We here at Abnormal Use are here to help. Over at the Drug and Device Law blog, author David Walk directs his readers’ attention to a new Eighth Circuit case about which he could not fully comment due to his firm’s involvement in that case. In light of that, and in the spirit of blogging collegiality, we thought we would do our own summary and analysis of the new opinion.
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approximately five months, the plaintiff discontinued his use of the drug after reading in the newspaper that Bayer had withdrawn Baycol from the market.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.