Tuesday, July 31, 2012

Chantix Warnings Adequate As a Matter of Law

            Last week we told you about a federal MDL court in Florida that found Accutane warnings adequate as a matter of law.   Ditto says the federal MDL court in Alabama presiding over the Chantix litigation. 
Since we haven’t spent much time talking about the Chantix MDL on this blog, here’s just a brief summary of the litigation.  Chantix is a drug approved by the FDA as a prescription medication to aid in smoking cessation.  In Re: Chantix Products Liability Litigation, 2012 U.S. Dist. LEXIS 101780, *11 (Jul. 23, 2012).  Plaintiffs allege that Chantix causes depression and other psychiatric disorders, including reports of suicide and attempted suicide.  Id. at *11-12.  As is true of all pharmaceuticals, the labeling accompanying Chantix changed over time and in 2009 a black box warning was added specifically warning about “[s]erious neuropsychiatric events, including, but not limited to depression, suicidal ideation, suicide attempt and completed suicide.”  Id. at *21.  In finding this 2009 warning adequate as a matter of law, the court offered some great language about the role of the learned intermediary.
            To start, the court framed the failure to warn question in the context of the doctor’s knowledge: 
Relevant to these arguments is whether the label sufficiently alerted medical professionals that their patients could suffer neuropsychiatric injuries from taking Chantix as prescribed. . . . Thus the court must consider the failure to warn claim in light of the warning's intended audience, medical doctors.
Id. at *24-25 (citations omitted).  The Chantix court also found that where the manufacturer warns of the very injury the plaintiff suffered – the warning is adequate. Id. at *29-30 n.10.
Faced with the law as stated above, plaintiffs couldn’t really argue that the 2009 label didn’t warn about neuropsychiatric injuries – because it did.  Indeed, their own expert’s report said the 2009 label contained a black box which is “the highest level warning possible, prominently displayed at the beginning of a drug's official prescribing information.”  Id. at *22.  So, instead, plaintiffs alleged that the warning was inadequate because it failed to “include a warning to prescribing doctors not to use Chantix as a first line treatment to assist in smoking cessation.”  Id. at *23-24.  The court recognized a novel and unsupported theory when it heard it:
Unlike the majority cases reviewed by this court, the plaintiffs seek to pursue their failure to warn claims post the 2009 black box warning, not for failing to warn of possible complications from Chantix, but for failing to tell physicians when to prescribe it.
Id. at *32.  The court wasn’t having it.  In taking apart plaintiffs’ argument, the decision offers up strong language about where a manufacturer’s duty ends and a physician’s begins.  Such as:
Yet surely the decision as to use a medication as a first-line treatment is uniquely up to the prescribing medical professional and based on a decision concerning his or her individual patient.
Id. at *25.  And:
Rather, as other courts have recognized, it is the responsibility of the physician as a learned intermediary to assess the risks and benefits of a particular course of treatment.
Id. at *31.  Quoting The Restatement (Third) of Torts: Products Liability § 6(d), comment b:
[O]nly health-care professionals are in a position to understand the significance of the risks involved and to assess the relative advantages and disadvantages of a given form of prescription-based therapy. The duty then devolves on the health-care provider to supply to the patient such information as is deemed appropriate under the circumstances so that the patient can make an informed choice as to therapy.
Id. at *31-32.  And finally, the court noted that a physician’s decision to prescribe a medication in the face of warnings is a matter of medical judgment: 
In other words, the label clearly sets forth potential side effects of Chantix. The decision to prescribe the medication anyway, given the severity of those side effects, is solely within the realm of medical judgment. An abuse or misuse of that judgment by a physician is far outside the scope of this action.
Id. at *32, n12.  Told you this was good stuff.         
            Another week, another MDL, another adequate warning.  Here’s hoping the streak continues. 

1 comment:

indswift said...

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