Dolin v. GlaxoSmithKline LLC

• Decision Date: 22 August 2018
• Docket Number: No. 17-3030,17-3030
• Citation: 901 F.3d 803
• Parties: 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.
• Court: U.S. Court of Appeals — Seventh Circuit

901 F.3d 803

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.

No. 17-3030

United States Court of Appeals, Seventh Circuit.

Argued May 30, 2018

Decided August 22, 2018

Rehearing and Rehearing En Banc Denied September 20, 2018

David E. Rapoport, Matthew S. Sims, Attorneys, Rapoport Law Offices, Chicago, IL, Robert Brent Wisner, Attorney, Baum, Hedlund, Aristei & Goldman, PC, Los Angeles, CA, for Plaintiff–Appellee

Lisa Schiavo Blatt, Stephen K. Wirth, William Perdue, Elisabeth Theodore, Attorneys, Arnold & Porter Kaye Scholer LLP, Washington, DC, Alan Scott Gilbert, Attorney, Dentons US LLP, Chicago, IL, Andrew T. Bayman, Todd Patrick Davis, Heather Howard, Attorneys, King & Spalding LLP, Atlanta, GA, for Defendant–Appellant.

Cory L. Andrews, Attorney, Washington Legal Foundation, Washington, DC, for Amicus Curiae Washington Legal Foundation.

Michael X. Imbroscio, Attorney, Covington & Burling LLP, Washington, DC, for Amicus Curiae Pharmaceutical Research and Manufacturers of America.

Kannon K. Shanmugam, Attorney, Williams & Connolly LLP, Washington, DC, for Amicus Curiae Chamber of Commerce of the United States of America.

Mary E. Signorille, Senior Attorney, AARP Foundation Litigation, Washington, DC, for Amicus Curiae American Association of Retired Persons.

Leslie J. Rosen, Attorney, Leslie J. Rosen, Attorney at Law PC, Chicago, IL, for Amicus Curiae Illinois Trial Lawyers Association.

Scott L. Nelson, Adina Hyman Rosenbaum, Attorneys, Public Citizen Litigation Group, Washington, DC, for Amicus Curiae Public Citizen, Inc.

Before Wood, Chief Judge, and Sykes and Hamilton, Circuit Judges.

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 was in his system. He was 57 years old.

At the time of Stewart’s death, GSK manufactured brand-name Paxil

and was responsible under federal law for the con-tent 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 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.

In this appeal, GSK challenges the district court’s conclusions about liability under Illinois law and preemption. GSK also argues that the evidence at trial did not support the jury’s verdict. We agree with GSK that federal law prevented GSK from adding a warning about the alleged association between paroxetine and suicides in adults. On that basis of federal preemption, we reverse the judgment. The case must be dismissed.

I. Legal and Factual Background

A. Regulation of Drug Labels

We start with the regulatory background that explains why the parties make the arguments they do. The Food, Drug, and Cosmetic Act bars pharmaceutical companies from manufacturing new drugs unless the Food and Drug Administration approves a "new drug application." 21 U.S.C. § 355(a). The new drug application must show that the drug is safe and effective, which requires an extensive series of clinical trials. Guilbeau v. Pfizer, Inc. , 880 F.3d 304, 307 (7th Cir. 2018) ; see also 21 U.S.C. §§ 355(b) & (d). The application must also include "the labeling proposed to be used for such drug." § 355(b)(1)(F); 21 C.F.R. § 314.50(c)(2)(i).

The label contains a lot more than the drug’s name. It must disclose, among other things, warnings and precautions related to the drug’s effects. The FDA reviews the proposed label to determine whether it is "false or misleading." 21 U.S.C. § 355(d)(7) ; 21 C.F.R. § 314.125(b)(6). Once the new drug application is approved, the manufacturer must distribute the drug using the FDA-approved label. Otherwise, the drug is misbranded and may not be distributed in the United States. See 21 U.S.C. §§ 331(a), 333(a), & 352(a), (c). In 1992, the FDA approved GSK’s new drug application for paroxetine, including a label.

Plaintiff’s theory of liability is based on GSK’s ability to change the paroxetine label after the FDA approved it in 1992. There were two ways relevant to this lawsuit for GSK to change the label without running afoul of federal law. First, GSK could have asked the FDA for permission to change the label. 21 C.F.R. § 314.70(b)(2)(v)(A). This is the default rule for most substantive changes to drug labels. Second, in narrow circumstances GSK could unilaterally change the label under what is called the "changes being effected" or CBE regulation. The CBE regulation is an exception to the general rule that changes require advance FDA permission. It allows manufacturers to change a label to "reflect newly acquired information" if, as relevant here, the changes "add or strengthen a ... warning" for which there is "evidence of a causal association...." 21 C.F.R. § 314.70(c)(6)(iii)(A). In other words, GSK needed FDA permission to change the paroxetine

label unless three things were true: (1) GSK had newly acquired information about paroxetine (2) that showed a causal association (3) between the drug and an effect that warranted a new or stronger warning. The FDA reviews CBE submissions and can reject label changes even after the manufacturer has made them. See 21 C.F.R. § 314.70(c)(6), (7).

The new drug approval process is "onerous and lengthy." Mutual Pharmaceutical Co. v. Bartlett , 570 U.S. 472, 476, 133 S.Ct. 2466, 186 L.Ed.2d 607 (2013). Generic manufacturers can avoid much of this costly process, but they have little influence on the contents of drug labels. Under the Drug Price Competition and Patent Term Restoration Act of 1984, commonly known as the Hatch-Waxman Act, a manufacturer can file an "abbreviated new drug application" for approval to distribute a generic drug. See 21 U.S.C. § 355(j). The Supreme Court summarized the requirements for generics:

First, the proposed generic drug must be chemically equivalent to the approved brand-name drug: It must have the same "active ingredient" or "active ingredients," "route of administration," "dosage form," and "strength" as its brand-name counterpart. 21 U.S.C. §§ 355(j)(2)(A)(ii) and (iii). Second, a proposed generic must be "bioequivalent" to an approved brand-name drug. § 355(j)(2)(A)(iv). That is, it must have the same "rate and extent of absorption" as the brand-name drug. § 355(j)(8)(B). Third, the generic drug manufacturer must show that "the labeling proposed for the new drug is the same as the labeling approved for the [approved brand-name] drug." § 355(j)(2)(A)(v).

Bartlett , 570 U.S. at 477, 133 S.Ct. 2466. "This allows manufacturers to develop generic drugs inexpensively, without duplicating the clinical trials already performed on the equivalent brand-name drug." PLIVA, Inc. v. Mensing , 564 U.S. 604, 612, 131 S.Ct. 2567, 180 L.Ed.2d 580 (2011).

In sum, "brand-name and generic drug manufacturers have different federal drug labeling duties." Mensing , 564 U.S. at 613, 131 S.Ct. 2567. "A brand-name manufacturer seeking new drug approval is responsible for the accuracy and adequacy of its label." Id. ; see also 21 U.S.C. § 355(b)(1), (d) ; Wyeth v. Levine , 555 U.S. 555, 570–71, 129 S.Ct. 1187, 173 L.Ed.2d 51 (2009). "A manufacturer seeking generic drug approval, on the other hand, is responsible for ensuring that its warning label is the same as the brand name’s." Mensing , 564 U.S. at 613, 131 S.Ct. 2567 ; see also 21 U.S.C. §§ 355(j)(2)(A)(v) & (j)(4)(G) ; 21 C.F.R. §§ 314.94(a)(8) & 314.127(a)(7). Thus, from 1992 to 2014, when GSK sold the right to distribute brand-name Paxil

, GSK was responsible for the "accuracy and adequacy" of the drug’s label. To change the label, GSK needed either FDA permission or newly acquired information that supported a strengthened warning under the CBE regulation.

B. The History of Paroxetine’s Label

Paroxetine

is a selective serotonin reuptake inhibitor, one of a class of antidepressants commonly called SSRIs. For decades, the FDA has scrutinized data on the relationship between SSRIs and suicidal behavior. The FDA’s analysis of that relationship is central to the preemption question in this appeal.

1. The New Drug Application Approval

GSK’s predecessor, ...