, tell if the person is available or not, and if they have informative statuses, what they’re up. (For example: “out to lunch until 1:30,” “working on Smith case,” “anyone know anything about suing a cop,” “afk” (away from keyboard), “working from home,” etc.) And if you use IM for work, don’t use your “BCEaglesROXNUMoneShoRTy” screen name from your foolish youth. Create a just-for-work screen name that’s professional and descriptive, like “johnsmithatXYZ.” And don’t give it out to your friends.

I don’t quite agree with the e-mail tips. I tend to think that you should keep your inbox small, but it doesn’t need to be cleared every day. My inbox is more of my mid- to long-term to-do list. Anything short-term I read and then archive or accomplish and then archive. Generally, I think once you file an e-mail away, it disappears unless you search for it. So if it’s not addressed or done, it can’t get filed away. But to keep your inbox slim, you have to address e-mails which gives you a satisfying incentive to get things done quick.

The PC hacks are a bit too technical. Plus, the recommendation of Quicksilver–which I use and love and couldn’t live without–is Mac-specific. (Launchy is the not-up-to-snuff PC variant.) But I’m totally on-board with the Google Desktop Search–or just Spotlight on the Mac OS–to search through documents, especially PDF files of cases.

Waffles! Hydra! Pink!

OiNK’s new home page is now hawking waffles—and links to a Google search on”what to use instead of oink.” (The first result is brokep’s (of The Pirate Bay) blog post, appropriately titled, “What to use instead of Oink (waffleswaffleswaffles and jam).”)

This seems to be a message to the world to support the “hydra” model of seeding and leeching content: Use lots of little sites instead of gravitating to a couple of big ones. The beast should be a many-headed hydra, and when you cut off one head, two more grow to take its place.

brokep was the first to herald this idea:

“So public message to people – start up your own torrent sites, make the internet the hydra it is and needs to be. If there’s hundreds of sites, they can’t all be shut down. And well, if they shut down the few that are today, there will be hundreds of sites, I’m sure, but let’s start them before so we can spread the word of them easier.”

Here’s another write-up on the OiNK and brokep talking about the hydra concept.

What a fantastic, rich concept in such a fascinating application. Decentralize for stability. But also specialize to serve the market better. On top of it all—globalize to protect international civil rights.

So while in this current context, it’s just about sharing music, it points down to deeper core principles about how these types of movements need to operate.

Extralegal Methods for Protecting Our Perceived File-Sharing Rights

In response to this dig on This Recording (where Alex Carnevale compares siding with the RIAA as supporting lynching): I can’t say that I support what the RIAA is doing. I think, reflecting upon Tim Wu’s articles on socially-acceptable crime, the RIAA is a private interest forcing the hand of government to expend tax-payers’ money in an area it might not be all that interested in. But by the current writing of the law, it has every right to do this.

Tim Wu argues that this is a failure in the political process: We have this law that doesn’t make sense and no one who can change it. Something has to change. Maybe the law *has* to change—but we, the people, don’t have the money or the political willpower to do that. In today’s society, we’d ideally want businesses to adjust their models, practices, and ultimately their ethics to suit their consumer base. But we know that’s not going to happen.

Our inability to act towards our own wants and desires in this sense is credited to our fear of the government watching us, catching us, and throwing us in the can. We get scared off from demonstrating to the government—or to the RIAA—what we think the law should really be.

In an upcoming article on privacy and e-mail, I wrote:

The panoptical society restricts individual autonomy by “unnecessarily constraining individual decision-making” through the constant threat of visibility leveraging the inherently unbalanced power dynamic favoring governmental actors.

(That’s academic-speak for saying the government, by watching us, scares us from making our own decisions about things.)

With the courts and Congress offering little protection for [our privacy concerns], and with the threat of a panoptical society on the horizon, individuals may be forced to adopt extralegal methods of protecting their perceived expectations of privacy. Fortunately, a number of technological innovations offer a variety of methods of prophylaxis from government intrusion.

And this is where things like OiNK come in. OiNK was an “extralegal” method of protecting our perceived rights. But it wasn’t secure enough. Now, to protect those perceived rights, people could then resort to better, more technologically savvy methods. Tighter, “more private” trackers. Tighter file-sharing communities. WASTE networks. Maybe even (gasp) BitTorrent over Tor.

And then hopefully Big Music and the government will see where this leads: They lose their ability to control the people when the people fritter away underground. Is this the type of arms race we want to be involved in? There’s obviously something wrong here—there’s this well-established disconnect between how music is consumed and how Big Music wants to distribute it. So someone’s got to give. And might it not be, in this case, the purpose of business to cede to consumers, and the government to cede to the people?

I suspect the MediaDefender debacle and this OiNK shut-down just hits the techie, hipster, and blogging communities closer to home than the everyman Napster and Kazaa controversies. This will soon blow over, and we’ll be back to the SNAFU we’ve be involved in for the last 20 odd years.