United States District Court, W.D. Virginia, Harrisonburg Division
KATHLEEN HIGGINS, Individually and as a personal representative of the estate of Francis Krivicich, Plaintiff,
FOREST LABORATORIES, et al., Defendants
For Kathleen Higgins, Individually and as a personal representative of te estate of Francis Krivicich, Plaintiff: Arnold Anderson Vickery, Fred H. Shepherd, LEAD ATTORNEYS, PRO HAC VICE, The Vickery Law Firm, Houston, TX; Christopher L. Coffin, LEAD ATTORNEY, PRO HAC VICE, Pendley, Baudin & Coffin, L.L.P., New Orleans, LA; Earl Landers Vickery, LEAD ATTORNEY, PRO HAC VICE, Law Office of Earl Landers Vickery, Austin, TX; Nicholas R. Rockforte, LEAD ATTORNEY, Pendley, Baudin & Coffin, LLP, Plaquemine, LA; Paul Rice Thomson, III, Thomson Law Firm, PLLC, Roanoke, VA.
For Forest Laboratories, Inc, Defendant: Christopher Paul Fisher, LEAD ATTORNEY, PRO HAC VICE, Ulmer & Berne LLP, Cleveland, OH; Christopher J. Mulvaney, John Richard Ipsaro, Joseph P. Thomas, LEAD ATTORNEYS, PRO HAC VICE, Ulmer & Berne, LLP, Cincinnati, OH; Brendan David O'Toole, Williams Mullen - Richmond, Richmond, VA; William Lewis Stauffer, Jr., Williams Mullen - Newport News, Newport News, VA.
Hon. Michael F. Urbanski, United States 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.
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 warranty  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 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 prescriber.
Hamrell Expert Report, Dkt. No. 88-1, at 3. 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.
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, 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.
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); Celotex Corp. v. Catrett, 477 U.S. 317, 322, 106 S.Ct. 2548, 91 L.Ed.2d 265 (1986); Glynn v. EDO Corp., 710 F.3d 209, 213 (4th Cir. 2013). When making this determination, the court should consider " the pleadings, depositions, answers to interrogatories, and admissions on file, together with . . . [any] affidavits" filed by the parties.
Celotex, 477 U.S. at 322. Whether a fact is material depends on the relevant substantive law.
Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 248, 106 S.Ct. 2505, 91 L.Ed.2d 202 (1986). " Only
disputes over facts that might affect the outcome of the suit under the governing law will properly preclude the entry of summary judgment. Factual disputes that are irrelevant or unnecessary will not be counted." Id. (citation omitted). The moving party bears the initial burden of demonstrating the absence of a genuine issue of material fact.
Celotex, 477 U.S. at 323. If that burden has been met, the non-moving party must then come forward and establish the specific material facts in dispute to survive summary judgment. Matsushita Elec. Indus. Co. v. Zenith Radio Corp., 475 U.S. 574, 586-87, 106 S.Ct. 1348, 89 L.Ed.2d 538 (1986).
In determining whether a genuine issue of material fact exists, the court views the facts and draws all reasonable inferences in the light most favorable to the non-moving party.
Glynn, 710 F.3d at 213 (citing Bonds v. Leavitt, 629 F.3d 369, 380 (4th Cir. 2011)). Indeed, " [i]t is an 'axiom that in ruling on a motion for summary judgment, the evidence of the nonmovant is to be believed, and all justifiable inferences are to be drawn in [her] favor.'" McAirlaids, Inc. v. Kimberly-Clark Corp., 756 F.3d 307, 2014 WL 2871492, at *1 (4th Cir. 2014) (internal alteration omitted) (citing Tolan v. Cotton, 134 S.Ct. 1861, 1863, 188 L.Ed.2d 895 (2014) (per curiam)). Moreover, " [c]redibility determinations, the weighing of the evidence, and the drawing of legitimate inferences from the facts are jury functions, not those of a judge . . . ."
Anderson, 477 U.S. at 255. However, the non-moving party " must set forth specific facts that go beyond the 'mere existence of a scintilla of evidence.'"
Glynn, 710 F.3d at 213 (quoting Anderson, 477 U.S. at 252). Instead, the non-moving party must show that " there is sufficient evidence favoring the non[-]moving party for a jury to return a verdict for that party." Res. Bankshares Corp. v. St. Paul Mercury Ins. Co., 407 F.3d 631, 635 (4th Cir. 2005) (quoting Anderson, 477 U.S. at 249). " In other words, to grant summary judgment the Court must determine that no reasonable jury could find for the non[-]moving party on the evidence before it." Moss v. Parks Corp., 985 F.2d 736, 738 (4th Cir. 1993) (citing Perini Corp. v. Perini Constr., Inc., 915 F.2d 121, 124 (4th Cir. 1990)).
" Under Virginia law . . . manufacturers and sellers of defective products can be held liable on theories of negligence and breach of the implied warranty of merchantability." Bly v. Otis Elevator Co., 713 F.2d 1040, 1042 (4th Cir. 1983) (citations omitted), on reh'g sub nom. Farish for Farish v. Courion Indus., Inc., 754 F.2d 1111 (4th Cir. 1985); see also Abbot by Abbot v. Am. Cyanamid Co., 844 F.2d 1108, 1114 (4th Cir. 1988) (" Under Virginia law, recoveries for personal injuries caused by defective products can be made as breach of an implied warranty of merchantability or under a tort theory of negligent design." ). The elements of both a negligence and a warranty cause of action are largely identical.
Under either the warranty theory or the negligence theory the plaintiff must show, (1) that the goods were unreasonably dangerous either for the use to which they would ordinarily be put or for some other reasonably foreseeable purpose, and (2) that the unreasonably dangerous condition existed when the goods left the defendant's hands.
Logan v. Montgomery Ward & Co., Inc., 216 Va. 425, 428, 219 S.E.2d 685, 687 (1975) (citations omitted). " Unreasonably dangerous" products include products that are not accompanied by adequate warnings about their hazardous properties. Butler v. Navistar Int'l Transp. Corp., 809 F.Supp. 1202, 1206 (W.D. Va. 1991) (collecting cases);
see also Abbot, 844 F.2d at 1114 (same). Here, Higgins asserts under both her negligence claim and her breach of warranty claim that Forest Labs failed to provide an adequate warning about the hazardous properties of Lexapro. One of the many defenses asserted by Forest Labs is that it is shielded from liability by the learned intermediary doctrine.
Generally, a manufacturer has a duty to warn its customers of risks posed by its products. In re Zyprexa Products Liab. Litig., No. 04-MD-1596, 2009 WL 2487305, at *12 (E.D.N.Y. July 27, 2009)(citing Stanback v. Parke, Davis & Co., 657 F.2d 642, 644 n.2 (4th Cir. 1981)). Where there is a genuine issue regarding the adequacy of the warning, summary judgment on a failure to warn claim is improper. Abbot, 844 F.2d at 1115 (citing Pfizer, Inc. v. Jones, 221 Va. 681, 683-84, 272 S.E.2d 43, 44-45 (1980)). However, the learned intermediary doctrine provides a limited exception to this general rule. Talley v. Danek Med., Inc., 179 F.3d 154, 162 (4th Cir. 1999) (citing Reyes v. Wyeth Lab., 498 F.2d 1264, 1276 (5th Cir. 1974)). Specifically,
[t]he " learned intermediary" doctrine provides that manufacturers of prescription drugs and medical devices discharge their duty of care to patients by providing adequate warnings to the prescribing physicians.
In re Zyprexa, 2009 WL 2487305, at *12 (citing Restatement (Third) of Torts: Products Liability § 6 cmt. d, reporters' note (1997);
Talley, 179 F.3d at 162). Critically, " [e]ven if a drug warning was deficient, a manufacturer is not liable when the prescribing physician was independently aware of the risks that should have been communicated by the manufacturer and chose to administer the drug anyway." In re Zyprexa, 2009 WL 2487305, at *13 (citing Stanback, 657 F.2d at 645); see also Talley v. Danek Med., Inc., 7 F.Supp.2d 725, 730 (E.D. Va. 1998) (citing Stanback, 657 F.2d at 645) (" Even if the manufacturer provides inadequate information, however, the manufacturer will not be liable if the plaintiff's physician independently knew of the risks and failed to advise the plaintiff." ), aff'd, 179 F.3d 154 (4th Cir. 1999). Indeed, " a plaintiff must not only show that a manufacturer's warning was inadequate, but that such inadequacy affected the prescribing physician's use of the product and thereby injured the plaintiff."
Talley, 7 F.Supp.2d at 730.
In 1980, the Supreme Court of Virginia called it " an elementary principle of law" that " in the case of prescription drugs, it is the general rule that the duty of the drug manufacturer is to warn the physician who prescribes the drug in question[.]"
Pfizer, 221 Va. at 684, 272 S.E.2d at 44 (internal quotation omitted). A year later, the Fourth Circuit in Stanback v. Parke, Davis & Co., observed that " the well-settled rule is that the duty an ethical [i.e., a prescription] drug manufacturer
owes to the consumer is to warn only physicians (or other medical personnel permitted by state law to prescribe drugs) of any risks or contraindications associated with that drug." 657 F.2d at 644 (collecting cases). Although the Fourth Circuit did not find a Virginia case on point, it " assume[d] that the Virginia Supreme Court would follow the general rule." Id.
In Stanback, a plaintiff contracted Guillain-Barre Syndrome (" GBS" ) after receiving a dose of the flu vaccine, Fluogen. Id. at 643-44. The package insert for Fluogen did not warn of the risk of contracting GBS. Id. at 644. The doctor who administered the vaccine testified that he did not read the Fluogen package insert, but he was aware of the risk of GBS associated with the vaccine. Id. The doctor did not advise patients about the risk of GBS either. Id. at 645. The Fourth Circuit determined that even if the manufacturer of Fluogen had adequately warned the administering doctor in that case, the " uncontradicted evidence establishe[d] that [the plaintiff] would have nevertheless received the flu vaccinations despite the slight risk, and would not have been informed of the risk." Id. at 645. Because the doctor was fully aware of the " information which an adequate warning would have contained" the manufacturer of Fluogen was not liable for its failure to warn. Id. The district court's granting of summary judgment in favor of the manufacturer was proper because the plaintiff " failed to adduce sufficient proof of causation under any of the theories of liability set forth in her complaint." Id. at 646.
In Barnette v. E.R. Squibb & Sons, Inc., 670 F.Supp. 650 (E.D. Va. 1987), the court cited the district court decision in Stanback and the Supreme Court of Virginia's decision in Pfizer in observing that " the parties were in agreement that, under Virginia law, the manufacturer of a prescription drug has a duty to warn the physician or medical profession of its potential side effects, but that this duty does not extend to the patient." Id. at 651 (citing Stanback v. Parke, Davis & Co., 502 F.Supp. 767, 770 (W.D. Va. 1980), aff'd, 657 F.2d 642 (4th Cir. 1981);
Pfizer, 221 Va. at 684, 272 S.E.2d at 44-45)). Similarly, the Fourth Circuit cited its previous decision in Stanback as well as the Pfizer case in Abbot, when it observed as follows: " With prescription drugs, the duty is not the normal duty to warn the ultimate consumer. Rather, the duty is to warn the physician administering the drug." 844 F.2d at 1115 (citing Stanback,
657 F.2d at 644; Pfizer, 221 Va. at 684, 272 S.E.2d at 44).
The Fourth Circuit addressed the learned intermediary doctrine under Virginia law twice more in the 1990s. In Kling v. Key Pharmaceuticals, Inc., 35 F.3d 556, 1994 WL 477815 (4th Cir. 1994) (unpublished per curiam table decision), the Fourth Circuit found that " [u]nder well-established Virginia law, a prescription drug manufacturer owes the consumer the duty of warning only the consumer's physician, or other person authorized to prescribe drugs, of risks or contra-indications associated with a drug." [WL] at *2 (emphasis added) (citing Stanback, 657 F.2d 642). In Kling, a plaintiff suffered a seizure that left him permanently disabled after taking a drug to treat his asthma. [WL] at *1. The sudden onset of seizures was a well-known side effect of the drug and documented in the Physician's Desk Reference and in the drug's package inserts. Id. The prescribing doctor testified that stricter warnings would not have affected his decision to prescribe the drug. [WL] at *2. The district court granted the manufacturer's Rule 50 motion, and the Fourth Circuit affirmed because seizures were well known side effects, and the plaintiff failed to prove causation
in light of the doctor's testimony that stronger warnings would not have altered his decision to prescribe the drug. [WL] at *2-3.
The Fourth Circuit again addressed the doctrine in Talley v. Danek Medical, Inc., 179 F.3d 154 (4th Cir. 1999). In Talley, the district court concluded that the plaintiff was essentially bringing failure to warn claims and held that under Virginia's learned intermediary doctrine the defendant need only warn physicians and not their patients. Id. at 162 (citing Abbot, 844 F.2d at 1115). On review, the Fourth Circuit held that " the district court correctly applied the learned intermediary doctrine." Id. at 164. In that case, a doctor had a consulting relationship with a medical device manufacturer. Id. The plaintiff failed to show causation where the doctor testified that he did not always choose that ...