The overarching background of this case obviously involves highly complex medical issues as well as a real human tragedy. Nevertheless, the outcome is ultimately determined by a relatively straightforward application of Virginia law.
That’s how the court in Higgins v. Forest Labs., 2014 U.S. Dist. LEXIS 124745 (W.D. Va. Sep. 8, 2014), concluded its opinion granting Forest Laboratories summary judgment. There certainly were complex medical issues and terrible tragedy, as the case involved a patient who took an SSRI, Lexapro, for depression and other symptoms but who ultimately committed suicide. But there also was a straightforward application of the law, as the testimony of the decedent’s prescribing psychiatrists obliterated plaintiff’s attempt to show proximate causation under the learned intermediary doctrine.
For those of us who take depositions of prescribing doctors, we know that what the doctor knew or didn’t know is the key testimony. Defense and plaintiffs’ attorneys often have a back-and-forth in which the defense attorney attempts to show what the doctor knew about the drug’s risk and the plaintiffs’ attorney attempts to show what she didn’t know. The outcome of that back-and-forth often doesn’t become clear until the deposition ends. Sometimes, frankly, it never becomes clear. Regardless, while that testimony is often important for trial, it also can be crucial for a summary judgment motion. In Higgins it was. It ultimately established, as the court put it, that the prescribers “were well aware of the risks of prescribing SSRIs such as Lexapro when they treated [the decedent] in 2004.” Id. at *19.
In the Higgins depositions, the back-and-forth was fairly one-sided. The defense attorney, through the use of open ended questions, established that the potential risk of suicide with the use of SSRIs was well known, there was a debate regarding it in the scientific community, and the prescriber knew the potential risk, considered it, discussed it regularly with his patients, and likely discussed it with the decedent and his family:
Q: Dr. Andres, going back to 2004, specifically the period of time when you treated Francis Krivicich, were you aware of a debate, a scientific debate or debate within the medical community, about the possible link between the use of SSRI medications and emerging suicidal thinking?
Q: Can you tell me what you understood of that -- that debate, that issue, in 2004?
A: Well, it became a -- something of that was well known to the public. And the -- debate was -- among the psychiatrists was ongoing. And some people were saying that it was a major problem, other people were not, but it was an issue. It was in the minds of people.
These -- in the department of psychiatry, we have case conference meetings and professional meetings that are held. And that -- that was an issue that would come up at times. The -- the end product of all of that was that it was -- even today it would be considered an issue in the younger population. So you become a little more -- in that group, a little more sensitive to the issue.
The latest kind of thinking is that the probability of suicide is less if you give the medication, because of the antidepressant effect. So it moves in the direction which is saying you should give the medications even to young people and then just be aware of the possibility.
With -- in the specific case with Mr. Krivicich, the -- I can't remember exactly the context where that came up. But my hunch is -- and I -- and that the family was aware of the debate and that that ended -- and that it influenced the conversation that he had with his family. So it -- it was an issue. My hunch is -- I can't remember exactly what was said. My hunch is the issue came up in that context and then he decided to continue with it at least for a while.
Q: Doctor, the issue that we're discussing, the ongoing debate about whether the SSRIs themselves could cause suicidal thinking or suicide, were you aware of that debate prior to 2004, prior to your treatment of Francis Krivicich?
A: I -- I'm not sure of the -- if it was in the -- in the public arena; it was in the private arena I'm sure because we saw a ton of people who were depressed . . . . That was the main diagnosis. . . . I can't imagine not having that kind of knowledge at issue.
Q: And to follow up on an answer you just provided, if I understand what you're saying, if there was information in the media, information in the scientific community, about the possible link between these two, you would have been aware of it when that became public?
* * *
Id. at *25-27.
This type of testimony blows a hole in a plaintiff’s case. Regardless of whether the doctor was properly warned, she knew the risk.
But plaintiffs’ attorneys, who are good at what they do, try to minimize the importance of such testimony. They seek to elicit from the prescriber testimony on other pieces of information or warnings that, had the prescriber known about it, might have made a difference. For instance, the current labels for SSRIs carry a black box warning on suicidality in young adults. It wasn’t there when these doctors prescribed to the decedent. So, would that have made a difference? Well, while the plaintiffs’ attorney may have addressed this, the defense attorney attacked it head on and got testimony from the prescriber that was devastating to plaintiff’s case:
Q. Okay. So, again, would this have changed in any way -- this warning, this black box warning, change in any way your decision to prescribe Lexapro to Mr. Krivicich, who was 60 at the time you treated him?
A. No. I mean I would feel free to use it.
Id. at *28.
Testimony from the second prescriber didn’t help either. He also recalled the debate in the scientific community on whether SSRIs increased the risk of suicide. He testified that he was aware of the potential risk and took it into consideration when prescribing SSRIs:
Q. Okay. Now, if you can, during that period, the '90s and early 2000s, what was your understanding of the debate at that time? And I appreciate you can't identify it to a specific day.
A. The debate was whether the medications gave -- caused patients to have de novo psychiatric ideation or worsened psychiatric ideation or whether this was simply suicidal ideation in a patient who is already severely depressed and might be having suicidal ideation anyway, regardless of whether or not he or she was taking medicine.
* * *
Q. Now, when you did become aware of the debate about the possible link between SSRI medications and depression -- and if I understand, you were aware of that before you treated Mr. Krivicich?
Q. Is that something that you took into consideration when you were treating patients that had depression or anxiety and for whom you may have considered prescribing antidepressants, SSRIs?
Q. And how did you factor that -- the debate, the discussion, into your treatment plan, if you will?
A. Again, it's difficult to do it around a specific time, but I suspect by the time my clinical stance was that many more lives were saved by the antidepressants and their appropriate use than were lost as a result of using the SSRIs. So even if the assertions that these medications might lead to suicidal behavior or make it worse were true and that some patients were lost as a result of that, the overall benefit was massively on the side of using the antidepressants for patients who are depressed.
Id. at *29-30. Moreover, his practice was to advise patients of the risk: “I routinely told patients then, as now, that a worsening of depressive symptoms, including suicidal impulses, could occur and those should be reported to me immediately.” Id. at *32.
This testimony left plaintiff’s case on the ropes. Plaintiffs’ attorney tried to fix it, but it only got worse, as the prescriber testified that the risk information was abundant in the literature. In fact, he may have gotten it from a Dear Doctor letter from Forest Laboratories:
Q: Did -- prior to treating Francis Krivicich --
Q: -- did either the literature or any sales representative or Dear Doctor letter from Forest Laboratories ever convey the message to you that the use of this medication can cause de novo suicidality or worsening of suicidality?
* * *
Q: Okay. What conveyed that to you?
A: It's hard for me to specify where that information came from, but my clinical literature from the journals and the newsletters was -- was all congruent around this issue. So there was abundant information to me from more than one source.
. . . .
Q: And it's your testimony that that article or something similar to that, prior to treating Francis, conveyed the message the medications do cause this, not can but do?
That’s that, really. Plaintiff has the burden to prove proximate causation. In failure to warn cases, that means plaintiff must prove that the alleged failure of the drug company to warn the prescribing doctor had a causal relationship with decedent’s injury. Yet, all that the back-and-forth questioning at the depositions established was that the prescribers knew the risk, took it into account, and prescribed anyway.
In other words, Plaintiff could not show proximate causation. That means summary judgment for the defendant. Straightforward.