Big Pharma to settle birth defect claims related to antidepressant Paxil

GlaxoSmithKline has agreed to settle yet another big group of product-liability lawsuits involving one of its popular meds. The latest deal involves an agrement to pay more than $1 billion to settle some 800 cases alleging its Paxil antidepressant caused birth defects. For more on this story go to AboutLawsuits and Pharmalot.

Bill would give FDA mandatory recall authority

In light of the Johnson & Johnson recall scandal, the House Committee on Oversight & Government Reform has, as promised, introduced a bill to give the FDA mandatory recall powers. Go here for the full story.

Recent developments regarding Avandia

Here are the headlines and links to several stories on Avandia since the recent reports on the FDA panel recommendation to keep it on the market and then reports on possible conflicts of interests of some members of the panel. FDA Halts A Controversial Avandia Study (Pharmalot, July 21) FDA Panel Members Talk About Avandia Conflicts (Pharmalot, July 21) FDA Asks HHS To Probe Avandia Panel Member (Pharmalot, July 26) Investigation Launched into Conflict on Avandia Panel (AboutLawsuits, July 27)

AstraZeneca Starts To Settle Seroquel Lawsuits

From a story in Pharmalot: Another day, another large settlement. Rather than ring up tabs for expensive lawyers and confront the possibility of bad publicity indefinitely, drugmakers are choosing to settle gobs of product-liability lawsuits with big settlements. Such moves, of course, appease anxious investors and allow senior execs to focus on the important stuff, such as their compensation packages developing new meds. Over the past few weeks, GlaxoSmithKline has been practically racing to resolve Avandia and Paxil lawsuits (see here and here). And Eli Lilly has done the same with its Zyprexa antipsychotic. Now, AstraZeneca has agreed to pay $2 million to settle more than 200 lawsuits charging its Seroquel antipsychotic causes diabetes, marking the first time the drugmaker agreed to settle such claims. To read the full story, go here. UPDATE: It is now reported that AstraZeneca has agreed in principle to settle nearly 4,000 claims that charged the drugmaker with hiding the risks of its Seroquel antipsychotic and links to diabetes. Go here for the full story.

Conflicts of interest revealed in FDA panel that voted to keep Avandia on the market

A few days ago, I reported that an FDA penal surprisingly voted to keep the diabetes drug Avandia on the market. In separate stories, it has not been reported that two different members of the panel had clear conflicts of interest and should not have been allowed to remain on the panel. One panel member had been a speaker for GlaxoSmithKline (Avandia's manufacturer) and had been paid $8,000 through 2008 and another $3,000 earlier this year. Another member of the panel was a paid speaker for Takeda Pharmaceutical, which sells Avandia's rival drug Actos. For more on this topic go here, here and here.

AboutLawusits has a story on Avandia

Here is a link to a story in AboutLawsuits on the vote to keep Avandia on the market.

Glaxo agrees to pay $460 million to settle Avandia lawsuits

Just as an FDA panel was meeting to determine whether to recommend to withdraw Avandia from the market, Bloomberg News, Pharmalot and AboutLawsuits are reporting that GlaxoSmithKline has agreed to pay $460 million to settle Avandia lawsuits filed by about 10,000 more people. The settlement would resolve the majority of the outstanding Avandia lawsuits that have been filed against GlaxoSmithKline alleging that they failed to warn about the increased risk of heart attacks and other potentially life-threatening heart problems with Avandia.

FDA panel votes to keep Avandia on the market

After years of debate, mountains of data, harsh opinions, corporate intrigue and agency infighting, the FDA advisory committee voted to 20-12 (with one abstention) to keep Avandia on the market, but with either restrictions or labeling changes. The FDA doesn’t have to follow the advice of its panels, but generally does. And so, FDA officials must decided whether to develop a package of caveats that will appease those who maintain Avandia is should remain on the market, despite the cardiovascular risks. This possibility suggests Avandia could remain available elsewhere, although European regulators hold their own review next week. Go to Pharmalot for the full story. I am a little surprised by the vote because even though some reports concluded the FDA was divided on the issue, the "build up" to the meeting was dominated by very negative stories. Here is a sample of some of those: An interview with the former FDA medical reviewer who left the agency three years ago amid controversy over her work on Avandia who had pressed for stiffer warnings on the drug, but was rebuked and excluded from safety meetings. See here. News that GlaxoSmithKline quietly began a study in 1999 to determine if the cardiovascular risks of its Avandia diabetes pill were greater than with Actos, a similar drug, and instead of publishing the results, the drugmaker spent 11 years trying to cover them up, according to Pharmalot and The New York Times. Claims that Glaxo withheld a study from the FDA showing a link to heart attacks. See AboutLawsuits, Bloomberg News, Pharmalot. News that a group of doctors today filed suit against the Food & Drug Administration for failing to alert diabetes patients to safer alternatives to Avandia and other diabetes drugs that may increase the risk of stroke, heart attack and death. See Blog of the Legal Times and Law.com. News that India has suspended Avandia clinical trials over risks.

TV report on Avandia

A few days ago, I posted that it appears increasingly likely that an FDA advisory panel will recommend to take Avandia off the market after two new studies provide further evidence that GlaxoSmithKline’s diabetes drug increases the risk of heart attack and life-threatening injuries. More on the story in Pharmalot and CBS news. The story was also discussed on the CBS national news show last Friday in a small segment in which the interviewed one of the authors of a study from back in 2007 that argued the drug was dangerous and should be taken off the market. Here is the video:

Debate as to whether Senate should eliminate punitive damages tax deduction

A couple of weeks ago, the Blog of the Legal Times reported that, despite opposition from the business community, the Senate appears ready to eliminate the federal tax deduction for companies who pay punitive damages awards (here). Here are two articles arguing opposite positions on the issue: an Op-ed piece in the New York Times and a comment on the Drug and Device Law Blog