Mass Tort Litigation Blog

"Infuse Bone Graft" Linked to Life-Threatening Complications

The FDA has received 38 reports that Medtronic Inc.'s "Infuse Bone Graft," typically used to encourage bone growth in spinal surgeries, causes neck and throat swelling--life threatening injuries.  The Wall Street Journal has a lengthy article by David Armstrong and Thomas Burton on the topic and the related lawsuits.  Here's an excerpt:

Doctors with financial relationships with Medtronic have written favorably about off-label uses of Infuse on Web sites, in medical journals and at educational meetings. Some of the most influential spine surgeons in the country are consultants to the company. Several of them benefit from sales of the product through royalty deals, according to disclosures they have made in professional journals and at medical meetings.

Three "whistleblower" lawsuits brought by former employees have alleged illegal marketing, seeking refunds for the federal government on Medicare and Medicaid payments to the company. The former employees, who share in any recovery under federal law, asserted in the suits that the company paid inducements to doctors to use Infuse and other Medtronic spine products. Medtronic agreed to pay $40 million to settle two of the cases, which were filed in federal district court in Memphis, Tenn., without admitting wrongdoing. One of the whistleblowers has challenged the company's agreement with the federal government, saying the sum is too small.

The lawsuit that hasn't been settled was filed last year in federal district court in Boston by two former Medtronic employees. It alleges that the company illegally marketed Infuse for off-label purposes through doctors who were paid inflated consulting fees and bogus royalty payments. Marketing off-label uses is not allowed under FDA regulations.

ECB

Laura Dooley on National Juries for National Cases

Professor Laura Dooley (Valparaiso; picture, left) has published her article, National , 83 N.Y.U. L. Rev. 411 (2008) Juries for National Cases: Preserving Citizen Participation in Large-Scale Litigation.  Here's the abstract from SSRN:

Procedural evolution in complex cases seems to have left the civil jury behind. The trend toward centralization of cases pending on the same topic in one court results in cases of national scope being tried by local juries; this reality is a catalyst for forum shopping and a frequent justification for calls to eliminate jury trial in complex cases altogether. Yet the jury is at the heart of a uniquely American understanding of civil justice, and the Seventh Amendment still mandates its use in federal cases. This article makes a bold new proposal designed to preserve the constitutional and functional value of citizen participation in the civil justice system by aligning the jury assembly mechanism with the scope of the litigation. Thus, in cases of national scope, juries should be assembled from a national pool. This idea would eliminate incentives to forum-shop into local jury pools, and would make the decisionmaking body commensurate with the polity that will feel the effects of its decisions. We might also expect a higher level of legitimacy for decisions rendered by a national jury in national cases because they would not be subject to the criticism that a local jury is imposing its values on the rest of the country, and because geographical diversification of the jury would enhance the quality of decisionmaking.

BGS

Roger Williams Law Review Symposium Issue on Genuine Tort Reform

The Roger Williams University Law Review has published its symposium issue on Genuine Tort Reform.  Included are the following:

Carl T. Bogus, Introduction: Genuine Tort Reform, 13 Roger Williams U. L. Rev. 1 (2008)

Deborah Hensler, Jurors in the Material World: Putting Tort Verdicts in Their Social Context, 13 Roger Williams U. L. Rev. 8 (2008)

Valerie P. Hans, Empowering the Active Jury: A Genuine Tort Reform, 13 Roger Williams U. L. Rev. 39 (2008)

Peter H. Schuck, FDA Preemption of State Tort Law in Drug Regulation: Finding the Sweet Spot, 13 Roger Williams U. L. Rev. 73 (2008)

Joseph Sanders, Reforming General Damages: A Good Tort Reform, 13 Roger Williams U. L. Rev. 115 (2008)

Ellen Wertheimer, Calling It a Leg Doesn't Make It a Leg: Doctors, Lawyers, and Tort Reform, 13 Rogers Williams U. L. Rev. 154 (2008)

Jay M. Feinman, Incentives for Litigation or Settlement in Large Tort Cases: Responding to Insurance Company Intransigence, 13 Roger Williams U. L. Rev. 189 (2008)

Ross E. Cheit, Tort Litigation, Transparency, and the Public Interest, 13 Roger Williams U. L. Rev. 232 (2008)

BGS

NEJM Says Too Early to Dismiss Cancer Concerns for Vytorin

Article in the Wall Street Journal -- Medical Journal Raises Concern About Vytorin, by Alicia Mundy and Jared Favole.  Here's an excerpt:

The editors of the New England Journal of Medicine, in a rare move, said that it is too soon to dismiss concerns about cancer risks linked to the popular cholesterol drug Vytorin, even as the journal published a report saying a previously reported cancer link was likely due to chance.

The NEJM's editorial was formally released just as experts were defending the drug's safety at a major medical conference in Europe. A study formally presented Tuesday, known as SEAS, raised questions about potential cancer links, and whether Vytorin helps prevent cardiovascular problems better than a placebo. Those conclusions were made public in July. But a prominent Oxford University researcher said the cancer risk wasn't credible. The New England Journal published both the SEAS study and the Oxford review of the cancer issue.

Later Tuesday, a powerful congressional committee that has been investigating Vytorin's safety and marketing sent a letter to Merck & Co. and Schering-Plough Corp., who sell the drug in a joint venture, asking for extensive details about the Oxford review that dismissed links between Vytorin and cancer deaths.

BGS

UK Changes Allow Investing in Law Firms

Article in the Economist -- Legal Advice: Should you buy shares in a law firm?, which discusses recent changes in the UK allowing for non-partnership structures for law firms, and external investing by the public via, for example, initial public offerings.  While there are real confidentiality concerns that would need to be addressed in any such proposal, investing in law firms strikes me as a proper way to harness the market to even the playing field in mass tort litigation.  In particular, plaintiffs' firms should have access to investment capital, so that claims that should be brought are in fact brought.  Then our litigation system can focus on getting the economic incentives right via the litigation system, confident that the firms will have the capital to respond.  Here's an excerpt from the article:

WERE it possible to buy shares in big British and American law firms, they would appear to be attractive investments. They boast double-digit revenue growth at a time when many companies are suffering. Baker & McKenzie, one of America’s biggest firms, has just announced a 20% increase in annual revenues, which exceeded $2 billion for the first time. Britain’s top four firms have reported revenues up by an average of 15% this year, with all four passing the £1 billion ($1.85 billion) mark.

Investing in law firms is more than just a pipe dream. A change in British law, introduced last year, enables law firms to use business structures other than private partnerships, and allows for external investment and initial public offerings (IPOs). Law firms will have to wait for a new regulator, the Legal Services Board, but everything is due to be in place by 2011.

BGS

Vytorin Study Results on Potential Cancer Link to Be Released Next Week

Article in Forbes -- Another Storm Brewing For Vytorin, by Matthew Herper.  Here's an excerpt:

When a study linking the widely used cholesterol drug Vytorin to cancer came out in July it caused a stir--for a few hours.

It should have lasted longer. A 1,873-patient study called SEAS found there were 50% more cancers among patients who took Vytorin than those who received placebo. Researchers involved in the study put together a hastily organized, company-funded press conference on July 21 to release the data.

There, Richard Peto, an Oxford University statistician, quieted the cancer scare before it really began. He pooled data from two much larger ongoing studies of Vytorin and said they showed that the cancer risk was a statistical fluke. He called the contention that Vytorin could cause cancer "bizarre." Deutsche Bank pharmaceuticals analyst Barbara Ryan says the impact of SEAS on Vytorin sales has been "negligible."

Shares of Vytorin makers Merck and Schering-Plough are still down 6% and 9%, respectively, since SEAS was released. The companies say the cancer finding is "an anomaly."

Next week, the full results of SEAS will be presented at a medical meeting in Munich, and, if some of world's top cardiologists, drug safety experts and statisticians are to be believed, the stage is set for yet another battle over Vytorin, which is already being haunted by worries over its effectiveness.

BGS

FDA Says Salmonella Outbreak Over -- Blaming Jalapenos, Not Tomatoes

Article in the Wall Street Journal -- Salmonella Outbreak Is Over, Federal Health Officials Say, by the Associated Press.  Now I can stop worrying about what to add to my Subway sandwiches.

BGS

Richard Epstein on Field Preemption of State Laws in Drug Cases

Professor Richard Epstein (Chicago) has published The Case for Field Preemption of State Laws in Drug Cases on Northwestern University Law Review's Colloquy.  Here's an excerpt:

This brief Comment renews my defense of strong field preemption for FDA regulation.  In Part I, I shall set out the emergence of modern preemption law in light of the vast expansion of federal power after the New Deal with special reference to two cases of great current concern, Riegel and Levine.  Thereafter, in Part II, I shall comment first not on Professor Sharkey’s article, but on a recent essay by David Kessler and David Vladeck that takes the strong view that the doctrine of implied preemption should not be applied in duty-to-warn drug cases.  Then, in Part III, I address Professor Sharkey’s agency model, and lastly, in Part IV, I offer a brief capitulation of my field preemption position.

BGS

Another Jackpot (In)Justice: Verdict Variability and Issue Preclusion in Mass Torts

I've posted my manuscript, Another Jackpot (In)Justice: Verdict Variability and Issue Preclusion in Mass Torts, on Bepress.  Here's the abstract:

If there are no prior inconsistent verdicts, non-mutual offensive issue preclusion generally allows a finding by a single jury to bar relitigation, in future cases, of the issue by the defendant who lost in the prior case. This approach, however, ignores the possibility that the first verdict delivered may have been an outlier if further verdicts were permitted to be delivered. In mass tort litigation, such a flawed approach may result in critical issues such as defect or negligence being resolved by only six jurors, whose potentially outlier verdict is then applied to resolve the cases of thousands, perhaps bankrupting a company or an industry when most juries would not so hold. Focusing on mass tort litigation, this article presents the growing empirical evidence of verdict variability and then critiques the use of issue preclusion, whose downside is applied only against defendants, not plaintiffs, because only defendants were parties to the prior action. As a result, the article argues that courts should exercise their discretion to deny issue preclusion in mass tort litigation. Instead, courts should join the emerging consensus of mass tort management that ultimately better serves the goals of efficiency and public respect supposedly underlying issue preclusion: allow multiple verdicts to unfold a more balanced view of liability that will frequently be used for well-informed and far-reaching settlements.

This manuscript extends the analysis begun in my prior article, Jackpot Justice: Verdict Variability in the Mass Tort Class Action, Temple L. Rev. (forthcoming 2008).

BGS

Nagareda on Class Certification in the Age of Aggregate Proof

Richard Nagareda has posted his article, Class Certification in the Age of Aggregate Proof, on SSRN.  It will appear this spring in New York University Law Review.  Here's the abstract:

Few pre-trial motions in our civil justice system elicit as much controversy as those for the certification of class actions. This Article offers the first account in the literature of the challenges faced today by courts in light of an important series of federal appellate decisions that direct the courts to resolve competing expert submissions on the class certification question in the pre-trial stage - even when the dispute overlaps with the merits of the litigation - in the course of determining the application of Rule 23.

Across broad swaths of class action litigation today, proponents of class certification invoke aggregate proof - evidence, typically of an economic or statistical nature, that presupposes the cohesiveness of the aggregate unit for litigation and, from that perspective, seeks to reveal quantitatively a common wrong attributable to the defendant. Debates over the proper role of aggregate proof unite what otherwise might seem disparate disputes over class certification today across securities, antitrust, RICO, consumer fraud, and employment discrimination litigation. Too often, however, courts have taken at face value the evidentiary form that aggregate proof assumes in class certification.

This Article urges a new conceptualization of the challenges facing courts in class certification today. The real question about aggregate proof in class certification is not one that speaks to the relationship between the court and the fact finder in the (usually, purely hypothetical) event of a class-wide trial. Rather, the institutional relationship that really matters is the one between the court and the legislature as expositors of governing law. Properly understood, aggregate proof offers not so much a contested view of the facts but, more fundamentally, a contested account of governing law - one eminently suited for judicial resolution and appellate correction de novo, without concern about possible intrusion into the role of the fact finder.

This Article exposes how renewed attention to the judicial role to say what the law is can lend coherence to the law of class certification, offering the first extended assessment of such controversial recent litigation as the civil RICO class action against the tobacco industry concerning its marketing of light cigarettes and the largest employment discrimination class action in history against Wal-Mart concerning the pay and promotion of its hourly female employees. The Article concludes by relating the analysis of class certification to larger changes in the civil justice system to grapple with the reality of settlement, rather than trial, as the endgame of litigation.

ECB

FDA May Set Rules for Food Allergy Warnings

Article on cnn.com -- FDA to consider rules for food allergy warnings, by the Associated Press.

BGS

New Scholarship on Using a Cost-Benefit Analysis in Certification

Patrick Luff, a student at Michigan, has posted his piece, "Bad Bargains: The Mistake of Allowing Cost-Benefit Analyses in Class Action Certification Decisions," on SSRN.  Here's the abstract:

The class action is a bete noir, attacked by corporate counsel, politicians, the media, and the public as unfair to businesses and individuals alike. In recognition of these complaints, proposed changes to the Federal Rules of Civil Procedure are a recurrent theme in complex litigation scholarship. One such example has been the suggestion that, in determining whether or not to certify a class action, the judge should weight the perceived costs and benefits that the certification decision would produce. However, as this Article will show, the arguments that favor a cost-benefit analysis stage in class action certifications fail because they are based on insufficient or misguided criteria. This Article emphasizes that the correct criteria by which to judge class certification decisions will be those that are conducive to public goods - such as deterrence of socially harmful conduct - and private goods - such as individual compensation for wrongdoing. In assessing proposed rules that would insert a cost-benefit analysis into class action certifications, this Article concludes that only a rule that avoids such a test can achieve the public and private goals that are the proper ends of the class action device.

ECB

Drug and Device Law on MDL

In this post on the Drug and Device Law Blog, a guest blogger Pearson Bownas discusses a defense side point of view on when the MDL grants motions to transfer.  An interesting post, and I'd be interested in hearing any contrary points of view.  You can find it here.

Iraq Injuries Spur Putative Class Action

According to the Fulton County Daily Report, a wrecker driver who was employed in Iraq with Houston-based Kellogg, Brown & Root claims that the company sent him without adequate training.  Here's a brief excerpt of the story:

On Tuesday, his lawyers filed a class action lawsuit in Fulton County Superior Court in Georgia outlining Curtis "Bubba" Coffey's own experiences with the multinational contractor and pointing to several other highly publicized reports of deaths, accidents and sexual assaults allegedly tied to the company. Similar actions have been filed in other court jurisdictions across the nation with mixed results.

The complaint, filed on the same day a Congressional Budget Office report estimated that the United States spent more than $85 billion on contractors in Iraq between 2003 and 2007, targets KBR and nine subsidiaries, describing them as a "sham" and "corporate fiction" designed to "perpetrate a fraud for the direct personal benefit of KBR."

But "our main focus is that KBR is taking American folks, telling them that everyone they'll be working with is skilled, that everyone's trained," said Atlanta attorney E. Adam Webb. "Then they get to Iraq, and there's no training, no experience, people that speak no English -- that's what caused the direct issue here."

According to Webb and details contained in the lawsuit, Coffey, 45, was an experienced tow-truck driver who had earned his "WreckMaster" certification and was hired by KBR to "recover disabled vehicles, including tanks, personnel carriers, jeeps, cars and trucks." He was told that only persons with more than three years of experience would be considered for such employment and that extensive specialized training would be provided. But upon arriving for training at Camp Anaconda in Iraq in February, Coffey was rushed through an "ineffectual" training regimen with "trainers who were often inexperienced themselves," according to the suit.

The case name and number are Coffey v. Kellogg Brown & Root, No. 2008-CV-154929 and is filed in the Fulton County Superior Court.  The article doesn't mention what the class definition is, but from the article itself, it sounds like one that might be subject to CAFA's removal provision.

ECB

Plaintiffs Rejecting Settlement Offers Fare Worse at Trial

While not exclusively related to mass torts, the ABA reports on the results of a new study of civil suits from 2000-2005, which found that 61% of plaintiffs rejecting settlement offers fared worse at trial. Here's a link to the New York Times story and an excerpt of the ABA story:

Sixty-one percent of plaintiffs who turned down settlement offers ended up faring worse at trial, according to a New York Times story on the study. The average settlement offer was $48,700 and the average award at trial was $43,000, a difference of $5,700.

Defendants were wrong in just 24 percent of the cases, but for them the cost of a bad gamble was must larger. The average plaintiff’s settlement demand in those cases was $770,900 and the average verdict was $1.9 million, a difference of more than $1.1 million.

ECB