Pfizer controversies
Controversies tied to this brand in public sources. A listing is not a finding of fault.
Back to profile14 entries
2024
Oxbryta withdrawal
Pfizer voluntarily withdrew voxelotor, sold as Oxbryta, from markets and stopped related clinical studies after updated safety and benefit-risk information prompted the company and regulators to conclude that continued use was not appropriate.
2023
Texas COVID-19 vaccine lawsuit
Texas authorities sued Pfizer alleging misleading statements about COVID-19 vaccine effectiveness. Pfizer disputed the allegations; the filing represents claims rather than a finding that the allegations were proven.
2022
Pfizer sues over alleged trade-secret theft
Lawsuit filed
Pfizer filed suit in the District of Connecticut against former employees Xiayang Qiu and Min Zhong and others. The complaint alleges that Qiu and Zhong stole Pfizer trade secrets and confidential information and later incorporated them into Regor; these are allegations in the complaint.
Source excerpt
Pfizer Inc. filed suit on Wednesday in the District of Connecticut against defendants Regor Therapeutics Inc., Qilu Regor Therapeutics Inc., Xiayang Qiu, Min Zhong, and more.
The complaint alleges that Qiu and Zhong, both former employees of the plaintiff, stole trade secrets and valuable information from Pfizer that they later illegally incorporated into a new company, Regor.
2021
Pfizer plaintiffs sue Qilu over Ibrance patent
Lawsuit filed
Pfizer and co-plaintiffs filed a lawsuit against Qilu in the District of Delaware, seeking a declaration of patent infringement and an order barring further infringement. The complaint concerns the patent for Ibrance. The infringement claims are allegations made in the lawsuit and have not been established. The filing date was June 29, 2021.
Pfizer and co-plaintiffs filed suit against Qilu in the District of Delaware, seeking a declaration of patent infringement and an order barring further infringement. The complaint concerns the patent for Ibrance; the infringement claims are allegations in the lawsuit.
Source excerpt
The plaintiffs are seeking a declaratory judgement of patent infringement and an order enjoining Qilu from further infringement. The case concerns the patent for Ibrance, used to treat breast cancer.
Pfizer, Inc. (Pfizer), Warner-Lambert Company LLC, and PF Prison IMB B.V. filed suit on Tuesday against Qilu Pharmaceutical Co., LTD, and Qilu Pharma, Inc. (Qilu) in the District of Delaware.
2021
Pfizer sues MSN Pharmaceuticals over palbociclib patent
Lawsuit filed
Pfizer filed a lawsuit against MSN Pharmaceuticals, alleging that MSN's proposed generic version of palbociclib would infringe Pfizer's patent. The source characterizes the infringement as an allegation rather than a court determination. The dispute concerns MSN's proposed generic product and Pfizer's patent covering palbociclib. No court ruling on the merits is reported in the source material.
Source excerpt
On Tuesday, pharmaceutical company Pfizer filed a lawsuit against fellow pharmaceuticals company MSN Pharmaceuticals Inc. for allegedly infringing on their drug patent.
The plaintiff stated that contrary to the claims made in the notice letter, the defendant’s generic version of the drug does directly infringe upon 3 claims within its patent and its relation to their brand name drug IBRANCE.
2021
Pfizer recalls Chantix smoking-cessation drug
Recall announced
In September 2021, Pfizer announced a recall of its smoking-cessation drugs Champix, also called Chantix. According to the announcement, the recalled products contain chemicals that cause cancer. The event was reported as a product recall by the company. The source statement describes the recalled drugs as containing cancer-causing chemicals, and the recall was announced by Pfizer for its Champix (Chantix) smoking-cessation medication.
Pfizer announced a recall of its Champix (also called Chantix) smoking-cessation drugs, saying they contain chemicals that cause cancer.
Source excerpt
Pfizer announced on Friday that they were recalling all the champix (aka chantix) drugs that are used to get over smoking because they contain chemicals that cause cancer.
2021
Pfizer expands Chantix recall to all lots
Recall announced
Pfizer expanded its recall of Chantix to all 156 lots of 0.5 mg and 1 mg tablets. The recall was due to the potential presence of the nitrosamine impurity N-Nitroso-varenicline at or above the FDA interim acceptable intake limit. The FDA said that long-term ingestion may be associated with a theoretical increased cancer risk, while also noting that there was no immediate risk to patients.
Pfizer expanded the Chantix recall to all 156 lots of 0.5 mg and 1 mg tablets because of the potential presence of the nitrosamine impurity N-Nitroso-varenicline at or above the FDA interim acceptable intake limit. The FDA said long-term ingestion may be associated with a theoretical increased cancer risk; it also noted there was no immediate risk to patients.
Company response
Remediation — Pfizer
Pfizer said it is undertaking this precautionary measure as alternative suppliers have been approved in the U.S.
Source excerpt
The current recall involves all (156) lots of Chantix 0.5 mg and 1 mg tablets.
T*hey were distributed to wholesalers and distributors across the U.S., US Virgin Islands and Puerto Rico from May 2019 to September 2021.
The company is yet to receive any reports of adverse events assessed to be related to this recall.
2021
Pfizer sues former employee over alleged file downloads
Lawsuit filed
Pfizer sued former employee Chun Xiao Li, alleging that she downloaded thousands of company files, including confidential information and trade secrets, to personal devices without permission. Pfizer sought a temporary restraining order and injunctive relief.
Company response
Investigation — Pfizer
Pfizer told NBC 7 in a statement that the company is still investigating and pursuing civil action against an employee who it believes improperly downloaded thousands of documents before a planned exit from the company.
Source excerpt
Pfizer told NBC 7 in a statement that the company is still investigating and pursuing civil action against an employee who it believes improperly downloaded thousands of documents before a planned exit from the company.
Trade SecretsThe pharmaceutical giant is suing Li for misappropriation of trade secrets in violation of the Defend Trade Secrets Act of 2016 and the California Uniform Trade Secrets Act; breach of contract; conversion; and trespass to chattel.
Pharmaceutical and biotechnology company Pfizer has sued a former employee for breaching her confidentiality agreement when she allegedly downloaded thousands of the company’s files, some of which contained trade secrets and confidential information, to her personal devices and attempted to “cover her tracks.”
2021
Judge temporarily bars Pfizer employee from using trade secrets
Ruling
In a 2021 legal development involving Pfizer, a U.S. District Judge temporarily blocked Chun Xiao Li from using the company's trade secrets. The judge also authorized Pfizer's lawyers to review accounts and devices where the trade secrets might have been stored. The order was temporary in nature, and the source material does not specify further outcomes, additional parties, or the substance of the trade secrets at issue. The event is recorded here solely on the basis of the available summary and source reference.
Source excerpt
In an order late on Tuesday, U.S. District Judge Cathy Ann Bencivengo temporarily blocked Li from using Pfizer's trade secrets, and said the company's lawyers can review accounts and devices where she might have stored them.
2021
Pfizer recalls selected Chantix lots over possible impurity risk
Recall announced
Pfizer recalled a dozen US lots of Chantix after they were found to potentially contain N-nitroso-varenicline above the company's acceptable daily intake limit. The article says prolonged ingestion of high quantities could potentially lead to cancer; Pfizer stated there was no immediate risk to patients and advised users to discuss replacement with a health care provider or pharmacy.
Company response
Clarification — Pfizer
There is no immediate risk to patients taking this medication
Source excerpt
Pfizer voluntary re-called its smoking cessation drug Chantix because it contains a chemical that may cause cancer.
The company says the possible substance was detected in 12 lots at levels above the company’s established acceptable daily intake.
Pfizer has not received any reports of adverse events that have been related to this recall to date.
2021
Pfizer recalls 12 distributed lots of Chantix
Recall announced
Pfizer recalled 12 additional lots of Chantix that had been distributed to wholesalers in the United States and Puerto Rico, after finding nitrosamine levels above the company’s acceptable daily intake level.
Company response
Recall — Pfizer
The July 16 recall, however, includes 12 more lots of the drug, which were already distributed to wholesalers in the U.S. and Puerto Rico between June 2019 and June 2021.
Clarification — Pfizer
'Patients currently taking Chantix should consult with their doctor to confirm if they received an affected lot, and if appropriate, about alternative treatment options,' the company said
Source excerpt
The impacted lots contain levels of carcinogenic chemicals, called nitrosamines, that are above the company's own acceptable daily intake level
The July 16 recall, however, includes 12 more lots of the drug, which were already distributed to wholesalers in the U.S. and Puerto Rico between June 2019 and June 2021.
Pfizer has expanded its voluntary recall of smoking cessation drug varenicline (Chantix) to 12 lots at the consumer level, according to an update posted on the US Food and Drug Administration (FDA) website.
2020
Pfizer responds to controversy over China’s exclusion from vaccine collaboration
Company response
Pfizer addressed controversy regarding the exclusion of China from its vaccine collaboration with BioNTech. According to Pfizer, the collaboration did not include China because BioNTech had already partnered with Fosun Pharma for the Chinese market. Pfizer stated that it was working to resolve details and was committed to access to medicines and vaccines for patients in China and globally.
Pfizer said its collaboration with BioNTech did not include China because BioNTech had already partnered with Fosun Pharma for the Chinese market. Pfizer said it was working to resolve details and was committed to access to medicines and vaccines for patients in China and globally.
Stated objective. Ensure global access to a safe and effective vaccine if the collaboration produces one.
Company response
Clarification — 辉瑞
辉瑞在声明中表示，如果辉瑞与BioNTech的合作最终创造出一种安全有效的疫苗，其目的和意图是确保全球范围内获得疫苗。
Source excerpt
辉瑞在声明中表示，如果辉瑞与BioNTech的合作最终创造出一种安全有效的疫苗，其目的和意图是确保全球范围内获得疫苗。鉴于形势的严峻性以及COVID-19在全球的蔓延速度，我们仍在努力解决细节问题，我们致力于为中国以及全球的患者提供获得优质药物和疫苗的机会。
3月19日，辉瑞生物制药集团（以下简称辉瑞）在官网发布声明称，近日，辉瑞公司和BioNTech SE宣布，两家公司已就共同开发和分销一种潜在的基于mRNA的冠状病毒疫苗达成意向书，以预防COVID-19感染。在此之前，BioNTech已宣布与复星医药合作开发中国市场。因此，辉瑞与BioNTech的协议不包括中国市场。
2009
Healthcare-fraud settlement
Pfizer agreed to a $2.3 billion settlement with U.S. authorities concerning allegations of unlawful promotion of medicines. A subsidiary pleaded guilty to a misdemeanor relating to promotion of Bextra, while the wider resolution included civil allegations involving several products.
2006
Torcetrapib clinical safety failure
Pfizer discontinued torcetrapib after a Phase III trial reported more deaths among participants receiving the torcetrapib regimen than expected. The event led to termination of the program and renewed attention to cardiovascular-drug safety monitoring.