Gibbons v. GlaxoSmithKline, LLC

2023 IL App (1st) 221666, 239 N.E.3d 10
CourtAppellate Court of Illinois
DecidedOctober 27, 2023
Docket1-22-1666
StatusPublished

This text of 2023 IL App (1st) 221666 (Gibbons v. GlaxoSmithKline, LLC) is published on Counsel Stack Legal Research, covering Appellate Court of Illinois primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
Gibbons v. GlaxoSmithKline, LLC, 2023 IL App (1st) 221666, 239 N.E.3d 10 (Ill. Ct. App. 2023).

Opinion

2023 IL App (1st) 221666

SIXTH DIVISION October 27, 2023

No. 1-22-1666

IN THE APPELLATE COURT OF ILLINOIS FIRST DISTRICT

NATHAN GIBBONS, ) ) Plaintiff-Appellee, ) ) v. ) ) GLAXOSMITHKLINE, LLC; GLAXOSMITHKLINE, ) Appeal from the PLC; BOEHRINGER INGELHEIM ) Circuit Court of PHARMACEUTICALS, INC.; BOEHRINGER ) Cook County INGELHEIM USA CORPORATION, INC.; SANOFI ) US SERVICES INC; SANOFI-AVENTIS U.S. LLC; ) No. 2021 L 007406 SAFEWAY, INC.; SAFEWAY HEALTH, INC.; ) GROCERY OUTLET; and DOES 1 THROUGH 100 ) The Honorable INCLUSIVE, ) Moira S. Johnson, ) Judge Presiding. Defendants, ) ) (Journal of the American Medical Association, ) ) Third-Party Respondent-Appellant). ) ) )

JUSTICE TAILOR delivered the judgment of the court, with opinion. Presiding Justice Mikva and Justice Walker concurred in the judgment and opinion.

OPINION

¶1 Peer reviewed publications, like the Journal of the American Medical Association (JAMA),

publish manuscripts authored by experts only after they have been reviewed by experts in the same No. 1-22-1666

field and determined to be scientifically sound and publication-worthy. A number of courts around

the country have recognized the importance of maintaining the confidentiality of the identities of

peer reviewers and their communications in order to promote complete and candid review and,

thereby, enhance scientific, academic, and professional quality. However, no Illinois court has

recognized a common law peer review privilege. Instead, publications like JAMA are considered

reporters whose sources are generally protected from disclosure by the Illinois reporter’s privilege

statutes found in part 9 of article VIII of the Code of Civil Procedure (735 ILCS 5/8-901 to 8-909

(West 2022)). This qualified privilege may only be divested by the court in certain limited

circumstances, which are not present here.

¶2 I. BACKGROUND

¶3 The plaintiff, Nathan Gibbons, brought a lawsuit against the defendants, GlaxoSmithKline,

LLC (GSK), and other pharmaceutical companies, alleging that Zantac, the brand name for the

drug ranitidine, caused his cancer. Zantac was first marketed and sold by GSK in 1983 and was

commonly used to treat acid reflux, heartburn, and ulcers. Gibbons’ lawsuit, which is currently

pending in California, is part of a multi-plaintiff and multi-defendant action. Thousands of

plaintiffs allege that Zantac caused them, or a deceased loved one, to develop cancer. They seek

to hold GSK and other pharmaceutical companies who sold and marketed Zantac liable,

contending that these companies knew or should have known of Zantac’s cancer risks. Zantac was

withdrawn from the market in April of 2020 at the Food and Drug Administration’s (FDA) request.

¶4 In September 2019, Valisure—an analytical laboratory whose mission is to help ensure the

safety, quality, and consistency of medications in the market—sent a citizen petition to the FDA,

warning that it had “detected extremely high levels of N-Nitrosodimethylamine [a contaminant

known by the acronym NDMA], a probable human carcinogen, in every lot [of Zantac] tested.”

2 No. 1-22-1666

Valisure asked the FDA to “recall and suspend sales of all” ranitidine products “[g]iven the drug’s

propensity to form the probable carcinogen NDMA.” It noted that “[i]nvestigators at Memorial

Sloan Kettering Cancer Center are actively studying ranitidine to evaluate the extent of the public

health implications of these findings.”

¶5 That same month, Dr. Lior Braunstein, an oncologist and scientist at Memorial Sloan

Kettering Cancer Center, submitted a manuscript that he and his colleagues had authored to JAMA

for consideration. The mission of the American Medical Association, which publishes JAMA, is

“to promote the science and art of medicine and the betterment of public health.” JAMA’s readers

are mainly physicians, clinicians, scientists, and researchers, but JAMA articles are also read by

policymakers, journalists, and the public.

¶6 Dr. Braunstein’s manuscript, which he titled “Ranitidine Use, N-Nitrosodimethylamine

(NDMA) Production, and Variations in Cancer Diagnoses,” linked Zantac to different types of

cancer. The manuscript noted “a possible association of ranitidine use with certain cancer

presentations,” and included a chart, depicting the “odds ratios of presenting cancer diagnoses in

an oncology population among those receiving ranitidine vs. other [medications].” It stated that

the data “may present a case for limiting ranitidine administration among patients who otherwise

have feasible therapeutic alternatives.”

¶7 JAMA subjected Dr. Braunstein’s manuscript to peer review. Afterwards, JAMA informed

Dr. Braunstein that while the manuscript was not yet suitable for publication, it could be published

if edits were made. One peer reviewer commented that the manuscript was a “clinically significant

and original research letter and should be published urgently given its potential impact on clinical

practice.” Another peer reviewer commented that the “[r]eported results raise potentially alarming

findings, though further confirmatory research is warranted.”

3 No. 1-22-1666

¶8 After Dr. Braunstein and his colleagues made JAMA’s requested edits, JAMA accepted

the manuscript and scheduled it for publication on January 10, 2020. On January 9, 2020, JAMA

sent an embargoed copy of the article to the media and Sanofi, the company that owns and controls

the Zantac brand. That same day, Dr. Braunstein received an e-mail from a news reporter, stating

that Sanofi had disputed the article, claiming it “consist[ed] of analytical data which resulted from

a testing methodology [the] FDA already has criticized as unsuitable for testing ranitidine and

epidemiology results that do not establish that ranitidine increases the risk of cancer.” Twenty-two

minutes later, JAMA’s editor-in-chief, Dr. Howard Bauchner, e-mailed Dr. Braunstein. He said

that “a number of concerns ha[d] been raised about the validity of some of the results” in the article

and that, “[b]ecause of the importance of the issue, and the public health implication of the reported

findings,” the article would no longer be published the next day, as scheduled. Dr. Braunstein later

learned from JAMA’s editorial group that “as [he had] anticipated, there were objections to the lab

method from a few vocal/influential sources.” Braunstein “presumed” it was the FDA that had

objected to his “use of the now-outdated FDA testing protocol,” but “d[id]n’t recall [JAMA

editors] explicitly saying so.” He noted that the lab method he had employed was “the only

protocol around when [his] work was done, and by the time [the article] reached publication, a

new method became standard.” JAMA told Dr. Braunstein that the article could still be accepted

if the new testing method was utilized, so Braunstein conducted additional studies using the new

testing method and then resubmitted his manuscript to JAMA.

¶9 On January 29, 2021, JAMA published a revised version of Dr. Braunstein’s article in

JAMA Network Open, which JAMA describes on its website as “an international, peer-reviewed,

open access, general medical journal that publishes research on clinical care, innovation in health

care, health policy, and global health across all health disciplines and countries for clinicians,

4 No. 1-22-1666

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2023 IL App (1st) 221666, 239 N.E.3d 10, Counsel Stack Legal Research, https://law.counselstack.com/opinion/gibbons-v-glaxosmithkline-llc-illappct-2023.