Eighth Circuit Engages Drug Manufacturer in Semantic Exercise

I know you lawyers can, with ease, twist words and meanings as you please.

John Gay

We here at Abnormal Use imagine the 18th Century wordsmith uttered these words in a derogatory tone, but we can still appreciate his sentiment.  After all, we do pride ourselves in our “interpretations” of laws, contracts, and transcripts.  But, we don’t like to call it “twisting.”  Rather, we are enaging in a “semantic exercise.”

Recently, in Schilf v. Eli Lilly & Co., No. 11-2082, 2012 WL 3139233 (8th. Cir. Aug. 3, 2012), the Eighth Circuit put on a fine display of its own expertise in the linguistical arts.

In that case, the Schilfs filed suit against Eli Lilly and Quintiles Transnational, alleging that Lilly’s failure to warn of a link between an anti-depressant and suicide caused the death of their teenage son.  The 16-year old boy visited his family doctor in November 2004 to discuss his depression.  The doctor gave the boy samples of the antidepressant, Cymbalta.  The medication had been removed from the packaging and, thus, lacked any warnings.  When dispensing the samples, the doctor informed the boy that there may be an increased “association” with anti-depressants and suicidal ideations, but “no completed suicides” occurred during the clinic trials.  The boy began taking the drug and committed suicide a few weeks later.  Thereafter, Lilly revised the literate for Cymbalta to include an FDA-approved black box warning.

The district court granted Lilly’s motion for summary judgment, holding (1) that a warning would not have informed the doctor of anything he did not already know and (2) that the doctor would have prescribed the drug even if he knew of the actual risks.  The Eight Circuit disagreed with both points.

Now, here comes the Olympic-esque semantic exercise.  As to the first point, the Eighth Circuit found that a warning could have pointed the doctor to more knowledge of the drug.  According the Court, the doctor was not aware of a “causal link” between Cymbalta and suicide, but, rather, an “association.”  In support, the Eighth Circuit pointed to the doctor’s deposition testimony, in which he stated that was aware of an FDA study finding such an association, but believed the FDA wasn’t “saying the risk was there.”  Under South Dakota law, warnings of side-effect associations are typically not warnings of causal connections.

Contrary to the doctor’s belief, the FDA press release did, in fact, find a causal connection.  The district court found that the doctor “read” this release and, thus, knew of the risks.  The Eighth Circuit pointed out, however, that the doctor only testified that he was “aware” of its existence. Clearly, a distinction.

On the second point, the district court based its finding on some testimony that the doctor still believed his prescription decision was appropriate.  Not so fast!  Being such fine stewards of the English language, the Eighth Circuit examined the testimony a little more closely.  When asked if there was anything he would differently, the doctor actually answered, “Not at the time.  I did – I did exactly what I would have done.”  “Not at the time” being the operative phase.  If he didn’t know of the suicide related information, he clearly wouldn’t have had reason to alter his decision.

If we were judges, we would have to give the Eighth Circuit high technical marks for its linguistic efforts.  However, instead of lecturing the district court on its interpretation of a deposition transcript, we would still would appreciate some more guidance on that whole failure to warn issue.