Opinion ID: 60277
Heading Depth: 2
Heading Rank: 1

Heading: Dr. Sonn's Testimony

Text: In her opposition to Wyeth's summary judgment motion, Ackermann proposed a specific warning for suicide risk that she contended Wyeth should have provided in January 2002. [8] Because Dr. Sonn had not been examined by either party regarding that proposed warning in his December 2005 deposition, Wyeth obtained permission from Ackermann to ask Dr. Sonn ex parte to review the postulated warning. [9] Dr. Sonn then executed a sworn declaration stating that he had reviewed the proposed warning and concluded: If the [proposed] warning ... had been communicated to me effectively and in a prominent manner before I prescribed Effexor XR to Martin Ackermann in January 2002, I would have considered or heeded it just as I consider or heed any warning, but it would not have changed my decision to prescribe Effexor XR to Martin Ackermann to treat his depression, beginning with low-dose pills. It also would have not changed my decision to monitor and observe Martin Ackermann closely for suicide-related risks as I did by, among other things, (a) seeing him in person four times in the eight days he was my patient, and (b) providing contact information and asking that I be informed immediately of any changes in his behavior. Dr. Sonn continued: If there were a legal requirement that I communicate the [proposed] warning... directly to a patient, I would comply with that requirement. Otherwise, and as I did with Martin Ackermann, I would address the suicide-related risks reflected in that warning by close monitoring and observation, rather than through discussions with the patient expressly mentioning the risk of suicide or drug-triggered suicide. Ackermann relies on this court's reasoning in McNeil to suggest that these statements are in conflict and create an issue of fact regarding causation. In McNeil, the prescribing doctor gave conflicting testimony regarding whether he would have prescribed Reglan had he known of significant risks associated with the drug. 462 F.3d at 372. He said he would have prescribed the drug and alerted the patient to significant risks had he been aware of them, but he also stated that he would not have prescribed the drug had the label stated that the benefits decrease while the risks increase with prolonged use. Id. On this basis, the court held there was a genuine issue concerning whether the doctor would have prescribed Reglan if given a proper warning. Dr. Sonn gave no such contradictory testimony; his testimony was unequivocal. In his deposition and in his later declaration, Dr. Sonn affirmed that he would have prescribed Effexor to Martin and adhered to the treatment regimen he used regardless whether he had received the proposed stronger warning. [10] In December 2005, he testified that he would not have warned Martin about the possibility of an increased risk of suicide primarily based on his belief that the suggestion would either plant seeds in the patient's mind that suicide was an option or would discourage the patient from pursuing pharmacological treatment. He testified that his medical training regarding clinical depression and his experience from treating other patients with Effexor made him aware of the need to monitor depressed patients for suicide ideation, but that he also read the warnings regarding the risk of suicide and believed they were adequate and did not provide him with new information. Other than some possible future legal requirement mandating that he tell patients about potential increased risk for suicide, Dr. Sonn stated that he would continue his normal practice of balancing the risks and benefits of the drug with the treatment needs of the patient when deciding what to disclose to patients. [11] Dr. Sonn was asked to review the warning label accompanying Effexor that was in effect at the time of his deposition in December 2005, which included a black box warning for potential increased suicide in children and adolescents. [12] When asked if the black box warning would change his practice with adults, he responded that he wouldn't feel medically that [providing specific suicide warnings] was indicated. When asked a follow-up question in August 2006 about a proposed similar warning for adults, Dr. Sonn reiterated his prior testimony and confirmed that it would not have changed [his] decision to prescribe Effexor XR to Martin Ackermann to treat his depression. Ackermann argues that Dr. Sonn's testimony, like the doctor's testimony in McNeil, is conflicting. She points to his comment: If there were a legal requirement that I communicate the warning set forth .... directly to a patient, I would comply with that requirement. She contends that a legal requirement to communicate warnings is implicit within the learned-intermediary doctrine. While the manufacturer can rely upon an intermediary to fulfill the manufacturer's duty to warn, this reliance seems less reasonable where the learned intermediary fails to pass necessary information to the patient because the manufacturer has understated the degree of risk. McNeil, 462 F.3d at 373 n. 6. Because she construes this as a no warnings case, she argues that Wyeth completely sabotaged the intermediary, who, in turn, failed to warn Martin of the risk of suicide. For this reason, she views Dr. Sonn's testimony that he would have given a required warning to mean, if Wyeth had given me a warning, I would have warned. [13] This interpretation, however, is incompatible with Dr. Sonn's testimony that his treatment protocol would not have changed and he still would have prescribed Effexor regardless of the warning given by the manufacturer. Ackermann's interpretation fails because (1) the warnings for Effexor did include warnings of the risk of suicide, and (2) Dr. Sonn was aware of the risk for suicide, not just from reading the warning label for Effexor, which mentioned the risk for suicide twice, but also from his training and experience as a psychiatrist treating depressed patients. Under McNeil, no genuine issue of material fact exists regarding whether the inadequacy of the warning was a producing cause of her husband's death. Dr. Sonn would have prescribed Effexor even had the warning been stronger.