Posted 9:18 AM by Howard Bashman

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May 15, 2008

FDA PRE-EMPTION UNDER SCRUTINY
Democrats Probe Uptick in Federal Clampdown on Liability Suits

By Lawrence Hurley
Daily Journal Staff Writer
WASHINGTON - The Bush administration's expanded use of federal pre-emption when it comes to oversight of drugs and medical devices is now coming under the microscope in Congress.

At a House of Representatives Oversight and Government Reform Committee hearing Wednesday, Los Angeles Democrat Rep. Henry Waxman led the inquisition over the Federal and Drug Administration's increased use of the pre-emption doctrine since 2002.

Waxman, who chairs the committee, and other Democrats claim the FDA is increasingly taking the position that drugs or medical devices that have been approved by the agency are not subject to product liability litigation in state courts. The FDA maintains it is merely trying to ensure there are uniform federal standards.

Democrats have labeled the administration's stance as a form of back-door tort reform.

Hollywood actor Dennis Quaid, testifying about the overdose of the drug-thinner Heparin his twin babies received last year due to a labeling problem - provided a celebrity gloss to an otherwise dry occasion.

The relationship between the FDA's authority and state law is an issue that the Supreme Court is also wrestling with this year.

Testifying on behalf of the FDA, Dr. Randall Lutter, deputy commissioner for policy, maintained Wednesday that pre-emption is a legitimate tool for preventing inconsistent state laws from muddying the legal waters as the agency seeks to create uniform rules around the nation.

He also denied the agency has drastically changed the approach that previous administrations have taken, testifying that the policy "goes back a couple of decades."

Waxman didn't buy that explanation.

He noted that the agency expanded the scope of definition "in a rather tricky way" by adding language "at the last minute" to the preamble of a new regulation on drug labeling in 2006.

"I'm offended by that," Waxman said. "There is a branch of government under the Constitution that's supposed to make laws, and Congress was never asked to change the law."

Lutter said the FDA has authority under the Supremacy Clause of the Constitution to be the primary arbiter of whether a drug or medical device is safe.

As such, the FDA's decision should not be "second guessed" by state courts, which lack the expertise of government scientists and doctors, he added.

Rep. Christopher Shays, R-Conn., attempted to defend the agency, saying he wasn't convinced that the FDA hasn't always had the authority to pre-empt state law.

"I think some of the power has been implicit for a long period of time," he said.

Shays suggested that the FDA's lawyers should provide more details about the history of the agency's use of pre-emption.

But a series of expert panelists - albeit ones picked to testify by Democrats - agreed with Waxman that the Bush administration has taken a different approach to previous administrations.

David A. Kessler, the FDA administrator under Presidents George H.W. Bush and Bill Clinton, testified that the state tort system and the FDA have always worked in tandem to provide consumer protection.

Kessler, trained as both a lawyer and a physician, is a professor at University of California, San Francisco, the university system's medical school.

Acting alone, he explained, the FDA does not have the resources to continue oversight of products once they have been approved.

It's the threat of lawsuits that acts as an incentive for manufacturers to be forthcoming about possible defects, Kessler added.

"The tort system has historically provided a critical incentive to drug and device companies to disclose important information to physicians, patients and the FDA about newly emerging risks," he said.

Putting a human face on the issue was actor Quaid, whose twins nearly died as a result of the Heparin overdose last year at Cedars-Sinai Medical Center in Los Angeles.

A nurse incorrectly gave the babies 1,000 times the amount of blood thinner they needed, in large part because the label on the bottle was very similar to the one that contained the smaller dose.

Quaid has since filed suit against the manufacturer, Baxter Healthcare Corp., which has now invoked the pre-emption argument in a bid to get the case dismissed, he testified.

The FDA has effectively given Baxter "the government's seal of approval, a get-out-of-jail-free card that denies us the right to hold the company accountable," he told lawmakers.

Although the focus of the hearing was on the Bush administration, it is the Supreme Court that has really set alarm bells ringing as far as Democrats are concerned.

By the end of this year it will have heard three cases on pre-emption within months.

In February, the court ruled that plaintiffs cannot file state suits against medical device manufacturers that require pre-market approval from the FDA. Riegel v. Medtronic Inc., 128 S. Ct. 999 (2008).

A month later, the court was deadlocked 4-4 in a case addressing whether state claims that an FDA drug approval was obtained by fraud are also pre-empted. Warner-Lambert Co. v. Kent, 06-1498.

This fall, the court will wade into the issue again when the court decides whether drug lawsuits should be pre-empted. Wyeth v. Levine, 06-1249.

Waxman is already planning to introduce legislation that would make it clear that FDA approval does not pre-empt state law claims, in large part as a reaction to Riegel.

Posted 12:25 PM by Howard Bashman

DAILY JOURNAL NEWSWIRE ARTICLE
http://www.dailyjournal.com
© 2008 The Daily Journal Corporation.
All rights reserved.

Posted with permission. This file cannot be downloaded from this page. The Daily Journal's definition of reprint and posting permission does not include the downloading, copying by third parties or any other type of transmission of any posted articles.

May 12, 2008

Getting on Scalia's Good Side

By Brent Kendall
Daily Journal Staff Writer

WASHINGTON - Vocal and persistent, Justice Antonin Scalia can be a source of deep anxiety for counsel during Supreme Court oral arguments, but he's an attorney's best friend in a new book aimed at making lawyers better advocates.

Along with author Bryan Garner, Scalia has penned "Making Your Case: The Art of Persuading Judges," a lightly written and often entertaining book that offers a panoply of tips on how to truly influence the men and women behind the bench - or at least how not to annoy them.

The slim 200-page book is broken into 115 sections of straightforward advice for briefing and oral argument that can improve any lawyer's chances of courtroom success. The tips at times may sound simple, but they can be tough to master: Never overstate your case. Face up to bad facts and don't duck tough questions. Be civil, likable and trustworthy. Skip the legal jargon in your writing, and make it interesting, organized and clear.

Scalia, sitting down with the Daily Journal in his chambers last week, said the biggest lesson lawyers should take from the book is the need to keep a clear focus on the principal job of an advocate.

"Your job is to help the judge, to make it as easy as possible for the judge to understand the case and to come out your way," Scalia said. "And anything that stands in the way of that is to be avoided."

"In a way, I'm feathering my own nest," Scalia said of the book. "To the extent you can get the lawyers to do a better job, the judge's job is easier."

Scalia and Garner spent 18 months on the book, and after a few preliminary meetings to sketch out their plan, the authors each took a crack at the first draft before melding their work together.

"It was genuinely a co-authored book," said Garner, editor in chief of Black's Law Dictionary and founder of LawProse, a company that provides seminars on legal writing and editing. "We were working on the same sections simultaneously, not knowing what the other would say."

Along the way, they received input from 47 judges and lawyers who offered eye-opening insight that made its way into the book, Scalia said.

Scalia, for example, said he learned that many judges prepare for cases by "retro-reading," reading legal briefs in reverse order, the reply brief first, then the responding brief and the opening brief last - just the opposite, of course, of what a lawyer would expect.

"I knew one judge who did that and I thought it was sort of weird," he said. "But it turns out, as we learned from consulting with these other people, that there are a lot of judges who do that. I think it's a dirty thing to do to counsel, but there's no doubt that it tells you right at the outset what the case is about."

A key piece of advice that the authors emphasize throughout the book is the need for lawyers to be as succinct as possible.

The best lawyers, they say, focus tightly on their strongest arguments, say what they need to say and then stop, even if they're well short of their word limit. Attorneys with a reputation for brevity, they say, will discover that judges read their briefs more closely.

"You can learn to do that right away," Scalia said. "Just squeeze all of the water out of each page. My law clerks, if there's one big message they learn here, it's that."

Other advice may take longer to learn.

Scalia and Garner write that a lawyer's only tool of persuasion is language, so he must develop an appealing style of writing and acquire a broad vocabulary - attributes that won't be developed from reading a steady diet of judicial opinions, "which are widely read not, heaven knows, because they are well written but because they are authoritative."

Lawyers, they say, can learn to write by reading good prose. The authors quote 7th U.S. Circuit Court of Appeals Judge Frank Easterbrook: "See if you can write your document like a good article in The Atlantic, addressing a generalist audience."

"That's easy advice to give, hard advice to take," Scalia said with a smile. "How do you make an ERISA case interesting? Well, you do your best. You at least make it clear, and not try to obfuscate it by using a lot of legal mumbo-jumbo."

While Garner says the level of advocacy in America "is not what it ought to be, generally speaking," Scalia says the book should not be read as an indictment of lawyers.

"I didn't mean it to be that," Scalia said. "I can't recall anything I wrote where I had a particular lawyer in mind. But they are all inadequacies that over the years I've seen in various counsel."

He said that in his own personal experience, "I've always thought, by and large, the lawyers do a good job."

Perhaps one of the most striking things about the book is Scalia's insistence that oral argument matters a great deal, a view that runs contrary to the belief among some court watchers that argument sessions are more show than substance.

"Oh yeah, I'm a big fan," said a laughing Scalia, who has a well-deserved reputation as the liveliest and most colorful justice on the bench.

"It rarely changes your mind, but often your mind is not made up when you go in," he said. "And in close cases, oral argument can very often make the difference."

When asked to name a rule from the book that lawyers break most often, Scalia doesn't hesitate.

"The refusal to answer questions," he said. "The thinking that you've scored a point or gotten away with something if you dance around the question and don't really answer it. That is never a success and it's always a failure. It is so often that a judge has to ask, 'Is that a yes or a no?'"

Despite its focus on core principles, "Making Your Case" offers many small nuggets of advice as well, and they're often entertaining.

For example, there's this tip on avoiding Latin phrases: "Judges are permitted to show off in this fashion, but lawyers are not."

And this tip on forgoing judicial flattery: "Never - never - patronize a judge by volunteering 'That's a good question.' Of course it is! All judges' questions are ex officio brilliant."

The authors also are not above suggesting that you try to change your personality, if need be: "All of us are more apt to be persuaded by someone we admire than someone we detest. ... Some people, it must be said, are inherently likable. If you're not, work on it. (It may even improve your social life.)"

Scalia and Garner both say they greatly enjoyed working together, but the men did have their differences, and they decided to air them in the book.

Among the biggest? A fight over the use of contractions - can't, won't, hasn't, didn't - in legal writing. Garner thinks it's fine, and even preferable, to use them (they're used in the book), while Scalia does not, arguing that some judges view them as an affront to the dignity of the court.

"I was afraid for a time that contractions would get in the way of our ability to finish the book," Garner said. "I wanted the contractions and he was un-contracting all of my stuff and I was putting contractions into all of his stuff. Finally, he deferred on that point. But he ended up writing a funny note on it."

In the book, Scalia chafed when Garner noted that some leading appellate judges, including 9th Circuit Chief Judge Alex Kozinski, use contractions themselves.

"Life tenure is a wonderful thing," Scalia wrote in response. "Neither they nor any client of theirs pays a price for their contractions. (Kozinski, for Pete's sake, has been known to write an opinion with 200 movie titles embedded within it.)"

Scalia, widely considered to be the best writer on the current Supreme Court, often has said that he likes having written, but not necessarily the writing process itself.

Working on the book, however, was different.

"This has been less painful than most writing," Scalia said. "Maybe because I had a co-author and we incited each other. Maybe also because what I was writing about was not hyper technical. But even so, if you think I didn't sweat over it, you're just wrong."

High Court's Outspoken Justice Weighs In on Several Topics

During an interview with the Daily Journal to discuss his new book, "Making Your Case: The Art of Persuading Judges," Justice Antonin Scalia shared a variety of thoughts on advocacy at the Supreme Court. Here are some of his remarks.

On the quality of Supreme Court advocacy:
"[Former Chief Justice Warren] Burger used to speak often about the inadequate level, especially of oral argument. That's never been my reaction. In fact, quite the contrary. I'm often amazed at how good some of these people from nowhere are - court appointed counsel from Podunk. Some of these people are very good. My reaction is, my God, we're devoting too many of our best minds to this enterprise of the law. This person should be inventing the gasoline-free automobile or doing something else."

On the trend of experienced Supreme Court lawyers landing more cases, at the expense of newcomers to the high court:
"For my own interest and amusement, I guess it's interesting to see different people. But as far as the quality of argument is concerned, people pay a whole lot for these frequent flyers simply because they're worth a whole lot. They are a lot better. Which is not to say that there aren't others who only appear rarely who are just as good. But, the specialists generally are better."

On how a bad oral argument affects the court:
"It always makes the case harder when the side that you think is probably the right side has not been presented well. Sometimes you wish you could give two grades: who wins on the law and who wins on presenting the law. ... It's only when you become a judge and sit on a bench that you realize how appropriate it is for lawyers to be referred to as officers of the court. They really are invaluable. You have bad lawyers, you're more likely to have a bad decision. They are the principal sources of information on both the facts and the law."

On which is more important, brief writing or oral presentation:
"Probably brief writing. Because, as I say, oral argument often makes the difference but the brief - you start off on the wrong foot, that's the first impression you get of the case. It's hard to rehabilitate a case at oral argument that has been badly presented in the brief."

On whether legal briefs should read like a good magazine article:
"I think they should. ... I try to follow my own advice. And what's said about briefs is probably true about judicial opinions. They also should be brief, and anything that is besides the point should just be scratched."

On whether judicial opinions are less eloquent than they were 50 years ago:
"Undoubtedly judges now have more cases in front of them and therefore have more assistants, known as law clerks. And so the product is increasingly a committee product. ... Most of my opinions I let the law clerk do the first draft. The principal part of my job is to delete, to cut it down to the muscle. And generally speaking, the longer the opinion, the less time the judge has spent on it, at least if the judge has law clerks."

On whether other judges would agree with the advice his book offers to lawyers:
"I hope so, and I hope that those that don't will let me know. Someday down the road we may do another edition. ... I'm sure there's stuff we haven't said that some judges think probably should have been said. I would hope to get that kind of feedback from the bench, or for that matter, from the bar. I'm sure there are some practicing lawyers who might read it and say, 'I have another gimmick that I have found very effective.'"