GlaxoSmithKline controversies
Controversies tied to this brand in public sources. A listing is not a finding of fault.
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2021
Virginia woman files Zantac cancer lawsuit
Lawsuit filed
In a lawsuit reported in August 2021, Deborah Haskins of Virginia sued the makers of Zantac, alleging that the drug caused her esophageal cancer and that its makers failed to warn consumers of the risks. The report notes that research had not explicitly linked Zantac to cancer. The account describes the filing and the plaintiff's allegations; it does not state a court outcome or any finding on the claims.
Deborah Haskins sued the makers of Zantac, alleging that the drug caused her esophageal cancer and that its makers failed to warn consumers of the risks. The article says research had not explicitly linked Zantac to cancer.
Source excerpt
In the lawsuit, Haskins also noted that if she had known about the unsafe levels of NDMA in Zantac, she never would have purchased the medication.
The lawsuit named Sanofi, Zantac's current manufacturer in the U.S. as a defendant. It also included previous makers, Boehringer Ingelheim Pharmaceuticals and GlaxoSmithKline.
While research has not explicitly linked Zantac to cancer, the esophagus is acted upon by the drug.
2021
AstraZeneca sues Glaxo over Zejula licensing agreement
Lawsuit filed
AstraZeneca filed a lawsuit in the U.K. against GlaxoSmithKline, alleging that a 2012 licensing agreement over the Zejula cancer drug was breached and seeking a greater share of sales.
Source excerpt
AstraZeneca (, AZN) filed a lawsuit in the U.K. against GlaxoSmithKline (GSK), saying a 2012 licensing agreement over the Zejula cancer drug was breached and, therefore, it should have a greater share of sales
2020
Federal Court fines GSK and Novartis over Osteo Gel marketing
Fine or penalty
The Federal Court ordered GlaxoSmithKline to pay $1.5 million and Novartis to pay $3 million after the companies admitted breaching Australian consumer law through their marketing of Osteo Gel between 2012 and 2017. The court found that the marketing misled consumers about the product's effectiveness compared with Emulgel.
Company response
Apology — GSK
In an affidavit, GSK's head of legal Navaneetha Dilipumakanth apologised for the company's conduct and admitted it had "fallen short of the standards expected of it under the Australian Consumer Law".
Source excerpt
GSK and Novartis admitted they had breached Australian consumer law with their marketing of Osteo Gel between 2012 and 2017.
In an affidavit, GSK's head of legal Navaneetha Dilipumakanth apologised for the company's conduct and admitted it had "fallen short of the standards expected of it under the Australian Consumer Law".
The parties also agreed on the question of penalties and Federal Court Justice Robert Bromwich today ordered GSK pay a fine of $1.5 million and Novartis pay $3 million.
2019
GSK announces global Zantac recall
Recall announced
GlaxoSmithKline announced a recall of prescription-only Zantac medicines in all markets as a precaution. The action followed a finding by the U.S. Food and Drug Administration of unacceptable levels of a probable cancer-causing impurity in the drug. GSK also stated that it was suspending the release, distribution and supply of all dose forms of Zantac products. The recall and suspension applied across all markets.
GlaxoSmithKline said it was recalling prescription-only Zantac medicines in all markets as a precaution after the U.S. Food and Drug Administration found unacceptable levels of a probable cancer-causing impurity in the drug. GSK said it was also suspending the release, distribution and supply of all dose forms of Zantac products.
Company response
Recall — GSK
GlaxoSmithKline <GSK.L> on Tuesday said it is recalling the popular heartburn medicine Zantac in all markets as a "precaution"
Investigation — GSK
GSK is continuing with investigations into the potential source of the NDMA
Source excerpt
GSK is continuing with investigations into the potential source of the NDMA (chemical),
Britain's medicines watchdog said GlaxoSmithKline (GSK) was recalling four prescription-only Zantac medicines: a syrup, an injection and tablets of 150 and 300 milligram (mg) dosages.
GlaxoSmithKline on Tuesday (Oct 8) said it was recalling the popular heartburn medicine Zantac in all markets as a "precaution", days after the United States Food and Drug Administration found "unacceptable" levels of probable cancer-causing impurity in the drug.
2015
LeClair family files Zofran birth-defect lawsuit against GSK
Lawsuit filed
Tomisha LeClair filed a lawsuit on behalf of her daughter against GlaxoSmithKline, alleging that GSK concealed birth-defect risks associated with Zofran and promoted it for morning sickness during pregnancy. The claims are allegations in the lawsuit.
Source excerpt
GSK not only concealed this knowledge from healthcare providers and consumers in the United States, and failed to warn of the risk of birth defects, but GSK also illegally and fraudulently promoted Zofran to physicians and patients specifically for the treatment of morning sickness in pregnancy women.
The lawsuit was filed on February 16 in the U.S. District Court for the District of Massachusetts.
A Massachusetts woman has sued GlaxoSmithKline, alleging the drug maker off-label marketed its anti-nausea drug Zofran as a morning sickness remedy while concealing its knowledge that ingestion of the drug by pregnant women can cause serious birth defects.
2014
China bribery investigation and settlement
Chinese authorities investigated allegations that GSK employees and intermediaries used improper payments and other inducements to influence medicine sales. The case led to criminal proceedings and a substantial fine against the company’s Chinese operating entity.
2012
U.S. healthcare fraud settlement
GSK reached a major U.S. resolution concerning allegations related to the marketing and pricing of several medicines, including promotion beyond approved uses and reporting issues. The matter included civil and criminal components.