Sanofi controversies
Controversies tied to this brand in public sources. A listing is not a finding of fault.
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2021
Sanofi workers strike over planned job cuts
Public backlash
In January 2021, unions at Sanofi held a one-day strike at a research and development facility in France to protest planned job cuts. Union members said the cuts could slow the fight against the coronavirus pandemic. The action was reported as a strike over job cuts at the French coronavirus vaccine maker.
Source excerpt
They said that hundreds of planned job cuts in France could slow the fight against the coronavirus pandemic.
Unions at French drug maker Sanofi have held a one-day strike at the lab where it is developing a Covid-19 vaccine to protest against job cuts.
2021
Virginia woman files Zantac cancer lawsuit
Lawsuit filed
In a lawsuit reported in August 2021, 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 report states that research had not explicitly linked Zantac to cancer. The account is limited to the filing and the plaintiff's allegations; it does not describe a court ruling, settlement, or regulatory finding.
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.
2020
Sanofi clarifies its position on global vaccine access
Company response
After its CEO's earlier remarks about US patients receiving priority access to doses produced in the United States angered the French government, Sanofi clarified that any Covid-19 vaccine it developed would be made available to all. The CEO said he was sorry his earlier remarks had caused a storm.
Company response
Clarification — Sanofi
Sanofi, which has urged stronger European coordination in the hunt for a vaccine and has US. financial support, clarified that any such vaccine would be made available to all.
Apology — Sanofi
he was sorry that his earlier remarks had created such a storm
Source excerpt
Hudson said yesterday it was vital that any coronavirus vaccine reach all regions and he was sorry that his earlier remarks had created such a storm.
PARIS, May 15 — Sanofi chief executive Paul Hudson said yesterday it was vital that any coronavirus vaccine reach all parts of the world, after angering the French government earlier by saying some countries would get priority access.
Sanofi, which has urged stronger European coordination in the hunt for a vaccine and has US. financial support, clarified that any such vaccine would be made available to all.
2020
Sanofi stops Kevzara COVID-19 clinical trials
Corrective action
Sanofi stopped clinical trials of Kevzara for COVID-19 after tests found adverse effects, including pneumonia and death in some patients. The company said it no longer planned further COVID-19 clinical studies of the drug.
Source excerpt
Sanofi has stopped the clinical trials of Kevzara, one of the drugs being tested to treat COVID-19.
On Tuesday, Sanofi said it had no longer plans to conduct further clinical studies for Kevzara in COVID-19
It manufactures Kevzara in partnership with American firm Regeneron.
2020
Court enters summary judgment in Mylan's favor in Sanofi lawsuit
Ruling
The U.S. District Court for the District of Kansas entered summary judgment in Mylan's favor in a lawsuit brought by Sanofi concerning EpiPen products. Viatris characterized the court action as rejecting Sanofi's allegations of anticompetitive practices. The source reports a judgment in Mylan's favor and does not describe a separate finding of misconduct.
Stated objective. Recover more than $27 million the county says it has paid to the companies.
Source excerpt
Viatris Inc. (NASDAQ: VTRS) today announced that the U.S. District Court for the District of Kansas entered summary judgment in Mylan's favor in the lawsuit brought against it by Sanofi related to its EpiPen® products.
it rejects Sanofi's baseless attempts to argue that Mylan used anticompetitive practices to market EpiPen
Harris County is suing three insulin manufacturers and four pharmaceutical benefit managers, claiming they colluded to drive up the price of insulin.
2020
Sanofi U.S. reaches $11.85 million settlement with federal government
Settlement
Sanofi U.S. announced an $11.85 million settlement agreement with the federal government to resolve an investigation relating to donations made in 2015 and 2016 to an independent charity patient assistance foundation. The company stated that the settlement did not constitute an admission of guilt.
Stated objective. Resolve an investigation relating to certain financial donations made in 2015 and 2016.
Source excerpt
Sanofi U.S. today announced that it has reached an $11.85 million settlement agreement with the federal government to resolve an investigation relating to certain financial donations made in 2015 and 2016 to an independent charity patient assistance foundation that aided patients living with multiple sclerosis.
It does not constitute any admission of guilt.
2019
Sanofi recalls Zantac in the United States and Canada
Recall announced
In October 2019, Sanofi announced that it would voluntarily recall Zantac from stores in the United States and Canada. According to the company, the recall would take place while Sanofi and regulators investigated NDMA detected in the drug. The announcement concerned the withdrawal of the product from the market in both countries during that investigation.
Sanofi said it would voluntarily recall Zantac from stores in the United States and Canada while the company and regulators investigate NDMA detected in the drug.
Company response
Recall — Sanofi
Sanofi said Friday it will recall the widely-used heartburn drug Zantac from stores in the United States and Canada
Source excerpt
Sanofi said Friday it will recall the widely-used heartburn drug Zantac from stores in the United States and Canada as the drugmaker and Food and Drug Administration investigate a probable carcinogen detected in the drug.
The FDA last month said it discovered a probable carcinogen called NDMA, or nitrosodimethylamine, in the drug Zantac and its generic versions.
2019
Sanofi Taiwan agrees to recall Tritace batch U322
Recall announced
Sanofi Taiwan agreed to a preventive recall of the entire Tritace 10mg batch U322 after dark spots were found on some tablets and contamination was suspected. The FDA said Sanofi Taiwan would be required to recall the batch by Jan. 9.
Company response
Recall — Sanofi Taiwan Co
the company said it was willing to issue a preventive recall of the whole batch.
Source excerpt
Pharmaceutical firm Sanofi Taiwan Co has agreed to recall a batch of heart disease medicine due to possible contamination, the Food and Drug Administration (FDA) said yesterday.
The FDA said in a statement that it had received a report about suspected contamination in Tritace 10mg tablets with the batch number U322, as dark spots were found on some tablets.
Taiwan’s Food and Drug Administration on Monday announced a recall of the tablets.
2006
Litigation over contaminated haemophilia blood products
Iraqi plaintiffs sued Sanofi and Baxter over HIV-contaminated haemophilia blood products sold in the 1980s through businesses connected with the predecessor Merieux organization. The matter concerned historical blood-product activities and predecessor corporate entities.