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Dolin v. GlaxoSmithKline LLC

United States District Court, N.D. Illinois, Eastern Division

September 14, 2017

WENDY B. DOLIN, Individually and as Independent Executor of the Estate of Stewart Dolin, Deceased, Plaintiff,
v.
GLAXOSMITHKLINE LLC, Defendant.

          OPINION AND ORDER

         A jury returned a verdict in the amount of $3 million in damages in a wrongful death and survival action in favor of plaintiff Wendy Dolin, executor of the Estate of Stewart Dolin, deceased, and against defendant GlaxoSmithKline LLC (“GSK”). The case was initiated in the Circuit Court of Cook County, Illinois and removed to this court based on diversity of citizenship. A motion to remand to the state court was denied (Dkt. 73).[1] This court has jurisdiction pursuant to 28 U.S.C. §§ 1332 and 1441.

         The case is now before the court for ruling on the defendant's reserved motions for judgment as a matter of law or for a new trial.

         Suit was brought to recover damages arising out of the death of plaintiff's husband, Stewart Dolin, a 57-year old attorney who was suffering from depression. He was prescribed and taking paroxetine, an antidepressant. Paroxetine is a drug designed, labeled and sold by GSK under the brand name Paxil. (The druggist who filled the prescription for paroxetine supplied a generic form of the drug produced and sold with the GSK Paxil label by Mylan Inc.) On July 15, 2010 Mr. Dolin left his office and went to a Chicago “L” train station and leapt in front of a train. Plaintiff alleges he was suffering from drug induced akathisia, a psychomotor agitation disorder.

         The case went to trial on the claim that GSK negligently failed to include a warning in the label that the drug can be a cause of adult suicide despite being aware of a significant risk of suicide in adults taking the drug. It is alleged that GSK allowed an affirmative misrepresentation to exist in the label that there is no risk of suicide beyond the age of 24 years. The plaintiff also asserts that the label did not warn of akathisia's association with suicidal behavior. Plaintiff contends that GSK negligently misled the medical profession (including Mr. Dolin's physician and the Food and Drug Administration (“FDA”)) by concealing and misrepresenting adult suicide risk data relating to paroxetine.

         Prior Rulings

         GSK moved for summary judgment three times. It first argued that because Mr. Dolin ingested a generic form of paroxetine it could not be liable for its conduct in creating and controlling the labeling used. The court disagreed. Dolin v. SmithKline Beecham Corp., 62 F.Supp.3d 705, 713 (N.D. Ill. 2014) (Zagel, J.) (Dkt. 110) (“Dolin I”). GSK moved to have the ruling certified under 28 U.S.C. § 1292(b) for an interlocutory appeal. After that motion was denied GSK petitioned the United States Court of Appeals for the Seventh Circuit for a writ of mandamus to compel certification of an appeal. The petition was denied. In re GlaxoSmithKline LLC., 557 F. App'x 578, 579 (7th Cir. 2014).

         GSK's second and third motions for summary judgment focused on Federal preemption as described in Wyeth v. Levine, 555 U.S. 555, 581 (2009). It argued that any state law claim was preempted because the FDA rejected its efforts to place certain warnings on the label. It was held that GSK failed to show that the FDA would have rejected a Paxil specific warning of the risk of adult suicide. In the third motion GSK urged that Mr. Dolin's physician was aware of the risks of adult suicide associated with the drug and that the label was adequate as a matter of law. Plaintiff's strict liability claims of design defect and failure to warn were dismissed. Negligence and consumer claims were allowed to proceed. Dolin v. Smith Kline Beecham Corp., 2016 WL 537949 (N.D. Ill. Feb. 11, 2016) (Zagel, J.) (Dkt. 348) (“Dolin III”).

         In Mut. Pharm. Co., Inc. v. Bartlett, 133 S.Ct. 2466 (2013) and in PLIVA v. Mensing, 131 S.Ct. 2567 (2011) the Supreme Court held that state-law label design defect claims that turn on the adequacy of label warnings are preempted by Federal law in the case of a generic supplier because a generic supplier has no power to change the label created by a brand-name supplier. See Bartlett, 133 S.Ct. at 2473; PLIVA, 131 S.Ct. at 2576. Accordingly, defendant Mylan Inc.'s motion to dismiss was granted. (Dkt. 110).

         GSK's Daubert motions to exclude the testimony of plaintiff's expert witnesses (David Healy, M.D., David Ross, M.D., Ph.D., M.B.I. and Joseph Glenmullen, M.D.) were denied. 2015 WL 7351678 (N.D. Ill. Nov. 20, 2015) (Zagel, J.) (“Dolin II”).

         The parties' motions in limine and objections to exhibits were resolved or reserved for ruling at trial. (Dkts. 465, 475, and 499.) Based on Rule 403 of the Federal Rules of Evidence, GSK's motion in limine to exclude any reference before the jury to criminal convictions of GSK for promoting Paxil in patients under age 18 and publishing misleading pediatric information with respect to Paxil was granted. The evidence in the case was limited to data dealing with adult suicide issues. Plaintiff was also precluded from offering studies showing minimal efficacy of paroxetine compared with placebo.

         Shortly before trial plaintiff moved to amend her complaint to limit her claims to one count of negligence and one count of negligence with intent to injure. Negligence with intent to injure was ruled not to be a plausible claim. (Dkt. 490.) The case went to trial on the negligence claim only. Under Illinois law, plaintiff's burden of proof was to prove every essential element of her claim by a preponderance of the evidence.

         The jury was instructed, in substance, as follows: GSK was responsible for the content of the paroxetine label. (21 C.F.R. § 201.80(e) and 121 Stat. 924-926.) GSK is charged both with crafting an adequate label and with ensuring that the warnings remain adequate as long as the drug is on the market. Under FDA regulations, GSK is required to revise and update its label to include a warning as soon as there is “reasonable evidence of an association of a serious hazard with the drug; a causal relationship need not have been proved” (21 C.F.R. § 314.80(e)).

         The jury was also told that FDA regulations permit a drug manufacturer to change a product label to add or strengthen a warning about its product without prior FDA approval so long as it later submits the revised warning to the FDA for review and approval (21 CFR §§ 314.70(c)(6)(iii)(A), (C)).

         In recognition of the learned intermediary doctrine, the jury was told that GSK had a duty to warn only the prescribing physician of the risks of which it knew, or in the exercise of ordinary care, should have known.

         Based on the rulings in Mason v. SmithKine Beecham Corp., 596 F.3d 387 (7th Cir. 2010) and, more recently, In re (Fosamax Alendronate) Sodium Prods. Liab. Litig., 852 F.3d 268 (3d Cir. 2017) the affirmative defense of Federal preemption as set forth in Wyeth v. Levine, 555 U.S. 555 (2009) was ruled to be a factual question for the jury. The court offered to submit the question to the jury with an appropriate burden of proof instruction. GSK took the position that preemption was a question of law for the court and declined to have its affirmative defense submitted to the jury in the form stated in the court's instructions.

         Standards

         Federal Rule of Civil Procedure 50(a) provides that if “a party has been fully heard on an issue during a jury trial and the court finds that a reasonable jury would not have a legally sufficient evidentiary basis to find for the party . . . the court may . . . grant a motion for judgment as a matter of law.” For a renewed motion for judgment as a matter of law the standard is whether the evidence presented, combined with all reasonable inferences, is sufficient to support the verdict when viewed in the light most favorable to the nonmovant. Dadian v. Vill. of Wilmette, 269 F.3d 831, 837 (7th Cir. 2001).

         A new trial may be granted if the verdict is against the clear weight of the evidence or the trial was unfair to the moving party. Whitehead v. Bond, 680 F.3d 919, 927 (7th Cir. 2012). When a motion for a new trial is based on a ruling of evidence, it must be shown that the error was such as to deny the party a fair trial. Perry v. Larson, 794 F.2d 279, 285 (7th Cir. 1986).

         The Evidence

         Paroxetine hydrochloride is a psychotropic drug of the Selective Serotonin Reuptake Inhibitor class (“SSRIs”). It is used, among other purposes, to treat major depressive disorders. The action of the drug on brain neurons is thought to be responsible for anti-depressant effects. Marketing of the drug began in 1992. Generic formulations have been available since 2003. The New Drug Application (NDA 20-031) was submitted in 1989 with data relating to suicides. In April 1991, the NDA was amended with a report containing data on suicides and suicide attempts. An approval letter for major depressive disorders (MDD) was issued on December 29, 1992. Paxil is not approved in the United States for any treatment in the pediatric population.

         The testimony of all of the medical experts who testified reveals that it is recognized in the medical community that some patients treated with SSRIs may be more likely to attempt or commit suicide. An SSRI may activate patients with suicidal ideations or induce symptoms of emotional volatility leading them to attempt or commit suicide in order to escape intolerable feelings.

         The so-called “black box” warning on the GSK label, the truth of which, in the case of Paxil, was a main focus of attention in this case (Joint Exhibit 1). Some content and the origin of the label is connected with criminal complaints against GSK by the Attorney General of New York in 2003 and later by United States Department of Justice resulting in a $3 billion fine against GSK for, among other things, withholding paroxetine data from the Food and Drug Administration (“the FDA”) and unlawfully promoting the drug for pediatric (under age 18) uses.[2] The FDA conducted a pooled statistical analyses of SSRIs, including paroxetine, finding an increase in suicide and suicide ideation in pediatric cases treated with SSRIs. It then ordered that each SSRI have a standardized “black box” warning which, in the case of Paxil, provides as follows:

         Suicidality and Antidepressant Drugs

Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of major depressive disorder (MDD) and other psychiatric disorders. Anyone considering the use of PAXIL or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond the age 24; there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on antidepressant 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. PAXIL is not approved for use in pediatric patients. (See WARNINGS: Clinical Worsening and Suicide Risk, PRECAUTIONS: Information for Patients, and PRECAUTIONS: Pediatric Use.)

         Another part of the GSK paroxetine/Paxil label which was a focus of attention in the evidence is the WARNINGS section:

         WARNINGS

Clinical Worsening and Suicide Risk: Patients with major depressive disorder (MDD), both adult and pediatric, may experience worsening of their depression and/or the emergence of suicidal ideation and behavior (suicidality) or unusual changes in behavior, whether or not they are taking antidepressant medications, and this risk may persist until significant remission occurs. Suicide is a known risk of depression and certain other psychiatric disorders, and these disorders themselves are the strongest predictors of suicide. There has been a long-standing concern, however, that antidepressants may have a role in inducing worsening of depression and the emergence of suicidality in certain patients during the early phases of treatment. Pooled analyses of short-term placebo-controlled trials of antidepressant drugs (SSRIs and others) showed that these drugs increase the risk of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults (ages 18-24) with major depressive disorder (MDD) and other psychiatric disorders. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond the age of 24; there was a reduction with antidepressants compared to placebo in adults aged 65 and older.
The pooled analyses of placebo-controlled trials in children and adolescents with MDD, obsessive compulsive disorder (OCD), or other psychiatric disorders included a total of 24 short-term trials of 9 antidepressant drugs in over 4, 400 patients. The pooled analyses of placebo-controlled trials in adults with MDD or other psychiatric disorders included a total of 295 short-term trials (median duration of 2 months) of 11 antidepressant drugs in over 77, 000 patients. There was considerable variation in risk of suicidality among drugs, but a tendency toward an increase in the younger patients for almost all drugs studied. There were differences in absolute risk of suicidality across the different indications, with the highest incidence in MDD. The risk differences (drug vs placebo), however, were ...

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