In re Rezulin

Decision of New York State District Court reported at 2004 WL 384897, decided 27 February 2004

Expert testimony based on subjective view rather than knowledge

Facts

The district court concluded that these experts’ opinions were based on their personal, subjective views, and hence should be rejected, and said: "These opinions therefore do not meet the core requirement that expert testimony rest on knowledge."

The court commented that assuming that the ethics testimony was reliable, it would in any event be irrelevant because it would not assist the trier of fact in determining any factual dispute in the case. Even if the ethics testimony was reliable and relevant, the experts’ opinion and rhetoric would be likely unfairly to prejudice and confuse the trier of fact (which in England would usually be the judge in civil cases but which, in the USA is frequently a jury).

The court considered that much of the plaintiffs’ proposed expert testimony regarding the motive, intent and state of mind of the FDA, and others, was ruled inadmissible by the court. The experts’ opinion had no basis in any relevant body of knowledge or expertise and described lay matters that the trier of fact could understand.

Thus the court excluded the plaintiffs’ experts’ testimony about FDA procedure and disclosure of facts by the defendant to the FDA. The court noted that testimony about FDA procedures relating to the factual accuracy of the defendant’s clinical data submissions was lay matter the trier of fact could understand without expert assistance.

Furthermore, the court observed, none of the plaintiffs’ proposed experts, except Dr Tolman, claimed expertise on the subject of FDA procedures and regulations. Thus, these experts’ opinions were inherently unreliable, the court said. As to Dr Tolman’s report, the court held that it was unreliable under the Daubert decision on expert evidence because he wrote the report before considering any of the data and materials in the case.

The plaintiffs’ offered Dr Gale to testify about selected regulatory events concerning Rezulin. The court rejected his testimony as an 

improper subject of expert testimony: The glosses that Dr Gale interpolates into his narrative are simply inferences drawn from uncomplicated facts that serve only to buttress plaintiffs’ theory of the case.

The court rejected the defendant’s argument that all of the plaintiffs’ expert evidence on the subject of foreign regulatory actions should be inadmissible as a matter of law in a US product liability action. Nevertheless, the plaintiffs’ experts were not the appropriate vehicles because of the lay subject matter.

The plaintiffs offered Dr Smith as an expert witness to testify about the defendant’s alleged suppression of the results of in-house scientific studies regarding Rezulin. The court excluded Dr Smith’s testimony, stating that (i) it pertained to lay matters that a jury can understand, and (ii) the plaintiffs were trying to use Dr Smith as a means of arguing from the witness stand.

The plaintiffs’ experts, Dr Kronmal and Dr Furberg, asserted that the defendant failed adequately to protect patients in clinical trials of Rezulin. The court said that this was not relevant because no plaintiff in the MDL had been identified as a participant in a Rezulin clinical trial.

The court excluded as unreliable and speculative the plaintiffs’ expert testimony as to how doctors in general interpreted the defendant’s statements about the risks and benefits of Rezulin. These witnesses were not, however, precluded from testifying as to the accuracy of the Rezulin label.

The court ruled that Dr Furberg’s testimony, as to whether physicians would have prescribed Rezulin if different information had been available, was unreliable because it was speculative and not based on scientific knowledge. Dr Furberg’s report also included statements regarding a company’s duty to warn patients in addition to physicians. The court held that this testimony was inadmissible because it addressed questions of law outside the province of an expert. The plaintiffs’ offered several experts to provide opinions regarding Rezulin’s efficacy, risk and risk-benefit ratio. The court rejected the opinions of Dr Bell, Dr Bonkorsky, Dr Day, Dr Furberg, Dr Julie, and Dr Gale on these topics because of lack of expertise in that area or speculative testimony.

Issues

The district court concluded that these experts’ opinions were based on their personal, subjective views, and hence should be rejected, and said: "These opinions therefore do not meet the core requirement that expert testimony rest on knowledge."

The court commented that assuming that the ethics testimony was reliable, it would in any event be irrelevant because it would not assist the trier of fact in determining any factual dispute in the case. Even if the ethics testimony was reliable and relevant, the experts’ opinion and rhetoric would be likely unfairly to prejudice and confuse the trier of fact (which in England would usually be the judge in civil cases but which, in the USA is frequently a jury).

The court considered that much of the plaintiffs’ proposed expert testimony regarding the motive, intent and state of mind of the FDA, and others, was ruled inadmissible by the court. The experts’ opinion had no basis in any relevant body of knowledge or expertise and described lay matters that the trier of fact could understand.

Thus the court excluded the plaintiffs’ experts’ testimony about FDA procedure and disclosure of facts by the defendant to the FDA. The court noted that testimony about FDA procedures relating to the factual accuracy of the defendant’s clinical data submissions was lay matter the trier of fact could understand without expert assistance.

Furthermore, the court observed, none of the plaintiffs’ proposed experts, except Dr Tolman, claimed expertise on the subject of FDA procedures and regulations. Thus, these experts’ opinions were inherently unreliable, the court said. As to Dr Tolman’s report, the court held that it was unreliable under the Daubert decision on expert evidence because he wrote the report before considering any of the data and materials in the case.

The plaintiffs’ offered Dr Gale to testify about selected regulatory events concerning Rezulin. The court rejected his testimony as an 

improper subject of expert testimony: The glosses that Dr Gale interpolates into his narrative are simply inferences drawn from uncomplicated facts that serve only to buttress plaintiffs’ theory of the case.

The court rejected the defendant’s argument that all of the plaintiffs’ expert evidence on the subject of foreign regulatory actions should be inadmissible as a matter of law in a US product liability action. Nevertheless, the plaintiffs’ experts were not the appropriate vehicles because of the lay subject matter.

The plaintiffs offered Dr Smith as an expert witness to testify about the defendant’s alleged suppression of the results of in-house scientific studies regarding Rezulin. The court excluded Dr Smith’s testimony, stating that (i) it pertained to lay matters that a jury can understand, and (ii) the plaintiffs were trying to use Dr Smith as a means of arguing from the witness stand.

The plaintiffs’ experts, Dr Kronmal and Dr Furberg, asserted that the defendant failed adequately to protect patients in clinical trials of Rezulin. The court said that this was not relevant because no plaintiff in the MDL had been identified as a participant in a Rezulin clinical trial.

The court excluded as unreliable and speculative the plaintiffs’ expert testimony as to how doctors in general interpreted the defendant’s statements about the risks and benefits of Rezulin. These witnesses were not, however, precluded from testifying as to the accuracy of the Rezulin label.

The court ruled that Dr Furberg’s testimony, as to whether physicians would have prescribed Rezulin if different information had been available, was unreliable because it was speculative and not based on scientific knowledge. Dr Furberg’s report also included statements regarding a company’s duty to warn patients in addition to physicians. The court held that this testimony was inadmissible because it addressed questions of law outside the province of an expert. The plaintiffs’ offered several experts to provide opinions regarding Rezulin’s efficacy, risk and risk-benefit ratio. The court rejected the opinions of Dr Bell, Dr Bonkorsky, Dr Day, Dr Furberg, Dr Julie, and Dr Gale on these topics because of lack of expertise in that area or speculative testimony.

Decision

The district court concluded that these experts’ opinions were based on their personal, subjective views, and hence should be rejected, and said: "These opinions therefore do not meet the core requirement that expert testimony rest on knowledge."

The court commented that assuming that the ethics testimony was reliable, it would in any event be irrelevant because it would not assist the trier of fact in determining any factual dispute in the case. Even if the ethics testimony was reliable and relevant, the experts’ opinion and rhetoric would be likely unfairly to prejudice and confuse the trier of fact (which in England would usually be the judge in civil cases but which, in the USA is frequently a jury).

The court considered that much of the plaintiffs’ proposed expert testimony regarding the motive, intent and state of mind of the FDA, and others, was ruled inadmissible by the court. The experts’ opinion had no basis in any relevant body of knowledge or expertise and described lay matters that the trier of fact could understand.

Thus the court excluded the plaintiffs’ experts’ testimony about FDA procedure and disclosure of facts by the defendant to the FDA. The court noted that testimony about FDA procedures relating to the factual accuracy of the defendant’s clinical data submissions was lay matter the trier of fact could understand without expert assistance.

Furthermore, the court observed, none of the plaintiffs’ proposed experts, except Dr Tolman, claimed expertise on the subject of FDA procedures and regulations. Thus, these experts’ opinions were inherently unreliable, the court said. As to Dr Tolman’s report, the court held that it was unreliable under the Daubert decision on expert evidence because he wrote the report before considering any of the data and materials in the case.

The plaintiffs’ offered Dr Gale to testify about selected regulatory events concerning Rezulin. The court rejected his testimony as an 

improper subject of expert testimony: The glosses that Dr Gale interpolates into his narrative are simply inferences drawn from uncomplicated facts that serve only to buttress plaintiffs’ theory of the case.

The court rejected the defendant’s argument that all of the plaintiffs’ expert evidence on the subject of foreign regulatory actions should be inadmissible as a matter of law in a US product liability action. Nevertheless, the plaintiffs’ experts were not the appropriate vehicles because of the lay subject matter.

The plaintiffs offered Dr Smith as an expert witness to testify about the defendant’s alleged suppression of the results of in-house scientific studies regarding Rezulin. The court excluded Dr Smith’s testimony, stating that (i) it pertained to lay matters that a jury can understand, and (ii) the plaintiffs were trying to use Dr Smith as a means of arguing from the witness stand.

The plaintiffs’ experts, Dr Kronmal and Dr Furberg, asserted that the defendant failed adequately to protect patients in clinical trials of Rezulin. The court said that this was not relevant because no plaintiff in the MDL had been identified as a participant in a Rezulin clinical trial.

The court excluded as unreliable and speculative the plaintiffs’ expert testimony as to how doctors in general interpreted the defendant’s statements about the risks and benefits of Rezulin. These witnesses were not, however, precluded from testifying as to the accuracy of the Rezulin label.

The court ruled that Dr Furberg’s testimony, as to whether physicians would have prescribed Rezulin if different information had been available, was unreliable because it was speculative and not based on scientific knowledge. Dr Furberg’s report also included statements regarding a company’s duty to warn patients in addition to physicians. The court held that this testimony was inadmissible because it addressed questions of law outside the province of an expert. The plaintiffs’ offered several experts to provide opinions regarding Rezulin’s efficacy, risk and risk-benefit ratio. The court rejected the opinions of Dr Bell, Dr Bonkorsky, Dr Day, Dr Furberg, Dr Julie, and Dr Gale on these topics because of lack of expertise in that area or speculative testimony.

Comment

This decision acts as a remarkable case study in how expert witnesses (and those instructing them) should not behave. The wasted costs relating to all the rejected evidence and the hearing as to admissibility must have been huge. Much of what the court said would be expressed in similar terms in an English judgment by a court applying the Ikarian Reefer principles and, notably, shows a commonality of judicial approach on both sides of the pond.