To view complete transcript click here
IN THE UNITED STATES DISTRICT COURT FOR THE WESTERN DISTRICT OF VIRGINIA HARRISONBURG DIVISION
Hon. Michael F. Urbanski United States District Judge
Entered: September 8, 2014
This is a failure to warn case regarding a prescription drug. Specifically, plaintiff Kathleen Higgins (“Higgins”), individually and as the personal representative of the estate of Francis Krivicich (“Krivicich”), brought this negligence and breach of warranty1 action pursuant to the diversity jurisdiction of the federal courts after Krivicich, her husband, committed suicide while taking Lexapro. Forest Labs is the manufacturer of Lexapro, a selective serotonin reuptake inhibitor (“SSRI”) antidepressant drug. Higgins asserts that Forest Labs failed to provide an adequate warning that Lexapro causes a new or increased risk of suicide among members of a certain at-risk subpopulation, particularly during a change in dosage.
That is, Higgins argues that Lexapro can actually cause some people to commit suicide who otherwise would not have done so. During the six months prior to his suicide, Krivicich received mental health treatment from Dr. Francis Andres, a board certified psychiatrist. Dr. Andres originally prescribed Krivicich Lexapro on February 28, 2004. On March 22, 2004, the United States Food and Drug Administration (“FDA”) issued a Public Health Advisory asking antidepressant manufacturers to change warning labels to recommend close observation of adult and pediatric patients treated with SSRI antidepressants for the emergence of suicidality. See March 22, 2004, FDA Public Health Advisory, Dkt. No. 90-9, at 2. The FDA specifically noted that it had not concluded that SSRIs cause worsening depression or suicidality. Id. Nevertheless, the FDA advised health care providers to carefully monitor patients at the beginning of drug therapy or when either increasing or decreasing dosages. Id.
Finally, the warning recommended that prescribers should instruct patients, their families, and their caregivers to be alert for the emergence of suicidality. Id. at 3. A significant amount of press coverage, both in mainstream media outlets (e.g., CBS News, the Associated Press, the New York Times, the Washington Post) and in medical publications (e.g., the New England Journal of Medicine, the Journal of the American Medical Association) followed this advisory. See
Aff. in Supp. of Mot. for Summ. J., Dkt. No. 146 (noting these publications).
On July 10, 2004, Dr. Andres wrote Krivicich an additional Lexapro prescription. Krivicich saw another psychiatrist, Dr. Brian Doyle, on July 16, 2004, who continued him on Lexapro and a short acting antidepressant, Klonopin. Krivicich took his own life nine days later, on July 25, 2004.
One of Higgins proffered expert witnesses, Dr. Michael Hamrell, Ph.D., gave the opinion that as early as 2001 Forest Labs should have provided a warning for Lexapro along the following lines:
Lexapro may increase the risk compared to placebo of suicidal thinking and behavior (suicidality). Anyone considering the use of Lexapro must balance this risk with the clinical need. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on Lexapro therapy should be monnitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber.
Hamrell Expert Report, Dkt. No. 88-1, at 3.2 Additionally, Higgins alleges that Forest Labs “did nothing to actually call [the March FDA Public Health Advisory] to the attention of practicing physicians, much less to patients or their families.” Am. Compl. (Third), Dkt. No. 136, at ¶ 15. Indeed, Higgins asserts that Forest Labs “told [its] sales people that they were NOT to proactively discuss any such side effect with the prescribers.” Id.
Forest Labs denies that Lexapro causes a new or increased risk of suicide in adults, asserts that it did in fact convey the March FDA Public Health Advisory to doctors, and argues that both Drs. Andres and Doyle were independently aware of the risks as to which Higgins claims Forest Labs should have warned. As such, Forest Labs has asserted a number of substantive and procedural defenses…
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. In light of the testimony of Drs. Andres and Doyle, and given the nature of the facts regarding the overwhelming abundance of information on the issue of SSRIs and the risk of suicidality of which they testified they were aware at the time they treated Krivicich, the court is constrained to conclude that there is no genuine issue of material fact in dispute. Because Virginia law does not permit a drug manufacturer to be liable for failure to warn of a risk of which a treating physician was independently aware, and Krivicich’s doctors plainly testified as to their awareness of the risk of increased suicidability associated with SSRIs, the court must award summary judgment in favor of Forest Labs. An appropriate Order will be entered this day. The Clerk is directed to send a copy of this Memorandum Opinion to all counsel of record.