Mass Tort Litigation Blog

Remittitur in Vioxx Case

Judge Eldon Fallon (E.D. La.), who is overseeing the Vioxx MDL, yesterday ordered remittitur in the Barnett case.  Last year, the plaintiff won a verdict of $51 million ($50 million compensatory plus $1 million punitive).  The court found the amount excessive and, last August, ordered a new trial on damages.  Yesterday, the court amended its order.  At plaintiff's request, the court granted remittitur (obviously it's unusual for a plaintiff to ask for remittitur, but in this case the alternative was a new trial on damages).  Specifically, the court ordered a new trial unless the plaintiff accepted a reduced damage award of $1.6 million ($600,000 compensatory plus $1 million punitive); the judge determined that $600,000 was the highest amount a jury could reasonably have awarded for compensatory damages.  Here's the AP story in the Houston Chronicle -- Vioxx Plaintiff Can Get Damages or Retry.

HME

Anatomy of a Mass Tort

Jim Beck and Mark Herrmann at the Drug and Device Law Blog have a wonderful post called Anatomy of a Mass Tort.  It's among the best short descriptions of mass tort litigation I've seen.  They describe the now-predictable life cycle of a mass tort:  triggering event, client-gathering, class suits, individual suits, peripheral litigation, MDL, statewide centralization, wholesale defenses, eve-of-limitations filings, choice of law battles, trial themes, and settlement.  What I like best is that they tell the story with just the right level of cynicism.  They assume that both sides respond to incentives, but they make no assumption concerning whether the underlying claims are either meritorious or non-meritorious.  Indeed, one of the most interesting (and troubling) things about mass tort litigation -- this, I think, is the main point of their post -- is the extent to which the story line looks the same regardless of whether the litigation involves a dangerous product and liability-worthy conduct.  I'm not saying (and neither are they) that results in mass tort litigation bear no relation to the truth.  Rather, they're making a subtler and more important point -- that once a trigger occurs, mass tort litigation takes on a life of its own.

HME

Aggregate Settlements and the Ethics Rules

It continues to amaze me how much confusion exists over the ethical obligations of lawyers when handling non-class aggregate settlements.  The ABA's partly to blame.  The model rule (RPC 1.8(g)) is sound as far as it goes, but there's a lot that it doesn't explain.  And the most recent ABA ethics opinion expounding on the rule (ABA Formal Op. 06-438) obscures as much as it explains.

I returned today from the ABA National Conference on Professional Responsibility in Chicago, where I chaired a panel on the ethics of aggregate settlements.  The other panelists were New York mass torts lawyer Paul Rheingold and Los Angeles ethics lawyer Diane Karpman.  We addressed four issues:  (1) the definition of "aggregate settlement" for purposes of the aggregate settlement rule (RPC 1.8(g), DR 5-106, Cal. 3-310, etc.); (2) the extent of disclosure required for informed consent; (3) whether advance consent should be permitted; and (4) restrictions on future practice in connection with settlement.  Every one of the issues engendered significant debate among the panelists and serious questions from the audience.  The one thing the panelists could all agree on, however, was dissatisfaction with Op. 06-438.

But mostly, I was struck by the extent to which even the most basic questions (like the definition of "aggregate settlement" or the appropriate disclosure) remain topics of debate and uncertainty.  No wonder mass tort lawyers worry so much about aggregate settlements.  Even when they take careful steps to obtain each client's informed consent to the deal, they have to worry about whether their steps will fail to satisfy someone else's interpretation of the rule.

HME

New Trial Ordered in Federal Vioxx Case

The wrongful death case of Plunkett v. Merck simply won't end.  The first Vioxx case to go to trial in federal court, it resulted in a hung jury in 2005.  At the retrial in 2006, Merck won an important defense victory.  But two days ago, Judge Fallon granted a new trial based on the revelation that one of Merck's expert witnesses had misrepresented his qualifications.  Here's an excerpt from the story in the Houston Chronicle by Janet McConnaughey of AP -- Judge Orders New Vioxx Trial:

A federal judge has ordered a third trial in a lawsuit by a woman who blamed Merck & Co.'s painkiller Vioxx for the heart attack that killed her husband.  A cardiologist who testified for Merck misrepresented his qualifications in the second trial last year, U.S. District Judge Eldon Fallon ruled.  Jurors in that trial ruled in favor of Merck and against Evelyn Irvin Plunkett, whose first husband, Richard "Dickie" Irvin, died of a heart attack after taking Vioxx for less than a month.

HME

U.S. Manufacturing Plant Found to Have Used Melamine in Feed

Article in the New York Times -- Melamine From U.S. Put in Feed, by Andrew Martin.  Here's an excerpt:

Ever since pet food contaminated with an industrial chemical was traced to shipments of wheat flour from China, American officials have concentrated on cracking down on imports.

It turns out the problem was closer to home, too.

Yesterday, federal officials announced that a manufacturing plant in Ohio was using the same banned substance, melamine, to make binding agents that ended up in feed for farmed fish, shrimp and livestock.

The problem surfaced after a distributor, concerned about what was in its feed binders after the reports from China, sent the product to a private laboratory for testing.

The melamine was used by Tembec BTLSR, a Canadian forest products company with a small chemical plant in Toledo, to make binding agents that keep pellets of animal feed together, said Dr. David Acheson, assistant commissioner for food protection at the Food and Drug Administration.

BGS

FDA Reform In Light of Recent Drug Safety Issues

Article in the New York Times -- F.D.A. Still Unsettled in Wake of New Questions, by Gardiner Harris.  Here's an excerpt:

When Dr. Andrew C. von Eschenbach took over the Food and Drug Administration in 2005, the agency had a crisis over drug approvals that had missed or ignored dangerous side effects in Vioxx, antidepressants and other prominent medications.

Dr. von Eschenbach promised improvements, and agency officials said they would no longer be caught flatfooted on drug safety.

But this month, The New England Journal of Medicine published a study suggesting that a major diabetes pill, Avandia, might increase the risk of heart attacks.

Concerns over that drug and others have led Republicans and Democrats in the House and the Senate to call for investigations. A House hearing is planned for June 6.

Dr. von Eschenbach said in a briefing on Wednesday that his agency needed to collaborate more closely with drug companies.

BGS

Sebok on the Limits of Attacking Tort Reform Myths

Tony Sebok of Cardozo Law School has posted a review essay on SSRN entitled Dispatches from the Tort Wars, reviewing books by Tom Baker, Herbert Kritzer, and William Haltom & Michael McCann.   Here's the abstract:

It is difficult to avoid the conclusion that, as a political matter, the modern tort reform movement has been very successful. This essay reviews three books that either rebut the tort reform movement's central theses or analyze the strategies that allowed the movement to prevail. I discuss Tom Baker's The Medical Malpractice Myth, Herbert Kritzer's Risks, Reputations, and Rewards: Contingency Fee Legal Practice in the United States, and William Haltom & Michael McCann's Distorting the Law: Politics, Media, and the Litigation Crisis. Although each book has a very different focus from the other two, I argue that a common theme which runs through all three books is that the tort reformers' success relies on promoting myths about how plaintiff's lawyers put their own interests above those of their clients and reject the political culture of individualism that forms the bedrock of American civil society. While I do not want to deny that there is a need for a rebuttal of this part of tort reformers' worldview, I argue that rebutting it has limited value to those who want to defend the current tort system. I argue that an exclusive focus on the myths that the tort reformers have told leaves unanswered other critiques of the current tort system which cannot be so easily dismissed. For example, the tort reformers, as well as others, have noted that the tort system dramatically expanded and changed in the 1960's and 1970's, and that this expansion was often based on academic and political arguments that celebrated the tort system's ability to perform certain functions beyond private redress for wrongs, such as cost-spreading or providing regulation in the face of legislative inaction. By failing to recognize these possible criticisms, the authors of the three books, I argue, leave the hardest battles for another day.

HME

Paxil Class Action Settlement Approved

A judge in Madison County, Illinois has approved a class action settlement in the Paxil litigation.  According to this May 25 article in the St. Louis Post Dispatch -- Judge Approves $64 Million Settlement Over Drug Paxil -- the court approved a nationwide settlement to reimburse parents for money spent on the GlaxoSmithKline antidepressant drug for their children.  The suit, Hoorman v. SmithKline Beecham Corp., alleged that the defendant withheld information about the safety of the drug, which has been linked to an increased risk of suicide in young people; the defendant denies the allegations.  Under the settlement, class members with receipts or pharmacy records can receive reimbursement of their out-of-pocket expenses, while those who lack documentation may receive up to $100.  The settlement is described at www.paxilpediatricsettlement.com.  The lawsuit was filed in 2004, which presumably explains why it was not removed to federal court under CAFA.  Significantly, the class settlement resolves only the parents' claims for reimbursement of out-of-pocket expenses, and does not preclude personal injury claims.

The Madison County class settlement contrasts with the January denial of class certification in a federal court Paxil class action.  Attribute the different outcomes in part to the difference between economic damages and personal injury, and in part to the different forums.

HME

Sen. Grassley Says FDA Study Also Shows Avandia Risk

Article in the Washington Post -- FDA Study Said to Show Avandia Risk, by Marilynn Marchione.  Here's an excerpt:

The government's own preliminary evaluation of the diabetes pill Avandia confirms the heart risks reported in a study earlier this week and suggests that as many as 60,000 to 100,000 heart attacks might be linked to its use since it came on the market eight years ago, a leading member of Congress said Thursday.

In a floor statement placed in the Senate record, Sen. Charles Grassley also said that safety watchdogs within the federal Food and Drug Administration "several months ago" recommended a "black box" on the drug's label _ the strongest possible warning.

It is the first confirmation that the FDA's own analysis of Avandia shows a similar magnitude of heart attack risks _ dangers that were first publicly raised in a medical journal report published earlier this week.

Grassley complained that FDA higher-ups have said they want to wait for results of an ongoing study that will not be available for two more years before making a decision.

BGS

Glaxo's Large Avandia Clinical Study In Question Because of Patients Dropping Out

Article in the New York Times -- Test of Drug for Diabetes in Jeopardy, by Stephanie Saul.  Here's an excerpt:

A large clinical study meant to test the heart safety of the diabetes treatment Avandia may be in jeopardy as a result of recent reports of the drug’s risks, according to an executive for its maker, GlaxoSmithKline.

Dr. Ronald L. Krall, the medical director for GlaxoSmithKline, said in a telephone interview yesterday that some of the 4,450 patients enrolled in the drug trial, called Record, have dropped out this week because of safety concerns about Avandia.

Dr. Krall said he did not yet know how many patients have withdrawn, but said Glaxo was now worried about whether it could complete the drug trial, which has been scheduled to run through next year. The company has been counting on a successful outcome from the study to dispel widespread concerns that Avandia carries a higher risk of heart attacks than other diabetes drugs.

Now, though, the independent research committees overseeing the study “are concerned about the ability of the study to continue” and are “considering what to do to prevent people from dropping out of the trial,” Dr. Krall said.

BGS

Contact-Lens Solution Linked to Rare, Serious Eye Infection

Article in the Wall Street Journal -- Contact-Lens Solution Is Tied to Eye Infection, by Jon Kamp.  Here's an excerpt:

U.S. health investigators have linked a contact lens solution made by Advanced Medical Optics Inc. to the outbreak of a rare but serious eye infection that can cause blindness.

The news comes just a day after Advanced Medical Optics said it's interested in exploring an offer for rival Bausch & Lomb Inc., which was hurt from the world-wide recall of a lens solution last year amid links to a different infection. The Advanced Medical Optics product at issue is called Complete MoisturePlus, one of several all-in-one-bottle solutions on the market.

As of Thursday, in a probe that includes 35 states and Puerto Rico, the U.S. Centers for Disease Control and Prevention has identified 138 "culture-confirmed" cases and has interviewed 46 patients.

Research shows 36 of those people wore soft contact lenses, 21 reported using the Advanced Medical Optics product a month before symptoms, and 14 used it exclusively. That was enough of a link to a product with limited market share to spark a public announcement, said Sharon Roy, medical epidemiologist with the CDC's division of parasitic diseases.

BGS

Glaxo Courts Doctor Support for Diabetes Drug Avandia

Article in the Wall Street Journal -- Glaxo Courts Doctor Support of Avandia: No Plans Currently Set To Run Consumer Ads To Defend Drug's Safety, by Jeanne Whalen and Anna Wilde Mathews.  Here's an excerpt:

GlaxoSmithKline PLC, under pressure to protect its diabetes drug Avandia, is reaching out to physicians to defend the drug's safety, but isn't currently planning a similar ad campaign for consumers.

In meetings with doctors, Glaxo sales representatives are focusing on data from a large clinical trial called A Diabetes Outcome Progression Trial, or ADOPT. "We are reassuring physicians about the safety data we have, particularly looking at ADOPT," said Alice Hunt, a Glaxo spokeswoman.

Monday, the New England Journal of Medicine released an analysis by Cleveland Clinic cardiologist Steven Nissen linking Avandia to a potential risk of heart attacks. Glaxo disagrees with the finding, which it says is contradicted by data the company considers stronger, including ADOPT data.

Congressional investigators are examining the Food and Drug Administration's and the company's handling of the drug. Yesterday, Republican Sen. Charles Grassley of Iowa said that the FDA's division of drug-risk evaluation had recommended a tough "black box" warning about heart-attack risk for the label of Avandia, which hasn't been added. He and Senate Finance Committee Chairman Max Baucus, a Montana Democrat, introduced a bill that would grant researchers access to Medicare data on medical treatments.

BGS

Glaxo's Agreement to Disclose Publicly Clinical-Trial Results Lead to Finding of Avandia Risk

Article in the New York Times -- For Drug Makers, a Downside to Full Disclosure, by Barry Meier.  Here's an excerpt:

When GlaxoSmithKline settled a lawsuit three years ago with the State of New York over the antidepressant medication Paxil, the company agreed to take an unusual step: publicly disclosing the results of its clinical trials for Paxil and other drugs.

The company, which was criticized at the time for failing to publicize all pediatric trials of Paxil, not just the positive ones, made good on its promise. The first posting on a new Web site was about 65 studies involving its popular diabetes drug, Avandia.

This week, GlaxoSmithKline learned what that greater disclosure could mean.

A cardiologist at the Cleveland Clinic, Dr. Steven Nissen, stumbled onto the Glaxo Web site while researching Avandia last April. He and a colleague quickly analyzed the data, and on Monday, The New England Journal of Medicine released its finding that Avandia posed a heightened cardiac risk.

“It was a treasure trove,” Dr. Nissen said about the Web site.

BGS