Mass Tort Litigation Blog

FDA Advisory Panel for Avandia Votes, Finds Heart Risk

Article in the Wall Street Journal -- Panel Keeps Avandia on Market: Glaxo's Diabetes Drug May Require Warning On Label for Heart Risks, by Anna Wilde Mathews.  Here's an excerpt:

A Food and Drug Administration advisory committee found that GlaxoSmithKline PLC's diabetes drug Avandia is tied to a risk of heart attacks, but it stopped short of voting to pull the medication off the market.

Several panel members said the drug should get a new heart-risk warning in its label, which would be a blow to the company but far less serious than a recommendation to end sales of Avandia. Last year, it was the company's second-biggest-selling drug with global sales of $3.38 billion, and it has been used by more than seven million patients world-wide.

The heart-risk warning is likely to accelerate the reshuffling of the growing market for diabetes drugs, boosting sales of older medications and Takeda Pharmaceutical Co.'s Actos, the only marketed rival that works the same way as Avandia. So far, Actos hasn't been linked to a heart-attack risk. The FDA doesn't have to follow the advice of its expert panels, but it typically does. An agency official said after the meeting that the FDA would aim to reach a decision quickly.

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New Medicare and Medicaid Rules for Anemia Drugs

Article in the Wall Street Journal -- A Victory for Anemia Patients?  Advocates Beat Back Effort To Limit Use of Popular Drugs That May Carry Heart Risks, by Marilyn Chase.  Here's an excerpt:

The Centers for Medicare and Medicaid Services -- amid pressure from patient advocacy groups, medical societies and legislators -- released new rules on its coverage of anemia drugs that are significantly less stringent than what the agency had originally planned.

The proposed changes, aimed at improving patient safety, had caused a public uproar for the past two months. More than 2,600 public comments were filed, many complaining that the proposals were Draconian and threatened to compromise patients' quality of life by withholding needed treatment.

The new guidelines apply mostly to people with cancer who are receiving chemotherapy that causes anemia -- a lack of red blood cells that ferry oxygen around the body. They also apply to myelodysplasia, a disorder of the bone marrow. Anemia can cause crushing fatigue, shortness of breath and cardiac arrhythmia.

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Upcoming FDA Advisory Panel Meeting on Glaxo's Avandia

Article in the Wall Street Journal -- FDA to Seek Guidance Over Avandia, by Jennifer Corbett Dooren and Anna Wilde Mathews.  Here's an excerpt:

The Food and Drug Administration is concerned about the potential heart-attack risk tied to the widely used GlaxoSmithKline PLC diabetes drug Avandia, and the agency will ask an advisory panel whether the medication should remain on the U.S. market.

In documents made public yesterday in advance of a public meeting set for Monday, FDA officials wrote that they view Avandia's potential heart-attack risk with "considerable concern," despite "somewhat inconsistent findings that complicate the interpretation of the available data." They wrote that "it is also important to place any risk into context of what is known about the risks of other available therapies" -- notably Japan's Takeda Pharmaceutical Co.'s Actos, the only marketed diabetes drug that works the same way as Avandia.

Monday's meeting could be as significant for the Takeda medication as it is for Avandia. In January, Avandia had 51% while Actos had 49% of the U.S. market for their class of drugs, according to a Morgan Stanley research report that cites data from IMS Health. In May, the New England Journal of Medicine published an analysis by Cleveland Clinic cardiologist Steven Nissen linking Avandia to a potential risk of heart attacks. By July 13, Avandia's market share had dropped to 33% and Actos had soared to 67%. Last year, Avandia was Glaxo's second biggest-selling drug with global sales of $3.38 billion, making up 7% of the Brentford, England, company's total sales of $47.63 billion.

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Merck Promotes General Counsel Kenneth Frazier, and Appoints Successor

Post on the Wall Street Journal Health Blog -- Merck’s Vioxx Warrior Gets Promoted, by Jacob Goldstein.  Here's an excerpt:

Frazier, 52, has won points among Merck defenders for his tell-it-to-the-judge style. He hasn’t settled any of the roughly 27,000 Vioxx lawsuits filed against the company following the withdrawal of the pain medicine. So far, the company has won 10 cases and lost five.

Frazier’s replacement as general counsel is Bruce Kuhlik, who joined the company in 2005 to help deal with the Vioxx litigation. He previously worked for PhRMA, the drug industry trade group.

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Pharmaceutical Company Job Cuts; Amgen & Aranesp

Article in the Wall Street Journal -- Drug Makers Tighten Their Belts Again: AstraZeneca Expands Job-Reduction Plan Bristol-Myers Sets Cuts, by Peter Loftus and Elena Berton.  Here's an excerpt with regard to Amgen and its drug Aranesp:

Amgen, Thousand Oaks, Calif., said profit soared from year-earlier results that were weighed down by a hefty acquisition charge, but the biotechnology company's revenue growth slowed considerably because of safety concerns surrounding antianemia drug Aranesp.

Amgen posted net of $1.02 billion, or 90 cents a share, up from $14 million, or a penny a share, a year earlier. Revenue rose 3% to $3.73 billion. The company posted revenue growth of 15% for both the first quarter and all of last year.

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Glaxo Maintains Profit Outlook Despite Avandia Concerns

Article in the Wall Street Journal -- Glaxo, Set Back By Diabetes Drug, Sticks to Forecast, by Elena Berton.  Here's an excerpt:

Sales for the Avandia family of drugs, which also include combination products Avandamet and Avandaryl, fell 22% to £349 million. Avandia has been hit by concerns about possible cardiovascular side effects linked to the drug. The company has mounted a robust defense of its second best-selling product, releasing data from studies that appear to back Avandia's safety.

A Food and Drug Administration panel of experts is scheduled to meet next week to decide whether Avandia should remain on the market and, if so, whether its use should be further restricted. Chief Executive Jean-Pierre Garnier said Glaxo has submitted to the U.S. regulator new data from an epidemiology study on 400,000 diabetes patients, which supports the safety of the drug.

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Merck Profit Soars Despite Vioxx Litigation

Article on cnn.com -- Merck soars on high profits, outlook: Profits grew 12 percent, helped by higher sales of new vaccines, medicines, by Reuters.  Here's an excerpt:

Merck & Co. said Monday that quarterly earnings rose 12 percent on strong demand for its newer vaccines and medicines, and raised its 2007 profit forecast, sending its shares up nearly 8 percent.

Merck (up $3.97 to $52.99, Charts, Fortune 500) shares jumped 7.8 percent in heavy midday trading on the New York Stock Exchange after it revealed second-quarter net income rose to $1.68 billion, or 77 cents per share, from $1.5 billion, or 69 cents per share, a year earlier.

The latest results include the impact of setting aside another $210 million for legal fees associated with litigation involving the company's Vioxx arthritis drug. Merck is facing about 27,000 lawsuits filed by people who claim to have been harmed by the widely used pill, which was withdrawn in 2004 after being linked to heart attacks.

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Nigerian Lawsuit Against Pfizer for Experimental Drug Testing

Article on cnn.com -- Nigeria to refile suit against U.S. drug giant Pfizer, by the Associated Press.  Here's an excerpt:

Nigerian government lawyers withdrew a $7 billion civil lawsuit against Pfizer Inc. on Friday, saying they have discovered new material and plan to file what they called an even stronger case against the U.S. drug maker.

The government has accused Pfizer of taking advantage of a 1996 meningitis epidemic to test an experimental drug without authorization or full understanding of the families involved -- allegedly contributing to the deaths of some of the children and sickening others. Pfizer denies wrongdoing.

"We are here this morning to move an application for notice of discontinuance of this case. ... We have planned to refile a new suit," government lawyer Babatunde Irukera said.

Irukera said lawyers recently discovered material that suggested Pfizer committed fraud in the administration of the drug. The new suit will include these materials, along with clarifying some of the government's original arguments.

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Second Circuit Hears Schwab Tobacco Oral Argument

Earlier this month, the Second Circuit Court of Appeals heard oral argument in the Schwab case.  Here's an excerpt from an article on Bloomberg.com describing the oral argument -- Cigarette Makers Ask Court to Block $200 Billion Suit, by Bob Van Voris:

Altria Group Inc.'s Philip Morris USA and other cigarette makers asked a federal appeals court to dissolve a $200 billion racketeering class-action lawsuit filed on behalf of smokers of ``light'' cigarettes in the U.S.

The companies argue that legal and factual differences between individual smokers make a trial of all the claims in a class-action, or group, lawsuit impossible. Lawyers for smokers said a class action is the only practical way for their clients to recover damages for an alleged decades-long fraud.

Smokers of ``65 brands with hundreds of advertising campaigns over 35 years'' couldn't have chosen to smoke light cigarettes for a single reason, Theodore Grossman, a lawyer for the companies, told a three-judge appeals panel today.

Class status gives plaintiffs more leverage, increasing potential damages at trial and enabling them to possibly force a better settlement. Filed in 2004 under the Racketeer Influenced and Corrupt Organizations Act, or RICO, the suit claims cigarette makers defrauded smokers of ``light'' and ``low-tar'' cigarettes by marketing them as safer than other brands.

If the appeals court permits the case to go forward, it would represent the biggest potential legal liability for the tobacco industry.

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Blog Roundup

Drug and Device Law Blog has an interesting post on Why The Changing Face Of The MDL Panel Won't Change The Outcome Of Your Transfer Motion, by guest blogger Pearson N. Bownas.

Point of Law has a post criticizing the Virginia Tech compensation fund: Government Compensation Folllies, by Michael Krauss.

Products Liability Prof Blog has a post on Consumer Class Actions Usurping Personal Injury Claims, by J. David Prince.

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Increasing Third Circuit Scrutiny of Mass Tort Settlements

Article in the ABA Journal -- Philadelphia Fee-dom: The 3rd Circuit tackles settlements that leave clients wanting, insurers burning, by Margaret Graham Tebo.  Here's an excerpt:

Much like the housing bubble, the days of huge class action settlements providing millions in attorney fees may be ready to burst, at least in one fed­eral circuit.

The Philadelphia-based 3rd U.S. Circuit Court of Appeals is starting to take a hard look at settlements that provide for huge attorney fees while leaving in­surance companies stuck with the bill—and some­times leaving plaintiffs claiming they got less than their fair share.

For years, critics say, it worked like this: Plaintiffs lawyers would file mass tort class actions—such as those for asbestos, tobacco and other products found to cause grave harm. Then, when the company allegedly responsible for damages filed for bankruptcy protection in the face of the claims, plaintiffs lawyers would settle for an amount that provided millions of dollars in attorney fees, while leaving individual claimants with a relatively small recovery. The company was then absolved of further liability and could reorganize and emerge relatively unscathed.

But recently that structure has begun to show cracks. In some instances, insurance companies—which usually pay the bulk of these settlements—have cried foul. The companies are seeking to intervene in cases where they face huge liabilities, sometimes joining forces with unhappy claimants who feel their lawyers didn’t have their best interests at heart when they agreed to the settlements.

In one case, the 3rd Circuit revived a suit last Octo­ber that had been filed by a group of asbestos workers alleging their former lead attorneys had breached their fiduciary duty in negotiating a settlement. Huber v. Taylor, 469 F.3d 67. 

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Congressional Investigators Criticize FDA

Article in the Wall Street Journal -- FDA Food Inspections Are Seen as Inadequate, by Jane Zhang.  Here's an excerpt:

Congressional investigators are expected to tell a House subcommittee today that the Food and Drug Administration's ability to ensure the safety of the U.S. food supply is "minimal" and agency plans to overhaul its inspection regime could make a bad situation worse.

FDA officials, under fire for the recent string of high-profile food scares involving both domestic and imported foods, have been asked to appear before a House Energy and Commerce investigations subcommittee hearing to discuss the agency's food inspections.

Committee staff reviewed the system extensively and found that a shrinking inspection staff examines less than 1% of all imported food. A typical inspector in the FDA's San Francisco office examines nearly 1,000 food entries a day -- roughly one every 30 seconds, the committee report found. The agency, it says, allows importers to take possession of their high-risk goods and arrange for testing by a private laboratory. Before melamine-contaminated pet food killed and sickened thousands of pets, the FDA had never inspected those ingredients from China.

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Catholic Church Sexual Abuse Settlement

Article in the New York Times -- After Abuse Settlement, an Apology to Victims, by Laurie Goodstein.  Here's an excerpt:

A day after agreeing to a record $660 million settlement with 508 victims of sexual abuse by members of the clergy in the Archdiocese of Los Angeles, Cardinal Roger Mahony apologized to the victims for “this terrible sin and crime” and said he hoped the settlement would bring a “final resolution.”

Four years of legal combat ended in a settlement agreement late Saturday, just two days before the scheduled start of a trial in which Cardinal Mahony would have been required to testify.

The settlement is the largest in any Roman Catholic diocese, amounting to about $1.3 million per victim. The Catholic Church in the United States has so far paid more than $2 billion in settlements and legal judgments to victims of sexual abuse and their families.

Lawyers for the archdiocese and the plaintiffs said they were still negotiating details but expected to present an agreement for approval to the judge in the trial this morning.

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CPSC Proposal to Strengthen Efforts Against Unsafe Imports

Article in the Wall Street Journal -- Product Safety Commission Aims to Strengthen Ability to Combat Unsafe Imports, by Christopher Conkey.  Here's an excerpt:

The Consumer Product Safety Commission says it has a new proposal to strengthen its ability to combat unsafe imports. But the measure faces limited resources and challenges from lawmakers.

Nancy Nord, the CPSC's acting chairman, plans to present Congress on Monday with several measures that would beef up the agency's ability to impose safety requirements and sanctions, such as by increasing its authority to stop unsafe imports at the border. Her plan also would increase the maximum fine for violations more than fivefold, to $10 million.

The proposals, which would need Congress's approval, come at a time of heightened concern over the hazards posed by Chinese-made products ranging from pet food to children's toys.

But Ms. Nord's plan wouldn't seek more funding, which many critics see as a central problem for the agency. The CPSC currently has about 400 full-time employees, and its work force has steadily declined in recent years, even as globalization has made product safety more challenging.

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Former Surgeon General Carmona Testifies About Administration Pressure on His Health Statements

Article in the New York Times -- Surgeon General Sees 4-year Term as Compromised, by Gardiner Harris.  Here's an excerpt:

Former Surgeon General Richard H. Carmona told a Congressional panel Tuesday that top Bush administration officials repeatedly tried to weaken or suppress important public health reports because of political considerations.

The administration, Dr. Carmona said, would not allow him to speak or issue reports about stem cells, emergency contraception, sex education, or prison, mental and global health issues. Top officials delayed for years and tried to “water down” a landmark report on secondhand smoke, he said. Released last year, the report concluded that even brief exposure to cigarette smoke could cause immediate harm.

Dr. Carmona said he was ordered to mention President Bush three times on every page of his speeches. He also said he was asked to make speeches to support Republican political candidates and to attend political briefings.

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Anti-Smoking Pill Chantix May Be Used to Curb Drinking

Article in the New York Times -- Anti - Smoking Pill May Help Curb Drinking, by the Associated Press.  A prior post on Chantix on the Mass Tort Litigation Blog lead to numerous posted comments noting negative health effects from taking Chantix.  Here's an excerpt:

A single pill appears to hold promise in curbing the urges to both smoke and drink, according to researchers trying to help people overcome addiction by targeting a pleasure center in the brain.

The drug, called varenicline, already is sold to help smokers kick the habit. New but preliminary research suggests it could gain a second use in helping heavy drinkers quit, too.

Much further down the line, the tablets might be considered as a treatment for addictions to everything from gambling to painkillers, researchers said.

Several experts not involved in the study cautioned that there is no such thing as a magic cure-all for addiction and that varenicline and similar drugs may find more immediate use in treating diseases like Alzheimer's and Parkinson's.

Pfizer Inc. developed the drug specifically as a stop-smoking aid and has sold it in the United States since August under the brand name Chantix. Varenicline works by latching onto the same receptors in the brain that nicotine binds to when inhaled in cigarette smoke, an action that leads to the release of dopamine in the brain's pleasure centers. Taking the drug blocks any inhaled nicotine from reinforcing that effect.

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David Bershad of Milberg Weiss & Bershad to Plead Guilty

Article on cnnmoney.com -- Defendant to plead guilty today in Milberg case, by Roger Parloff.  Here's an excerpt:

Defendant David J. Bershad, 67, a named partner at the indicted class-action law firm now known as Milberg Weiss & Bershad, is expected to plead guilty to conspiracy to obstruct justice at 2 p.m. PT today in Los Angeles federal court.

By pleading guilty to non-fraud counts, Bershad will limit his sentencing exposure under the guidelines. By cooperating with the government, as he is also understood to be doing, he will be eligible for a “downward departure” from those guideline recommendations.

According to a person familiar with the situation, Bershad’s plea will relate to the core allegations of the indictment: misleading judges into believing that plaintiffs were being paid by Milberg Weiss, when in fact the firm was paying them. A “factual statement” accompanying the plea is also expected to unveil new details of the government’s allegations against the still unindicted “Partner A” and “Partner B,” who are widely assumed to be, respectively, name partner Melvyn Weiss and former name partner William Lerach. Lerach and the San Diego-based west coast office of Milberg Weiss split away from Milberg Weiss in 2004 to found Lerach Coughlin Stoia Geller Rudman & Robbins.

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Vioxx MDL Judge Rejects FDA Preemption of Warnings-Based Claims

Article in the New York Times -- Judge Rejects Merck’s View on F.D.A. Issue, by the Associated Press.  Here's an excerpt:

Food and Drug Administration approval of a drug label does not clear the manufacturer of claims that its warnings were inadequate, a judge ruled in a decision that could potentially affect thousands of federal suits against Merck over the painkiller Vioxx.

“The F.D.A.’s current view on the question of immunity for prescription drug manufacturers is entirely unpersuasive,” Judge Eldon E. Fallon of Federal District Court wrote in the opinion, handed down Tuesday.

Had Judge Fallon sided with Merck, the drug company could have challenged claims brought by thousands of other plaintiffs who say it is to blame for heart attacks and other cardiovascular problems.

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Feinberg to Dispense Virginia Tech Shooting Fund

Article in the New York Times -- Lawyer Who Directed Sept. 11 Compensation to Oversee Virginia Tech Program, by Ian Urbina.  Here's an excerpt:

Kenneth R. Feinberg, the Washington lawyer who directed the federal program to compensate relatives of victims of the Sept. 11 terrorist attacks, will oversee the distribution of the $7 million that has been donated to Virginia Tech after the April campus massacre, university officials said Thursday.

“There is no script for a tragedy of this magnitude and depth of pain,” the university’s president, Charles Steger, said. “I am very pleased to have someone of Ken Feinberg’s caliber, experience and long career to help guide us.”

In November 2001, Mr. Feinberg was appointed special master of the Sept. 11 Victim Compensation Fund by then-Attorney General John Ashcroft. A former chief of staff for Senator Edward M. Kennedy, Mr. Feinberg has extensive experience in mediating complicated compensation disputes, including those that arose over the Agent Orange defoliant used in the Vietnam War and the Dalkon Shield birth control device.

While Mr. Feinberg’s job will involve the difficult responsibility of assigning monetary values to human lives, he said his current task would be much smaller and less complicated than his work on the Sept. 11 case.

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