Pfizer is one of the world’s largest pharmaceutical companies. It faces lawsuits over several of its popular products, including Lipitor, Zithromax, Depo-Testosterone, Effexor, Zoloft and Eliquis.
The company got its start in 1849 when cousins Charles Pfizer and Charles Erhart combined their chemistry and confectionery skills and started a business. They began in Brooklyn, N.Y., with one building used as an office, laboratory, factory and warehouse. One of their first products was Santonin, a cure for intestinal worms, a common ailment of the day. They sold the remedy with an almond toffee flavor and were an instant success.
Today, Pfizer operates in 180 countries and employs more than 110,000 people worldwide with revenue topping $49 billion in 2014. It operates in five areas: Primary Care, Specialty Care and Oncology, Established Products and Emerging Markets, Animal Health, and Consumer Health Care and Nutrition.
But the company has had more than its share of controversy, including four settlements – one totaling $2.3 billion – over charges of illegal marketing in the last decade alone. It’s also involved in countless personal injury lawsuits. Pfizer’s portfolio of problematic drugs includes Zithromax, Chantix, Lipitor, Geodon, Trovan, Bextra, Celebrex, Lyrica, Effexor, Zoloft and Eliquis.
History of Pfizer
After its launch in 1849, Pfizer grew during the Civil War selling painkillers, preservatives, disinfectants and solutions like iodine, morphine, chloroform, camphor and mercurial. As the company expanded, the headquarters moved to Manhattan in 1868, and a warehouse was opened in Chicago in 1882. The company’s next major discovery was pioneering the mass production of citric acid which is used in Coca-Cola, Dr. Pepper and Pepsi — drinks that were growing in popularity. Pfizer’s studies of citric acid and fermentation technology later would assist the company in penicillin production.
By the 20th century, Pfizer had established itself as a successful business. It celebrated its 50th anniversary and continued to increase profits, exceeding sales of $3 million in 1906. In 1941, Pfizer began mass production of penicillin, responding to the U. S. government’s request to provide World War II soldiers with the new antibiotic. By taking an active role in dispersing this antibiotic, Pfizer cemented its place in medical history.
Another major discovery for Pfizer around this time was a fermentation-free method of producing vitamin C. Researchers noted that the vitamin could be used as a defense against scurvy and the common cold. Pfizer built a new plant dedicated to nonstop production and quickly became the world’s top producer of vitamin C.
|Fast facts about Pfizer|
|Founders: Charles Pfizer and Charles Erhart|
|Headquarters: New York City|
|Size: More than 110,600 employees worldwide|
|2014 Revenue: $49.6 billion|
By 1952, Pfizer had moved into eight new international locations — Belgium, England, Cuba, Canada, Brazil, Mexico, Panama and Puerto Rico — and had established its Agricultural Division, which later would be known as Animal Health. As its international business grew, so did its staff. In 1958, international personnel increased from 4,300 to more than 7,000.
Pfizer continued to reinvest its profits in new research and development and began to acquire other companies, like J.B. Roerig and Co. and Mack Illertissen, that were already involved in research and development of new pharmaceutical products. Within a few decades, the efforts paid off, as new drugs brought in billions. In 1980, Feldene, an anti-inflammatory pain medication, became Pfizer’s first billion-dollar product. Pfizer created antibiotics, antifungal medications, blood pressure, diabetes and depression drugs and was named the world’s most admired pharmaceutical company by Fortune magazine in 1997.
The 1990s and early 2000s were a time of blockbuster drugs for Pfizer, including a popular erectile dysfunction drug and a statin drug called Lipitor that proved far better than its competitors in clinical trials. Lipitor was originally developed by Warner-Lambert, which merged with Pfizer in 2000. Lipitor quickly grew to be the largest-selling pharmaceutical of any kind in history, reaching $9.6 billion in revenue in 2011. The company also had two other major successes at the time, Chantix (a smoking cessation drug) and Bextra (a painkiller).
In 2009, Pfizer acquired another giant company, Wyeth, broadening its product offerings and expanding its workforce. At the end of 2011, however, Lipitor lost patent protection. In order to combat decreased sales revenue from patent expiration of Lipitor and other drugs, the company cut back on around 600 primary care sales employees. It stated the downsizing move would put the company in a place that would best utilize its resources and meet the needs of the business as it continued to change over time.
Fraud Charges and Litigation
Amid all of its success, Pfizer faced a growing number of scandals involving some of its most popular drugs. In the 21st century, Pfizer has agreed to multiple settlements over charges of illegal marketing. Bextra was at the center of one of the cases, costing the company $2.3 billion to settle civil and criminal allegations and setting a record at the time for the largest health care fraud settlement and the largest criminal fine of any kind.
Although Bextra was only approved for arthritis and menstrual cramps, sales representatives reportedly were instructed by Pfizer to tell doctors it could be used for unapproved indications, like acute and surgical pain, and that it could be taken in high doses. However, the drug came with serious heart and skin risks, which caused Pfizer to withdraw it in 2005 and face a criminal investigation for misbranding the drug.
Other drugs associated with illegal marketing charges include Geodon, an antipsychotic, Zyvox, an antibiotic, Lyrica, a drug for nerve pain, Nuerontin, an epilepsy drug, Detrol, used for treatment of overactive bladder and Lipitor.
In 2002, Pfizer paid a $49 million fine based on claims that it defrauded the Medicaid program and overcharged consumers for Lipitor. Other settlements varied in size – the Nuerontin settlement in 2004 cost $430 million, and Detrol in 2011 cost $14.5 million – but they all cast a looming shadow over the company’s integrity.
Pfizer continues to face legal difficulties. In 2012, it paid $164 million to settle a lawsuit that claimed it misled investors about the clinical results of Celebrex, used to treat arthritis. A month after that case was finalized, Pfizer settled a class-action lawsuit concerning investors who were misled about the risks associated with the antidepressant drug Pristiq. The Pristiq case cost the company $67.5 million.
Dangerous Drugs and Litigation
On top of illegal marketing charges, Pfizer faces litigation as a result of claims that many of its drugs are dangerous. For more than a decade, people harmed by drugs manufactured by Pfizer claim the company was negligent in its design and production, failed to warn of risks and failed to adequately monitor and report the safety of the drugs once they reached the market.
Antidepressant sales account for a large portion of Pfizer’s success during the last two decades. However, two antidepressants sold by the company, Effexor and Zoloft, carry a low risk of serious birth defects if taken during pregnancy. A growing number of families have sued Pfizer after having a child who suffered.
Wyeth, one of the many companies that Pfizer acquired, began marketing Effexor, the first serotonin-norepinephrine reuptake inhibitor (SNRI) antidepressant, in 1993. By 2007, the drug had been prescribed to more than 17.2 million people, becoming the sixth most prescribed antidepressant in the United States that year.
But studies linked Effexor to serious side effects, especially for women taking the drug while pregnant. Studies indicated antidepressants like SNRIs and selective serotonin reuptake inhibitors (SSRIs) can increase the risk of birth defects like respiratory distress, anencephaly, craniosynostosis, heart defects, omphalocele, cleft lip and cleft palate in rare cases.
Pfizer was the creator of another blockbuster antidepressant, an SSRI called Zoloft (sertraline chloride). The FDA approved Zoloft in 1991. By 2002, the drug was the most popular antidepressant nationwide, bringing Pfizer nearly $2.9 billion that year. It lost patent protection in 2006.
Unfortunately, Zoloft also can cause birth defects, including persistent pulmonary hypertension of the newborn (PPHN), facial malformation and anencephaly, which impedes brain and skull development. Pfizer also faces lawsuits over Zoloft. Hundreds of people have filed claims against the company for the drug’s serious adverse effects.
Pfizer’s antipsychotic Geodon (ziprasidone) is used to treat schizophrenia and bipolar disorder, but the sales of the drug struggled against competitors, reaching just $150 million in 2001. In response, Pfizer promoted the drug off-label and sales grew to more than $1 billion in 2008. Pfizer later paid a $2.3 billion fine for illegally marketing Geodon and other drugs.
Illegal marketing isn’t the only problem Pfizer faced with Geodon. A 2015 study linked the drug to a potentially fatal skin reaction. The FDA announced a warning that Geodon could cause a fatal skin condition called Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS). The reaction can cause lymph nodes to swell, fevers and organ damage.
Zithromax, one of the most commonly prescribed antibiotics in the world, is linked to very serious side effects. A 2012 study found that patients taking Pfizer’s popular antibiotic had a higher risk of cardiovascular death than patients taking other antibiotics or none at all.
Although the risk for most patients was found to be very low, the high rates of death found in Zithromax users with previous heart conditions was concerning enough for the FDA to issue a warning about the drug in March 2013. Lawsuits were expected to follow.
The FDA approved testosterone replacement therapies to treat men with low testosterone because of a medical condition, but many men use testosterone supplements for non-approved uses. Pfizer and its subsidiary Pharmacia & Upjohn Co. have a product in the multi-billion dollar testosterone market called Depo-Testosterone.
Depo-Testosterone is a liquid that is injected into muscle. But testosterone supplements have been linked to cardiovascular issues like heart attacks and strokes, and the FDA ordered manufacturers to add information on the increased risk to warning labels in March 2015.
People who were harmed while taking testosterone filed lawsuits against Pfizer, Pharmacia & Upjohn Co. and other companies claiming the drugs caused heart-related problems. Testosterone lawsuits were consolidated in U.S. District Court for the Northern District of Illinois, a multidistrict litigation court. The first trials are set to begin in 2016.
Pfizer is also facing lawsuits over its blockbuster drug Lipitor, which has been linked to serious side effects, including type 2 diabetes and complications of the muscles, liver and kidneys. The first bellwether cases are scheduled to begin in November 2015. More than 2,000 cases are pending in multidistrict litigation.
Pfizer partnered with Bristol-Myers Squibb to develop a new anticoagulant (blood thinner) called Eliquis to give patients an alternative to warfarin. Blood thinners are used to reduce the risk of stroke in people at risk for developing blood clots. Warfarin was the most commonly prescribed blood thinner for decades, but it requires lengthy patient monitoring.
Pfizer and Bristol-Myers lost the race for new blood-thinner approval to rival companies after the FDA delayed its approval as a result of sloppy clinical trials. Bristol-Myers conducted studies to prove the efficacy of Eliquis in China, but an alleged cover-up, missing data and a controversial publication resulted in Eliquis being the last new blood thinner to receive FDA approval.
Pfizer and Bristol-Myers claim the drug is one of the safest on the market, but the families of some patients who took the drug say it can cause uncontrollable bleeding and even death. The first lawsuit against Pfizer and Bristol-Myers claiming Eliquis caused the death of a man was filed in July of 2015 and more lawsuits are expected.
Pfizer is seeking to recover from losses from the patent expiration of Lipitor. The company hopes to compensate by acquiring smaller drug companies already in the process of producing what could be the next blockbuster drug.
Despite litigation resulting from some of its drugs, Pfizer continues to dominate the pharmaceutical industry. It continues to earn billions off of its primary care drugs like Lyrica, for pain, and Celebrex, for arthritis. Sales of Eliquis more than quadrupled from 2013 ($146 million) to 2014 ($774 million), and Pfizer hopes it will continue to grow in coming years.