February 1, 2008
More Scholarship on Preemption
Preemption seems to be the topic of the day. In addition to Catherine Sharkey's article "Products Liability Preemption: An Institutional Approach," the following pieces have been posted on SSRN:
Trevor Morrison (Cornell) has posted "The State Attorney General and Preemption" on SSRN. In this book chapter, Morrison
examines the implications of agency preemption for state attorneys general, and vice versa. Its principal intended audience is not so much the courts as Congress and the federal agencies; its prescriptions are less about judicial doctrine (though there are implications along those lines) than about choices the legislature and agencies could make to better accommodate the important functions of democratically accountable state attorneys general. As to Congress, I suggest that it should directly address whether any or all of the work of state attorneys general should be preempted by any particular enactment it passes, and should include a provision making clear the extent of its intent to preempt. As to agencies, I suggest that, in the absence of clear statutory language addressing the question, they should be reluctant to promulgate regulations preempting the investigatory or enforcement authority of state attorneys general. Unlike the Supreme Court's current "presumption against preemption," the approach I advocate does not turn on the particular subject matter of the state or federal law in question. Instead, it focuses on the identity of the actor enforcing the state law.
Peter Schuck (Yale) has posted "FDA Preemption of State Tort Law: Finding the Sweet Spot" on SSRN. He describes the contributions of this paper to the debate on FDA preemption as follows:
First, it augments prior analyses of the comparative institutional competence, going beyond the common emphasis on relative expertise to stress the agency's far greater democratic accountability and policy learning capacity.
Second, having made the case for broad FDA preemption in the drug area, it proposes an exception to FDA preemption that is both broader and narrower than under existing law or the existing scholarship. The exception to preemption would be broader in that it would go beyond fraud on the agency to encompass all disclosure deficits on the part of drug manufacturers, whether fraudulent, negligent, or innocent. The exception to preemption would be narrower in that in order to survive a motion to dismiss, the tort plaintiff would have to meet a hyper-heightened pleading standard requiring greater specificity with respect to both the allegations of disclosure deficit and the supporting factual evidence than that required by the already heightened standard that the Federal Rules of Civil Procedure now imposes on federal court complaints alleging fraud.
The third proposed change concerns the status under state tort law of a regulatory compliance defense, which only Michigan has adopted as a complete defenser state law. Although modifying FDA preemption principles as I propose would block much design and warning defect litigation in state courts (at least prima facie) as a matter of federal law, there is much to be said for also effecting this change as a non-constitutional matter under state tort law by crafting a regulatory compliance defense consistent with my other proposed changes. The paper concludes with a brief discussion of whether FDA preemption, properly designed, would leave a compensation void with respect to those harmed by FDA-regulated drugs.
Merck: Facing Grand Jury Probe and more Vytorin Suits
Merck’s made today’s headlines yet again. The Wall Street Journal Reports that a federal grand jury is investigating whether Merck appropriately handled Vioxx. Here’s a short excerpt:
The grand-jury investigation comes at a time when thousands of plaintiffs are weighing whether to enroll in the pending settlement.
"The potential of an indictment can clearly be an incentive for [Merck] to settle civil cases," said Joseph L. Doherty, of Doherty & Quill, a Boston law firm. Mr. Doherty has one Vioxx client, whom he says he hadn't intended to enroll in the settlement. "The mere potential of an indictment probably won't change too many people's minds about whether to enter the proposed settlement."
In February 2007, the Whitehouse Station, N.J., company disclosed in its regulatory filings that the Justice Department issued a subpoena requesting information relating to the company's research, marketing and sales of Vioxx as part of a federal investigation under criminal statutes.
Merck disclosed in that filing that 31 state attorneys general and the District of Columbia are investigating its sales and marketing of Vioxx. The company said it is cooperating with authorities in all of these investigations.
And the Daily Record in Kansas City, Missouri reported last Wednesday that there are more than 50 Vytorin cases pending against Merck in Missouri’s Eastern and Western districts. Several of these suits seek class action status and damages of over a billion dollars. The theory, according to Benjamin Bertram of Bertman & Graf, is that "By not releasing data from the study . . patients were buying Vytorin when they could have had the same results from Zocor for a third of the costs."
January 31, 2008
Vladeck on Direct-to-Consumer Drug Advertising
Professor David Vladeck (Georgetown) has posted his article, The Difficult Case of Direct-to-Consumer Drug Advertising, Loyola L.A. L. Rev. (forthcoming 2008). Here's the abstract:
This article will appear in a symposium to pay tribute to Professor Steven H. Shiffrin, one of the leading First Amendment theorists of our time. The author was asked to focus on Professor Shiffrin’s contribution to the development of the commercial speech doctrine. To reflect on the wisdom of Professor Shiffrin’s refusal to rely on general First Amendment theories, the article focuses on the difficult First Amendment problem of regulating direct-to-consumer (DTC) advertising of prescription drugs. In his famous dissent in Virginia Pharmacy Board, then-Justice Rehnquist forecast that, as a consequence of the Court’s ruling, drug companies would soon advertise directly to consumers on television and other media. Justice Rehnquist argued that “there are sufficient dangers attending” the use of drugs “that they simply may not be promoted in the same manner as hair creams, deodorants, and toothpaste.”
Today drugs are promoted in much the same way as other products. Drug companies devote forty percent of their advertising expenditures — over $4 billion per year — to DTC ads. The average American views as many as 16 hours of prescription drug ads per year, far exceeding the average time spent with a primary care physician. The question is whether proposals before Congress to limit or ban DTC advertising would pass constitutional muster. The article canvasses the arguments in some detail and concludes that legislation restricting DTC advertising to enable the FDA to assess the risks of a drug might withstand constitutional attack, but that an all-out ban on DTC advertising would not likely be sustained. The point of this discussion is to illustrate the complexity of commercial speech questions and to demonstrate that Professor Shiffrin was correct when he observed that “the commercial speech problem is in fact many problems,” and that “the small questions [it poses] will not go away.”
Kessler and Vladeck on FDA Preemption of Failure-to-Warn Claims
Former FDA commissioner David Kessler and Professor David Vladeck (Georgetown) have posted their article, A Critical Examination of the FDA’s Efforts to Preempt Failure-to-Warn Claims, Georgetown L. J. (forthcoming 2008). Here's the abstract:
This article explores the legality and wisdom of the FDA’s effort to persuade courts to find most failure-to-warn claims preempted. The article first analyzes the FDA’s justifications for reversing its long-held views to the contrary and explains why the FDA’s position cannot be reconciled with its governing statute. The article then examines why the FDA’s position, if ultimately adopted by the courts, would undermine the incentives drug manufacturers have to change labeling to respond to newly-discovered risks. The background possibility of failure-to-warn litigation provides important incentives for drug companies to ensure that drug labels reflect accurate and up-to-date safety information. The article next explains why the agency’s view that it is capable of singlehandedly regulating the safety of drugs is unrealistic. The agency does not have the resources to perform the Herculean task of monitoring the performance of every drug on the market. Both the Institute of Medicine and the Government Accountability Office have explained the shortcomings in the FDA’s recent performance, and they express doubt that the FDA is in capable of facing an increasingly challenging future.
The article then explains how state damages litigation helps uncover and assess risks that are not apparent to the agency during a drug’s approval process, and why this “feedback loop” enables the agency to better do its job. FDA approval of drugs is based on clinical trials that involve, at most, a few thousand patients and last a year or so. These trials cannot detect risks that are relatively rare, affect vulnerable sub-populations, or have long latency periods. For this reason, most serious adverse effects do not become evident until a drug is used in larger population groups for periods in excess of one year. Time and again, failure-to-warn litigation has brought to light information that would not otherwise be available to the FDA, to doctors, to other health care providers, and to consumers. And failure-to-warn litigation often has preceded and clearly influenced FDA decisions to modify labeling, and, at times, to withdraw drugs from the market.
January 30, 2008
Reports of Lilly Reaching Settlement with Federal Prosecutors
With all of the attention Merck’s been receiving lately, it’s nice (in an abstract sense) to see some headlines about Zyprexa. The New York Times reported today that Eli Lilly is discussing the possibility of settling civil and criminal investigations by federal prosecutors, with Lilly paying more than $1 billion to federal and state governments. Here’s a bit of the New York Times piece, Lilly in Settlement Talks with U.S.:
Zyprexa has serious side effects and is approved only to treat people with schizophrenia and severe bipolar disorder. But documents from Lilly show that between 2000 and 2003, Lilly encouraged doctors to prescribe Zyprexa to people with age-related dementia, as well as people with mild bipolar disorder who had previously been diagnosed only as depressed.
Although doctors can prescribe drugs for any use once they are on the market, it is illegal for drug makers to promote their medicines any uses not formally approved by the Food and Drug Administration.
Lilly may also plead guilty to a misdemeanor criminal charge as part of the agreement, the people involved with the investigation said. But the company would be allowed to keep selling Zyprexa to Medicare and Medicaid, the government programs that are the biggest customers for the drug. Zyprexa is Lilly’s most profitable product and among the world’s best-selling medicines, with 2007 sales of $4.8 billion, about half in the United States.
Lilly would neither confirm nor deny the settlement talks.
"We have been and are continuing to cooperate in state and federal investigations related to Zyprexa, including providing a broad range of documents and information," Lilly said in a statement Wednesday afternoon. "As part of that cooperation we regularly have discussions with the government. However, we have no intention of sharing those discussions with the news media and it would be speculative and irresponsible for anyone to do so."
Lilly also said that it had always followed state and federal laws when promoting Zyprexa.
The Lilly fine would be distributed among federal and state governments, which spend about $1.5 billion on Zyprexa each year through Medicare and Medicaid.
The fine would be in addition to $1.2 billion that Lilly has already paid to settle 30,000 lawsuits from people who claim that Zyprexa caused them to suffer diabetes or other diseases. Zyprexa can cause severe weight gain in many patients and has been linked to diabetes by the American Diabetes Association.
January 29, 2008
Philip Morris to Spinoff International Operations
Article in the Wall Street Journal -- Philip Morris Readies Aggressive Global Push, by Vanessa O'Connell. Here's an excerpt:
Sitting in his office overlooking Lake Geneva, Philip Morris International Chief Executive André Calantzopoulos takes a long drag from an unusually short cigarette. Called Marlboro Intense, the product has been shrunk down by about a half inch, and offers smokers seven potent puffs apiece, versus the average of eight or so milder draws.
The idea behind Intense is to appeal to customers who, due to indoor smoking bans, want to dash outside for a quick nicotine hit but don't always finish a full-size cigarette. Pointing to his lit Intense, the CEO says there are "possibly 50 markets that are interested in deploying it."
Marlboro Intense is likely to be part of an aggressive blitz of new smoking products PMI will roll out around the globe once the company -- now a unit of New York-based Altria Group Inc. -- becomes a standalone entity. That change will be set into motion tomorrow, when the Altria board is expected to approve a long-awaited decision to split PMI from Philip Morris USA. The move would free the tobacco giant's international operations of legal and public-relations headaches in the U.S. that have hindered its growth.
The separate entity, for example, would be exempt from U.S. tobacco regulations and out of reach of American litigators. Importantly, its practices would no longer be constrained by American public opinion, paving the way for broad product experimentation.
SEALS Mass Tort Related Panels
The Southeastern Association of Law Schools (SEALS) has released a draft of its 2008 meeting program, which is at the Ritz Carlton in West Palm Beach from July 27-August 2, 2008. (If you haven't been before, it's a wonderful conference.) There are several panels that may be of interest to mass tort scholars on Friday, August 1. Tom Metzloff (Duke) has put together a civil procedure workshop that includes a luncheon where Francis McGovern (Duke) will speak about Handling Hurricanes and Other Mass Litigation Problems: Lessons from Katrina, and, later that evening, Bob Klonoff (Lewis & Clark), Lonny Hoffman (Houston), Scott Dodson (Arkansas) and I will speak about Frontier Issues in Civil Procedure. My talk will be on Aggregate Procedural Justice, a piece that’s currently in its nascent stages but is largely directed toward mass torts. Here’s the full tentative civil procedure line up for many of you with broader civil procedure interests. And thanks to Tom Metzloff for all of his efforts in organizing the workshop.
Workshop on Civil Procedure
10:15- 10:25 Welcome and Overview
Workshop Organizers: Professor Thomas B. Metzloff, Duke University School of Law (& SEALS President-Elect); Professor Michael P. Allen, Stetson University College of Law (& SEALS Board of Directors)
10:25- Noon Reflections on the Federal Rules at 70
This panel will address varying perspectives on the history behind and the impact of the adoption of the Federal Rules of Civil Procedure in 1938. Among other issues, the panelists will discuss whether the Rules have been a "success" as well as where they may be headed in the future.
Moderator: Professor Michael Kelly, University of San Diego School of Law.
Speakers: Professor Paul Carrington, Duke University School of Law; Professor Richard Freer, Emory University School of Law; Professor Carl Tobias, University of Richmond School of Law?
Noon- 1:30 Luncheon: Handling Hurricanes and Other Mass Litigation Problems: Lesson from Katrina (ticket required)
This program will be a moderated discussion among academics, practitioners and judges concerning the role of the legal system when facing mass litigation.
Speaker: Professor Francis McGovern, Duke University School of Law.
1:30 - 3:00 Challenges (and Solutions) Teaching Civil Procedure
This panel will discuss the challenges associated with teaching Civil Procedure. The Panelists will suggest innovative means to deal with the topic.
Moderator: Professor Carol Andrews, University of Alabama School of Law.
Speakers: Professor Mary Alegro, Loyola University, New Orleans, School of Law; Professor David Hricik, Mercer University Law School; Professor Benjamin Madison Regent University School of Law; Professor A. Benjamin Spencer, Washington & Lee University School of Law.
3:00-3:15 Break (Sponsored by Aspen Publishing Co.)
3:15-4:45 "The Devil is in the Details" -- The Rules in Operation
This panel will focus on the detailed operation of the Rules as interpreted by the federal courts in a number of contexts including pleadings, discovery and resolution.
Moderator: Professor Trina Jones (invited)
Speakers: Professor Dwight Aarons, University of Tennessee College of Law; Professor Michelle Slack, Southern Illinois University School of Law; Professor Suzette Malveaux, Catholic University of America, Columbus School of Law.
4:45-5:00 Break (Sponsored by Aspen Publishing Co.)
5:00- 6:30 Frontier Issues in Civil Procedure
This panel will address cutting-edge issues in Civil Procedure today. Among such issues are developing class action practice, issues associated with electronic discovery, potential development in notice pleading standards, and personal jurisdiction to just name a few.
Moderator: Professor Louis Virelli, Stetson University College of Law.
Speakers: Professor Beth Burch, Samford University, Cumberland School of Law; Professor Scott Dodson, University of Arkansas, Fayetteville, Leflar Law Center; Professor Lonny Hoffman, University of Houston Law Center; Dean Robert Klonoff, Lewis & Clark Law School.
FDA Difficulties in Inspecting Medical Devices
Article in the Wall Street Journal -- FDA Faulted for Scrutiny Of Medical-Device Makers, by Anna Wilde Mathews. Here's an excerpt:
The Food and Drug Administration can't keep up with requirements to inspect domestic makers of medical devices to assure manufacturing quality, and the agency rarely examines foreign facilities, according to congressional investigators.
In testimony scheduled to be delivered today before a House Energy and Commerce subcommittee, the Government Accountability Office will tell lawmakers that it found "weaknesses" in the agency's oversight of an industry that makes products ranging from contact lenses to defibrillators. According to FDA officials' own estimates, overseas makers of the riskiest products, such as pacemakers, were examined only every six years, and moderate-risk device manufacturers on average went an estimated 27 years between FDA inspections.
The GAO testimony on medical devices will be a part of the hearing's broader effort to highlight an issue that has turned up in reports and critiques over the past few years: concerns the FDA's resources and technology aren't enough to meet its regulatory responsibilities to oversee drugs, food and other products.