FDA News, Drug Daily Bulletin: Litigators Set Sights on Chantix — (FDA News)

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FDA News

July 15, 2008  | Vol. 5 No. 137

A lawsuit claiming Pfizer’s smoking-cessation drug Chantix caused a suicide was filed in Indiana federal court earlier this month, and a major law firm is investigating similar legal action against the manufacturer.

Philadelphia-based Levin, Fishbein, Sedran & Berman,­ not a party in the Indiana suit but whose partner Arnold Levin was a member of the committee that negotiated the $4.5 billion Vioxx (rofecoxib) settlement against Merck ­ has a number of clients with potential claims involving Chantix (varenicline tartrate), according to Michael Weinkowitz, a mass tort and class-action attorney at the firm. Investigations into the cases continue, he said.

Chantix was approved in May 2006 and at least 4 million people have been prescribed the drug in the U.S., Pfizer has said. Since its launch, the product has experienced strong uptake, making $193 million in U.S. sales during the first quarter of 2008.

The drug has been suspected of being associated with suicidal thoughts and aggressive and erratic behavior. The FDA issued a MedWatch report and an early communication highlighting the issues last November. Pfizer added a warning to Chantix physician labeling Jan. 18 recommending that patients be observed for suicidal thoughts or behaviors, agitation and depressed mood.

The Indiana lawsuit, Linda Collins v. Pfizer, Inc., accuses Pfizer of contributing to the death of her husband, who began taking Chantix last October. He died of a self-inflicted gunshot wound Jan. 3.

The suit contends that Pfizer’s revised Chantix label is inadequate to properly warn patients of the drug’s risks. According to the complaint, the man had no history of mental illness.

The plaintiff alleges that Pfizer should have known about the safety issues with the drug because of knowledge the firm had of other products, which the lawsuit says have a similar mechanism of action,­ such as antidepressant Zoloft (sertraline HCl).

 

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ENTRY ON DEFENDANT’S MOTION FOR PARTIAL DISMISSAL — (Justia)

This case is a product liability action arising from the death of David Collins. Mr. Collins began taking the smoking cessation drug Chantix in October 2007. On January 3, 2008, he died of a self-inflicted gunshot wound. Acting both individually and as the representative of David’s estate, his wife Linda Collins filed a complaint against Pfizer, the maker of Chantix, on July 7, 2008. That original complaint pled claims for negligence, strict liability, breach of express warranty, breach of implied warranty, fraudulent misrepresentation, fraudulent concealment, reckless and/or negligent misrepresentation and concealment, gross negligence, and unjust enrichment. Pfizer filed a motion to dismiss all claims except for strict liability and unjust enrichment. Pfizer argued that all other claims are subsumed or preempted by the Indiana Product Liability Act (“IPLA”).
Pfizer also argued that claims for punitive damages, attorney fees, pain and suffering, and loss of enjoyment of life are barred under Indiana law. The present motion does not address any issues going directly to whether the drug is actually defective or whether any defect could have been a proximate cause of Mr. Collins’ death – matters addressed in considerable detail in the complaint.

Mrs. Collins responded to Pfizer’s motion by filing an amended complaint that concedes some issues by alleging only claims for product liability, breach of express and implied warranties, and unjust enrichment. The amended complaint also deleted express references to damages for Mr. Collins’ pain and suffering and loss of enjoyment of life. As is often the case with motions to dismiss on the pleadings, the target has moved, and some of the argument has become abstract and speculative, with stakes that are not at all clear. As explained below, Pfizer’s motion to dismiss is denied as to the breach of warranty claims…