FDA

MJLST Guest Blogger, Tommy Tobin

[Editor’s Note: This post is #2 in a series on current FDA issues. You can find the previous post here.]

Smoking cessation is a difficult process. To assist patients in the process, many physicians are turning to Chantix (Varenicline), which is advertised as the nation’s #1 prescribed prescription anti-smoking medication. Health professionals have lauded the product as a useful adjunct to other methods of smoking cessation treatment and over 10 million Americans have received prescriptions for the drug.

After the introduction of Chantix into the market, reports of adverse events, including potentially serious neuropsychiatric effects, prompted the FDA to issue a black box warning in 2009 for the drug. In 2014, McClatchy reported that Pfizer, Chantix’s manufacturer, had paid at least $299 million to settle civil claims regarding the drug and its alleged neuropsychiatric effects. In December 2016, the FDA approved the removal of this black box warning. While these events certainly are of interest to drug manufacturers and regulators, they also have surprising implications for criminal law.

What if your anti-smoking drug led you to commit a violent crime? Could you convince a jury that the anti-smoking pill made you do it? That is precisely the question posed by some criminal defendants across the country.

Involuntary intoxication can be an affirmative defense for criminal offenses, and this defense is recognized as a complete defense. As a complete defense, the court recognizes that the defendant committed the action alleged but absolves the accused of criminal responsibility due to the circumstances surrounding the commission of the crime.  While standards for this defense vary, criminal defendants alleging such a defense generally claim that they were intoxicated and that this intoxication was not the result of their voluntary action. Many courts apply the same standard as in an insanity defense, which asks whether the intoxicated defendant became unable to distinguish right from wrong.

In one high-profile case, an American soldier repeatedly stabbed and brutally murdered another soldier at Fort Benning, Georgia. The defendant in this case, United States v. MacDonald, was taking Chantix and claimed that he should have been afforded an involuntary intoxication instruction at trial. The US Court of Appeals for the Armed Forces ruled that the lower court had a sua sponte duty to instruct on the defense of involuntary intoxication, finding that it was error to fail to provide a separate and distinct involuntary intoxication instruction in such a case. The MacDonald defendant was granted a rehearing, whereupon his sentence was decreased from life without parole to 45 years with credit for time served pursuant to a plea deal. The case went up on appeal on January 27, 2017 and was affirmed.

In another case, a Maryland man invoked Chantix when he was accused of attempting to kill his wife. As reported in the Washington Post, the man shot his wife and tried to get a second shot off but the gun malfunctioned. At trial, he claimed that Chantix caused an internal imbalance of chemicals, resulting in involuntary intoxication. The judge agreed and ordered that he be released. The local paper reported that a small protest followed the Maryland order, with protestors carrying signs that read “Abusers blame victims, Judges blame Chantix.”

When defendants allege a so-called “Chantix defense,” it is far from a sure thing. Providing a court with evidence in addition to conclusory allegations may improve the chances of a favorable finding.  For example, a Florida man argued with his father and shortly thereafter killed him. Subsequent to the murder, the man called 911 attempting to blame a non-existent intruder. According to the court, the “Chantix defense” was considered but ultimately rejected by the defense counsel. After trial, the man brought a prisoner litigation action. In rejecting the suit, the court concluded, inter alia, that “even if a reasonable juror could find that Chantix rage exists,” the prisoner had presented no evidence that he was so affected.

As noted in the Washington Post, involuntary intoxication is not a new defense but it is being invoked with increasing success nationwide. While the FDA recently removed Chantix’s black box warning, the “Chantix defense” demonstrates the fascinating interplay between FDA law and criminal law. It remains to be seen just how much the defense bar will incorporate this defense into clients’ strategies.

MJLST Guest Blogger, Tommy Tobin

[Editor’s Note: This post is #2 in a series on current FDA issues. You can find the previous post here.]

Smoking cessation is a difficult process. To assist patients in the process, many physicians are turning to Chantix (Varenicline), which is advertised as the nation’s #1 prescribed prescription anti-smoking medication. Health professionals have lauded the product as a useful adjunct to other methods of smoking cessation treatment and over 10 million Americans have received prescriptions for the drug.

After the introduction of Chantix into the market, reports of adverse events, including potentially serious neuropsychiatric effects, prompted the FDA to issue a black box warning in 2009 for the drug. In 2014, McClatchy reported that Pfizer, Chantix’s manufacturer, had paid at least $299 million to settle civil claims regarding the drug and its alleged neuropsychiatric effects. In December 2016, the FDA approved the removal of this black box warning. While these events certainly are of interest to drug manufacturers and regulators, they also have surprising implications for criminal law.

What if your anti-smoking drug led you to commit a violent crime? Could you convince a jury that the anti-smoking pill made you do it? That is precisely the question posed by some criminal defendants across the country.

Involuntary intoxication can be an affirmative defense for criminal offenses, and this defense is recognized as a complete defense. As a complete defense, the court recognizes that the defendant committed the action alleged but absolves the accused of criminal responsibility due to the circumstances surrounding the commission of the crime.  While standards for this defense vary, criminal defendants alleging such a defense generally claim that they were intoxicated and that this intoxication was not the result of their voluntary action. Many courts apply the same standard as in an insanity defense, which asks whether the intoxicated defendant became unable to distinguish right from wrong.

In one high-profile case, an American soldier repeatedly stabbed and brutally murdered another soldier at Fort Benning, Georgia. The defendant in this case, United States v. MacDonald, was taking Chantix and claimed that he should have been afforded an involuntary intoxication instruction at trial. The US Court of Appeals for the Armed Forces ruled that the lower court had a sua sponte duty to instruct on the defense of involuntary intoxication, finding that it was error to fail to provide a separate and distinct involuntary intoxication instruction in such a case. The MacDonald defendant was granted a rehearing, whereupon his sentence was decreased from life without parole to 45 years with credit for time served pursuant to a plea deal. The case went up on appeal on January 27, 2017 and was affirmed.

In another case, a Maryland man invoked Chantix when he was accused of attempting to kill his wife. As reported in the Washington Post, the man shot his wife and tried to get a second shot off but the gun malfunctioned. At trial, he claimed that Chantix caused an internal imbalance of chemicals, resulting in involuntary intoxication. The judge agreed and ordered that he be released. The local paper reported that a small protest followed the Maryland order, with protestors carrying signs that read “Abusers blame victims, Judges blame Chantix.”

When defendants allege a so-called “Chantix defense,” it is far from a sure thing. Providing a court with evidence in addition to conclusory allegations may improve the chances of a favorable finding.  For example, a Florida man argued with his father and shortly thereafter killed him. Subsequent to the murder, the man called 911 attempting to blame a non-existent intruder. According to the court, the “Chantix defense” was considered but ultimately rejected by the defense counsel. After trial, the man brought a prisoner litigation action. In rejecting the suit, the court concluded, inter alia, that “even if a reasonable juror could find that Chantix rage exists,” the prisoner had presented no evidence that he was so affected.

As noted in the Washington Post, involuntary intoxication is not a new defense but it is being invoked with increasing success nationwide. While the FDA recently removed Chantix’s black box warning, the “Chantix defense” demonstrates the fascinating interplay between FDA law and criminal law. It remains to be seen just how much the defense bar will incorporate this defense into clients’ strategies.