The pharmaceutical company Pfizer manufactures Xeljanz, a popular pill for treating rheumatoid arthritis. Xeljanz, however, has been linked to severe side effects, including cancer, liver damage, and pulmonary embolism. Some of these side effects can be fatal. Hundreds of Xeljanz lawsuits against Pfizer have been filed by people who have been hurt by these side effects, claiming that Pfizer defectively designed the drug and then failed to adequately warn doctors and patients of the significant risks of taking it. It was only in July of 2019 that the FDA ordered the drug’s packaging to contain a black box warning.
The attorneys at the Shouse Law Office legally represent victims of Xeljanz. In this article, they discuss:
- 1. The Pfizer pharmaceutical company
- 2. Pfizer’s history
- 3. Approval of Xeljanz in the U.S.
- 4. Patent protection for Xeljanz
1. The Pfizer pharmaceutical company
Xeljanz was designed and is manufactured by Pfizer, the giant U.S. pharmaceutical company.
Pfizer is headquartered in Manhattan, New York. However, it has offices in most of the other countries in the world, and has had a strong international presence since the 1950s.
Much of the research and development that Pfizer performs, though, happens outside of its corporate headquarters. Major research and development facilities include those in:
- Groton, Connecticut,
- La Jolla, California,
- Cambridge, Massachusetts,
- St. Louis, Missouri,
- Sandwich, United Kingdom, and
- Chennai, India.
Altogether, these research and development facilities have more than an $8 billion budget to develop new drugs, devices, and healthcare technologies.
At the end of 2018, Pfizer claimed to employ 92,400 people around the world.1
2. Pfizer’s history
Pfizer was founded in 1849 in Brooklyn, New York. It was quickly a success, but profits took off with the sale of penicillin during World War II.
Already a huge pharmaceutical company heading into the 21st century, Pfizer aggressively merged with or bought out numerous other pharmaceutical and healthcare companies, including:
- Warner-Lambert, in 2000,
- Pharmacia, in 2003,
- Esperion Therapeutics, also in 2003,
- Meridica, in 2004,
- Vicuron Pharmaceuticals, in 2005,
- Angiosyn, in 2005,
- Idun, also in 2005, and
- Wyeth, in 2009.
Pfizer’s biggest merger – with Ireland-based pharmaceutical company Allergan, Plc – was stopped in 2016 when the U.S. Treasury changed its rules to rein in tax evasion by multinational companies.
A powerhouse in the field of medical research and development, Pfizer has designed and released numerous famous drugs, including:
- Lyrica, a neuropathic painkiller and epilepsy drug,
- Lipitor, a cholesterol drug,
- Zoloft, an antidepressant,
- Norvasc, a treatment for high blood pressure,
- Zithromax, an antibiotic,
- Xeljanz, a pill for rheumatoid arthritis,
- Celebrex, a drug that treats inflammation, and
- Viagra, for erectile dysfunction.
2.1. History of lawsuits against Pfizer
Pfizer has also been the subject of numerous lawsuits. Some of these were brought by victims of the company’s drugs, and claimed that Pfizer either designed them poorly or failed to warn people about how dangerous they could be. Others were brought by the U.S. government for fraudulent or illegal marketing tactics.
The most famous lawsuit that Pfizer has faced was to compensate victims who developed mesothelioma and cancer after being exposed to insulation that contained asbestos. All told, these lawsuits have recovered nearly a billion dollars in compensatory damages from several companies, including Pfizer.
For a short period of time, Pfizer had the third-largest settlement with the U.S. Department of Justice for pharmaceutical malfeasance. In 2004, their subsidiary, Warner-Lambert, came to a $430 million settlement with the Justice Department for their illegal off-label promotion of the drug Neurontin.2 While the U.S. Food and Drug Administration (FDA) had approved Neurontin for seizures, Warner-Lambert had promoted it as a painkiller and migraine treatment.
Most recently, Pfizer is facing hundreds of mass tort claims by victims who have taken its drug Xeljanz, suffered from its serious side effects and are seeking compensation for their injuries.
3. Approval of Xeljanz in the U.S.
On November 6, 2012, the FDA approved Xeljanz for use in the U.S. to treat rheumatoid arthritis.3 However, the drug’s development began long before then.
As early as 1994, scientists from the National Institutes for Health (NIH) approached Pfizer about developing a partnership to develop drugs that utilized Janus kinase enzymes. Pfizer refused to participate until the NIH waived a provision in the contract that would have allowed the government agency to dictate the price of whatever drugs came of the partnership. Such a provision would have drastically reduced the amount that Pfizer could charge consumers for whatever drugs came of the NIH partnership, making it a nonstarter for any further research and development.
One of the drugs to come of that partnership with the NIH was Xeljanz. However, development of the drug took nearly another decade as Pfizer honed its chemical composition.
Once it was released, Pfizer began selling Xeljanz by charging over $2,000 per month for the pill, a price that disturbed many medical professionals.4
4. Patent protection for Xeljanz
Pfizer has exclusive rights to sell Xeljanz in the United States until at least the end of 2020. Until then, no one else can make a generic version of Xeljanz. However, this period can be extended if Pfizer comes up with a new application for the drug.
In order to incentivize research and development, the FDA gives pharmaceutical companies the exclusive rights to sell drugs that they create for a set period of time. The temporary monopoly over the drug allows companies like Pfizer to set whatever price they want, in the knowledge that no one can create copy the chemical composition of their drug and create a generic version of it.
This period of exclusivity can be extended if pharmaceutical companies tweak their drug to make it safer or more effective, or if they prove that it can be used to treat other medical conditions in addition to what it has already been approved to treat.
Needless to say, this period of exclusivity is when pharmaceutical companies like Pfizer make the most money off their drugs, and is the main reason why pharmaceutical companies spend so much on researching and developing new drugs.
- Pfizer Form 10-K (2018) (page 9).
- Press Release, “Warner-Lambert to Pay $430 Million to Resolve Criminal & Civil Health Care Liability Relating to Off-Label Promotion,” Department of Justice (May 13, 2004).
- Xeljanz Approval Letter.
- Garber K, “Pfizer’s first-in-class JAK inhibitor pricey for rheumatoid arthritis market,” Nature Biotechnology 31(1):3-4 (January 2013); Allison Prang, “FDA Requires Box Warnings for Pfizer Drug Xeljanz Patients taking 10-milligram dose twice a day could experience a higher risk of blood clots or death,” Wall Street Journal (July 26, 2019).