Wednesday, June 2, 2021

The Failed Roundup Gambit

*First published as Multidistrict Litigation and Bayer's Roundup Gambit in Westlaw Today/Reuters Legal

Bayer and the plaintiffs’ lawyers suing it over its popular weed killer, Roundup, are playing a high-stakes, billion-dollar chess match. Like most corporate defendants in Bayer’s position, it wants lawsuits to end.

But finality eludes Bayer for two reasons.

First, non-Hodgkin’s lymphoma, the disease several juries linked to Roundup’s active ingredient glyphosate, doesn’t develop overnight. It takes a while, often 10-15 years after exposure. Yanking Roundup off the market today would still leave Bayer with at least another decade of litigation.

Second, Roundup makes Bayer lots of money. Sticking a warning label on it would hurt the company’s bottom line. Why would consumers risk cancer to kill dandelions?  

Enter Bayer’s elaborate gambit.


Step one: preemption.

Bayer accurately predicted that the Ninth Circuit (despite a relatively conservative panel) would reject its argument that the Federal Insecticide, Fungicide, and Rodenticide Act, fondly known as FIFRA, preempts claims that it failed to warn weed exterminators about the risks of non-Hodgkin lymphoma. In May, the majority in Hardeman v. Bayer ruled that Mr. Hardeman’s failure-to-warn claim was “equivalent to” and “fully consistent with” FIFRA and thus not preempted under the Supreme Court’s 2005 precedent, Bates v. Dow Agrosciences LLC.

While it awaited the Hardeman decision, Bayer worked to manufacture a circuit split elsewhere that might tempt the Supreme Court to weigh in and reconsider Bates. For that, it tapped Dr. John Carson, a Georgia plaintiff who alleged a type of cancer that science has not linked to Roundup, malignant fibrous histiocytoma. Siding with Bayer, the Southern District of Georgia dismissed Dr. Carson’s failure-to-warn claim because FIFRA preempted it. Bayer won.

But that short-term win undermined its overarching goal. So, Bayer sacrificed by entering into a settlement of sorts with Dr. Carson: for $100,000, he would appeal the dismissal and the preemption ruling. Winning on preemption before the Eleventh Circuit would increase the likelihood of Supreme Court review, at least by a little, despite Bayer’s sly pay-to-appeal scheme.

The possibility of a circuit split and complete preemption serves another purpose, too. It acts like a sword of Damocles endangering plaintiffs who haven’t yet settled, haven’t yet sued, or haven’t yet developed non-Hodgkin lymphoma despite using Roundup. Plaintiffs won all three jury trials to date, notwithstanding a bifurcated trial structure that tends to favor defendants. Compared with the mature asbestos cases that led to the derailed Amchem settlement, the Roundup suits are barely entering grade school. But plaintiffs’ fortunes can turn.

Step two: certify a futures class.

Pressing the slimmest of advantages (after all, the Supreme Court grants certiorari in only around 3.4% of civil cases per year), Bayer teamed up with the same amenable plaintiffs’ counsel whose attempt at certifying a futures class last summer ended in a swirl of controversy and a withdrawn motion. Presenting a second, then a third futures class proposal, they purport to shelter three groups of class members from preemption’s peril: (1) people diagnosed with non-Hodgkin lymphoma after Roundup exposure that haven’t hired lawyers yet; (2) people who have used Roundup but haven’t yet developed non-Hodgkin lymphoma, and (3) all of their spouses, parents, and dependent children—collectively, the “derivative claimants.”

But the preemption refuge and the benefits last a mere four years. And they come at a steep price. In exchange for notice, medical help, and some streamlined compensation, class members must give up punitive damages and medical monitoring claims, as well as bind themselves (with little wiggle room) to a seven-member science panel’s verdict about whether glyphosate can cause non-Hodgkin lymphoma.

After the four-year détente lifts, few plaintiff’s lawyers would litigate Roundup claims in the face of such weighty impediments.

For the gambit to work, the judge must certify the class. But Judge Vince Chhabria is no pawn and he declined to do so. His brief six-page opinion followed a day-long hearing transparently livestreamed in Brady-bunch boxes for a clamoring public to see.

In both the hearing and the opinion, Judge Chhabria challenged the settlement’s upside: Four years of medical monitoring for a disease with a 10-15 year latency period is “far less meaningful than the attorneys suggest.” Those with later diagnoses “will not be able to request compensation from the fund,” he wrote.

As Judge Chhabria pointed out, problems with the proposed futures class abound, including, most centrally, the constitutionality and utility of notice and the hamstrung tort claims. For plaintiffs, the downsides require “major sacrifices,” he explained.

First, on notice, what value does the settlement add that a well-incentivized plaintiffs’ bar lacks? The proposal allocates up to $55 million for settlement administration and notice costs for five months. Yet, over two years ago, the Wall Street Journal reported that plaintiffs’ lawyers spent an estimated $77.8 million to advertise Roundup lawsuits for eight months.

Setting aside the constitutional impossibilities of notifying future spouses and unborn children, what people need is meaningful information at a meaningful time. Noise fills the world. Our bandwidth is limited.

A Roundup user without cancer is far more likely to mindlessly scroll through whatever notices pop up than to engage and investigate. Someone newly diagnosed with non-Hodgkin lymphoma, however, is hungrily Googling for information and answers.

Second, consider what plaintiffs bestow upon Bayer by giving up punitive damages—absolution. But the alleged bad behavior continues. Imagine fining attempted murderers and freeing them to continue their spree. Roundup still lines store shelves and if it does what plaintiffs contend, it will endanger public health for decades to come.

Third, class members must litigate under the umbrella of the science-panel’s findings. “But the reason Bayer wants a science panel so badly is that the company has lost the ‘battle of the experts’ in three trials,” wrote Judge Chhabria.

It is possible that the parties will attempt yet another class settlement geared toward only those Roundup users who have non-Hodgkin lymphoma but no lawyer. Still, what is the upside to the court? Frame it in terms of class superiority: Is certifying a class better than the other ways courts can fairly and efficiently resolve plaintiffs’ claims? Judge Chhabria already faces a scrum of centralized lawsuits. And certifying a class will not end disputes.

Despite a settlement class in the NFL Concussion cases, litigation continually bubbles up, most recently in terms of Black players alleging class settlements show bias. Despite a settlement class in BP’s Deepwater Horizon Oil Spill, over 6,300 clean-up workers have continued to sue over latent injuries like blood-related cancers from chemical dispersants through the settlement’s back-end litigation option. Despite a settlement class in Diet Drugs, 50,000 would-be class members opted out, claims overwhelmed the class, and litigation before the same judge continues today—21 years later.

There is no neat end game in sight for Bayer or the courts, even as it debuts its five-point plan to reassure stockholders. Remanding cases once common discovery ends and taking up the old saw of trial may sound antiquated in the face of futuristic procedures that promise the next best thing. Yet, it has worked for centuries. Perhaps it’s just that the weeds always seem greener on the other side.

June 2, 2021 in Mass Tort Scholarship, Preemption | Permalink | Comments (0)

Wednesday, January 22, 2020

Symposium on New Frontiers in Torts: The Challenges of Science, Technology & Innovation at Southwestern Law School in Los Angeles

The Southwestern Law Review Symposium, New Frontiers in Torts: The Challenges of Science, Technology, and Innovation, will take place on Friday, February 7, 2020 at Southwestern Law School in Los Angeles.  The Symposium is the inaugural event of Southwestern Law School’s Panish Civil Justice Program, which was endowed by one of the country’s leading trial lawyers, Southwestern Law School alumnus Brian Panish.  The Symposium's first panel will focus on tort practice, addressing an eclectic mix of subjects ranging from predictive analytics and e-discovery to scientific evidence and the cognitive science of jury persuasion.  Next, panel two will examine recent trends in financing lawsuits and proposals for changing non-lawyer relationships with law firms.  In panel three, the discussion turns to new forms of tort litigation, including recent developments in multidistrict, complex, class, and toxic tort actions such as the opioid mass litigation, among others.  The fourth panel will examine tort theory, analyzing both how traditional theories can deal with new tort problems and how new theories may help place old quandaries in sharper focus.  The Symposium will also include a luncheon keynote discussion on the past, present, and future of torts.  Registration for the symposium is available now.

Speakers and moderators at the symposium will include the following:

  • Ronald Aronovsky, Professor of Law, Southwestern Law School;
  • Mark Behrens, Partner and Co-Chair, Public Policy Practice Group, Shook, Hardy & Bacon;
  • John Beisner, Partner and Leader, Mass Torts, Insurance and Consumer Litigation Group, Skadden Arps Slate Meagher & Flom LLP;
  • Alan Calnan, Professor of Law, Southwestern Law School;
  • Fiona Chaney, Investment Manager and Legal Counsel, Bentham IMF;
  • James Fischer, Professor of Law, Southwestern Law School;
  • Manuel Gomez, Associate Dean of International and Graduate Studies and Professor of Law, Florida International University College of Law;
  • Michael Green, Bess and Walter Williams Professor of Law, Wake Forest University School of Law;
  • Gregory Keating, Maurice Jones, Jr. – Class of 1925 Professor of Law and Philosophy, University of Southern California Gould School of Law;
  • Richard Marcus, Coil Chair in Litigation and Distinguished Professor of Law, UC Hastings College of Law;
  • Francis McGovern, Professor of Law, Duke Law School;
  • Linda Mullenix, Morris & Rita Atlas Chair in Advocacy, University of Texas at Austin School of Law;
  • Brian Panish, Founding Partner, Panish, Shea & Boyle;
  • R. Rex Parris, Founding Partner, Parris Law Firm;
  • Christopher Robinette, Professor of Law and Director, Advocacy Certificate Program, Widener University Commonwealth Law School;
  • Michael Sander, Managing Director and Founder, Docket Alarm, and Director, Fastcase Analytics;
  • Victor Schwartz, Partner and Co-Chair, Public Policy Practice Group, Shook, Hardy & Bacon;
  • Anthony Sebok, Professor of Law, Yeshiva University Cardozo School of Law;
  • Catherine Sharkey, Crystal Eastman Professor of Law, New York University School of Law;
  • Kenneth Simons, Chancellor’s Professor of Law, UC Irvine School of Law;
  • Byron Stier, Associate Dean for Strategic Initiatives and Professor of Law, Southwestern Law School;
  • Dov Waisman, Vice Dean and Professor of Law, Southwestern Law School; and
  • Adam Zimmerman, Professor of Law and Gerald Rosen Fellow, Loyola Marymount University Law School Los Angeles.

January 22, 2020 in Aggregate Litigation Procedures, Class Actions, Conferences, Ethics, Lawyers, Mass Tort Scholarship, Preemption, Procedure, Products Liability, Punitive Damages, Science, Trial | Permalink | Comments (0)

Wednesday, August 21, 2019

Douglas Smith on a Shift in the Preemption Landscape

Douglas Smith (Kirkland & Ellis LLP) has posted to SSRN his article, A Shift in the Preemption Landscape?, Tenn. L. Rev. (forthcoming).  Here is the abstract:

This article discusses the Supreme Court's recent decision in Merck, Sharp & Dohme v. Albrecht and its effect on the law of preemption. The Supreme Court held that judges, not juries, should decide preemption questions. It also issued a series of non-binding statements regarding the standards for preemption. This article discusses the Supreme Court decision and its potential effects on future cases.


August 21, 2019 in FDA, Preemption, Products Liability | Permalink | Comments (0)

Thursday, September 5, 2013

Wall Street Journal Editorial on Innovator Liability in Alabama

The Wall Street Journal editorial, Innovator Liability, Take Two, discusses the Alabama Supreme Court's reconsideration this week of innovator liability.


September 5, 2013 in Pharmaceuticals - Misc., Preemption, Products Liability, Regulation | Permalink | Comments (0) | TrackBack (0)

Wednesday, July 3, 2013

Justice Kagan Interview

You can find an interview with Justice Kagan here.  


At around 20:52 you can see her speaking about Italian Colors and then whether this is a pro-business Supreme Court.

Note the caveat then the description and what looks like a "yes".  She says:

"None of us decide cases based on who the parties are.  Its not like the Chamber of Commerce appears in court and you say I like the Chamber of Commerce...or a consumer appears in court and you say I like consumers or they need more protection or they don't.  I mean, I think people look at the individual cases before them.  But I do think in a number of cases with respect to a number of areas of law there is a majority of the court that has a set of legal views that, you know, provide some significant relief from both federal and state regulation to businesses.  So if you look at just even the last couple of weeks of the term there were a couple of cases in which the Court very restrictively read anti-discrimination laws, made it harder to bring anti-discrimination suits.  There was another case where the Court made it harder for local governments to put conditions on development permits or to do environmental mitigation of some kinds.  There was another case where people made it -- where the Court made  it -- much harder for injured plaintiffs who have had terrible reactions to various kinds of pharmaceutical drugs to sue for injury.  So I think there were a number of cases where the Court made it more difficult for injured persons to come to court and to use federal and state law to hold business to account for injuries that they've done."

At 31.09 Toobin asks her about public opinion's effect on the Court - do they read polls?  Her answer, not really any more enlightening than you'd think it would be:

"I don't think we read polls like that and I don't think polls influence what we do, but you know, on the other hand, we live in a world and I think...all of us are products of that world and understand things that are going on with it.  And I think it would just not be right to say that the trends in what people think and societal attitudes don't affect what the Court does."


July 3, 2013 in Current Affairs, Preemption | Permalink | Comments (0) | TrackBack (0)

Monday, January 21, 2013

Skadden Analysis of 2013 Potential Developments in Global Litigation

Skadden has issued a useful analysis of upcoming cases to watch and potential developments for 2013 in class actions and product liability.  The analysis includes contributes by Skadden's John Beisner, J. Russell Jackson, and Jessica Miller.


January 21, 2013 in Aggregate Litigation Procedures, Class Actions, Preemption, Procedure, Products Liability, Punitive Damages | Permalink | Comments (0) | TrackBack (0)

Tuesday, November 16, 2010

Brunet on AT&T (and the NYTimes Coverage of the case)

Edward Brunet, an eminent civil procedure scholar and expert on arbitration, sent the following to me regarding the recent NY Times coverage of the AT&T Mobility case:

            Adam Liptak’s excellent treatment of the AT&T Mobility oral argument would  have been even better if he had just used this word:  FEDERALISM..

            The case and context of this case scream out unforgivable breaches of federalism policy.  Both the Times coverage and oral argument undervalue federalism theory

            The dispute is not one about state regulation of class action arbitration.  Rather, the case concerns a dispute of state contract interpretation and asks simply whether the cell phone contract’s ban on class actions is unconscionable.  This is a state contract law issue, traditionally left to the state because of respect  for state common law regulation.  There is very little federal contract law.  Alternatively, the issue presented is one of consumer protection, a subject matter also left to state regulation. This litigation involves a double dose of federalism deference to the states based on questions of contract law and consumer protection

            This analysis appears to have been understood by Justice Scalia who nicely asked whether the Supreme Court would “tell the State of California what it has to consider unconscionable?”

            There exists a textual basis to reach the same result for the respondent.  Under section 2 of the FAA the courts are to treat arbitration agreements as enforceable, except when matters of state contract law require a contrary result.  The end of the prior sentence, termed the “savings clause of the FAA,” should control this case.  Essentially section 2 requires that a court enforce as written agreements to arbitrate unless some rule of state contract doctrine(e.g., adhesion , covenant of good faith and fair dealing, unconscionablity, or lack of mutuality) requires the opposite result. Here the California Supreme Court offered what should have been the last word on the subject  Its ability to do so advances federalism values in a collaborative manner not unlike the interactive federalism notions set forth by Professor Robert Shapiro.

            This case has nothing to do with preemption despite the efforts of AT&T”S counsel to twist the case out of context.  There is no difference between California’s law of unconcionability and federal law presented.  Indeed, there is no relevant federal conflicting norm involving unconscionability.  That should have been the end of the matter but kudos to AT&T counsel for a great job of (mis)framing the issue here to try to take advantage of a lame and disappointing group of arbitration preemption decisions.  The Casarotto opinion of Justice Ginsburg  used a strange preemption approach by asking whether arbitration had been “singled out” for special treatment and failed to follow a more conventional “obstacle” test used several years earlier by Chief Justice Rehnquist in the Volt decision.  Under either test the respondent should prevail here  The interpretation of the contract ban on class actions fails to single out arbitration and represents little threat to the FAA.

            Readers who want more should consult the following: Brunet, The Minimal Role of Federalism and State Law in Arbitration, 8 Nev. L.J. 326 (2007) (arbitration symposium), Brunet, Speidel, Sternlight & Ware, Arbitration Law in America: A Critical Appraisal (Cambridge 2007); Robert Schapiro, Monophonic Preemption, 102 Nw. L. Rev.(2007).

* * * *

I am a big fan of both Brunet and Schapiro's work.  ADL

November 16, 2010 in Class Actions, Mass Tort Scholarship, Preemption | Permalink | Comments (0) | TrackBack (0)

Tuesday, October 20, 2009

Fall 2009 Newsletter for ABA Mass Torts Litigation Committee

The newsletter is now available and includes articles on Lone Pine orders, public nuisance law, federal preemption, sophisticated user and sophisticated intermediary defenses, the Fake Bad Scale Test, and document review.


October 20, 2009 in FDA, Mass Tort Scholarship, Medical Devices - Misc., Preemption, Procedure, Products Liability, Regulation | Permalink | Comments (0) | TrackBack (0)

Saturday, August 15, 2009

Richard Epstein on Preemption and the Medical Device Safety Act

Richard Epstein (Chicago & NYU) discusses them both in his recent Forbes column.


August 15, 2009 in FDA, Mass Tort Scholarship, Pharmaceuticals - Misc., Preemption | Permalink | Comments (0) | TrackBack (0)

Friday, August 14, 2009

Rollback of Preemption Under Obama Administration

Discussed by Carter Wood at Point of Law.


August 14, 2009 in Preemption | Permalink | Comments (0) | TrackBack (0)

Third Circuit Rejects FDA Preemption for Snapple Consumer Fraud Suit

More from Allison Frankel's short article in Am Law Daily.  Here's the opinion.

UPDATE:  The Consumer Advertising Law Blog has analyzed the opinion (H/t Point of Law).


August 14, 2009 in Aggregate Litigation Procedures, Class Actions, FDA, Food and Drink, Preemption, Procedure | Permalink | Comments (0) | TrackBack (0)

Kyle Logue on Coordinating Sanctions in Torts

SSRNKyle D. Logue (Michigan) has posted to SSRN his article, Coordinating Sanctions in Torts.  Here's the abstract:

This Article begins with the canonical law-and-economics account of tort law as a regulatory tool, that is, as a means of giving regulated parties the optimal ex ante incentives to minimize the costs of accidents. Building on this regulatory picture of tort law, the Article asks the question how tort law should coordinate with already existing non-tort systems of regulation. Thus, for example, if a particular activity is already subject to extensive agency-based regulation, regulation that already addresses the negative externalities or other market failures associated with the activity, what regulatory role remains for tort law? Should tort law in such cases be displaced or preempted? The answer is: It depends. Sometimes, even in the presence of overlapping non-tort regulation, there is a regulatory role that tort law can play, sometimes not. 

For one example, if the non-tort regulatory standard is already “fully optimizing,” in the sense that the regulatory standard (a) sets both an efficient floor and an efficient ceiling of conduct and (b) is fully enforced by the regulatory authority, then tort law arguably should be fully displaced in the sense that no tort remedy should be available for harms caused by such an activity. If, however, the regulatory standard is only “partially optimizing” (for example, it is only an efficient minimum or efficient floor or it is only partially enforced), then tort law continues to have an important regulatory role to play. 

This framework can be used to explain such tort doctrines as negligence per se and suggests circumstances in which there should be a corollary doctrine of non-negligence per se. It also helps to explain recent federal preemption cases involving overlapping tort and regulatory standards. Finally, the framework produces insights for how tort law might efficiently be adjusted to coordinate with overlapping social norms, which are also considered within the L&E tradition to be a form of regulation.


August 14, 2009 in Mass Tort Scholarship, Preemption, Procedure, Products Liability | Permalink | Comments (0) | TrackBack (0)

Wednesday, August 12, 2009

Jason C. Miller on Michigan's Regulatory Compliance Defense

SSRN Jason C. Miller of University of Michigan has posted to SSRN his Note, When and How to Defer to the FDA: Learning from Michigan's Regulatory Compliance Defense, 15 Mich. Telecomm. & Tech. L. Rev. 565 (2009).  Here's the abstract:

Should FDA approval of a drug affect products liability litigation? This remains one of the most debated questions in the law. Although the Supreme Court recently held that state tort law is not forced to defer to the FDA's finding that a drug is safe through preemption, states remain free to defer to the FDA by providing a regulatory compliance defense in state substantive law. Michigan made exactly such a choice in enacting the only complete defense for FDA-approved drugs. Compliance with FDA regulations conclusively establishes a lack of products liability under Michigan law. With preemption seemingly off the table after Wyeth v. Levine, advocates of greater deference to the FDA may use Michigan as a model for legislation in other states. Much can be learned from examining Michigan's law. 

Michigan's regulatory compliance defense properly recognizes that an FDA-approved drug carrying an FDA-approved label should not be considered defective. However, the statute's absolute immunity provides no compensation for injured parties in any circumstance, including situations where the FDA process has failed to protect consumers. This Note examines the question of FDA approval in state tort actions, discusses Michigan's answer to that question, and offers a proposal that would block most private actions against FDA-approved drugs (as Michigan has done), but would allow a state attorney general to bring suits in certain circumstances. The state attorney general model detailed in this Note stakes out a middle ground in the debate over the significance of FDA approval. The proposal recognizes the primacy of the FDA, but also recognizes the need for a back-up that can provide deterrence and compensation in the few cases that slip through the FDA's regulatory cracks.


August 12, 2009 in FDA, Mass Tort Scholarship, Preemption, Products Liability | Permalink | Comments (0) | TrackBack (0)

Monday, August 10, 2009

Bernstein on Implied Reverse Preemption

Anita Bernstein (Brooklyn Law) has recently posted an intriguing article in SSRN entitled "Implied Reverse Preemption."    Here is the abstract:

When they apply the doctrine of preemption, courts refuse to hear claims for personal injury on the ground that adjudication of these claims would be inconsistent with a regulatory scheme. Finding that federal law preempts personal injury in those cases where Congress has not made this declaration overt is an inference about congressional purpose and intent. Because what Congress meant to do does not appear in the words of a statute, implied preemption can be more accurately understood as "inferred preemption."

Current preemption law asymmetrically assumes that Congress sometimes intends to preempt tort liability yet never intends to abandon this kind of preemptive design once undertaken. This assumption is inaccurate, as a study of one exemplar - consumer product safety regulation - reveals. Because old inferences of preemption can grow obsolete and inaccurate after Congress has moved in a different direction, the judge-made doctrine of implied preemption calls for a complementary doctrine of implied reverse preemption.

An elegant idea.  ADL

August 10, 2009 in Preemption | Permalink | Comments (0) | TrackBack (0)

Wednesday, July 22, 2009

The Advance and Retreat of Pre-emption

Was going through some old issues of the ABA Journal and found this interesting article from the May issue -- Business Downturn: As the market tumbles, so does the corporate pre-emption defense, by David G. Savage.  Here's an excerpt:

For much of the decade, business lawyers and the Bush administration insisted state liability laws and state regulation amounted to a costly nuisance and a drag on the economy. They said uniform national regulation of business made more sense, and they urged the Supreme Court to limit lawsuits and to pre-empt state regulations.

For years those arguments were winners. Last year, Riegel v. Medtronic barred most lawsuits against the makers of medical devices. Lawyers for the Bush administration and device makers said state jurors should not be permitted to second-guess Food and Drug Administration regulators once they have approved a device as safe and effective.


July 22, 2009 in FDA, Medical Devices - Misc., Pharmaceuticals - Misc., Preemption, Products Liability | Permalink | Comments (1) | TrackBack (0)

Sunday, July 5, 2009

Robert Rabin on Conflicting Conceptions of Tort Preemption

Rabin_Robert Professor Robert Rabin (Stanford) SSRN has posted on SSRN his article, Territorial Claims in the Domain of Accident Law: Conflicting Conceptions of Tort Preemption, Brook. L. Rev. (forthcoming 2009).  Here's the abstract:

Beginning in 1992, with the landmark decision in Cipollone v. Liggett Group, Inc., the U.S. Supreme Court has decided a burgeoning number of preemption cases, squarely challenging the continuing vitality of tort in many domains of accident law. Cipollone addressed the preemption question in an atypical context. The case did not involve competing claims to territorial authority between a regulatory regime and state tort law. Rather, Cipollone involved a challenge to the continuing viability of tort in the face of statutory directives mandating explicit industry conduct; more specifically, the explicit warnings required in the 1969 version of the cigarette labeling act.

In this article, I begin by revisiting Cipollone to reassess what it has to offer as a foundation for setting the boundaries of regulatory containment of the tort system. Next, I discuss three leading cases from the series of efforts by the Supreme Court to grapple with express preemption clauses in a variety of regulatory schemes. Against this backdrop, I then explore the circumstances under which it might be justified to imply preemption despite the absence of an express provision, with particular reference to the recent Supreme Court decision in Wyeth v. Levine, addressing preemption in the context of FDA regulation of prescription drugs. A concluding note ties the strands together.


July 5, 2009 in FDA, Mass Tort Scholarship, Medical Devices - Misc., Pharmaceuticals - Misc., Preemption, Tobacco | Permalink | Comments (0) | TrackBack (0)

Douglas Smith on Preemption After Wyeth v. Levine

SSRN Douglas Smith (Kirkland & Ellis) has posted on SSRN his article, Preemption After Wyeth v. Levine, Ohio St. L.J. (forthcoming 2009).  Here's the abstract:

This Article addresses the Supreme Court’s recent preemption decision in Wyeth v. Levine. In Wyeth, the Court held that the Food and Drug Act did not preempt a state law tort suit alleging that the labeling for an anti-nausea medication, Phenergan, failed to adequately warn about the risks associated with IV-push administration of the drug. Already, Wyeth has been interpreted by some as sounding the death knell for the preemption doctrine in the context of pharmaceutical products. However, a careful analysis of the Court’s decision indicates that this is far from the case. The majority underscored that its decision was a 'narrow' one based largely on the facts and circumstances before it. In particular, the Court made a point of noting that the record was devoid of evidence that the particular risks at issue had actually been considered by the FDA and that the defendant had thus failed to show that there was an actual conflict between FDA regulation and the state law tort suit. The majority’s analysis therefore suggests that state law tort suits based on an alleged failure to warn are preempted in cases in which the FDA has specifically considered the particular risks at issue and has determined that the pharmaceutical product’s labeling adequately warns of those risks. I argue that the ruling thus construed has significant benefits. As the Court has repeatedly recognized, there is an inherent tension between the congressional establishment of a federal regulatory regime for the labeling of pharmaceuticals and medical devices by experts at the FDA and allowing a jury of ordinary citizens with no specialized expertise to render their own judgment regarding, and in effect overrule, such expert determinations. As several members of the Court have noted, there is a potential danger in allowing these expert decisions to be undermined by state court juries. Moreover, such an outcome may have undesirable indirect effects, such as raising the prices of pharmaceutical products to satisfy state court judgments that are not warranted based on the best available scientific evidence and the potential confusion and inconsistency that may result with juries in fifty-two separate jurisdictions imposing different standards concerning what constitutes appropriate labeling. The Court’s decision properly balances these competing considerations.


July 5, 2009 in FDA, Mass Tort Scholarship, Pharmaceuticals - Misc., Preemption, Products Liability | Permalink | Comments (0) | TrackBack (0)

Monday, June 8, 2009

Tobacco, the FDA, and Preemption

Op-ed in today's Wall Street Journal -- Tobacco and the Tort Bar, by Mark H. Berlind.  Here's an excerpt:

Congress is on the verge of passing sweeping legislation that would empower the Food and Drug Administration (FDA) to regulate tobacco products. Antitobacco activists are cheering, while some tobacco companies are raising the specter of First Amendment violations. Lost in the debate is the fact that this bill will continue to allow consumers to sue manufacturers that fully comply with the FDA's content and labeling rules.


Today's legislation would impose strict limits on tobacco advertising and labeling, mandate stronger warning labels, and require advance FDA approval of any reduced-risk claims. It would also empower the FDA to change cigarettes' content to make them less addictive and lethal.

However, in a little-noticed provision, the bill also expressly provides that "no provision of this chapter . . . shall be construed to modify or otherwise affect . . . the liability of any person under the product liability law of any State." In other words, the regulatory regime that the legislation would establish can't protect companies from tort liability -- even if they rigorously follow every FDA rule.


June 8, 2009 in FDA, Preemption, Tobacco | Permalink | Comments (1) | TrackBack (0)

Wednesday, March 4, 2009

Wyeth v. Levine in the Blogosphere

Scotusblog's summary is linked here. The folks at Drug and Device Law have posted their reactions.  For a counterpoint, you might want to check out Public Citizen's statement on the opinion. 


March 4, 2009 in Pharmaceuticals - Misc., Preemption | Permalink | Comments (0) | TrackBack (4)

Wyeth v. Levine -- Supreme Court Finds No Preemption

I'm sure we'll have more posts about this on the blog, but here's today's opinion, hot off the presses: Download Wyeth_v_Levine_US_Sup_Ct.pdf


March 4, 2009 in Pharmaceuticals - Misc., Preemption, Products Liability | Permalink | Comments (0) | TrackBack (0)