THE GIANT PFIZER FULL OF:
Fraud Charges and Litigations
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.
Antidepressants
Antidepressant sales account for a large portion of Pfizer’s success during the last two decades. However, two antidepressants sold by the company, Effexor andZoloft, 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.
Effexor
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.
Zoloft
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.
Did you or your child suffer unexpected side effects from Pfizer’s Zoloft?
Geodon
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
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.
Depo-Testosterone
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.
Lipitor
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.
Eliquis
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’s Future
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.
Last modified: May 26, 2016
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