More than 3,000 individuals have sued Takeda Pharmaceuticals, the Japanese manufacturer of Actos. As we have previously reported, Actos was approved by the FDA for the treatment of type 2 diabetes in 1999. Despite strong evidence that the drug could cause bladder cancer, no warning appeared on the label until 2011, far too late for Jack Cooper to avoid bladder cancer.
The jury heard opening statements in Mr. Cooper’s lawsuit in a California state court on February 28, 2013. After deliberating several days, the jury returned a verdict in favor of Mr. Cooper in the amount of $6.5 million on April 26. Mr. Cooper’s principal causation expert, Dr. Norm Smith, is a urologist specializing in bladder cancer. He testified that, based on his differential diagnosis, Actos was the cause of Mr. Cooper’s bladder cancer. Prior to trial, the Judge ruled that Dr. Smith could testify as to “general causation,” but deferred ruling on whether he could testify regarding specific causation. On May 1, the Court excluded Dr. Smith’s specific causation testimony and granted Takeda a non-suit (in essence a judgment notwithstanding the verdict), which was a blow to Mr. Cooper.
The Court noted that in California a Plaintiff only need show an exposure’s contribution to a disease was more than negligible or theoretical and that the use of a differential diagnosis was accepted by an “overwhelming majority of courts.” In the Cooper case, however, the Court found that Dr. Smith did not conduct a reasonable differential diagnosis, but based his analysis on speculation and lacked intellectual rigor. Dr. Smith previously published an article in which he listed numerous known and potential causes of bladder cancer. In forming his opinion that Mr. Cooper’s bladder cancer was caused by Actos, the court said Dr. Smith did not:
• evaluate potential exposures Mr. Cooper may have had at work;
• know Mr. Copper had continued to smoke for two decades after Dr. Smith thought he had quit;
• review medical records revealing Mr. Cooper suffered from chronic kidney disease and skin cancer; and
• rely on well conducted studies as the basis of his opinions.
The Court also relied heavily on Dr. Smith’s failure to rule out age, sex and race as a cause of Mr. Cooper’s cancer. These were all risk factors noted by Dr. Smith in his article. It appears this Court, like many others, fell for the “cloud of confusion” tactic thrown up by every pharmaceutical defendant. Age, sex and race are risk factors for most types of cancer. But they are NOT causes of cancer and studies are careful to adjust for these factors when evaluating relative risk. The Court also seemed to have adopted the “defense interpretation” of every study upon which Dr. Smith relied.
Nothing could possibly be more frustrating to the jurors, the Plaintiff or Plaintiff’s lawyers than to have a judge deciding after a verdict is returned what testimony the jury should and should not have heard and thereby employing such delayed rulings to nullify the jury’s verdict. The practical lesson to learn from this court’s ruling, however, is that it is imperative for your expert in a case not only to have, but to review, all relevant information before rendering an opinion. In any event, it’s difficult to understand why this judge delayed his ruling until after a verdict was returned and judgment entered.
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