Wednesday, October 17, 2012

Chantix - let the games begin

Judge Denies Pfizer Request for Delay in Chantix Trial

A federal judge denied Pfizer Inc.'s (PFE) request to delay the start of the first product-liability trial surrounding its smoking-cessation drug Chantix, a delay the company said was needed because of newly released clinical data.

New York-based Pfizer is facing more than 2,600 lawsuits in federal court containing accusations that the smoking-cessation drug Chantix caused users to commit suicide or experience other mental-health problems, and that the drug maker failed to adequately warn of these risks. Safety concerns surrounding the drug have hurt its sales growth.

The first trial is scheduled to begin Monday in federal court in Alabama, and stems from a lawsuit brought by a Duluth, Minn., woman alleging her husband's use of Chantix caused him to commit suicide in 2007. Judy Whitely accused Pfizer of failing to properly warn of the risks before her husband Mark began using Chantix, and she is seeking damages.

Pfizer has denied the allegations, arguing in court papers that there is no evidence Chantix causes suicide-related events, and that it has properly warned of the various potential risks of the drug.

Tuesday, lawyers for Pfizer filed a motion seeking to delay the trial's start until Jan. 22, because the company released results Tuesday of a clinical trial involving Chantix. The study found Chantix was more effective than a placebo in helping people with past or present depression quit smoking, and there was no difference between the drug and a placebo in measures of psychiatric health, according to Pfizer's press release.

Pfizer asked a federal judge to delay the trial "to allow all parties to complete discovery and any pre-trial motion practice" related to the new clinical data, according to a motion filed by Pfizer Tuesday.

Amy Schulman, Pfizer's general counsel, said, "It's a time-honored legal principle that the law should follow science and not lead it," and Pfizer is asking the court to delay the start of the trial in order for the new data on the safety of Chantix to be weighed.

"The court should want a full and complete record before it, and in order to ensure that, the trial should be delayed to permit this evidence to be explored," she said.

However, U.S. District Judge Inge Prytz Johnson denied Pfizer's request later Tuesday. She wrote that Pfizer performed the study and controlled the release of its results, and noted more than 90 potential jurors have already been summoned for consideration to serve on the trial jury.

"Defendant's concern about litigation getting ahead of science does not create any cause for a sudden halt to litigation which has been pending since 2009, based on a study for which defendant controlled when the results were made public," the judge's ruling said.

Tara D. Sutton, an attorney for Ms. Whitely, declined comment.

In addition to preparing its defense, Pfizer is trying to keep its chief executive, Ian Read, out of the courtroom. A U.S. District Court judge has permitted Ms. Whitely's lawyer to call Mr. Read as a witness in the trial, but Pfizer last week appealed the decision, arguing his appearance would be burdensome and unnecessary. An appellate court decision is pending.

Chantix was initially a Pfizer success story when it was introduced in 2006, with the company predicting annual sales would eventually top more than $1 billion. Early sales were brisk because clinical trials showed it was an effective aid to help people stop smoking.

But safety concerns soon emerged, including a 2007 report that a rock musician in Texas engaged in erratic behavior after using Chantix, which preceded his shooting death.

The U.S. Food and Drug Administration and watchdog groups began issuing alerts about the drug's safety, including the FDA's 2009 requirement that the drug's prescribing label carry a prominent, "black box" warning of the risk of serious mental health events including suicidal thoughts and hostility associated with Chantix.

Sales growth has stalled out. For the first half of 2012, Chantix sales fell 10% to $350 million.

The lawsuits filed against Pfizer have generally alleged use of Chantix caused suicides, suicide attempts and other injuries.

The lawsuits also accuse Pfizer of improperly promoting the drug as a safe medication. They say Pfizer didn't include sufficient warning about neuropsychiatric risks in the Chantix prescribing label, even after Pfizer made revisions to the label in 2007 and 2008. The lawsuits allege that Pfizer should have issued the black-box warning for Chantix much sooner than 2009, and even the 2009 warning is insufficient.

In September, Ms. Whitely's lawyers served a subpoena to summon three Pfizer officials including Mr. Read to testify as witnesses at the trial. Mr. Read served as head of Pfizer's worldwide pharmaceutical operations when Chantix was launched, before ascending to the CEO post in 2010.

Pfizer asked the court to quash the subpoena, saying the court has no authority to enforce a subpoena issued to an officer of a party to a lawsuit who lives or works more than 100 miles from the courthouse.

Pfizer also noted Mr. Read has given a five-hour videotaped deposition that can be used at the trial. Pfizer said Mr. Read's responsibilities for marketing and commercial activities surrounding Chantix aren't relevant to the case because there is no evidence Mr. Whitely or his doctor ever saw any Chantix marketing materials.

Judge Johnson ruled on Oct. 4 that Mr. Read was subject to subpoena because he is a Pfizer officer, and that prior court rulings have allowed subpoenas on officers beyond the 100-mile radius.

Pfizer appealed the ruling to the U.S. Court of Appeals for the 11th Circuit in Atlanta.

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