Sunday, May 31, 2009

DOJ's RICO Win Against Tobacco

The Justice Department has won a big victory in the U.S. Court of Appeals for the D. C. Circuit. In U.S.A. v. Philip Morris et al. the court
opinion upheld the 1,742 page opinion by District Judge Gladys Kessler finding the defendant tobacco companies liable under the federal Racketeer Influenced and Corrupt Organizations Act. (RICO) Some modifications were made regarding remedies.

The manufacturers and the Tobacco Council appealed from a judgment that they are "liable for conducting the affairs of their joint enterprise through a pattern of mail and wire fraud in a scheme to deceive American consumers." As Judge Jed Rakoff once remarked of Federal prosecutors mail fraud is "our Stradivarius". It was played well here but one would pick up a 1,742 page set of findings of fact about as slowly as one would a Stradivarius.

Fortunately there is an alternative. The findings have been extracted and aesthe他ically presented by Mike Freiberg, et al. It is a product of William Mitchell Law School's Tobacco Control Legal Consortium: The Verdict Is In: Findings from United States v. Philip Morris, The Hazards of Smoking (2006). It is available here from SSRN.

The headline is the conclusion:

4034. The foregoing Findings of Fact demonstrate that, over the course of approximately fifty years, different Defendants, at different times, took the following actions in order to maintain their public positions on smoking and disease-related issues, nicotine addiction, nicotine manipulation, and low tar cigarettes, in order to protect themselves from smoking and health related claims in litigation, and in order to avoid regulation which they viewed as harmful: they suppressed, concealed, and terminated scientific research; they destroyed documents including scientific reports and studies; and they repeatedly and intentionally improperly asserted the attorney-client and work product privileges over many thousands of documents (not just pages) to thwart disclosure to plaintiffs in smoking and health related litigation and to federal regulatory agencies, and to shield those documents from the harsh light of day.

Of particular note is that although the Justice Department attorneys attacked the role of tobacco defense attorneys (Shook Hardy, et al. prominent among them) (see decade-old reports here and here) the lawyers and law firms were not made defendants. Nor were ethics complaints ever filed against them. Statute of limitations presumably bar action at this point, leaving the story to historians' inquiry.

The decision upholding the findings should provide support for HR 1256 - a bill to bring tobacco marketing within the jurisdiction of the FDA, a Clinton Administration regulatory effort derailed by the Supreme Court in FDA v. Brown & Williamson (2000).

HR 1256 Family Smoking Prevention and Tobacco Control Act

Friday, May 29, 2009

Judge Aldisert - Golden Pen Award

Ruggero Aldisert is a master of legal writing. His Logic for Lawyers, his practical guide to brief writing, his classic work on judicial opinion writing have earned high praise. Of his Logic Justice William J. Brennan said:

"This is a book about legal reasoning or legal logic. While not challenging Justice Holmes' classic statement, 'The life of the law has not been logic; it has been experience,' it offers telling arguments that legal reasoning or legal logic may play an equal or even more significant role in the life of the law..."

The old master (he has had senior status on the U.S. Court of Appeals for the 3rdCircuit for 23 years) recently accepted the Golden Pen Award of the Legal Writing Institute, which is dedicated to improving just that. Judge Aldisert's remarks to legal writing profs are themselves a classic statement about the nature of legal writing:

"You teach what J.L. Austin described in his book, How to Do Things with Words, as “performative utterances.” This is because legal writing is more than describing something. It is designed to produce action, that is to say, to perform. The ultimate object of a lawyer who writes is to have his or her opponent concede or settle, or that failing, to have a court issue an order in his or her favor.

Thus, legal writing is not designed to describe something like a journalist, to report what is true or false. It is not what Austin describes as “to constate” or to give information on an action that has taken place. Instead it is designed to convince, to deter, or to persuade. And all this means is to perform, and thus produce future action.

When you are a judge, or are a law clerk writing for a judge,every document you write is a “performative utterance.” It is writing that concludes with a definite performance, such as “Motion denied” or “Judgment for plaintiff” or “Affirmed” or “Reversed.” Thus, when I say that as a judge I am indebted to you, it is because to the extent you produce lawyers with better writing skills, the better we judges can properly understand the nuances of arguments presented. And the higher degree of understanding we acquire, the higher a quality of fairness and justice ensues."

The current issue of the peer-reviewed Journal of the Legal Writing Institute features Aldisert's remarks and an essay by Mark DeForrest on introducing persuasive writing through Martin Luther King's Letter from a Birmingham Jail.

Thursday, May 28, 2009

Let's Bail Out Legal Services - support for S. 718

The editorial board of the New Jersey Law Journal has lauded as a "step in the right direction" the Civil Access to Justice Act of 2009, S-718 , recently introduced by Sen. Tom Harkin. It would restore Legal Services Corporation funding to 1981 levels: $750 million in 2009 dollars.

The Board observed that "Legal Services was born in the War on Poverty as the Office of Economic Opportunity. It irked many with its early projects challenging Federal and especially state laws and practices that affect the poor, the disabled, military families, and others served by the program. Mobilization for Youth Legal Services (MFY) and California Rural Legal Assistance were emblems of the aggressive legal services litigation that engendered resistance."

Congressional opponents not only cut federal funding for Legal Services, the Board observed They also imposed "practice restrictions — barring class actions, and barring Legal Services-funded agencies from collecting counsel fees — even when fee-shifting statutes warranted an award."

"One of the first programs -Mobilization for Youth (MFY) in New York City - brought the landmark case Goldberg v. Kelly, 397 U.S. 254 (1970), in which the U.S. Supreme Court held that a state could not terminate "public assistance payments to a particular recipient without affording him the opportunity for an evidentiary hearing prior to termination." The concept of fair hearings is now commonplace, and millions of Americans continue to benefit from this decision.

Twenty years later, MFY prevailed in New York v. Sullivan, 906 F.2d 910 (2d Cir. 1990), a class action that successfully challenged procedures of the Social Security Administration for evaluating cardiovascular disabilities, the board noted.

Nine years ago MFY gave up federal funding to avoid practice restrictions that would have prevented it from again bringing New York v. Sullivan . Few local legal aid organizations have such an option. All are laboring under severe economic constraints, exacerbated as one of their primary sources of funding — interest on lawyers' trust accounts — has collapsed with the real estate and credit markets."

The Harkin measure, which has 15 senate co-sponsors has been referred the the Health EducationLabor andPensions Committee. For the text and current status of S 718 check out Open Congress here.

Although the omnibus appropriations bill signed by President Obama on March 11 gave Legal Services a $40 million increase, the programs remain hobbled by the collapse of the housing markets - and interest rates- an ironic result of the Fed's efforts to stabilize the financial system. Legal Services agencies have depended heavily on interest on lawyers' trust accounts. The courts collect the interest on lawyers trust accoount balances during the brief period between deposit and disbursement of routine transations like house closings.

To learn about the work of Legal Services go to the website of LSC - the national legal services corporation.

Tuesday, May 26, 2009

A sixth Catholic on the Supreme Court?

Sonia Sotomayor was raised Catholic and went to parochial grammar school and the diocesan Cardinal Spellman H.S. in the Bronx. Does that make her the 6th Catholic on the Supreme Court?

Justice Antonin Scalia, who went to Xavier H.S. in Manhattan (when they still wore military tunics), attends a Latin mass every Sunday. He may not be impressed with Sotomayor's Christmas and Easter cultural Catholic presentation.

Manya Brachear - the Chicago Tribune religion reporter - discussed it on her blog with Notre Dame lawprof Cathleen Kaveny:

A sixth Catholic with views like Sotomayor’s also would put the American church’s diversity on display.“My guess is she’s very much operating in accordance with the commitments of the Catholic social justice tradition which is emphasizing … inclusion, solidarity, justice to those least among us,” Kaveny said. “It’s a strand of American Catholic teaching that is somewhat distinct from other Catholic teaching but not incompatible. People emphasize different aspects.” “‘Different gifts from the same spirit’ to quote St. Paul,” Kaveny added.

Antonin Scalia asserts that as a textualist his Catholicism does not affect his judgecraft. Maybe. But his conception of what his faith and tradition require seems to be worn on his sleeve - particularly in his harsh attack on the majority opinion in the VMI case which compelled an end to single-sex education at the Virginia state military university. See Michael Frost’s Justice Scalia's Rhetoric of Dissent: A Greco-Roman Analysis of Scalia's Advocacy in the VMI Case, 91 Kentucky Law Journal 167 (2002)

Villanova law prof Robert Miller discussses and presents Scalia's 2007 Villanova address on the role of a Catholic judge at First Things blog.

For myself - Vatican II Catholicism affects my teaching and my lawyering: my adherence to the civil rights agenda, to John Courtney Murray's views on religious freedom, to the value of trade unions, opposition to the death penalty, and support of the peace movement agenda on nuclear arms.

Gonzalez: "I'm proud of my service"

Former Attorney General Alberto Gonzalez appeared today on CNN to comment on the nomination of Sonia Sotomayor as an Associate Justice of the Supreme Court.

The unfailingly polite Wolf Blitzer asked if he was afraid that Justice Department lawyers who wrote the torture memos would be subject to discipline.  Gonzalez responded that he was "afraid that lawyers who gave the best legal advice that they could during a dangerous time for our country" would be punished for it.

The issue rather will be whether they did a competent and diligent job.  Did they, for example, give independent advice.  That will be measured by whether in advising the United States they gave sufficient attention to contrary authority as to enable their client to make an informed decision on the matter of interrogation techniques.  That will include whether they exhibited a "decent respect for the opinions of mankind", as expressed in treaties to which we adhere.

Just Like Family - a keyhole view of the lives of nannies

“It wasn’t her thing to snoop,” said Ms. Blaine, of Claudia, a nanny poking around on the father's desk.... In the absence of any direct discussion of the schedule, Ms. Blaine explained, “she did it to figure it out.”

That describes the author, my step-daughter, as well. Intrigued by her own experience as a Fifth Avenue nanny, socializing with the others in Central Park, she wanted to figure it out: what it meant for the nannies who left their own children behind, for the families they joined - sort of- and the children for whom they cared.

The result is "Just Like Family: Inside the Life of Nannies, the Parents They Work for, and the Children They Love, released this month. You will find an excerpt here.
Featured in today's Times, it is a keyhole view of the lives of three nannies. Tasha will be responding to reader' comments today online.

She will be reading excerpts on Wednesday, June 10 at 6 PM at The Corner Bookstore, 1313 Madison Avenue at 93rd Street.
image: Max Whittaker, NY Times

Wednesday, May 20, 2009

Back to the Ice House? Obama, Brandeis and Federal Preemption

"As Justice Brandeis explained more than 70 years ago, "[i]t is one of the happy incidents of the federal system that a single courageous state may, if its citizens choose, serve as a laboratory; and try novel social and economic experiments without risk to the rest of the country."
Barack Obama, May 20, 2009 - quoting New State Ice Co. v. Liebmann, 285 U.S. 262 (1932)

The White House today issued a Presidential Memorandum to the heads of all federal agencies. It instructs them to spurn the Bush administration's "backdoor federalization" - use of the regulatory preamble to establish federal preemption of state law where neither regulation nor statute explicitly called for it. Obama mandated a review of preemptive regulations taken in the past 10 years:

"3. Heads of departments and agencies should review regulations issued within the past 10 years that contain statements in regulatory preambles or codified provisions intended by the department or agency to preempt State law, in order to decide whether such statements or provisions are justified under applicable legal principles governing preemption. Where the head of a department or agency determines that a regulatory statement of preemption or codified regulatory provision cannot be so justified, the head of that department or agency should initiate appropriate action, which may include amendment of the relevant regulation."

But federalism is a wall on which all can write, as the Bush administration did despite leaving untouched Clinton's 11th hour Executive Order 13132 - Federalism. The first federalists were nationalists. Today's are states righters - except when it comes to litigation costs that business would rather avoid.

Momentum matters in football, and in litigation. Catherine Sharkey and Samuel Issacharoff described that momentum in Backdoor Federalization, 53 UCLA L. REV. 1353 (2006). But the Obama memo combined with the plaintiffs' win in Wyeth v. Levine enables us to say that the Big Mo has stalled if not reversed.

Not all have gotten the message. In Bruesewitz v. Wyeth, 561 F.3d 233, the 3rd Circuit found a DPT vaccine design defect claim to be impliedly preempted by the 1982 Childhood Vaccine Compensation Act- despite the Levine decision. The Circuit rejected the Georgia Supreme Court's contrary conclusion in American Home Products v. Ferrari, 284 Ga. 384 (2008)

States are certainly proving to be a laboratory on the same-sex marriage front as Maine has just demonstrated. But the nationalizing argument is certainly stronger when it comes to governing commerce. As Stephen Sugarman has pointed out liberals flip-flopped on tort law. Once celebrants of the regulatory state that FDR built, in the last three decades they became defenders of state prerogatives in tort law.

One cannot accuse the plaintiffs lawyers of flip-flopping. The American Association for Justice (once the National Organization of Claimants Compensation Representatives, then the Trial Lawyers) [of which I am a long-time member] was built by the `King of Torts' Melvin Belli and then-retired Harvard Law School Dean Roscoe Pound, a New Deal skeptic. John Fabian Witt in Patriots and Cosmopolitans has brilliantly chronicled that history.

Today Obama's regulatory policy czar Cass Sunstein is unlikely to follow the Roscoe Pound model. In `Is Tobacco a Drug? Administrative Agencies as Common Law Courts', 47 DUKE L.J. 1013 (1998) he defended the Clinton Administration's expansive view of FDA jursidiction over tobacco. And his pro-regulatory cost-benefit approach is controversial among those who claim to comprehend it. See, e.g. his Catastrophic Harm Precautionary Principle here.

Tuesday, May 19, 2009

Call to bishops for civility on abortion issue

Turning the abortion debate into a single-issue take-no-prisoners crusade has marginalized Catholic influence on the issue according to John Langan, S.J., Rector of Georgetown's Jesuit community. He spoke out at a recent seminar on Capitol Hill sponsored by Catholic University, National Catholic Reporter

In remarks delivered two weeks before Barack Obama struck a comparable note at Notre Dame's commencment Fr. Langan, the Cardinal Joseph Bernardin Professor of Catholic Social Thought, said:

"The bishops are certainly right to condemn the moral evil of abortion and to warn us against the individualism, selfishness and greed which have had such a devastating effect on American culture and family life as well as on our financial institutions,” he said.

“But if they think they make their witness more credible and more effective by developing a quasi-excommunication of the Democratic Party and by aligning themselves with politicians who think that combining pro-life slogans with American chauvinism and exercising American military power without regard to international criticism constitutes an adequate response to evil in the world, they are sadly mistaken,” he added.

Bishops who try to make abortion the sole or overriding political issue for Catholics are “marginalizing the church’s political influence,” he said.

Monday, May 18, 2009

H.R. 1346 - Medical Device Safety Act of 2009

The FDCA has a provision which expressly preempts state regulations that contradict federal regulatory decisions. Justice Scalia (and a 7-2 majority of the Supreme Court) read that broadly to bar design defect claims against FDA-cleared devices in
Riegel v. Medtronic.

The Institute of Medicine's report The Future of Drug Safety made clear the FDA is neither designed to nor is it competent to determine what design choices the manufacturer could have made. Its passive role is as gatekeeper not designer. The FDA's definition of safe and effective is an unquantified "net benefit" - "better than placebo". Yet the Court found that state product liability actions are barred because FDA approval of a new device essentially satisfied the "reasonably safe product" duty imposed on sellers by state common law.

Lower courts promptly barred claims even for admittedly defective cardiac defibrillators. In re Medtronic, Inc., Sprint Fidelis Leads Product Products Liability Litigation, 592 F. Supp. 2d 1147 (D. Minn. 2009) (MDL Proceeding)

Now Henry Waxman, sponsor of H.R. 1346 - the Medical Device Safety Act of 2009 - proposes to reverse that decision. (see Open Congress status widgets below)

House Energy and Health subcommittee hearings were held May 12. The complete record including videos and prepared testimony can be found here.

Witnesses were:
  • David Vladeck, J.D., Professor of Law, Georgetown University Law Center
  • William H. Maisel, M.D., M.P.H., Director, Medical Device Safety Institute, Department of Medicine, Beth Israel Deaconess Medical Center, Boston
  • Gregory Curfman, M.D., Editor, New England Journal of Medicine
  • Bridget Robb, Gwynedd, Pennsylvania
  • Richard Cooper, Partner, Williams & Connolly LLP
  • Michael Kinsley, Seattle, Washington

"Disbar the torture lawyers"?

I am not committing myself on the legal merits of the effort but here is the website of Velvet Revolution's campaign to "disbar the torture lawyers". It provides the disciplinary complaints they have filed against Bush administration lawyers who were policy architects or authored the notorious memos, and the key documents.

As a teacher of professional responsibility I will withhold judgment until I have studied them. I will acknowledge though that when on his first day in the Oval Office President Obama stood with the admirals who had pressed the issue and signed the executive order that interrogations must adhere to law - to the Army field manual - tears welled up as the weight of shame lifted.

And I voted with the majority on a yet-to-be-published editorial in the New Jersey Law Journal entitled Enabling Torture. It concludes:

"Law is powerful and lawyers who construe and implement law have extraordinary power. If that power is used to enable torture, criminal punishment and professional discipline may well be warranted."

p.s. - 12/1/2009 A coalition of NGO's has filed more state bar complaints against lawyers in the Bush administration. The documents can be found HERE

Obama at Notre Dame

Abortion. Choice. Planned Parenthood. Life.

The debate has divided the American polity for forty years. The dominant opinion has ben "pro-choice". The Catholic hierarchy has so staked its case on "pro-life" that those who disagree on banning abortion have been banished from campuses and barred from receiving Communion - the central sacrament of Catholic practice.

I attended a commencement a few years ago. The speaker (I don't remember who) said he would be brief. He had once before given such an address. He asked his son if he remembered who had spoken at the son's commencement. NO, the son responded. "It was me", said the father. That won't happen to those who graduated from Notre Dame yesterday.

Barack Obama, in language that reminds me of his speech on race, has sought to bridge the divide - without claiming it can be erased. The full text is here. An excerpt follows. The video is on the Notre Dame site, as is Judge John Noonan's address.

As I considered the controversy surrounding my visit here, I was reminded of an encounter I had during my Senate campaign, one that I describe in a book I wrote called The Audacity of Hope. A few days after I won the Democratic nomination, I received an email from a doctor who told me that while he voted for me in the primary, he had a serious concern that might prevent him from voting for me in the general election. He described himself as a Christian who was strongly pro-life, but that’s not what was preventing him from voting for me.

What bothered the doctor was an entry that my campaign staff had posted on my website - an entry that said I would fight “right-wing ideologues who want to take away a woman’s right to choose.” The doctor said that he had assumed I was a reasonable person, but that if I truly believed that every pro-life individual was simply an ideologue who wanted to inflict suffering on women, then I was not very reasonable. He wrote, “I do not ask at this point that you oppose abortion, only that you speak about this issue in fair-minded words.”

Fair-minded words.

After I read the doctor’s letter, I wrote back to him and thanked him. I didn’t change my position, but I did tell my staff to change the words on my website. And I said a prayer that night that I might extend the same presumption of good faith to others that the doctor had extended to me. Because when we do that - when we open our hearts and our minds to those who may not think like we do or believe what we do - that’s when we discover at least the possibility of common ground.

That’s when we begin to say, “Maybe we won’t agree on abortion, but we can still agree that this is a heart-wrenching decision for any woman to make, with both moral and spiritual dimensions.

So let’s work together to reduce the number of women seeking abortions by reducing unintended pregnancies, and making adoption more available, and providing care and support for women who do carry their child to term. Let’s honor the conscience of those who disagree with abortion, and draft a sensible conscience clause, and make sure that all of our health care policies are grounded in clear ethics and sound science, as well as respect for the equality of women.”

Understand - I do not suggest that the debate surrounding abortion can or should go away. No matter how much we may want to fudge it - indeed, while we know that the views of most Americans on the subject are complex and even contradictory - the fact is that at some level, the views of the two camps are irreconcilable. Each side will continue to make its case to the public with passion and conviction. But surely we can do so without reducing those with differing views to caricature.

Sunday, May 17, 2009

Vioxx: Australia trial - deja vu

Tufts University cardiologist Marvin Konstam
was lead author but made made "no significant contribution"
to a Merck-financed 2001 article in a leading journal that discounted
Vioxx health risks.

The Australian, a leading daily newspaper - and Wall Street Journal affiliate - has excellent coverage of the current Vioxx trial there. There are many demonstrations of marketing's triumph over science like those familiar to me from my work for plaintiffs in McDarby v. Merck: the hard sell, the misleading marketing, the wining and dining of doctors, the struggle with regulators. The Australian's index page for Vioxx is here

The current Vioxx trial in Federal Court replicates in may ways the U.S. experience: Merck struggling - with considerable success - to get regulators to soften the warnings, pointing to and developing the ambiguities in the medical evidence.

It is a much easier thing than one might think. Scientists are so imbued with fealty to the null hypothesis that it is rare to see them state a conclusion with any definiteness. Evidence always suggests, never shows, never proves. Thus

"On the witness stand yesterday, Mr Back (of Merck) admitted the company "pushed back" on the wording of the suggested warnings by the TGA in the product information, which was aimed at doctors.

"The company didn't believe (the warning) was supported by the data," he said.

When Mr Back, who is now the company's associate director of regulatory affairs, was asked by Mr Burnside who the warnings had to be made "palatable" for, he said it was for Ms Loran (a Merck marketing exec in the U.S.).

The court heard that the TGA finally accepted the revisions in November 2001 after Merck successfully changed the warning from Vioxx-specific to just referring to the class of drug.

Lead plaintiff Graeme Peterson, representing more than 1000 other Australians, claims Vioxx caused his heart attack in 2003. He is suing Merck & Co and Merck, Sharp and Dohme for compensation."

For excellent discussion of the issues, take a look at Concurring Opinion for its discussion of "mercketing". And for the particularly serious problem of pharmaceutical companies like Merck's ghost-writing medical literature, see Sergio Sismondo's Ghosts in the Machine.

Thanks to Mass Tort Litigation blog for the tips on Concurring Opinion and Sismondo.