Higgins ex rel. Krivicich v. Forest Laboratories

48 F. Supp. 3d 878, 2014 U.S. Dist. LEXIS 124745
CourtDistrict Court, W.D. Virginia
DecidedSeptember 8, 2014
DocketCivil Action No. 5:07cv00054
StatusPublished
Cited by3 cases

This text of 48 F. Supp. 3d 878 (Higgins ex rel. Krivicich v. Forest Laboratories) is published on Counsel Stack Legal Research, covering District Court, W.D. Virginia primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
Higgins ex rel. Krivicich v. Forest Laboratories, 48 F. Supp. 3d 878, 2014 U.S. Dist. LEXIS 124745 (W.D. Va. 2014).

Opinion

MEMORANDUM OPINION

MICHAEL F. URBANSKI, District Judge.

Pending before the court are several motions, including three summary judgment motions filed by defendant, Forest Laboratories, Inc. (“Forest Labs”). The court addresses herein the most recent of these motions for summary judgment. Dkt. No. 144. For the reasons that follow, the court will grant the motion, rending all other pending motions moot.

I.

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 Kri-vicich, 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, [881]*8812004, 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 sui-cidality. 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 Lex-apro 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 monitored 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 preseriber.

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,3 asserts that it did in fact convey [882]*882the 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.

II.

This matter has taken several years and a rather circuitous path to reach its present procedural posture. Higgins originally filed suit on July 18, 2006, as part of Multi-District Litigation (“MDL”) 1736 in the Eastern District of Missouri. The MDL court transferred the matter here on March 29, 2007, but it was transferred back to the MDL on July 20, 2007. Dkt. No. 39. On July 26, 2013, the action was remanded back to this district along with an MDL pretrial order, Dkt. No. 41, and an order reopening the case was entered on August 26, 2013. Dkt. No. 42. This court heard oral argument on a number of motions on June 20, 2014. Dkt. No. 133. At the hearing, the court granted Higgins’ motion to amend her complaint,4 denied her motion to certify a question of state law to the Virginia Supreme Court, and took under advisement the four remaining motions: two summary judgment motions by Forest Labs and a Daubert motion from each party. The court also requested the full deposition transcripts of a number of expert and fact witnesses, including Drs. Andres and Doyle. Finally, because the court permitted Higgins’ to amend her complaint, it gave leave for Forest Labs to file a responsive summary judgment motion within two weeks.

Forest Labs filed the instant motion for summary judgment on July 11, 2014. Dkt. No. 144. Forest Labs seeks summary judgment on both Higgins’ negligence claim and breach of warranty claim on a number of grounds. Most notably Forest Labs argues it is shielded from liability under the learned intermediary doctrine because both Drs. Andres and Doyle were independently aware of the risks as to which Higgins claims Forest Labs should have warned. Higgins filed her response on July 17, 2014, Dkt. No. 149, and Forest Labs filed its reply on August 6, 2014. Dkt. No. 151. The court has carefully reviewed the entirety of the voluminous pleadings and evidence that have been submitted by the parties both before and after the hearing, and the matter is now ripe for adjudication.

III.

Pursuant to Federal Rule of Civil Procedure 56(a), the court must “grant summary judgment if the movant shows that there is no genuine dispute as to any material fact and the movant is entitled to judgment as a matter of law.” Fed.R.Civ.P. 56(a); Cel-otex Corp. v. Catrett, 477 U.S. 317, 322, 106 S.Ct. 2548, 91 L.Ed.2d 265 (1986); Glynn v. EDO Corp.,

Free access — add to your briefcase to read the full text and ask questions with AI

Related

WILKINS v. GENZYME CORPORATION
D. Massachusetts, 2022
Knapp v. Zoetis Inc.
E.D. Virginia, 2022
Bennett ex rel. Bennett v. Forest Laboratories
99 F. Supp. 3d 1360 (M.D. Florida, 2015)

Cite This Page — Counsel Stack

Bluebook (online)
48 F. Supp. 3d 878, 2014 U.S. Dist. LEXIS 124745, Counsel Stack Legal Research, https://law.counselstack.com/opinion/higgins-ex-rel-krivicich-v-forest-laboratories-vawd-2014.