Pfizer Inc, has a long history of lawsuits. The company has been sued for unapproved clinical trials on children and even resolved the biggest health care fraud in history with a $2.3 billion settlement. Despite the long list of its legal battles, the pharma giant became the first to receive emergency authorization by the Food and Drug Administration for its Covid-19 vaccine.
Pfizer Inc. is an American multinational pharmaceutical corporation known for products like Advil, Zoloft, Viagra, Xanax, and others. In March 2020, Pfizers’ net worth was approximately $160.86 billion, and as of December 2020 Pfizer it was $221 billion, making it one of the most profitable companies in the world. Pfizer and its partner BioNTech were the first companies to receive an authorization to produce and distribute a vaccine for Covid-19.
In getting this approval, Pfizer became the first company with the fastest ever approved vaccine in human history with just under a year of research and development. Typically, a vaccine development process and approval can take upto 10-15 years. In 1902, the United States Congress passed the Biologics Control Act “to regulate the sale of viruses, serums, toxins, and analogous products”.
After the 1954 poliovirus vaccine incident where 40,000 children got infected with polio, 10 died and 200 were left with some form of paralysis, the Division of Biologics Standards (DBS) was formed to oversee the safety and regulation of vaccines. Later, it was renamed the Bureau of Biologics and also became a part of the FDA.
In 2008, ABC news reported that Pfizer ended most of its lawsuits with a $894M deal over two prescription relievers, Celebrex and Bextra. About 90% of personal injury lawsuits claimed that the pills caused heart attacks, strokes and other issues. Of the total settlements, about $745 million went to settle personal injury cases, $60 million covered attorney settlements, and $89 million covered consumer fraud class action cases over reimbursement for money spent on the two drugs.
Some of the drug recalls Pfizer has done in the last few years have been due to lawsuits with accusations of fraud, death and injuries in adults and children. It was involved in the largest health care fraud settlement in history, totalling $2.3 billion to resolve criminal and civil allegations. The company illegally promoted the use of four of its drugs.
In 1996, Pfizer conducted an unapproved clinical trial involving children with Meningitis in Nigeria. With 11 children dead and dozens disabled, the company paid out $175,000 in 2011 to each family. Due to the drug Trovan and the unapproved clinical trial, the company set up a $35 million fund for those affected. Other lawsuits include:
- In 2012, about 10,000 women filed Prempro breast cancer lawsuits against Pfizer. The company settled most of the claims which cost them more than $1 billion.
- In 2012, an estimated 3,000 people filed a Chantix lawsuit, in which people claimed that the drug caused suicidal thoughts and severe psychological disorders. The company set aside $288 million to resolve these cases.
- In 2012, lawsuits claimed that Effexor caused birth defects.
- In 2013, Pfizer paid $55 million to settle criminal charges because they failed to warn customers of risk posed to kidneys by Protonix.
- In 2014, the company recalled 104,000 bottles of antidepressant drug Effexor XR due to a heart pill Tikosyn being present in it. The combination of the two drugs posed a deadly risk.
- In 2020, more than 7,800 testosterone therapy lawsuits were filed against the manufacturers. The testosterone products caused strokes, blood clots and heart attacks.
Yet, despite all of its legal battles and frequent trips to the courts, Pfizer continues to dominate the pharmaceutical industry. The Covid-19 vaccine has been designed by BioNTech and Pfizer. The latest countries that have approved emergency use of the vaccine are The United Kingdom, Bahrain, Canada, Saudi Arabia, Mexico, and The United States.
According to the latest numbers, the Pfizer/BioNTech emergency vaccine has already been distributed to 12.5 million Americans, however reports of allergic reactions have already been announced, even though The U.S Food and Drug Administration states that there are no major side effects. Although the risks are there with every vaccine and every drug, this is an unusual circumstance when it comes to the speed of approval and release for a vaccine that has been in production for less than a year.
Featured Image (left): Courtesy of Canadian Press
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