Concurrence By Justice Thomas?

Major new preemption decision by the Supremes -- sanity has been (somewhat) restored:

WYETH v. LEVINE

CERTIORARI TO THE SUPREME COURT OF VERMONT

No. 06–1249. Argued November 3, 2008—Decided March 4, 2009

Petitioner Wyeth manufactures the antinausea drug Phenergan. After a clinician injected respondent Levine with Phenergan by the “IVpush” method, whereby a drug is injected directly into a patient’s vein, the drug entered Levine’s artery, she developed gangrene, and doctors amputated her forearm. Levine brought a state-law damages action, alleging, inter alia, that Wyeth had failed to provide an adequate warning about the significant risks of administering Phenergan by the IV-push method. The Vermont jury determined that Levine’s injury would not have occurred if Phenergan’s label includedan adequate warning, and it awarded damages for her pain and suffering, substantial medical expenses, and loss of her livelihood as aprofessional musician. Declining to overturn the verdict, the trial court rejected Wyeth’s argument that Levine’s failure-to-warn claimswere pre-empted by federal law because Phenergan’s labeling hadbeen approved by the federal Food and Drug Administration (FDA). The Vermont Supreme Court affirmed.

Held: Federal law does not pre-empt Levine’s claim that Phenergan’slabel did not contain an adequate warning about the IV-push method of administration. Pp. 6–25.

(a) The argument that Levine’s state-law claims are pre-empted because it is impossible for Wyeth to comply with both the state-lawduties underlying those claims and its federal labeling duties is rejected. Although a manufacturer generally may change a drug labelonly after the FDA approves a supplemental application, the agency’s“changes being effected” (CBE) regulation permits certain preapproval labeling changes that add or strengthen a warning to improve drug safety. Pursuant to the CBE regulation, Wyeth could have unilaterally added a stronger warning about IV-push administration,and there is no evidence that the FDA would ultimately have rejected 2 WYETH v. LEVINE

Syllabus

such a labeling change. Wyeth’s cramped reading of the CBE regulation and its broad assertion that unilaterally changing the Phenerganlabel would have violated federal law governing unauthorized distribution and misbranding of drugs are based on the fundamental misunderstanding that the FDA, rather than the manufacturer, bearsprimary responsibility for drug labeling. It is a central premise of theFood, Drug, and Cosmetic Act (FDCA) and the FDA’s regulationsthat the manufacturer bears responsibility for the content of its labelat all times. Pp. 11–16.

(b) Wyeth’s argument that requiring it to comply with a state-lawduty to provide a stronger warning would interfere with Congress’ purpose of entrusting an expert agency with drug labeling decisions is meritless because it relies on an untenable interpretation of congressional intent and an overbroad view of an agency’s power to preempt state law. The history of the FDCA shows that Congress didnot intend to pre-empt state-law failure-to-warn actions. In advancing the argument that the FDA must be presumed to have established a specific labeling standard that leaves no room for different state-law judgments, Wyeth relies not on any statement by Congress but on the preamble to a 2006 FDA regulation declaring that statelaw failure-to-warn claims threaten the FDA’s statutorily prescribed role. Although an agency regulation with the force of law can preempt conflicting state requirements, this case involves no such regulation but merely an agency’s assertion that state law is an obstacleto achieving its statutory objectives. Where, as here, Congress has not authorized a federal agency to pre-empt state law directly, theweight this Court accords the agency’s explanation of state law’s impact on the federal scheme depends on its thoroughness, consistency,and persuasiveness. Cf., e.g., Skidmore v. Swift & Co., 323 U. S. 134. Under this standard, the FDA’s 2006 preamble does not merit deference: It is inherently suspect in light of the FDA’s failure to offer interested parties notice or opportunity for comment on the preemption question; it is at odds with the available evidence of Congress’ purposes; and it reverses the FDA’s own longstanding positionthat state law is a complementary form of drug regulation without providing a reasoned explanation. Geier v. American Honda Motor Co., 529 U. S. 861, is distinguished. Pp. 17–25.

___ Vt. ___, 944 A. 2d 179, affirmed.

STEVENS, J., delivered the opinion of the Court, in which KENNEDY, SOUTER, GINSBURG, and BREYER, JJ., joined. BREYER, J., filed a concurring opinion. THOMAS, J., filed an opinion concurring in the judgment. ALITO, J., filed a dissenting opinion, in which ROBERTS, C. J., and SCALIA, J., joined.

Wow -- I never thought I would see the day I would find myself agreeing with something Justice Thomas said:

Because such a sweeping approach to pre-emption leads to the illegitimate—and thus, unconstitutional—invalidation of state laws, I can no longer assent to a doctrine that preempts state laws merely because they “stan[d] as an obstacle to the accomplishment and execution of the full purposes and objectives” of federal law.

Justice Thomas, a serious legal scholar on preemption?

I better read the opinion again.

Defendant's Discovery Responses

From a friend.

You can see the rest of the courtoons here.

Paul Schwiep and "Neutered" Appear In Same Sentence.

Hey Marlins stadium supporters (that would be Dave Samson and....uh, Dave Samson), here's how we do accountability in Miami-Dade County:

Miami-Dade County commissioners on Tuesday are expected to dramatically loosen the rules over the government's use of the half-cent local sales tax for transportation.

Proponents inside County Hall say the government needs the additional flexibility as Mayor Carlos Alvarez's administration continues ''right-sizing'' Miami-Dade Transit with fewer workers and less bus and rail service.

But opponents say the changes represent the last chapter in a ''bait-and-switch'' with voters who supported the sales tax expecting a massive expansion in rail and bus service, synchronized traffic lights, thousands of jobs and independent citizen oversight.

''It's going to be viewed as a money grab and a bait-and-switch. There's no way around it,'' said Paul Schwiep, a Miami lawyer and appointee to the neutered oversight panel, the Citizens Independent Transportation Trust.

HAHAHAHA -- oh boy that's a knee-slapper, Paul Schwiep on a "neutered" oversight panel.

Oh man.

Hmm, now that I think of it, the laugh's on us:

As a Miami Herald series pointed out last year, instead of ''New Money for New Projects,'' the bulk of the $900 million that has been generated to date has been spent on routine transit agency operations, higher salaries and to repair the underfunded problems of yesteryear.

Proponents, including Commission Chairman Dennis Moss and Transit Committee chairwoman Barbara Jordan, say the county has tried for more than six years to fulfill all of the promises of the 2002 campaign.

Moss said the county admitted its missteps at a highly unusual daylong ''summit'' in November and that now is the time to move forward with a more realistic set of expectations for future expansion.

The problem: The county still doesn't have enough money to operate and maintain the current system without raising fares and billions of dollars in additional taxes over the next 30 years.

A handful of transportation advocates have protested the changes. They are holding out faint hopes that someone will organize a referendum to repeal the tax. But nothing formal has surfaced to date.

If the measure is approved on Tuesday, the county would:

• No longer be bound to complete the multibillion dollar list of rail, bus, road and public works projects in the People's Transportation Plan that voters approved in 2002.

• No longer have to provide a painstaking accounting of how much sales-tax money is being used by the transit agency for everything from repair parts and bug-killing contracts to office rental payments.

• Give the government a lot more flexibility in determining how to blend sales-tax revenues into the budgets of the transit agency and other county departments like public works, the 311 call center and the General Services Administration.

Who needs public transit anyways -- this is the 21st Century!! We can all fly around in jet cars, and jet packs, and -- I don't know -- horse-drawn "jet" carts?

I love the future.

February 27, 2009

Aime, 34 FLW 381, 4th DCA, Manslaughter with a firearm, evidence insufficient to support conviction where state failed to establish that the def was the shooter or aided and abetted in the shooting - def convicted of manslaughter with f/a as lesser included offense of first degree murder did not waive to raise sufficiency of evidence of manslaughter by failing to object to state's request for instruction of necessarily LIO

Reyes, 34 FLW 396, 3rd DCA, ofc had well founded suspicion justifying the investigatory stop where, upon approaching the defendant, officer noticed that the scooter had no key, def was nervous and sweating, he was coming from the direction of the scooter store, ofc had knowledge of recent scooter thefts in the area and he stated the scooter belonged to a friend whose name and address he did not know - ofc conducted a pat down and felt no weapon in def's clothing ofc actions in reaching into the pocket and retrieving driver's license was not valid - trial court properly suppressed evidence regarding def's identity, before the def arrested other ofc ran check on scooter's VIN and discovered that scooter belonged to the scooter store, evidence regarding ownership of the scooter was erroneously suppressed - evidence was secured independently from pat down search and was legally obtained followed valid investigatory stop and temporary detention

Kanji, 34 FLW 411, 5th DCA, denial of expungement, discretion of court to deny in not unfettered, remanded where no reason was given for the denial for the lower court to either grant or give reasons for denying the petition

Also, three cases about DHSMV cases about different issues where writs of cert granted by the trial court was overturned, cases more important for those who handle administrative hearings in refusal cases, Nader, 34 FLW 414, 2nd DCA, Escobio, 34 FLW 417, 2nd DCA, Yankey, 34 FLW 418, 2nd DCA.



The Law Offices of Roger P. Foley, P.A.

Come Back to the Five and Dime, Bowman Brown, Bowman Brown.

Oh Bowman Brown, why have you left us all alone?

Where will we get all of our super easy Stanford scandal posts? Will we have to put some effort into this blog again? Oh hail.

Let’s take a wistful look back at the evolution of a media anecdote writ large:

Our story begins on February 17, when the breaking news of the scandal emerged, with this quote from Brown:

''The Miami operation was an important focal point for international investors, especially from Latin America'' said Bowman Brown, a Miami attorney, who has several clients who bought CDs from the loosely regulated Antiguan bank. ``The consequences, particularly in Venezuela and also in Colombia and other Caribbean jurisdictions, will be significant.''

By Sunday, February 22, however, this blockbuster anecdote appeared in the Palm Beach Post:

During the 1980s, Stanford came calling at the office of Miami attorney Bowman Brown, a respected banking lawyer with the Shutts & Bowen law firm. Stanford needed help setting up a new venture.

"He wanted to set up an offshore operation with an office in Miami that would not be regulated by U.S. regulators," Brown said.

Suspicious, Brown declined the job.

Stanford ended up going elsewhere for legal help, and established the Miami office of Stanford International Bank of Antigua. The bank grew to three floors of an office building in downtown Miami. But around town, the Stanford bank's credibility wasn't high.

"It was an open secret in the banking community that the business model wasn't right," Brown said. "If you're paying above market rates and have a small accounting firm in a jurisdiction where they don't heavily regulate banks, and the process involves putting money into a black box and it comes out enhanced ... something is wrong."

About nine months ago, Brown said he saw Stanford in the elevator of his building, and Stanford bragged about the billions of dollars under management. But Brown got the last laugh. Last week, the Securities and Exchange Commission charged Stanford with orchestrating an $8 billion fraud selling high-yield certificates of deposit in his Antiguan bank. The SEC froze the assets of three of the companies Stanford controls: the bank; Stanford Group Co., a broker-dealer; and Stanford Capital Management, an investment adviser.

All Brown can say now is: "I am so glad I took a pass."

Ahh, a delicious war story, one of the best in my opinion.

The story of Bowman's Nostradamus-like good judgment was picked up everywhere, with inevitable TV interviews, and by the time the DBR picked it up, the story had this additional detail:

"What he wanted to do was just not workable in my view, it was not anything I wanted to be near," Brown said. "I told him that I couldn't help him, so he went across the street and found somebody who could and set up in Miami."

Now we know Shutts & Bowen (and Stanford's offices) are located in the Miami Center. And the American Lawyer reported this about Stanford's counsel:

One issue in particular, though, is relevant for the Am Law community: that an attorney for the company, Thomas Sjoblom of Proskauer Rose, sniffed out the fraud, withdrew his representation, and told federal investigators he essentially took back everything he had told to them in recent weeks, according to Bloomberg.

Sjoblom didn't return calls for comment, nor did Richard Razook of Hunton & Williams, another attorney reportedly representing Stanford.

Richard's office is not "across the street," it's well down the street on Brickell, and thus the mystery remains.

So by my estimation there are at least two more news pegs to this great anecdote -- (1) just who Bowman was vaguely alluding to without really identifying anyone in particular; and (2) the indignant denial by whoever the lawyer is that Bowman didn't specifically identify.

Come on folks, these posts don't write themselves. Give a brother a hand, will ya?

Put Down That Crackberry, You Plebes!

We've discussed before the social disconnect that many of us have with everyone else in our lives due to the constant, incessant demands of technology.

Here's a nice summation I came across today:

We are having distracted bits and pieces of conversation via text to people who aren't with us, which of course makes us have distracted bits and pieces of conversation with the people who are. We all go about our lives now with one foot in the invisible realm of our e-social lives. Admit it, if you're out with a friend and they get up to go to the bathroom, the first thing you do is reach instinctively for your PDA/phone, when you used to just sit idly and people-watch. Because even when it's quiet, it never stops whispering at you from your pocket or your purse: "cheeeeck meeeee. I could be that person who blew you off, finally coming to my senses. I could be that work email you've been waiting for. I could be that invitation to something better than where you are now." It whispers, it calls to us, it is both our social wellspring and the black hole devouring The Now.

I thought a brilliant film exploring this very disconnect was Ridley Scott's overlooked A Good Year, where during the course of the film Russell Crowe learns how to disengage, drop the Treo, and not coincidentally fall in love both with the gorgeous Provence countryside and a captivating local French waitress.

In Jeremy Rifkin's The Age of Access, the Wharton scholar warned us nearly a decade ago:

... while we have created every kind of labor- and time-saving device and activity to service one another's needs and desires in the commercial sphere, we are beginning to feel like we have less time available to us than any other humans in history.

... The network-based economy does indeed increase the speed of connections, shorten durations, improve efficiency, and make life more convenient by turning everything imaginable into a service. But when most relationships become commercial relationships and every individual's life is commodified twenty-four hours a day, what is left for relationships of a noncommercial nature -- relationships based on kinship, neighborliness, shared cultural interests, religious affiliation, ethnic identification, and fraternal and civic involvement?

Who the hail cares -- see you all on Twitter!

Jackie Bueno Sousa, Legal Scholar.

Hi folks, what a pleasant surprise -- a few more days of sweater weather! Enjoy it while it lasts....

Like her Herald brethren Glenn Garvin, new local conservative Herald columnist Jackie Bueno Sousa is also a legal scholar.

The problem -- yawn -- big jury awards!

Zzzzz.....

(Sorry, I fell asleep there for a moment....)

The solution, like any intellectually rigorous conservative will tell you, involves the state taking the money from the risk-taking individual and giving it to the government:

One method several states have used is a concept called split recovery: The plaintiff only gets a portion of the award, while the other portion goes to a fund created by the state, to be used for a public purpose.

Here's my solution -- give all the money to Alex Alvarez. Frankly, that makes a lot more sense then giving it to the government. Sheesh, what is it with conservatives lately?

Better yet, give Alex Alvarez your column because this is utter crap.

Oy, I feel like I am back listening to South Florida talk radio from the 70s......Normie help me out here.....next up on Steve Kane, Jews vs. slightly more reformed Jews, and then Alan Burke will host an abortion debate!