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.

“WARNING! FLAMMABLE! VAPORS HARMFUL AND MAY CAUSE FLASH FIRE” and “BEFORE USE TURN OFF MAIN GAS VALVE.” The lid further instructs the user to keep the product away from heat, electrical sparks, and flame; to shut off pilot lights; to refrain from smoking; to prevent buildup of vapors by opening windows and doors; and to shut off stoves, heaters, and appliances. In addition, the lid depicts an open can with vapors emanating toward a cigarette labeled “smoking,” a gas valve labeled “gas,” a flame labeled “flame/heat,” and electrical volts labeled
“electricity/sparks.” Each of the four pictures contain a bold red line crossed through the black-and-white image.The can further includes “Precautionary measures for use, handling, storage and disposal”:Use in a well ventilated area. Provide fresh air such that chemical odors cannot be detected during use and while drying. Vapors are heavier than air and will collect in low areas. Check all low areas (basements, sumps, etc.) for vapor before entering. Vapor may ignite explosively. Keep away from heat, sparks, and flames. Do not smoke. Extinguish all flames and pilot lights. Turn off stoves, heaters, electric motors and other sources of ignition during use and until all vapor is gone. Keep container closed when not in use. Do not reuse the empty container. Do not use in areas where static electric sparks may be generated. Empty container may contain explosive vapors. Do not weld, cut or torch on or near this container. Store away from oxidizers and caustics. Wear gloves. Avoid skin contact. Wear eye protection with side shields.

The can also included the following warnings: “DANGER! FLAMMABLE LIQUID AND VAPOR HARMFUL OR FATAL IF SWALLOWED,” “VAPOR HARMFUL,” “BEFORE USE TURN OFF MAIN GAS VALVE,” “VAPORS CAN TRAVEL ALONG FLOOR TO ANY SOURCE OF HEAT, SPARK OR FLAME IN NEXT ROOM OR BASEMENT .”

Obviously, when not handled properly, this product can have grave consequences. The plaintiff’s decedent in this case unfortunately learned this fact first-hand. He purchased a can to install new baseboards in his house, and accidentally spilled some of it in his laundry room. When he went to wipe it up, the vapors ignited and caused a flash fire. Mr. Mwesigwa suffered extensive burns and died because of his injuries. His widow and children sued the manufacturer, DAP, for (1) wrongful death on theories of negligence, strict liability, and failure to warn; (2) for negligent misrepresentation; and (3) for violations of the Consumer Product Safety Act. The district court granted summary judgment in favor of DAP. The plaintiffs appealed the summary judgment on the wrongful death failure to warn claims.

The Court did a nice job summarizing its findings in this way: “The label complies with the FHSA because the principal hazard to be avoided is flammability, and the way to avoid that hazard is to remove all potential ignition sources.” Because the extensive labeling on the can of DAP complied with those requirements, summary judgment was affirmed as to the failure to warn claims.

Bicknese also performed a subsequent round of testing, after which he reported that “the second test continued to support his theory that the fire was the result of the deterioration of the rubber propane hose caused by contact with the heated grease tray.”

The facts are these: Plaintiff feels fine; Plaintiff takes prescription medication to reduce his cholesterol; Plaintiff develops symptoms of pain and fatigue. Such facts do not proof of causation make, the Eighth Circuit Court of Appeals affirmed. In re Baycol Products Litigation, —F.3d—, No. 08-3524, 2010 WL 711972 (8th Cir. March 3, 2010) [PDF]. In that case, the appellate court upheld summary judgment in favor of the drug-manufacturer defendant. In so doing, it held that the mere fact that a plaintiff developed physical symptoms in the months following his consumption of a defendant’s drug is insufficient to support a medical expert’s opinion that the drug was responsible for the onset of those symptoms.

The plaintiff was prescribed Baycol in February 2001 after being diagnosed with high cholesterol. On March 15 of that year, he began complaining to his doctor of general body pain and fatigue and of localized lower body pain. His complaints continued throughout July of 2001. In August, after taking the drug for approximately five months, the plaintiff discontinued his use of the drug after reading in the newspaper that Bayer had withdrawn Baycol from the market. He thereafter sent a letter to his doctor, in which he opined that Baycol was the cause of his symptoms. A subsequent blood test did reveal that the plaintiff had increased levels of creatine kinase, which is one indication of the presence of myopathy.

The plaintiff filed suit, alleging theories of strict liability, negligence, breach of express and implied warranties, and unjust enrichment. The court noted that it was the plaintiff’s burden, pursuant to his strict liability and negligence claims, to prove causation through the use of a medical expert. He essentially offered two. The first of those was in the form of “various generic causation experts” who would testify that Baycol was capable of causing myopathy. The report of the second expert garnered the most attention from the court. In it, the expert opined in what the court regarded as “conclusory remarks,” that causation was established because: (1) the pain was of new onset; (2) he had no other explanation for the injury; (3) the pain was “reasonably contemporaneous” with the plaintiff’s ingestion of Baycol; and (4) the pain didn’t get worse after he stopped taking the drug.

The court held that such conclusory remarks of “temporal association,” without sufficient evidentiary support, were wholly insufficient to prove that the defendant’s conduct contributed to the plaintiff’s injury. The court upheld entry of summary judgment in favor of Bayer on the basis of the plaintiff’s failure to present competent expert testimony on the issue of causation.

The court’s analysis with regard to these expert witness issues may provide ammunition for defendants during preliminary stages of litigation. It certainly highlights the importance of attacking the sufficiency of expert reports and of demanding competent, factually based testimony that creates triable issues of fact.