Earlier this year, the first of 3000 injury cases against Japanese pharmaceutical company Takeda was heard in a Los Angeles court. The allegation: their flagship product, Actos, had caused plaintiff Jack Cooper to develop bladder cancer. Although Mr. Cooper had been a cigarette smoker earlier in life (he managed to quit several years ago) – but there is arguably much more powerful medical evidence demonstrating the connection between the long-term use (six months or more) of Actos and the increased risk of bladder cancer – not to mention heart problems and blindness. (For a simplified explanation of how Actos increases the risk of cancer, go here.)
Furthermore, evidence from numerous sources strongly indicate that Takeda executives were aware of the adverse events that could result from Actos as far back as 2004.
According to Mr. Cooper’s lawyers, the Actos Bladder Cancer connection was a clear case of negligence and failure to warn – and the jury agreed. Mr. Cooper was awarded $6.5 million in damages. This amount of money should be relatively easy for Takeda to pay, as the company netted $1.6 billion in profits last year, with total revenues for 2012 at $19.1 billion (source: CNN Money, 6 May 2013). The verdict could have gone a long way toward compensating Mr. Cooper for his medical expenses as well as his soon-to-be widow for her husband's pain and suffering and loss of consortium.
However, Judge Kenneth Freeman decided to overturn the verdict
Judge Freeman's reasoning? The plaintiff failed to produce sufficient evidence to show his cancer was caused by the medication. Apparently, expert testimony from Dr. Norman Smith, a professor of urology at the University of Chicago, was “inherently unreliable,” according to Judge Freeman's ruling. More specifically, Dr. Smith failed to demonstrate that Actos was the direct cause of Mr. Cooper's illness. While the judge was willing to accept the doctor's testimony as establishing “general causation,” he stated that it failed to establish Actos as the “direct cause” of the plaintiff's cancer.
In his testimony, Dr. Smith said that Actos was the “most likely cause” of Mr. Cooper's illness. When cross-examined by the defense, he admitted that while Mr. Cooper had a history of tobacco use, it was “not extensive enough to have been a substantial factor in his diagnosis” - nor did Mr. Cooper have any family history of cancer.
Pennsylvania attorney James Beck, who currently works on defense strategies for corporate clients being sued for product liability, elaborated in a piece on Lexology.com:
This particular diagnosis failed because...the expert didn't have all of the relevant medical records and thus didn't know all of the necessary information about the other causes (particularly smoking, environmental exposures, occupational exposure) for bladder cancer as they related to this individual.
According to Mr. Beck, the expert witness in the case failed to take the plaintiff's complete medical history into consideration, including how long Mr. Cooper had been smoking and possible occupational exposure to industrial substances allegedly known to cause bladder cancer.
Of course, neither Judge Freeman nor Mr. Beck have medical training. Judge Freeman’s decision to overturn the jury’s verdict is an example of how scientific evidence standards place a great degree of power in the judge’s hands, often leaving a judge to decide complex issues of medicine and science, rather than allowing testimony and vigorous cross-examination to be the standard of proof. Recently, more and more states have been passing the Daubert standard, which allows a judge to throw out an expert’s testimony based on a series of “factors.” Although California has not fully adopted the Daubert standard, California law still allows a Judge to throw out a verdict based on whether or not the Judge feels the science fits certain factors of reliability. The end-all question is: how much science do we want judges to decide in lieu of good old fashioned expert testimony and cross examination? What is frustrating about the Cooper case is that Judge Freeman had opportunity to hear out pre-trial motions related to scientific evidence, indicated that he felt Dr. Smith’s testimony was inadequate, but decided to withhold his ruling and wait until after a grueling and lengthy trial. At trial, the jury was allowed to hear the scientific testimony and the rigorous cross examination, and deliberated for several days. At the end of the day, the judge still decided to throw out both Dr. Smith’s testimony and the $6.5 Million verdict, even after the jury weighed all the evidence. The issue of whether or not scientific evidence standards place too much power in the hands of judges will always be the subject of hefty debate, and the Cooper case is yet another example of a frustrating and arguably wasteful outcome.
Although Takeda may be gloating, the fight isn't over. Plaintiff's counsel Michael Miller told Bloomberg that he believes Judge Freeman “misinterpreted the law,” and expressed confidence that the decision the throw out the case will be overturned by an appellate court.
Beck, James M. “Breaking news - Opinion Reversing $6.5 Million Actos Verdict.” Lexology.com, 2 May 2013. Available at http://www.lexology.com/library/detail.aspx?g=df0605d2-950f-4df1-91a5-a28a3fe9f3b8.
Feely, Jeff. “Takeda Gets $6.5 Million Diabetes-Drug Verdict Thrown Out.” Bloomberg, 6 May 2013.
N/A. “Urology Expert Testifies that Actos was the Most Substantial Cause of Patient’s Bladder Cancer.” PRWeb, 1 April 2013. Available at http://www.prweb.com/releases/2013/4/prweb10581403.htm.
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