Mass Tort Litigation Blog

NJ Supreme Court decides Sinclair v. Merck

The New Jersey Supreme Court issued its decision in Sinclair v. Merck, a medical monitoring class action filed against Merck on behalf of Vioxx users who had not filed personal injury claims.   The opinion is available here.   The court rejected the plaintiff's claims.  This opinion joins a spate of recent decisions in Merck's favor.  Vioxx continues to be a vehicle for making new law and rethinking old ones.  Whether the New Jersey courts' tightening of medical monitoring claims is a good idea from a policy perspective will have to wait to another day. 

For a defense-side take on this opinion, see the Drug and Device Law Blog here.  Their analysis is useful.  Thanks to Mark Hermann for bringing this to my attention. 

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Antiobesity Drug Linked to Deaths in U.K.

Today's Wall Street Journal reports that Acompli has been linked to several deaths in the United Kingdom. The U.S. FDA rejected Acompli for sale in the United States last year. Here's an excerpt from the Journal's report:

A spokesman for Paris-based Sanofi-Aventis said two of the deaths were the result of heart attacks, a risk that is linked to obesity. One patient died of infectious disease, and the fifth died from "sudden death," he said. The deaths occurred mostly before 2008, he said. He declined to comment further.

With such "real-world" reports, it is often unclear if the drug was the culprit. It isn't clear what actions regulators will take, if any. All approved drugs must have surveillance programs after they go on sale to record adverse reactions or deaths in patients taking them. The document, posted Tuesday on the agency's Web site, is a routine report.

That said, this report may draw more scrutiny, given Acomplia's difficulty getting approval in other countries.

With so many people suffering from obesity around the world, drug companies have been eager to find drugs to treat the disease. Before regulators' concerns, Acomplia and a drug from Merck & Co. had initially seemed promising, offering a new kind of obesity treatment that blocks certain brain receptors that regulate appetite.

ECB

Mel Weiss Receives 30-Month Sentence

Article in the Wall Street Journal -- Weiss Gets 30-Month Sentence, by Rhonda L. Rundle and Nathan Koppel.  Here's an excerpt:

The career of one of the nation's most entrepreneurial, controversial, philanthropic and rich lawyers came to a close Monday, as Melvyn Weiss was sentenced to 30 months in prison for his role in a scheme in which he and his partners used kickbacks to gain an advantage in lucrative cases.

Mr. Weiss pleaded guilty this year to conspiracy in a long-running prosecution of him and his famed law firm, now known as Milberg LLP, in which the government alleged that the lawyers paid kickbacks to clients to serve as name plaintiffs in class actions. The scheme, prosecutors said, allowed Milberg to have a ready stable of plaintiffs that filed cases quickly, enabling the firm to become lead counsel in a case and claim a larger share of the fees.

In handing down a sentence near what prosecutors sought -- 33 months -- Judge John Walter noted the seriousness of the offense, which he said involved a "nationwide conspiracy that continued for decades." But the judge, in sentencing him three months shy of the maximum plea term, also appeared moved by Mr. Weiss's good works and his age, 72.

BGS

Milberg LLP Nears Settlement Deal

Today's Wall Street Journal reports that prosecutors are close to reaching a $75 million deal with Milberg LLP, although both sides declined to comment. Here's an excerpt:

If the amount under discussion in the Milberg talks holds, the government will be able to claim more than $100 million in fines and penalties in the case -- factoring in the more than $30 million that other defendants in the case have agreed to pay. That total figure would make the case one of the largest-netting prosecutions of a law firm. Last year, Jenkens & Gilchrist, a now defunct Dallas firm, agreed to pay $76 million to resolve a federal tax-shelter investigation.

Milberg has asked Coughlin Stoia Geller Rudman & Robbins LLP, a powerful San Diego law firm that spun off from Milberg several years ago, to chip in part of its payout in the settlement, but the Coughlin firm has refused, say two people familiar with the matter. The Coughlin firm hasn't been charged in the case.

Since its 2006 indictment, Milberg has lost many lawyers and considerable business, but it has continued to earn fees, including some large sums from its previously filed class actions. This year, it was paid more than $120 million as part of a settlement of a class action alleging securities fraud at Tyco, according to two lawyers in the case.

ECB

Florida Asbestos Cases Revived

The Fourth District Court of Appeal in Florida revived thousands of Florida asbestos suits last week by ruling that the Florida Asbestos and Silica Compensation Fairness Act couldn't be applied retroactively. Here's an excerpt of the Daily Business Review's story:

Judge Gary Farmer wrote for the unanimous court that the Florida Asbestos and Silica Compensation Fairness Act "may not constitutionally be applied to eliminate the existing vested rights in the lawsuits pending when the act became effective" July 1, 2005. Judges W. Matthew Stevenson and Carole Taylor concurred.

The ruling reversed 13 decisions by Palm Beach Circuit Judge Elizabeth Maass upholding retroactivity. Some of the cases date back to 1999. The decision revives them in the lower court.

"It certainly means that there are thousands of cases that were in the pipeline that were retroactively thrown out by this legislation that now may see new life," said Miami solo practitioner Joel Perwin, who helped handle the 4th DCA appeal for plaintiffs.

The 2005 law set impairment standards for plaintiffs. People with nonmalignant asbestosis must have lost at least 20 percent of their breathing capacity to sue, and those with lung cancer would have to have asbestosis and diminished breathing capacity to discount the effects of smoking.

"There are limits to legislative power," Perwin said. "You don't take away rights that have already been accrued when you're passing new laws."

Coral Gables, Fla., attorney David Jagolinzer, a partner in the Ferraro Law Firm who has represented asbestos victims at the trial level, said he is "extremely happy" with the new ruling. He said it could restore as many as 4,000 asbestos illness cases statewide.

"The importance of this decision is that the whole statute is unconstitutional," Jagolinzer said. The law "established a level of sickness, a level of impairment which you never had before" as a threshold for a lawsuit.

The appeals court said it could not sever the provisions of the act dealing with retroactivity from other provisions.

"The act in its entirety may not constitutionally be applied to require claimants with accrued causes of action for damages resulting from exposure to asbestos to plead and prove that any malignancy or physical impairment results from their exposure to asbestos," the court ruled. "Instead, their accrued causes of action required them to show only that they suffered from an injury from an asbestos-related, nonmalignant disease." The ruling means the 2005 law cannot be applied to anybody with an asbestos-related disease whether or not they sued before the law took effect, Jagolinzer said.

ECB

Judge Grants Initial Approval to Pet Food Class Settlement

Article in the Associated Press -- Recalled pet food settlement gets initial approval, by Geoff Mulvihill.  Here's an excerpt:

A judge granted initial approval Friday to a settlement in which companies that manufactured or sold contaminated pet food would compensate pet owners for all costs related to the death or illness of their dogs and cats.

Under the deal, granted initial approval by U.S. District Judge Noel Hillman, pet owners in the United States and Canada would be notified of the settlement by June 16 and would have until early December to submit claims. A final hearing on the $24 million settlement is scheduled for Oct. 14.

The settlement doesn't pay pet owners for pain and suffering from injuries to their pets.

BGS

WSJ on Vioxx Appellate Rulings

Editorial in the Wall Street Journal -- Vindicating Vioxx.  Here's an excerpt:

Texas and New Jersey may have different political cultures, but appeals courts in both states this week delivered a one-two punch to the liability suits against Merck for its Vioxx painkiller. In Texas, a court overturned a $26 million 2005 jury verdict against the drug company, while New Jersey's court whittled down an earlier verdict to exonerate Merck from a finding of consumer fraud and eliminate punitive damages.

The rulings are evidence that some sanity still exists in the tort system – at least at the appellate level. In Texas, the court's Chief Justice Adele Hedges said there was "no evidence" that the patient had suffered a cardiovascular event as the result of a blood clot or that Vioxx was in any way related to the death. Those are strong words for a case that the trial bar had celebrated as the start of a huge payday.

At the beginning of the Vioxx hysteria, some analysts predicted Merck's liability could spiral as high as $30 billion, threatening the company itself. Last year, Merck settled most of the cases for $4.85 billion. But since Vioxx was taken off the market in 2004, only three of the 20 suits that have gone to juries have ended favorably for plaintiffs. There were other reality checks along the way: Vioxx plaintiffs were denied class-action status in a federal court in 2006, and by the New Jersey Supreme Court last year.

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Texas and New Jersey Courts Overturn Vioxx Verdicts

Article in the Houston Chronicle -- Court tosses Vioxx award: Houston panel rules plaintiff will get none of the $26 million, by Mary Flood.  Here's an excerpt in which I'm quoted:

A Houston appellate court Thursday overturned a $26 million Angleton jury finding that a 59-year-old triathlete died because of his use of the popular painkiller Vioxx.

The 14th Texas Court of Appeals ruled that Bob Ernst's widow, Carol Ernst, should receive nothing because the more than one month of testimony in the nation's first Vioxx trial contained insufficient evidence to prove the drug caused his heart problem and death.

***

The ruling on the 2005 trial came the same day a New Jersey court struck down most of a 2006 jury verdict against Vioxx maker Merck & Co.

Earlier this month, an appellate court in San Antonio overturned a $32 million jury award to a widow in South Texas who claimed her husband died of a heart attack because of Vioxx.

***
Los Angeles-based Southwestern Law School professor Byron Stier, who writes about cases like the Vioxx suits, said that though these big cases are all different, Merck's success with trying many cases and keeping the damage contained will be a lesson to others.

Merck saved about $40 million in damages and attorneys fees in just these two decisions Thursday.

"A mass tort that could have bankrupted Merck has become manageable," Stier said.

AmLaw Daily has a related post, Mark Lanier's Faith Tested: He Loses Two Vioxx Appeals in One Day, by Andrew Longstreth.  Here's a roundup of media coverage from the Wall Street Journal Health Blog.

BGS

ABA Mass Torts Litigation Committee Spring 2008 Newsletter

The ABA's Mass Torts Litigation Committee has posted its Spring 2008 Newsletter, which includes the following articles:

Foreign Torts and the Commerce Clause: Territorial Limitations On State Power To Impose Punitive Damages, by William E. Thomson (Gibson Dunn)

Public Nuisance Update: This Dog is Still Barking, by Charles H. Moellenberg, Jr., Lisa G. Silverman, and Laura E. Ellsworth (all of Jones Day)

Climate Change Litigation: When and Where Will the Next Storm Hit, by Christopher R. Reeves (Swift Currie)

Shining a Spotlight on Stipulated Class Counsel Fee Awards—The Trend Toward Greater Judicial Scrutiny, by Christopher H. Angins (Holland & Knight)

Three Rules for Young Lawyers, by Christopher G. Campbell (DLA Piper)

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Pfizer Begins Public Relations Campaign to Counter Chantix Concerns

Article in the Wall Street Journal -- Pfizer Seeks to Counter Chantix Concerns, by Alicia Mundy and Avery Johnson.  Here's an excerpt:

Pfizer Inc. is preparing an advertising and public-relations campaign to counter concerns about its antismoking drug Chantix, once trumpeted as a potential billion-dollar-a-year blockbuster.

Chantix is drawing scrutiny from federal regulators and a tough congressional critic of the pharmaceutical industry following revelations about potentially dangerous adverse events such as heart irregularities, seizures and more than 100 accidents linked to use of the drug.

An important issue is whether Chantix is effective at dosage levels that are safe for its users. This was a concern for FDA researchers prior to the drug's approval, according to agency records.

BGS

Pfizer to Hire Amy Schulman as Next General Counsel

Amy Schulman, who heads the mass tort/class action practice at DLA Piper, will be the next general counsel at Pfizer.   Ms. Schulman lead the Celebrex and Bextra litigations for Pfizer (see WSJ blog and article), and was also the subject of a Harvard Business School case study entitled, Leadership in Law: Amy Schulman at DLA Piper.  For more, see this post from AmLaw Daily.

BGS

Mel Weiss Files Sentencing Memo

Article in AmLaw Daily -- Defending Mel Weiss, by Ben Hallman.  Here's an excerpt:

Mother Teresa, move aside. Melvyn Weiss, a plaintiffs lawyer who made millions of dollars by suing corporate America--and who recently pleaded guilty to a racketeering conspiracy for paying kickbacks to clients in many of those cases--deserves recognition as "one of the greatest humanitarians of our time," according to a sentencing memo his lawyer filed Friday.

The table of contents sets the tone for the memo, which is effusive in its praise of Weiss. "The scope of the charity and generosity of Melvyn Weiss is breathtaking," reads the header to one section. Weiss has a "compulsion" to make the world a better place, reads another. He is also "spontaneously kind," the memo says.

On March 17, Weiss signed a plea deal calling for a sentence of 18-33 months, admitting that he "engaged in a pattern of racketeering activity" for at least 26 years. In a subsequent memo to the court, prosecutors asked California district court judge John Walter to sentence Weiss to the full 33 months. The Weiss memo, filed by attorney Benjamin Brafman, pleads for leniency. "The shame Mr. Weiss has suffered and will continue to suffer is overwhelming," it says. "To be candid, it is difficult to imagine a greater punishment than the punishment that has already been imposed by the public humiliation...as he now deals with the prospect of incarceration and the indignity of disbarment."

BGS

$24 Million Pet-Food Settlement

Article in the L.A. Times -- Pet food companies OK $24-million settlement, by the Associated Press.  Here's an excerpt:

Companies that were sued over contaminated pet food linked to the deaths of perhaps thousands of dogs and cats have agreed to pay $24 million to pet owners in the United States and Canada.

The settlement is detailed in papers filed late Thursday in U.S. District Court in Camden, N.J. It still needs a judge's approval; a court hearing is set for May 30.

"The settlement attempts to reimburse pet owners for all of their economic damages," said Russell Paul, a lawyer for the plaintiffs.

AmLaw Daily provides more detail in its post, Massive Pet Food Recall Lawsuit Settles, by Andrew Longstreth.  Here's a link to the joint motion filed for certification and approval of the class settlement.

BGS

FDA to Expand Post-Approval Review of Drugs

Gardiner Harris of the New York Times reports today in an article entitled "FDA to Expand Scrutiny of Risks From Drugs After They're Approved for Sale" that the FDA has a new program called the "Sentinel Initiative" that will monitor how approved drugs affect consumer health.  They will use information from Medicare beneficiaries. 

Researchers praised the government initiative, but many said its fruits would take years to realize. And several said the Bush administration’s policy of delivering the Medicare drug benefit through myriad private plans made the effort that much more difficult.

“This is going to take a lot of work,” said Dr. Bruce Psaty, a professor of medicine and epidemiology at the University of Washington.

Mr. Leavitt said “the power of this is in the capacity to take disparate databases and use it in a productive way.” Dr. Janet Woodcock, director of the F.D.A.’s drug center, agreed that much work remains to be done.

The article points out that this is better than what the FDA does now (the article explains that the FDA currently has "an unsystematic system in which doctors, patients and manufacturers report problems with drugs and medical devices when they deem them important.")   There are several problems with using Medicare data, including the fact that it is claims data not patient records and the fact that Medicare recipients use many more drugs than the general population, and are sicker than the general population. 

ADL

Institute for Safe Medicine Practices Releases New Chantix Report

The Institute for Safe Medicine Practices, a non-profit group organized to improve drug safety and review the FDA's adverse-event reports, recently released a study on Chantix. The report indicated a greater spectrum of side effects, including heart trouble, seizures, and diabetes in addition to the effects already identified such as suicide and depression. Here's an excerpt from the Wall Street Journal:

Thomas Moore, the study's lead author and the institute's senior scientist for drug safety, called on Pfizer and the FDA to "immediately" strengthen Chantix's label warnings and rigorously examine emerging safety issues. "Based on the data available now, the existing warnings are completely inadequate," he said. "You'd expect a stop-smoking drug to have a relatively low number of reports," because it isn't used in high-risk patients.

. . .

Mr. Moore's study links the drug to a greater spectrum of maladies. The report identified 173 injuries, including falls and traffic accidents, involving people taking Chantix that were possibly the result of such factors as muscle spasms, dizziness and confusion. The FDA data also contain 224 reports of potential heart-rhythm disturbances, 372 reports of possible movement disorders and 544 reports of likely glycemic problems, including diabetes.

After just months on the market, Chantix broke into the small group of medicines with more than 100 reports of serious injury. In the 2007 fourth quarter, with nearly 1,000 reports, it topped the group's list of 769 drugs examined in the U.S. for serious side effects. By contrast, the median number of serious-injury reports for other drugs is five. Most medications that came close to Chantix carry the FDA's most-serious "black box" warning, the study says.

The institute's findings have limitations. Using adverse-event reports doesn't establish a causal relationship between a drug and a side effect. Such reports are turned in by doctors, patients and sometimes plaintiffs' lawyers positing a connection but not proving one. Mr. Moore, who has consulted for plaintiffs' attorneys on drug issues, said the study isn't being published in a medical journal because he wanted to publicize the findings more promptly. A spokeswoman for the ISMP says that the group doesn't receive funding from plaintiffs' attorneys or other parties with a commercial interest in this report, and is primarily financed through subscriptions to its newsletter and grants.

ECB

Fen-Phen Kentucky Lawyers on Trial

There have been several reports lately about the mishandling of Fen-Phen settlement funds in Kentucky. Here are two excerpts. The first is from the Wall Street Journal Law Blog:

There are many bizarre aspects of the story behind the three Fen Phen lawyers on criminal trial for alleging bilking their clients out of $65 million of settlement money. The most well-reported oddity is that two of the lawyers used settlement funds to invest in the race horse, Curlin. But how about their decision to donate $20 million of the $200 million settlement to a charitable fund — called the Kentucky Fund For Healthy Living — that they created and controlled, and for which they allegedly paid themselves about $150,000 each to manage?

That part of the case came to light yesterday, as Joyce Brown, a plaintiff in the Fen-Phen case, testified in federal court that she specifically opposed the charity idea. According to this report in the Herald-Leader, Brown testified that she phoned the law office of William Gallion (pictured, right), one of three lawyers now on trial, to express her opposition, but a woman told her that the charity plan was going through, and that she had no choice in the matter. Another plaintiff, Connie Centers, testified that no one discussed a charitable contribution with her.

The second is from the Lexington Herald-Leader:

A Lexington woman who was a plaintiff in a $200 million fen-phen class action settlement testified in federal court Tuesday that she specifically opposed plans by three lawyers in the case to donate leftover settlement money to charity.

Joyce A. Brown said that when she telephoned the Lexington law office of William Gallion to express her opposition, a woman on the phone told her that the charity plan was going through, and that she had no choice in the matter.

Another plaintiff, Connie Centers of Lawrenceburg, said no one ever discussed a charitable contribution with her.

Gallion and fellow attorneys Melbourne Mills Jr. and Shirley Allen Cunningham Jr. ultimately placed about $20 million of settlement money in a charitable foundation they created and controlled. They also paid themselves about $150,000 each to manage the fund, called the Kentucky Fund For Healthy Living.

Mills, Cunningham and Gallion are on trial in federal court for conspiracy to commit wire fraud in their handling of the settlement, which grew out of a class-action lawsuit they filed in Boone Circuit Court in 1998 against American Home Products, the company that marketed fen-phen.

Prosecutors allege that the defendants unlawfully pocketed millions from the settlement, defrauding their clients out of about $65 million.

ECB

FAA Bans Chantix Use By Pilots and Air Traffic Controllers

Article on cnnmoney.com -- FAA bans Pfizer anti-smoking drug.  Our initial Chantix blog post in November 2006 has so far lead to 178 comments, most of them describing physical and mental problems occurring in people using Chantix.  Here's an excerpt from today's article:

Pfizer Inc.'s once-promising anti-smoking drug Chantix received another blow Wednesday after a nonprofit group's report about serious physical side effects prompted the Federal Aviation Administration to ban the drug's use by pilots and air traffic controllers.

The report, from the Institute for Safe Medication Practices, points out hundreds of serious problems reported since the popular drug was approved in May 2006, including dizziness, loss of consciousness, seizures, and abnormal spasms and movements.

BGS

Merck to Settle Vioxx Advertising Claims by AGs for $58 Million & Ban on Medical Ghostwriting

Article in the Wall Street Journal -- Merck Will Pay $58 Million To Settle Vioxx Ad Claims, by Kevin Kingsbury.  Here's an excerpt:

Merck & Co. agreed to pay $58 million to settle claims by 28 states and the District of Columbia that the drug maker used deceptive advertising for its Vioxx painkiller.

The drug maker also agreed to a ban on medical ghostwriting, under which an author's true identity is concealed. Last month, two medical-journal studies suggested Merck violated scientific-publishing ethics by ghostwriting dozens of academic articles, and minimized the impact of patient deaths in its analyses of some human trials involving Vioxx.

Pennsylvania Attorney General Tom Corbett said Tuesday that in 1999, Merck launched "an aggressive and deceptive advertising campaign which misrepresented the safety and improperly concealed the increased risks associated with Vioxx." The drug was pulled from the market in 2004, after safety concerns were raised.

BGS

10 Best Law Review Articles on Mass Torts

Since law professors love lists and hierarchies, I thought it might be fun to consider the best articles on the subject of this blog: mass tort litigation.  I have excluded from the list below (1) any participants in this blog and (2) empirical studies.  Of course, books are excluded as well.  A list of the best empirical studies on complex litigation is a project for another day.  I suggest 7 below, thanks to at least one wise suggestion, and look forward to more nominations.  Those of you starting out in the field, these might be a good place to begin your research.

So, without further ado, my suggestion for the best law review articles on mass torts, in chronological order.

David Rosenberg, The Causal Connection in Mass Exposure Cases: A "Public Law" Vision of the Tort System, 97 Harv. L. Rev. 851 (1984).

Francis McGovern, Resolving Mature Mass Tort Litigation, 69 B.U. L. Rev. 659 (1989)

Robert G. Bone, Statistical Adjudication: Rights, Justice and Utility in a World of Process Scarcity, 46 Vand. L. Rev. 561 (1993)

Jack B. Weinstein, Ethical Dilemmas in Mass Tort Litigation, 88 Nw. U. L. Rev. 469 (1994)

Richard A. Nagareda, Turning From Tort to Administration, 94 Mich. L. Rev. 899 (1996)

William B. Rubenstein, A Transactional Model of Adjudication, 89 Geo. L.J. 371 (2001) 

Samuel Issacharoff & John Fabian Witt, The Inevitability of Aggregate Settlement: An Institutional Account of Tort Law, 57 Vand. L. Rev. 1571 (2004)

ADL