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Dolin v. GlaxoSmithKline LLC

United States Court of Appeals for the Seventh Circuit

May 30, 2018, Argued; August 22, 2018, Decided

No. 17-3030


 [*805]  Hamilton, Circuit Judge. Defendant GlaxoSmithKline LLC (GSK) appeals from a jury verdict awarding $3 million to plaintiff Wendy Dolin for the death of her husband, Stewart Dolin. Mrs. Dolin alleges that GSK's negligent omissions in the drug label for Paxil caused her husband's death. Stewart did not actually take Paxil. In 2010, a doctor prescribed Paxil, the brand-name version of paroxetine, to treat Stewart's depression and anxiety. But his prescription was filled with generic paroxetine manufactured by another company (one that is no longer a defendant). Six days later, Stewart committed suicide. Blood tests showed that paroxetine [**3]  was in his system. He was 57 years old.

At the time of Stewart's death, GSK manufactured brandname Paxil and was responsible under federal law for the content of the drug's label. When Stewart died, the labels for paroxetine and similar antidepressant drugs warned that they were associated with suicide in patients under the age of 24. The labels did not warn about any association between the drugs and an increased risk of suicide in older adults.

The current state of federal law makes it virtually impossible to sue generic drug manufacturers on a state-law theory for failure to warn. In response to this legal landscape, plaintiffs have advanced a new theory of liability and have sued brand-name manufacturers, who have more control over drug labels, for injuries caused by taking the generic drugs. Mrs. Dolin followed this recent trend here, suing GSK on the theory that it negligently failed to include warnings that paroxetine was associated with suicide in patients older than 24.

Throughout the lawsuit, GSK has maintained that it is not liable under Illinois law simply because Stewart Dolin did not consume a drug that GSK manufactured. Mrs. Dolin responds that the relevant harm was caused [**4]  by the incomplete label, not the drug, and that under federal law, only GSK could change the label. GSK also argued that federal law preempted Illinois law from requiring the warning that Mrs. Dolin claims was negligently omitted because the FDA had rejected GSK's attempts to add just such a warning. The district court disagreed with GSK's various arguments, and the case proceeded to trial and a verdict for Mrs. Dolin.

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901 F.3d 803 *; 2018 U.S. App. LEXIS 23598 **

WENDY B. DOLIN, Individually and as Independent Executor of the Estate of STEWART DOLIN, Deceased, Plaintiff-Appellee, v. GLAXOSMITHKLINE LLC, Formerly Known as SMITHKLINE BEECHAM CORP., Defendant-Appellant.

Subsequent History: Rehearing denied by, Rehearing, en banc, denied by Dolin v. Glaxosmithkline LLC, 2018 U.S. App. LEXIS 26997 (7th Cir. Ill., Sept. 20, 2018)

US Supreme Court certiorari denied by Dolin v. GlaxoSmithKline, LLC, 139 S. Ct. 2636, 204 L. Ed. 2d 282, 2019 U.S. LEXIS 3719 (U.S., May 28, 2019)

Reopening denied by Dolin v. GlaxoSmithKline LLC, 2020 U.S. App. LEXIS 7063 (7th Cir. Ill., Mar. 6, 2020)

Prior History:  [**1] Appeal from the United States District Court for the For the Northern District of Illinois, Eastern Division. No. 12-CV-6403 — William T. Hart, Judge.

Dolin v. SmithKline Beecham Corp., 62 F. Supp. 3d 705, 2014 U.S. Dist. LEXIS 26219 (N.D. Ill., Feb. 28, 2014)


warning, label, suicide, paroxetine, manufacturer, adults, preemption, regulation, patients, paroxetine-specific, brand-name, antidepressants, federal law, state law, new drug, acquired information, adult-suicidality, drugs, newly, preempted, generic, placebo, argues, major depressive disorder, clear evidence, district court, class-wide, generic drug, unilaterally, permission

Business & Corporate Compliance, Governments, Agriculture & Food, Federal Food, Drug & Cosmetic Act, Constitutional Law, Supremacy Clause, Federal Preemption, Civil Procedure, Trials, Judgment as Matter of Law