November 24, 2007
FDA Questions Child Safety of Glaxo Asthma Drugs Serevent and Advair
Article in the Wall Street Journal -- Questions the Safety Of Asthma Drugs for Kids, by Jenifer Corbett Dooren and Anna Wilde Mathews. Here's an excerpt:
Food and Drug Administration drug-safety reviewers questioned whether the GlaxoSmithKline PLC asthma drugs Serevent and Advair are appropriate for use in pediatric patients, and said the issue needs further review.
The asthma-drug findings came in documents posted Friday in advance of a meeting of the FDA's pediatric advisory committee. The session, which starts Tuesday, is expected to focus on the safety of a number of drugs, including the influenza medications Tamiflu, from Roche Holding AG, and Relenza, made by Glaxo.
Serevent and Advair, which both contain the active ingredient salmeterol, already carry a strong "black box" label warning about a risk of asthma-related death. The agency's reviewers said they hadn't identified side effects unique to children.
November 23, 2007
FDA Recommends Child Neurological Warnings for Flu Drugs Tamiflu and Relenza
Article on cnn.com -- FDA wants behavior warning on flu drugs. Here's an excerpt:
Government health regulators recommended adding label precautions about neurological problems seen in children who have taken flu drugs made by Roche and GlaxoSmithKline.
The Food and Drug Administration on Friday released its safety review of Roche's Tamiflu and Glaxo's (Charts) Relenza. Next week, an outside group of pediatric experts is scheduled to review the safety of several such drugs when used in children.
November 21, 2007
FDA Investigates Chantix Link to Suicidal Thoughts, Aggressive Behavior, and Drowsiness
The FDA is looking into possible links between Pfizer's anti-smoking drug Chantix and various mental or emotional effects. In its announcement yesterday -- Early Communication About an Ongoing Safety Review: Varenicline (marketed as Chantix) -- the agency summarized the reports it has received about side effects of Chantix. The FDA is working with Pfizer "to further evaluate the potential association between Chantix and suicidal thoughts, aggressive and erratic behavior, and impairment that affects one’s ability to drive or operate machinery," and will report its conclusions and recommendations as soon as it completes its analysis. In the meantime, "The FDA urges both healthcare professionals and patients to report side effects from the use of Chantix to the FDA's MedWatch Adverse Event Reporting program."
Here's an excerpt from today's Wall Street Journal article:
The Food and Drug Administration has received reports of "suicidal thoughts and aggressive and erratic behavior" in people taking Chantix, the smoking-cessation drug sold by Pfizer Inc., but it is too soon to say whether the drug is clearly linked with such problems, the agency said yesterday.
Pfizer said yesterday that it had updated the drug's label to include "reports of depressed mood, agitation, changes in behavior, suicidal ideation, and suicide in patients attempting to quit smoking while taking Chantix."
... The agency said it is reviewing reports of drowsiness in some people taking the drug, and it recommended that patients taking Chantix be careful driving and operating machinery until they know how the drug affects them. Patients should tell their doctors if they have mood or behavior changes while taking the drug.
Pfizer denies proof of causation. The WSJ article quotes a Pfizer medical director who emphasized that quitting smoking can cause nicotine-withdrawal symptoms regardless of whether an anti-smoking drug is used. At Pharmalot, Ed Silverman wrote about this yesterday in Up in Smoke? Pfizer's Chantix and Suicidal Thoughts, and reports Pfizer's reaction:
A Pfizer spokesman e-mailed us to say that Chantix labeling has been updated to reflect the various reports, but emphasized that “there is no scientific evidence establishing a causal relationship between Chantix and these reported events…In clinical trials involving more than 5,000 patients, adverse events related to changes in behavior or psychiatric symptoms, including suicidal ideation, were rare and occurred at a rate comparable to placebo-treated patients. There were no suicides in patients taking Chantix in our clinical trials.”
A post on Chantix on the Mass Tort Litigation Blog one year ago has generated 100 comments, mostly by Chantix users discussing side effects they have experienced. To our surprise as blog editors, the comments page to that post has become something of a chat room for worried Chantix users. Is this the first stages of the sort of mass tort networking about which Byron Stier has written?
I understand that neither Chantix users nor Pfizer looks at this from an academic perspective. I also understand that, for them, this is not (or at least, one hopes, not primarily) about tort liability and litigation. For users, this is about personal health, and for Pfizer, it's about both corporate responsibility and a product that is critical to the company's revenue.
But for those of us who try to understand the development of mass tort litigation, it's fascinating to watch the seeds of potential litigation at a point when we know that some litigation is inevitable but do not know whether the lawsuits will flourish and replicate. Four million U.S. patients took Chantix. There are plaintiffs' attorneys advertising for Chantix clients. But it's very early. Beck and Herrmann, in their Anatomy of a Mass Tort (which I think was right on target), described how mass torts begin:
A mass tort does need a trigger. We'll bet the mortgage that one of these five events started the avalanche: (1) bad press -- Connie Chung or Mike Wallace said something nasty, (2) regulatory action -- the FDA added a black box warning to a drug or the National Highway Traffic Safety Administration recalled a car, (3) a voluntary recall -- although no government agency demanded it, a manufacturer took its product off the market, (4) a big jury verdict -- nothing catches the eye of the plaintiff's' bar like money, or (5) a critical article in the scientific literature -- historically, we didn't see this trigger too often, but it's becoming increasingly common.
Even as we watch a potential endgame in Vioxx with Merck's settlement offer, and follow asbestos litigation in its over-mature stage, it's interesting to look at yesterday's FDA announcement when we don't yet know whether that announcement will turn out to be a mass tort trigger, and to look at the informal networks developing among Chantix users when we don't yet know whether the chat room will become a litigation plaintiff network.
November 20, 2007
Medtronic Feels Financial Effect of Recall of Sprint Fidelis Heart Leads, Mentions Ready for Litigation
An article in the Wall Street Journal -- Medtronic Net Slips on Recall, by Thomas M. Burton and Jon Kamp -- discusses the significant negative financial impact on Medtronic from its recent recall of Sprint Fidelis heart leads and mentions possible related litigation against Medtronic. Here's an excerpt:
Regarding the potential for litigation linked to the recall, [Medtronic chief executive] Mr. Hawkins said it is too soon to say what the impact may be. "We're well-prepared financially and legally for any legal actions that come our way," he said.
Defibrillators are designed to correct potentially lethal racing heartbeats by dispatching a powerful jolt to the heart. A lead fracture can mean the electrical therapy doesn't get sent to the heart, and the patient can die. In the case of Sprint Fidelis, it has also meant that unnecessary shocks are sent to some patients' hearts. The company has said this phenomenon was at work in some of the five patient deaths that may have resulted from the fractured leads.
Sebok and Zipursky on Vioxx Settlement Ethics
Excellent FindLaw column today by Tony Sebok and Ben Zipursky -- Getting With the Program: The Vioxx Settlement Agreement. One of their central points is that Vioxx plaintiffs need advice to decide whether to accept the Merck settlement offer, but it is hard for clients to trust their lawyers' advice when the lawyers have already agreed to recommend the settlement to every client.
Perspectives on Asbestos Litigation Symposium at Southwestern Law School
On Friday, January 18, 2008, Southwestern Law School will present a symposium entitled, Perspectives on Asbestos Litigation. Scheduled speakers and moderators include Judge Barbara Jacobs Rothstein (Federal Judicial Center, Director); Justice Helen Freedman (N.Y. Supreme Court); Deans Bryant Garth (Southwestern) and Gregory Keating (USC); Professors Ronald Aronovsky (Southwestern), Anita Bernstein (Brooklyn), Alan Calnan (Southwestern), Howard Erichson (Fordham (Visiting) & Seton Hall), James Fischer (Southwestern), Mark Geistfeld (NYU), Michael Green (Wake Forest), Deborah Hensler (Stanford), Keith Hylton (Boston U.), Francis McGovern (Duke), Linda Mullenix (Texas), Richard Nagareda (Vanderbilt), David Owen (South Carolina), Joseph Sanders (Houston), Judy Sloan (Southwestern), and Neil Vidmar (Duke); and distinguished practitioners Marh Behrens (Shook, Hardy) and Steven Kazan (Kazan, McClain).
Professor Alan Calnan and I are serving as co-chairs for the conference, and I will also moderate a panel on Public and Private Law Perspectives. The Southwestern University Law Review will subsequently publish an issue based on the symposium. Hope you can join us for what promises to be an interesting and informative day.
Pfizer Wins Daubert Motion in Celebrex Litigation
Pfizer has won a Daubert motion in the Celebrex litigation that may significantly reduce the size of the litigation. Here's an excerpt from the Wall Street Journal article, Pfizer Legal Win Might Block Some Lawsuits Over Celebrex, by Nathan Koppel and Heather Won Tesoriero:
Pfizer Inc. scored a victory yesterday through a federal ruling that might wipe out some lawsuits alleging that the drug maker's painkiller Celebrex caused heart attacks and strokes.
U.S. District Judge Charles R. Breyer of San Francisco ruled that plaintiffs in the litigation haven't presented scientifically reliable evidence that Celebrex caused heart attacks or strokes when taken at a daily dosage of 200 milligrams. That is the most common dosage, according to Pfizer.
Celebrex is the last drug in the COX-2 inhibitor class that is sold in the U.S. Merck & Co.'s Vioxx and Pfizer's other COX-2 painkiller, Bextra, were withdrawn from the market amid safety concerns.
There are more than 3,000 Celebrex plaintiffs, according to the ruling, but it isn't clear how many the ruling will affect. Paul Sizemore, a plaintiffs' attorney with Girardi & Keese in Los Angeles, estimates that about 900 Celebrex cases involve plaintiffs who were prescribed the 200-milligram dose. However, he says, many of the plaintiffs took the drug twice a day.